Asahi-America Validation Guide PDF

ASAHI/AMERICA
Life Science
Application
and Validation
Guide
High Purity Piping

Systems
Specialty Valve &
Components
Transitioning from
Steel to Performance
Plastics
Asahi/America Application and Validation Guide Life Science Application and Validation Guide
Section One
Section 1
Introduction
pg. 1
Section Two
Section 2
Application and Design: Purad PVDF

USP Purified Water pg. 5 SDR21, PN16/230psi, Sizes 20-280mm
SDR33, PN10/150ps1, Sizes 90-315mm
Section Three
Section 3
Alternative Applications
for Thermoplastics pg. 13
Section Four
Section 4
Material Comparisons PolyPureTM, Natural PP

pg. 21 SDR11, PN11/150psi, Sizes 20-110mm
Section Five
Section 5
Validation Plan and

Sample Protocols pg. 29
Section Six Proline Pigmented PP

Section 6
SDR11, PN11/150psi, Sizes 20-500mm

Materials and Also Available as SDR17 and SDR32.5
Systems Overview pg. 33
Section Seven
Section 7
Piping Design: High Purity

Water Systems pg. 47
Section Eight Ultra Proline E-CTFE

Section 8
SDR21, PN10/150psi, Sizes 32, 50, 63, 90 and110mm

Specifications
pg. 57
Purad, PolyPure, Proline and Ultra Proline are Trademarks of Asahi/America, Inc.
35 Green Street - Malden, MA

Phone: (781) 321-5409 Fax: (781) 321-4421 ASAHI/AMERICA
www.asahi-america.com
Introduction APP-02
Section One: Introduction Asahi/America Application and Validation Guide
Hot WFI water can be 10X more expensive than

Section One the higher quality DI alternative.
Section 1
Introduction Hot WFI requires expensive utilities support and
poses safety risks due to its high temperature.
This guide contains many possible applications but its
main focus is on High Purity Water. High Purity Water
Production is perhaps the most visible and important High purity DI water should replace low purity WFI
system in a Biopharmaceutical manufacturing facility. water in all applications except the final purification of
As a critical system evaluated for facility licensing, the parenterals.
water systems importance cannot be overstated. The
FDA utilizes the water system as a benchmark indicator A high purity or DI water system should meet the
of a facilitys current Good Manufacturing Practice following objectives:
(cGMP) suitability because it is an universal compo-
nent, regardless of the intended application. 1) Economically provide high purity water of
exceedingly high quality, suitable for all applica-
The major goal of this application guide is to provide a tions.
high purity water design philosophy to economically 2) Provide water without disruption 24/7/365
improve the quality, reliability, and broaden the utiliza-
tion of Purified Water (PW) systems in pharmaceutical 3) Provide water of suitable quality and consis-
manufacturing. Too much emphasis has been placed tency so as to eliminated water as a variable in
upon the regulatory perceptions of pharmaceutical research and manufacturing.
water systems at the expense of the water quality. PW
systems must fulfill their role as the primary water High quality Purified Water will fulfill virtually all of the
source for most pharmaceutical applications, and technical water requirements of the BioPharm industry.
expensive Water For Injection (WFI) should be rel- PW quality should not be measured by the minimal
egated only to applications as defined by the name; regulatory definition of PW, but be defined as the
water for injection. standard of quality routinely delivered by a DI water
system.
The conceded microbiological integrity of WFI comes
at a price; high cost, low purity and high metals The water should have a TOC less than 50 ppb,
content. Too often, WFI grade water is chosen to meet preferably less than 10 ppb.
all facility applications, without regard to quality, to
The microbial activity should be less than one
avoid regulatory scrutiny. This is costly both technically
colony forming unit (cfu/ml), and typically much
and economically. WFI water is not a high grade of
less.
water. WFI grade water is in contact with the atmo-
sphere and, when piped in stainless steel, has an The water should have no detectable endotoxin.
alarming metals content (see graph on page 2).
Rouging has been treated as an unfortunate byproduct The water should exceed 17.5 MegOhm resistiv-
of pharmaceutical water quality and not recognized as ity and there should be no detectable fluctuations
the gross contaminant that it is. Hot WFI water, in quality, day to day, year to year.
recirculating in 316 L Stainless Steel pipe, will consis- The DI water contains no detectable ions to one
tently contain Iron, Molybdenum, Tungsten, Chrome, part per billion.
Nickel and Cobalt, as well as Copper, Zinc and traces
of other heavy metals. The water should require no heating or cooling to
maintain quality.
Metal laden WFI water, which has a significant
The water quality is reproducible from facility to
carbon dioxide content, is not suitable for most
facility and is easily scaled up.
laboratory, research or chromatographic applica-
tions. The water quality varies and is difficult to The DI water must be piped in thermoplastic
reproduce from facility to facility. There is a con- materials and be provided on an instantaneous
cern that this water impairs some cell culture basis, suitable for all applications, including the
processes as well. feed source of the WFI make up.

1 APP-02
Asahi/America Application and Validation Guide Section One: Introduction
PW should comprise the bulk of a facilitys water use challenges of the industry. An Asahi/America system is
with WFI utilized on an as directed basis. This specified with confidence.
Section 1
approach provides high quality water on demand with

considerable savings on utility infrastructure and With superior product design and ISO 9001 manufac-
support, operating expense and capital equipment turing, Asahi/America has remarkable product breadth.
savings. This application guide is provided to assist Valves and pipe are offered in numerous thermoplastic
pharmaceutical engineers to apply these concepts materials, and range from to 24. Offerings include
based upon a wealth of real world application and pneumatic and electric actuators, thermoplastic com-
experience. The goal is to improve pharmaceutical pressed air and ventilation/exhaust systems, and
water quality, reliability and efficiency. This application extensive custom fabrication.
guide will also investigate other functions in the facility
where thermoplastic products can be applied to in- Products are available through one of the industrys
crease productivity and improve quality. largest distributor networks, nearly 1000 locations
nationally and throughout Latin America. Customer
Asahi/America - The Company support comes from knowledgeable distributors and
Asahi/America pioneered the development of corrosion from a sales and engineering staff dedicated to ther-
resistant thermoplastic fluid flow products in the United moplastic system design.
States. As a leader in thermoplastic fluid flow products,
Asahi/America offers expertise in product, system Please feel free to contact the Asahi/America experts
design and installation. This approach is the Total with any questions about its products and how they fit
Systems Approach. With a focus on high purity and DI your pharmaceutical and biopharmaceutical applica-
water applications, Asahi/Americas knowledge in the tions. Asahi-America - The Wet Process People
application is the foundation for products to meet the
HP PVDF vs. 316L SS Pipe

100
10
1
316L Stainless Steel
Biotech Systems
ppb 0.1
0.01
0.001
High Purity PVDF

0.0001 Semiconductor Systems
A l Ba B
Ca Cr Co
Cu Fe M g
Mn Mo
Ni K Si Na Sr
Elements W Zn
FIGURE 1.A: ION CONTAMINATION COMPARISON BETWEEN FOUR ACTUAL HP INSTALLATIONS. ION CHROMOTOGRAPHY MEASURE-
MENTS TAKEN ON DYNAMIC WATER SAMPLES DEPICT EXPECTED PURITY LEVELS BETWEEN POLYMER AND STAINLESS SYSTEMS.

ASAHI/AMERICA Phone: (781) 321-5409 Fax: (781) 321-4421
APP-02
2 www.asahi-america.com
Section One: Introduction Asahi/America Application and Validation Guide
1.1 PURPOSE OF THIS GUIDE 5. Create Specifications (Refer to the Section 8 for
the specifications of our products).
Section 1
This guide is presented in a unique format, a total stand 6. Prepare a Process and Instrumentation Drawing
alone document which answers questions for the design, (P&ID).
construction, commissioning and validation of a pharma-
ceutical PW system or process application. It is a 7. Prepare Equipment and Materials List.
combination handbook and textbook to guide you
through the entire process from conception to successful 8. Prepare a validation plan.
operation. 9. Order the equipment and materials.
This guide is a source of information for pharmaceuti- 10. Prepare construction and piping drawings
cal and biopharmaceutical managers who need to including isometrics.
make critical decisions in regard to process systems. It 11. Prepare construction schedule.
is directed to high purity applications and takes you
through conception, validation and successful opera- 12. Startup and commissioning
tion.
13. Validation
It is organized in such a way to lead the user through 14. Operation
the steps in the design and construction of an engi-
neering project.
Asahi/America is prepared to assist you in all phases

of a project from start to finish to make your planning
and installation as smooth as possible.
1.2 HOW TO USE THIS GUIDE
The following is a suggested approach to a typical

project:
1. Select your application from the following catego-
ries or create a new possible application:
- USP Purified Water
- Water for Injection (WFI)
- Solution and Buffer Preparation
- Fermentation or Cell Culture Media
Preparation
- Clean in Place Systems (CIP)
- Pure Air and Gasses
- Equipment Hook-up
2. Refer to our generic designs which are shown in

Sections 4 and 5. Section 4, (USP Purified Water)
includes a basic list of equipment, valves, piping and
instrumentation. Also included is information on
recommended materials of construction.
3. Define the project including a schedule.
4. Create a preliminary Process Flow Diagram (PFD)

3 APP-02
Asahi/America Application and Validation Guide Section One: Introduction
Section 1
This Page Intentionally Left Blank

APP-02
Section Two: Applications and
Design - USP Purified Water Asahi/America Application and Validation Guide
Section Two Classification Purified WFI

Standard Suggested
RO/DI Levels
Applications and Design
Resistivity
USP Purified Water (M/cm)
<1 <1 17.5 18.1
Conductivity
<1 <1 0.057 0.056
As stated in the introduction the major goal of this (S)
application guide is to provide a high purity water design TOC
< 500 < 500 < 50 <5
(ppb)
Section 2
philosophy to economically improve the quality, reliability
and broaden the utilization of Purified Water systems in Bacteria*
< 10,000 10 < 100 < 10
pharmaceutical manufacturing. Purified Water systems (cfu/100ml)
must fulfill their role as the primary water source for most Endotoxin
NA < 0.25 < 0.25 < 0.03
pharmaceutical applications. Expensive WFI water (EU)
should be relegated only to applications as defined by TABLE 2.1 WATER QUALITY COMPARISON
the name, Water for Injection.
Based on the premise that Purified Water (PW) systems higher water quality is actually required to maintain
should be the major water source in a manufacturing and microbial control. Any credible thermoplastic
lab facility, it then needs to be economical and reliable. (RO/DI) water system design should make water that is
Proper utilization of thermoplastic piping systems from 17.5 (0.055 uS), TOC < 50 ppb and bacteria at about
Asahi/America is part of the equation. The design options 1 cfu/ml. By properly utilizing TOC UV lamps in the
provided in section 4.1 are provided to better understand design, the water should be less than 10 ppb TOC, and
PW systems and the use of thermoplastics within these bacteria at considerably less than one cfu/ml.
systems.
2.2 System Design
2.1 USP Purified Water (USP 25) 2.2.1 Design Philosophy

Generally speaking, it is not recommended to utilize a
This is the most common type of high purity water used chemical addition approach to water treatment.
in the pharmaceutical and biopharmaceutical industries. Sequestrants, dispersing agents, chlorine addition and
It may possibly be the most important system in the bisulfite additions all add chemicals that eventually have
facility, considering so much importance rides on the to be removed again. The pretreatment should rely upon
quality of the purified water and its relation to the success backwashable filter media for suspended solids removal,
of the validation and licensing of a manufacturing facility. not cartridge filtration alone. A high purity water system
Problems with a PW system invite more scrutiny on the should be based upon reverse osmosis, for economic
quality of the rest of the manufacturing process. PW and technical reasons. If ion exchange resins and a TOC
systems that vastly exceed expectations emphasize the UV light unit are properly utilized, there is no reason the
quality of the enterprise as a whole. system cannot provide the following design goals:
Purified Water is frequently misunderstood. It is techni- 1. Exceedingly high quality Ultra Pure Water (see
cally a relatively low grade of high purity water at one , Suggested Levels for Table 2.1)
500 ppb TOC (Total Organic Carbon) and a liberal bacteria 2. No detectable product water quality fluctuations.
count of 100 cfu/ml.* The designation PW quality, is a 3. Reduced capital investment
regulatory designation, and often higher product water 4. Minimal operating costs
quality is actually desired. It is important not to confuse 5. Virtually no maintenance except for one scheduled
or combine regulatory specifications with product water maintenance day per year.
quality requirements. From a design viewpoint,
These goals are routinely achieved in the semiconduc-
tor industry and have become more common in the
*The Pharmaceutical Industry usually utilizes a WFI product water
specification of 10 cfus/ ml by convention. Actually there is no biopharmaceutical water systems. With the use of
bacteria specification in the Pharmacopoeia for either Purified or WFI proper design and thermoplastic materials truly re-
water, but the FDA still enforces USP 22 microbiological require- markable water quality is becoming routine.
ments.

5 APP-02
Asahi/America Application and Validation Guide Design - USP Purified Water
It is exceedingly difficult, if at all possible, to constrain In addition to the Table 2.2, please refer Asahi/Americas
microbiology in the pretreatment vessels and in storage Engineering Design guide for complete listings of
tanks. A microbiological control strategy is to allow pressure drops and fluid velocities based on total flow
normal levels of microbiological activity in the pretreat- through a pipe diameter.
ment and storage tanks, but to prevent inoculation of the
distribution loop, and retard growth of organisms in the The storage tank should be sized proportionally with the
product water. RO unit to provide design balance. A rule of thumb is the
RO unit should be capable of filling the tank in no less
Section 2
Pretreatment of bacteria prior to the RO have virtually no than an hour and no more than 3 hours. The RO sizes
relation or effect upon bacteria levels after the RO unit the required pretreatment and feedwater piping and
due to the almost impenetrable RO membrane. Microbi- heating (if used) requirements. You can then figure out
ology in plastic storage tanks should stabilize at no more utilities, electrical, floor drains and room sizing.
than 20 cfu/ml, and are typically in the 1 cfu/ml range.
There should be no or just barely detectable slime layer
under the water line of a DI storage tank. One should be 2.3 Process Design
very concerned with effective microbial control after the
storage tank. Control microbiology in the distribution loop The design of a Purified Water system can be broken
by preventing the inoculation of the distribution loop with down into four sections of design consideration:
a 3 stage barrier to microbes (post treatment) and by
making the product water inhospitable to by operating at 1. Feed Water
less than 10 ppb TOC in the distribution loop. Bacteria 2. Pretreatment
will always be present in a distribution loop, but if there is 3. Purification
no food (i.e.; TOC) in the distribution loop, bacteria may 4. Post Treatment
survive, but they cannot thrive. Microorganisms should
stay almost irreversibly attached to the hydrophobic Each of these categories can be further broken down
surfaces of plastic pipe, resulting in virtually no detect- into the details of the equipment utilized and specific
able bugs in the bulk phase product water. piping layout.
2.2.2 System Sizing 2.3.1 Process Design: Feed Water

Water systems are best sized by their distribution loops The feed water is either city water or on site well water.
(typically 1, 1 , 2.0 or 3.0 for USP systems). You The feed water must meet EPA potability standards, or
first must know approximately how much water you need the system must address any feed water quality deficien-
to provide, on an instantaneous basis, and on a daily cies. The feed may be surface water or well water, or a
basis/shift. Instantaneous water usage should not combination. Surface waters are often characterized by
exceed 1/3 the distribution loop flow rate for semiconduc- low salt content and suspended solids that foul RO units.
tors, and 1/2 the distribution flow rate for Bio-Pharm Well waters are often free of suspended solids, but have
where pressure and flow stability are not as critical. The a high salt content that consumes mixed bed polisher life
instantaneous usage sizes the required post treatment after the RO.
and distribution loop or loops. The daily usage sizes the
RO make up capacity and the storage tank(s). The municipal treatment plant, phone numbers, treat-
ment process and chemical additions supplied in the
drinking water should be known and taken into consider-
Pipe Size Flow Range System Pressure Drop per 100ft ation when designing a water system. The presence of
mm (inches) (gpm) Length (ft) PVDF PP chloramines, elevated pH and chemical coagulants all
32 (1) 10-15 500 2.16 - 4.57 2.70 - 5.72 may cause considerable problems if not addressed from
50 (1 ) 25 - 35 1,500 1.11 - 2.08 1.64 - 3.49 the beginning.
63 (2) 50 - 70 2,000 1.17 - 2.18 1.93 - 3.60
90 (3) 65 - 90 3,000 0.25 - 0.49 0.75 - 1.22 Following the initial feedwater, standard RODI water
system design is best divided into three stages. They are
TABLE 2.2 SUGGESTED SYSTEM FLOW RATES AND SIZES conveniently classified as: Pretreatment, Purification and
Post Treatment.

APP-02
PURIFICATION
PRETREATMENT Material:
REVERSE OSMOSIS SKID
WATER
SOFTENING PolyPure/Proline PP
SF-1
5 MICRON
PI P2 PREFILTERS
CITY FEED
WATER
Section 2
MULTIMEDIA MM-1 CF-1
FILTRATION CARBON pH
SF-2
FILTRATION
Material:
PolyPure/Proline PP Material:
Purad PVDF
STORAGE
TANK Material: RESITIVITY MONITOR
FINAL AND ALARM
Purad PVDF FILTRATION
QUALITY INDICATOR
LIGHT POINTS OF USE
TOC REDUCING
ULTRAVIOLET
STERILIZER Material:
Purad PVDF
POST TREATMENT
RESITIVITY MONITOR
ION EXCHANGE AND ALARM
(electronic deionization may replace mix bed ion exchange)
FIGURE 2.A SAMPLE PROCESS PIPING P&ID
2.3.2 Process Design: Pretreatment Water Softening

The function of pretreatment is the reduction of sus- Feedwater with a hardness that exceeds 50 % of the
pended solids as evidenced by Silt Density Index (SDI). TDS or 35 ppm of CaCO3 require softening. Softening
The presence of suspended solids will typically impair should also be considered if continuous Deionization
carbon absorption efficiency and RO output capacity. (CDI or EDI) will be used or if the RO reject is to be
Therefore, pretreatment is a vital component in the reutilized (in Cooling Tower make-up, etc). Softening
overall process. Several pretreatment options and may be used to remove iron providing it does not com-
methods are availble: prise more than 15 % of the hardness of the feed water.
Softening can also provide some RO membrane fouling
- Media Filtration (i.e. multi-media, manganese green protection via a colloidal stabilization process called
sand or sand filters) shielding.
- Water Softeners (usually duplex)
- Carbon Filtration Carbon Filtration
- RO Prefilter Cartridges Carbon is used to remove chlorine ahead of the RO and
also to reduce incoming organics (TOC). The carbon filter
Media Filtration is often unfairly considered the source of microbial
Surface feedwater with greater than 10-15 SDI requires problems in water systems. Based on experience,
pretreatment filtration (multi -media) not only to protect pretreatment microbiological activity is not a problem. The
the RO unit from fouling, but also the carbon and water RO unit will reject sodium ions up to 99% efficiency so
softeners. Very difficult waters may be treated with bacteria are thoroughly and efficiently sent to waste.
coagulants such as Alum, PAC (poly aluminum chlorate), Therefore, bacteria do not pass through RO membranes.
or polyelectrolytes. Some will protest that an RO can become biofouled.

7 APP-02
Biofouled TFC RO membranes are a symptom of poor RO molecular weight Organics due to smaller interstitial
design or insufficient pretreatment filtration resulting in pore spaces. High Micropore density, low Macropore
fouling of the RO membranes. The fouled RO membranes density.
provide a food source that quickly slimes over (instant
biofilm). The RO often fouls on surface feedwater due to Coal based - Bituminous (Steam) Activated Carbon -
excessively high conversions (RO product vs reject ratio) cheaper, may be dirtier, higher ash (10%) content,
or reject water recirculation to conserve water, both of medium dust content. Good physical stability (Abrasion
which are a function of proper RO design per application. #). High micropore & medium macropore density to
Section 2
In lieu of carbon pretreatment, a bisulfite addition is remove wider molecular range of organics.
sometimes utilized to neutralize chlorine. Bacteria can
metabolize the bisulfite itself, that plus the lack of an Lignite Based - a low ranked coal. GAC made from
additional filtration step, can also result in biofouling. lignite has a large pore size. This may result in higher
Bisulfite additions in place of carbon filtration may also TOC removal capacity, perhaps for large fulvic and
results in excess TOC in the product water. High TOC humic acids (organics). This higher capacity may be
levels can result in product water bacteria. offset by reduced physical integrity and high fines
content.
Therefore, the use of carbon in pretreatment is preferred.
Carbon pretreatment effectively removes chlorine mol- Wood based Carbon Low Micropore & High
ecules and does not contribute to TOC build up. Carbon Macropore density. Ash content (5%), dust level High.
beds do not require steam or hot water sanitization, as it
does not enhance performance. Acid washed Carbon (low to no ash due to acid
washing) Low pH > 2, phosphoric acid washed, may
Carbon in pretreatment is found as Granular Activated damage older RO membranes if not rinsed properly.
Carbon (GAC). GAC uses surface area to absorb (trap)
impurities. GAC is an effective filtration method and can NOTE: Check pH of feedwater and new carbon
have a surface area of 1000 1200 square meters per effluent. High pH (approximate 10) due to ash throw
gram. This is equal to 100 football fields laid out side by may cause a significant loss of RO membrane ion
side per pound of GAC rejection. This may occur in non-acid washed (high
ash) carbon.
GAC types are distinguished by raw materials and pore
size distribution. Other properties include Iodine, carbon Coconut shell carbon is recommended for chloramine
tetrachloride activity, surface area, pore volume, moisture removal due to the propensity of micropores present
content, particle size distribution, mean particle size, and when compared to coal based carbon. Beware though,
soluble ash content. The Table 2.3 lists the most common Coconut shell carbon may foul more quickly on the
GAC Types and their properties. macromolecular TOC found in surface water sources.
Coconut Shell - Low ash (5%), low dust, better on low Further, a long path (high column or dual beds in series)
is recommended for chloramine removal, due to the
Property Coconut Coal Lignite Wood slow reaction rate and the formation of carbon oxides
from chloramine removal.
Micropore High High Medium Low
Macropore Low Medium High High In surface waters with chloramines, a safe path may be to
Hardness High High Low Medium use a tall (72 inch straight shell) vessel with coal based
GAC. In severe cases, coal based GAC may be used in
Ash (percent) 5 10 20 5 the primary bed, followed by a coconut shell carbon for
Water Soluble Ash High Low High Medium chloramines in a second carbon bed, operated in series.
Dust Low Medium High Medium
Other chloramine removal techniques involve chloramine
Regeneration Good Good Poor Fair destruction via the addition of sodium hypochlorite and UV
Density (g/cm3) 0.42 0.48 0.3 0.35 dissociation of chloramines utilizing intense levels of high-
pressure UV lamp irradiation.
Iodine # (mg/gm) 1100 1000 600 1000
TABLE 2.3 ACTIVE CARBON COMPARISON Source: Henry G.

Nowicki; Water Technology; March 1997

APP-02
2.3.3 Process Design: Purification

FIRST PASS / SINGLE PASS RO UNIT PRODUCT OR
The function of purification is to remove dissolved TO 2ND PASS
impurities. The presence of suspended solids will
impair most purification technologies.
The Purification phase of treatment deals with dissolved

impurities, primarily salts or ions.* All high purity water SECOND STAGE
REJECT
systems should employ an RO unit. This is important FIRST STAGE
Section 2
because the RO membrane provides an impenetrable
SECOND PASS PASS RO UNIT
barrier to all solids, including colloids and microbes
found in the city feed. Without this barrier, problems
downstream will eventually become overwhelming. This
is especially true for microbial related issues.
SECOND STAGE
Reverse Osmosis REJECT
A single pass RO unit is typically all that is required in FIRST STAGE
purification for standard DI water systems when the

size of the RO unit is less than 40 gpm, and or the city FIGURE 2.B SINGLE / DOUBLE PASS RO UNIT
fed is less than 300 ppm salt. Larger RO units (ie.
water systems) or saltier feed water may benefit economi-
cally from a double pass RO unit, or a secondary ion Warm or Cold Operation
exchange process, such as CDI/EDI or ion exchange RO units should not require warm water operation to meet
polishers on the RO product, prior to storage. quantity levels. The product output of TFC RO membranes
are not as temperature dependant as they once were. The
A pH adjustment system may be advised if the feedwater water system pumps also dampen out and generally warm
pH range is outside of 7-9, or the RO is larger than 10 the product water more than one would expect. However,
gpm or is a double pass RO system. a cold water RO may cause a seasonal product water
temperature drift if there is a big difference between
*Carbon Filtration and Water Softening could be included summer and winter feed temperatures.
in this category, but are typically classified in pretreatment.
Storage Tank Design
RO units should: Storage tanks less than a thousand gallons are typically
molded plastic (polypropylene or polyethylene) with a
1. Utilize Thin Film Composite (TFC) membranes. conical bottom on a non-corrosive stand. Larger tanks are
2. Operate at 50% conversion with higher rates allowed often Fiber Reinforced Plastic (FRP) or powder coated
if no fouling occurs. Larger RO systems (> 25 gpm) steel for very large tanks above 10,000 gallons. Large
require higher conversions as part of the design basis tanks should employ a sloped bottom for complete
and require a more refined approach. drainage. Specially designed FRP tanks and or lined steel
3. Media should speed up in the RO unit, not slow down tanks are required for ozonated applications.
(Membrane Staging).
4. Not be operated continuously. Spray balls are not considered useful and promote
5. Have a significant run when utilized; not short spo- premature polisher exhaustion due to enhanced carbon
radic usage. dioxide pick up. Consider piping the return water to
6. Not operate more than 14 hours/day (undersized). storage under the water line to reduce carbon dioxide pick
7. Provide better than 97% rejection for ions, organics up.
and silica.
8. Not require membrane sanitization (no oxidant Overflows are desired as a safety feature to help prevent
tolerance). tank collapse and tank bursting.
9. Not require more than 2 cleanings/year, ideally none
(use effective pretreatment filtration).
10. Reutilize the high quality RO reject, but not back into
the high purity water system (cooling towers, etc.)

9 APP-02
2.3.4 Process Design: Post Treatment

The purpose of post treatment is to polish intermediate
quality stored water to specification on demand, remove
system generated impurities, and provides emergency
back- up protection.
Post Treatment design typically involves pumps, mixed

beds, and an UV unit followed by final filtration. This
Section 2
standard Post Treatment configuration is responsible for

much of the problems associated with purified water
systems due to potentially high microbiological activity in
the product water. The primary problems with the
standard approach are a lack of TOC control and the FIGURE 2.C UV LIGHT TRAP DESIGN
improper use of regenerated ion exchange media. The
product water TOC in this approach generally ranges pretreatment. Be certain to employ light traps as the
from 20 200 ppb, typically above 50 ppb. TOC at these short wave, high energy 185 nm TOC destruct unit will
levels provide a nurturing microbiological environment attack polypropylene and PVDF pipe.
resulting in frequent ion exchange replacements. Re-
generated media, in turn, may result in much of the Ion Exchange Media
microbial activity. The result is a continuous fluctuating The use of regenerated ion exchange media is often
bioburden despite routine decontamination. The follow- associated with high bioburden loading from recycled,
ing alternatives are offered: regenerated resins. Monitor the microbiological quality of
incoming regenerated ion exchange resins to evaluate
Distribution Velocity vendor Ion Exchange Quality Control. Virgin, Low TOC
Too much emphasis has been placed upon velocity of ion exchange resin will not support microbiological
water in distribution to control microbial activity. There is activity, but must be utilized in an efficient manner due to
evidence excessive velocity and turbulence increases the high expense. It is recommended to consult expert
product water microbial counts. A certain level of biofilm UPW design consultants or OEM manufacturers for
will always exist within a water systems piping. This is designs of efficiency, utilizing virgin resins.
unavoidable. The biofilm will reach equilibrium based
upon the nutrition level (i.e. TOC levels) in the water Final Filtration
system. Excessive turbulence tends to cause a shearing Final filters should not be relied upon to solely meet
action and flush bacteria from the biofilm into the product product water quality. These filters serve as final protec-
water. The remaining biofilm will reproduce to its equilib- tive measures to prevent ion exchange media from
rium and the cycle will repeat with excessive velocities. getting downstream in the event of a failure in the
Biofilm will affix to pipe walls at low velocities but not polishers. Final filters should run for years with no
shed continuously into the product stream. Product detectable pressure drop. Pressure drops across the
water velocity of 3-5 ft/sec is always considered ideal, but final filter housings for any reason is an indication of a
in certain cases lower velocities may be considered processing problem up stream.
better than higher. (See page 46 for further discussion on
system velocities) SECTION 2.3 PROCESS DESIGN ACKNOWLEDG-
MENT
TOC Ultraviolet Destruction Unit The water system design and data provided in this
A more prudent, and now more common approach is to section was provided to Asahi/America and its custom-
use a TOC UV Unit, ahead of mixed bed polishers, to ers from Arion Water of Hyannis Massachusetts. The
provide continuous TOC reduction. Low TOC product design is provided to assist in the concept of designing a
water is excellent protection against microbial prolifera- reliable and low maintenance water system based on
tion, and combined with defenses to prevent loop combining proper design with sensible materials of
inoculation, provides an effective microbiological control construction.
strategy . A TOC UV Unit sized for 2X the size of a
standard 254 nm ultraviolet (bug) lamp will provide Asahi/America thanks Arion Water for their assistance
adequate TOC control, especially if carbon is used in the and efforts to building this application design guide.

APP-02
2.4 Materials of Construction filtration. PVC contains an enormous amount of process-

ing agents and solvent cement joining techniques add
Many polymeric materials are used in the design of a TOC to the system.
USP Purified Water System. In the pretreatment section,
the material of choice has been polyvinyl chloride (PVC) It is equally important only to accept systems specifically
or chlorinated polyvinyl chloride (CPVC). They are very manufactured and engineered for high purity applica-
cost effective with easy installation and maintenance. In tions. PP and PVDF systems are manufactured with a
recent years the use of PVC has started to decline in variety of resins and manufacturing techniques. Not all
Section 2
favor of Polypropylene. Polypropylene offers thermal systems are the same. Many production techniques are
welding techniques similar to the purification and post suited for industrial applications but are detrimental to
treatment sections and offers enhanced purity properties. system purity. At a minimum, all valves, fittings and
Thermal welding eliminates solvent cement in the piping should be produced in a clean environment and
system, which is a major contributor to TOC. Many PW packaged to protect product cleanliness. Pipe should
systems are exceptionally served by the use of PP be capped and bagged immediately after production.
throughout the entire system. Furthermore, all fittings and valves should be rinsed with
DI water before individual packaging.
System Recommended Product Maximum The evaluation and selection of materials will have a
Description Material Name Temperature direct impact on system quality. A complete review of
Pigmented PP Proline available materials and joining methods is recom-
Pretreatment 195F
Natural PP PolyPure mended. Section Eight contains detailed product
Natural PP PolyPure specifications and Asahi/Americas Engineering Design
Post Treatment 195F
HP PVDF Purad Guide is and excellent source of information for design
Natural PP PolyPure and installation requirements.
Distribution Loop 250F
HP PVDF Purad
Finally, a comparison between thermoplastic and
TABLE 2.4 MATERIALS OF CONTRUSTION BY APPLICATION stainless systems is found in Section Four and more
*See Section 7 for discussion on SIP parameters
detailed information on thermoplastic system properties
is contained in Section Six of this guide.
In post treatment (which is the material immediately after
the reverse osmosis unit) PP or PVDF should be utilized
due to its superior purity compared to other materials.
The requirements for water quality and system cleaning
techniques are the determining factor for which material
should be utilized. Polypropylene is a clean and smooth
material that can operate up to 195F. PVDF offers
superior purity and surface finish over polypropylene and
can withstand most chemicals used in cleaning as well
as ozone sanitization. For exact recommendations on
operating conditions, contact Asahi/Americas Engineer-
ing Department for assistance.
2.4.1 MATERIAL PURITY

High performance thermoplastics, much like high grades
of stainless steel, should be manufactured, packaged
and installed in clean environments. Only pure resins
and materials should be specified for PW and WFI
applications. Materials which use excessive additives,
stabilizers or un-pure joining techniques should be
avoided as they are potential water contamination
sources. Using components made of PVC should be
discouraged for anything after the initial pretreatment

11 APP-02
Section 2

APP-02
Section Three: Alternate Applications
for Thermoplastic Systems Asahi/America Application and Validation Guide
Section Three 3.1 Water for Injection (WFI)

Alternate Applications
Although normally constructed with stainless steel, the
for Thermoplastic Systems use of thermoplastics should be considered as a cost
effective substitute in Water for Injection (WFI) applica-
3.0 Scope tions.
The applications in this section are those which are 3.1.1 Overview
normally constructed with stainless steel but the use of WFI is also commonly used in pharmaceutical and
thermoplastics should be considered as a cost effective biopharmaceutical applications similar to the ones listed
substitute. Table 3.1 provides a quick reference of for Purified Water. WFI systems are considered the most
various pharmaceutical and biotech processes in which critical water system and generally receive the highest
thermoplastics may be considered. A brief description of degree of regulatory scrutiny. High quality WFI systems
these applications (with the exception of Purified Water are often considered an excellent indication of a total
Section 3
which is dealt with in Section Two) can be found in the quality facility.
balance of Section Three.
WFI is most commonly prepared by distillation. The stills
The intent of the process diagrams and corresponding are either multi-effect or vapor compression. Materials of
discussions is to highlight areas in which thermoplastics construction for the stills are generally 316L stainless
should be considered. Many process related issues steel. USP-25 now recognizes WFI can be produced
such as corrosion, pitting and metal ion contamination without distillation by means of Reverse Osmosis and
are effectively resolved with thermoplastics systems. Deionization. However, Japan and Europe still require
The application discussion provides a specific summary distallation for WFI systems.
of features and benefits of thermoplastic utilization.
Although the discussion is by no mean all-inclusive, it 3.1.2 Design
should serve as a guide for initial consultation. Asahi/ The most common WFI system design is a single
Americas experienced staff is available for further storage tank with a continuous recirculating hot loop (65-
clarification or discussion pertinent to your application. 80oC.) loop (see Figure 3.A). A specially designed
Material Ambient Pressure

System Description Material Brand Application
Temp. Rating Rating
Natural PP PolyPure
Purified Water 20 to 80C 150 psi Ambient DI Water
PVDF Purad
316/316L SS N.A. - -
WFI* Hot Water
PVDF-230 Purad 121-130C* 150/230 psi
316/316L SS N.A. - -
Solution Prep Varies
PVDF-230 Purad 121-130C* 150/230 psi
Fermentation and cell 316/316L SS N.A. - -

Varies
culture media prep PVDF-230 Purad 121-130C* 150/230 psi
Polypropylene Proline < 95C 150 psi Material selection based
Clean-in-Place (CIP) PVDF Purad < 121C 150/230 psi upon compatibility with
E-CTFE Halar < 121C 150 psi cleaning agents
Eltex Tube124
Pure Air and Gases Air-Pro 20 to 60C 230 psi Pure Air and Gases
HDPE
Table 3.1 Material Selection Guide by System Application

These recommendations are provided as a guideline to the usage of thermoplastic piping in pharmaceutical and biotech applications. Specific
design considerations apply to each system. Consult Asahi/Americas technical department for more information.
*See Section 7 for exact SIP parameters

13 APP-02
Asahi/America Application and Validation Guide for Thermoplastic Systems
cooled point of use or a separate ambient loop are Purified Water is fed to the still and by the process of
sometimes employed. The other type is the batched tank evaporation, impurities are removed. The vapors are
with a recirculating hot loop. This is almost exclusively condensed by a heat exchanger and the water flows by
used when QA release is required for actual preparation gravity to the storage tank. The water is maintained at
of injectable compounds. approximately 65o to 80o C. and is pumped through the
distribution loop and back to the tank. There are hot and
3.1.3 Materials of Construction cooled Points of Use. Materials of construction histori-
Traditionally WFI systems have been constructed using cally have been 316L stainless steel but Purad PVDF
316L stainless steel. The semiconductor industry has can be substituted in many areas of the system, provid-
demonstrated that PVDF is actually a better material of ing improved purity.
construction in terms of both cost and vulnerability to
contamination. Please refer to Section Seven and
consult Asahi/America for exact conditions under which Utilities
Purad PVDF systems may be steam sterilized for WFI Feed Water Purified Water
applications. Plant Steam 70 to 110 psig.
Section 3
Clean Steam 45 to 75 psig. (optional)

3.1.4 System Design Instrument Air (80 psig. minimum)
The following is a design option for a typical Water for Cooling Water or Chilled Glycol
Injection system utilizing distillation. A WFI System
generates water, which meets USP 25 standards and is
used in various operations to produce pharmaceutical Feed Water Package (typical)
and biopharmaceutical products. The system consists of This package is a 50 gallon tank with a level control and
a multi-effect or vapor compression still, a storage tank a vent filter. A 2 HP sanitary pump feeds the still.
and a hot distribution loop.
Purified Water Feed

Purad PVDF
Purified
20 to 80C up to 230 psi
Water Clean Steam Feed
Storage
316L SS
Instrumentation Air
AirPro HDPE
Cooling Water Supply

WFI 50 psig Steam
Proline PP/PE
Still To Heated Vent Filter
20 to 40C up to 150 psi Condensate
Header
Heat Exchanger
Cooling Water Return (as needed)
Proline PP/PE
Purad PVDF
Purad PVDF 20 to 130C* up to 230 psi
Condensate
WFI
Storage Tank
POINTS OF USE
316 SS
Purad PVDF
Purad PVDF 20 to 130C* up to 230 psi
To Drain * = Please Consult Factory for exact pressure vs. temperature

FIGURE 3.A Single storage WFI PI&D ratings of Purad PVDF and Steam In Place Applications

APP-02
Still Description the loop. It measures both conductivity and Total Organic
For a typical 4 effect unit, the first effect is heated by plant Carbon.
steam and subsequent effects are heated by the product
steam from the previous shell and tube heat exchangers It is important to mention at this point that when utilizing a
(effects). Only the first effect utilizes a double tube sheet PVDF piping system for WFI, certain design requirements,
design. The material of construction is 316L stainless steel. such as thermal stress calculations and related expansion
of the piping must be taken into consideration during the
Condenser design process. For more information on thermoplastic
The condenser is a shell and tube heat exchanger pipe system design, please refer to Asahi/Americas
located on the top of the still. Cold feed water and Engineering Design Guide.
additional cooling water is used for condensation. Pure
steam enters from the evaporator heat exchangers
(except the first effect). The top of the condenser is
vented with a sterile cartridge filter. The pure distillate
drains out of the bottom through temperature and
Section 3
resistivity sensors, a diverter valve and finally to the
storage tank.
Preheaters
Warm feedwater from the condenser enters the heater
on the last effect. This helps to cool the hot overflow from
the last column. The water then goes to the previous
effect and the process is repeated until it reaches the first
effect where it is fed into the column as hot feed water.
Controls
The still system is controlled by a PLC. The panel board
contains the various alarm functions. A chart recorder
provides the temperature and quality information for the
distillate. If the distillate is out of specification, it will be
diverted to drain. A clock recorder indicates the duration
of the still operation.
The temperature and pressure in the distribution loop are

monitored and alarmed. Also monitored are the level in
the storage tank and resistivity at the still and loop return.
Storage Tank
This is a 316L stainless steel insulated vessel. It is fitted
with level control, temperature element, rupture disc,
spray ball, jacketed 0.2 micron vent filter and SIP con-
nections.
Distribution Loop
The WFI is distributed by single or dual sanitary pumps.
Points of use are cooled by heat exchangers or may be
used hot. All points of use are fitted with sanitary
diaphragm valves. A back pressure regulating valve
maintains loop pressure. A heat exchanger downstream
of the pump is used to maintain the temperature of the
water in the loop return by means of a temperature
controller. A TOC meter is installed at the beginning of

15 APP-02
3.2 Solution and Buffer Preparation reason the use of Purad PVDF provides an excellent
substitute. Its high temperature capabilities allow for both
This section describes a design for preparing various sanitization and sterilization if required.
solutions in a fermentation or cell culture facility.
3.2.3 System Description
3.2.1 Overview Figure 3.B shows a typical solution preparation system. It
There are many requirements for preparing various consists of a batching tank followed by a sterile product filter.
solutions in both pharmaceutical and biopharmaceutical The tank has provisions for adding high purity water and
operations. Solutions are typically used in such opera- solids. It is fitted with a sterile vent filter, agitator, sample port,
tions as chromatography, filtration or other purification pH and conductivity probes, jacket cooling water or glycol.
steps. If sterilization is required, Purad PVDF may be Transfer of final buffer is most often accomplished by
utilized. Many solutions are prepared with salts or pressurizing the tank with sterile air.
corrosive chemicals, therefore a thermoplastic material is
superior to stainless steel. A typical solution preparation After the batching tank has been cleaned, sanitized and
design is shown in Figure 3.B but it should be noted that inspected, the required amount of high purity water is
Section 3
these designs may vary considerably since every added. With agitation, the chemicals are charged in
application is different. either solid or liquid form through the additional port on
the top of the tank. pH is adjusted as necessary. The
3.2.2 Materials of Construction solution is agitated for one hour and cooled to 5o C. After
Many solutions and buffers are required in a typical cell integrity testing the sterilizing filter, the batch is filtered
culture or fermentation operation. They are used in into another tank by pressurizing the tank with com-
purification steps particularly in column chromatography. pressed air. Equipment is rinsed with a predetermined
The use of stainless steel frequently causes problems amount of high purity water and added to the batch. The
when salts or acids are used in the formulation. For this buffer process is now complete.
CLEAN 316L SS
STEAM Vent to Safe Place

PVDF
T COLD WFI
F-2
HS
PY
HV
PROCESS
AirPro HDPE PV AirPro HDPE AIR
TRANSFER
PVDF
PVDF
AirPro HDPE
PUMP
PVDF
PT PIC
PSE
PVC
PI
SGL ZS XY ZAL
FLOOR
SGL
PVDF
MANWAY LT LI
AE AT AI
316L SS
Carbon Steel
PH
SOLUTION AE AT AI
CIP PREP COND
Chilled
TANK SPARE
SUPPLY Water
PVDF
SAMPLE VALVE
F-1
PVDF PVDF PVDF Sterile

Buffer
PVDF
PVDF
TE TI
CIP
Return
PVDF
PVDF
T
CHEM WASTE
COLLECTION
FIGURE 3.B SOLUTION PREP DESIGN

APP-02
3.3 Fermentation and Cell Culture Media 3.3.3 System Description

Preparation A media prep procedure may be as follows:
After the batching tank has been cleaned, sanitized and
This section describes a design for preparing medium for a inspected, the required amount of high purity water is
fermentation or cell culture facility. added. With agitation, the chemicals in either solid or
liquid form are charged through the additional port on the
3.3.1 Overview and Material Recommendation top of the tank. pH is adjusted as necessary. The media
Media is usually prepared and then either filtered or steam is agitated for one hour and cooled to 5o C. After integrity
sterilized. This media may be used for initial batching or an testing the sterilizing filters, the batch is filtered into
in-process feed. If the media is filter sterilized, both PolyPure another tank by pressurizing with compressed air.
and Purad PVDF can be used. For steam sterilization, Purad Equipment is rinsed with a predetermined amount of
is a more appropriate material. Media is often prepared in USP high purity water and added to the batch. The
stainless steel equipment and may be contaminated with media is now ready for use.
trace metal ions. To avoid this problem, Purad PVDF is an
Section 3
excellent substitute. The high temperature properties of
Purad PVDF allow for steam sterilization in the same fashion
as 316L stainless steel. Considerations to thermal expan-
sion of PVDF must be accounted for in the design.
3.3.2 Equipment
Figure 3.C shows a typical design for media preparation.
The equipment is similar to that used by buffer prepara-
tion. The tank is outfitted the same way and is supplied with
the same utilities. The only major difference in the setup is
that either 2 or 3 final filters are used to ensure sterility.
CLEAN 316L Stainless Steel

STEAM
PVDF
T
COLD
PVDF
WFI
F-4
PROCESS
AIR
AirPro HDPE
AirPro HDPE AirPro HDPE
CIP PVDF
SUPPLY
PVDF
PVDF
PT PIC
PVDF PVC
MEDIA
MEDIA PREMIX FLOOR
MANWAY
PI PI
TK-1
PVDF
SAMPLE VALVE F-1 F-2 F-3
M
PVDF
PVDF
PVDF
PVDF PVDF STERILE MEDIA

HOLD TANK
PVDF
CIP
PVDF
RETURN PVDF
T PVDF
TE
TI
FIGURE 3.C MEDIA PREP DESIGN

17 APP-02
3.4 Clean-in-Place Systems Polypropylene is ideal for high pH medias and in some
cases strong acids. Polypropylene is not recommended
3.4.1 Overview for chlorinated service or extremely high acid concentra-
Clean-in-Place (CIP) Systems are commonly used in tions.
pharmaceutical and biopharmaceutical facilities. Figure
3.D shows a typical two tank CIP system. Similar designs PVDF is ideal for aggressive acids and many chlorinated
are found with single and three tank variations. services. However, it is not recommended for high pH
levels.
3.4.2 Materials
E-CTFE, known as Halar, is an excellent plastic for a
Although CIP systems are frequently constructed with
broad range of aggressive chemicals. In particular,
either 304 or 316 stainless steel, the use of PVDF or
E-CTFE is excellent in Sodium Hypochlorite applications.
polypropylene (pigmented or unpigmented) can be a
viable alternate. Advantages include: reduced installation
For all systems, factors such as thermal expansion and
costs, corrosion resistance, less insulation needs (for hot
UV exposure must be considered.
Section 3
systems), reduced or eliminated borescoping require-

ments and no passivation.
3.4.3 System Description
A CIP system is a packaged unit of integrated compo-
Thermoplastic materials will out perform metal systems
nents.
exposed to caustics, acids or chlorinated medias.
However, no one single plastic material is ideal for all
- Controlled Rinsing: Controlled temperature rinsing
media. It is important to consult Asahi/Americas
which involves partial cleaning without the usage of
engineering department for a specific recommendation.
chemicals.
Flow Control Valve
CIP Piping
Vortex Purified
Flow Meter Water
Water Purified
Supply Water
Temperature Water
Supply
Steam Pressure
Supply Level Level
Steam
Water
Water Recirc Conductivity
or or
Recirc Solution
Heat Exchanger Tank Recovery Temperature CIP
(as needed) Tank Return Process Vessel
Return Piping
T
Flow Probe
(to be cleaned)
Drain
Valve
Air Relief
CIP Supply Valve
Pump
Chemical PumpCase Tank Tank To Further
DrainValve Outlet Inlet Processing
Cleaning
Chemical
Feed Loop
Alkaline Acidic
FIGURE 3.D TWO TANK CIP SYSTEM (Note: Either Proline PP or Purad PVDF can be used as piping material depending upon cleaning
agent used. Proline PP is excellent for most caustic agents)

APP-02
- Controlled temperature washing automatically controls tion or cell culture facility.

the systems exposure to the cleaning agents and rinses
to insure consistent results. By controlling volume and 3.5.1 Overview
pressure, sufficient turbulence is created to insure See Figure 3.E for a typical compressed air system. The
optimum cleaning conditions. Air-Pro Compressed Air Piping System is a cost effective
alternative to carbon steel, stainless steel and copper. It
- Controlled chemical concentrations results in effective is a safe and reliable system with many of the advan-
cleaning. Consistent and repeatable chemical dosage is tages of thermoplastic construction. These include:
essential from maximum effectiveness
Convenient light weight
- Final rinsing is usually performed with high purity water. Faster/lower installation cost
It may be sent to drain or used as the first stage rinse of More flexible installation
the next cycle. Minimal system pressure drop over the life of the
system
CIP systems are used in many industries and now have Corrosion resistance- will never corrode, flake or pit.
Section 3
become a standard for pharmaceutical and
biopharmaceutical applications. The material is a special grade of high density polyethyl-
ene (HDPE) resin specifically approved for compressed
air systems. HDPE may also be used for special gasses
3.5 Pure Air and Gases such as nitrogen, oxygen, carbon dioxide and others that
are used in both chemical and biopharmaceutical
This section describes a design for the generation and processes. The gas is usually supplied in cylinders or
distribution of compressed air and gasses in a fermenta-
COOLING COOLING
WATER WATER
PSV
ROOM AIR
TI
KO
Oil Free AFTER COOLER POT
F-1
COMPRESSOR Storage
INLET
FILTER Vessel
PSV
C-1
P P
Dryer
P
PL
TK-2
F-2 PI PAL
D-1
PT PI
P F-3 P PLANT AIR

OIL
INDICATOR TO
DISTRIBUTION
FIGURE 3.E COMPRESSED AIR SYSTEM

19 APP-02
tanks To assure required sterility at points of use, a final 0.2

micron filter is usually recommended. A single com-
3.5.2 Applications pressed air system should be sized to provide instrument
The following Systems are usually found in both pharma- air as well as emergency breathing air if required.
ceutical and biopharmaceutical facilities:
Consult the Asahi/America Piping Design Guide for the
Compressed Air proper design and layout of a compressed air piping
Process system.
Instrument
Breathing
Nitrogen
Carbon Dioxide
Oxygen
Both process air and nitrogen are used for transfer of

Section 3
fluids. Carbon dioxide is used in fermentation or cell

culture for pH control. Oxygen and compressed air are
used in fermentation and cell culture to supply dissolved
oxygen.
Although stainless steel with compression fittings are

used, it is neither required nor cost effective. All of these
systems may be constructed of thermoplastics. The
piping systems should be readily cleanable from the
outside. Support spacing is an important design consid-
eration.
3.5.3 Gasses
Bulk storage of gasses using multiple cylinders or a
single large storage tank is the preferred method. A
segregated access controlled area should be located
outdoors adjacent to the building. A contract with a local
provider assures that there is always an adequate
supply.
3.5.4 Compressed Air

Oil free compressors are required. The system contains
the following components:
Inlet filter
One or two compressors
After cooler
Storage Tank
Air dryer (refrigerated or desiccant type - depending
on dryness required)
Final 0.2 micron filter

APP-02
Section Four: Material Comparisons Asahi/America Application and Validation Guide
Section Four 4.1 Dimensional Comparison

Material Comparisons
One common issue that needs to be better communi-
cated by polymer piping manufacturers to users is the
dimensional difference between SDR thermoplastic
4.0 Scope piping and stainless steel tubing. The two terms here that
need to be stressed are pipe and tube.
This section is intended to point out the technical differ-
ences between stainless steel and thermoplastic piping While a 316 stainless tube is rigid and looks like a pipe, it
systems. While plastic will never fully replace stainless is generally provided in tube dimensions, therefore it is
steel, in many applications it is a far superior choice in referred to as tubing.
terms of ease of installation, operational cost reductions,
and long term performance.
4.1.1 Pipe to Tube Dimensional Comparison
1.40 Pipe dimensions are larger than tube dimensions. For
example a 1 tube is roughly the equivalent of 1
1.20 (40mm) pipe. Therefore if a system is designed based on
tube dimensions and thermoplastic pipe is to be used,
1.00 select a nominal pipe OD one size smaller than the tube
for equivalence. A basic rule of thumb is a nominal pipe
Section 4
0.80
size is equal to one tube dimension size larger. Table 4.1
0.60
compares the dimensions of stainless steel tube to
thermoplastic piping.
0.40
EP 316L Another important factor is the connection and use of

0.20 EP 304L sanitary style ends and clamps. While these are now
E-CTFE
HP PVDF readily available in PVDF and Polypropylene, they are
0.00
HP PP again not the same dimensions. For example, a 1
Clean PVC (40mm) pipe with a sanitary end will need a 1 Sani-
FIGURE 4.A Estimated Installed Cost Comparison of different tary clamp and will directly connect to 1 stainless steel
materials of construction whereas PVDF = 1.0 sanitary end. Table 4.2 is a chart depicting the compari-
son for ease of selection.
Stainless Tube Purad PVDF, SDR21 PolyPure and Proline PP, SDR11
OD ID OD ID OD ID
Nominal Actual Actual Nominal Actual Actual Nominal Actual Actual
inch inch inch inch inch inch inch inch inch
0.5 0.37
0.75 0.62 20 0.79 0.64 20 0.79 0.59
1 1 0.87 25 0.98 0.83 25 0.98 0.77
1 1 32 1.26 1.07 1 32 1.26 1.02
1 1.5 1.37 1 40 1.57 1.39 1 40 1.57 1.3
2 2 1.87 1 50 1.97 1.74 1 50 1.97 1.61
2 2.5 2.37 2 63 2.48 2.24 2 63 2.48 2.02
3 3 2.87 2 75 2.95 2.66 2 75 2.95 2.41
TABLE 4.1 Tube vs Pipe Dimensional Comparison

21 APP-02
Asahi/America Application and Validation Guide Section Four: Material Comparisons
Thermoplastic Pipe Size Clamp Size Microbial Fouling of Materials in UPW

Average Direct Cell Count/cm2 (thousands) - Flow Velocity at 3 feet per second
Nominal Actual (Nominal Tube) 120
" 20mm " / "

100
" 25mm 1"
Greater Than 400,000

1" 32mm 1 " 80
1 " 40mm 1 "

60
1 " 50mm 2"
2" 63mm 2 " 40
Table 4.2 Sanitary Clamp Size Selection

20
4.2 Surface Finish Comparison 0

MP316L EP316L PVDF 1 PVDF 2 PVDF 3 E-CTFE 1 E-CTFE 2 E-CTFE 3 E-CTFE 4
Table 4.4 Bio-adhesion Comparison between MP 316L,

It is believed that the electropolished pipe is the smooth- EP 316L, PVDF and E-CTFE Materials
est pipe available. Table 4.3 compares internal surface
finish between PURAD PVDF, 316 electropolished (EP)
At weekly intervals 3 randomly selected discs of each test
and 316 mechanically polished (MP). The data is based material [were] removed from the sampler, rinsed with a jet
on manufacturers published data and not test results.
Section 4
of double filtered UPW to remove non-firmly associated

From the chart it can be seen that comparable PVDF cells, stained with acridine orange, then viewed with
systems provide a smoother surface finish as compared epifluorescent illumination at 1,2400X.
to stainless steel. The Purad System is over 8%
smoother than standard EP stainless steel and 30% The samples were examined and had their biocoloniza-
smoother than most MP stainless steel. tion levels directly counted. The results of which are
shown on Table 4.4
Material RA Result
From these tests, it is evident high performance thermo-
Purad PVDF (20mm - 90mm) 7.8 max plastics are more resistant to bioadhesion than high
grades of stainless steels.
EP 316L Stainless Steel 15-25 average
MP 316L Stainless Steel 20-30 average In addition Purad PVDF, Proline PP and PolyPure
surface finishes are continuously monitored during
Table 4.3 Surface Finish Comparison PVDF and 316L Stainless production. The roughness data is kept on record by
production lot number. The data from this testing showing
Purad PVDF surfaces are continuously monitored during the Ra values for each production lot can be made
production. In addition to production control, the Quality available upon request.
Control department conducts separate inspections of
surface finish and other quality measures of each lot of
production. 4.3 Leachout Performance
Studies conducted by G. Husted of MicroTechno While the surface profile is an important factor in terms of
Research, Inc have compared the bioadhesion proper- reducing bioadhesion, the leachout from a pipe system is
ties of high performance thermoplastics (PVDF and E- more important to a systems overall purity level. A piping
CTFE) with that of high grades of EP and MP 316L system is the transporter of water to the point of use. Its
stainless steel. Test samples were continuously rinsed at material of construction and joining method directly
a velocity of 3 feet per second with E-1 quality UPW impacts the ability to maintain strict levels of purity. While
stream. the piping cannot positively influence water quality it can
have a dramatic negative effect on water quality.

APP-02
It is well known; stainless steel piping systems leach ment, it is likely to incorporate contaminates from the
higher rates of metal ions than thermoplastic systems. surrounding production environment. These contami-
Table 4.5 provides a comparison of detectable ions and nants may later leach into the water system.
trace metals in high purity water systems with materials
of construction of PVDF and 316L SS. Water samples When evaluating the merits of a particular material,
were drawn from similar points and analyzed for con- review the production and packaging specification of
tamination levels. As should be expected, metal ion various manufacturers. Systems well suited for PW
contamination levels in the PVDF systems are dramati- applications are easily identified by dedicated cleanroom
cally lower than those of the stainless steel systems. production and protective packaging. Systems such as
(Also refer to Chart Figure 1.1 in Section One). The these will best prevent introduction of contaminates alien
higher rates of contamination of stainless steel systems to material composition.
contribute to elevated conductivity levels, high TOC
levels and increased rates of microbial activity by
providing bacteria a nutrition rich environment.
4.4 System Assembly
As with stainless steel, thermoplastics are not all the
same. Differences exist within each material type as well Orbital welding is the most common method of joining
as between material type. A PVC system, even if made high grades of stainless steel in pharmaceutical and
clean, leaches high amounts of TOC into a system due biotech water systems. Used primarily for 300-series
to the organic matter found in all solvent cements. Other stainless steel, properly conducted orbital welding
sources of contamination can be introduced from the provides reliable, beadless welds. Standard procedures
for orbital welding requires weld inspection coupons at
Section 4
manufacturing method. This is true for all thermoplastic
materials including high performance types such as PP the beginning of every shift and change of material lot or
and PVDF. Unless pipe is made in a cleanroom environ- operator. This requirement is necessary due to the
intrinsic variances in material composition of stainless
Dynamic Leachout Comaprison of HP PVDF vs 316L SS steel. ASTM A270 specifies the allowed variances of
Element PVDF-1 PVDF-2 316L-1 316L-2 composition including iron, carbon, chromium, nickel and
Al < DL 0.006 < DL 0.007 molybdenum. This normally occurring variance trans-
Ba < DL < DL < DL 0.14
lates into slightly different welding characteristics. Which
in turn, explains why welding inspection coupons are
B < DL < DL 5.6 1.7
continuously justified.
Ca < DL < DL < DL 1.1
Cr < DL 0.004 0.03 0.023 The iron content of austenitic stainless steels increases
Co < DL < DL 0.03 0.033 during the orbital welding process. This in turn disturbs
Cu < DL < DL 0.007 0.011
the chromium/iron balance at the product surface.
Systems become more susceptible to corrosion when
Fe < DL < DL < DL 0.02
this balance is disturbed. Passivation is required to
Mg < DL < DL 0.002 0.36 restore the corrosion resistance properties of austenitic
Mn < DL < DL 0.019 0.041 stainless steels.
Mo < DL < DL < DL 0.022
Ni < DL < DL 0.44 0.24 ASTM A380-99 Standard Practice for Cleaning,
Descaling, and Passivation of Stainless Steel Parts,
K < DL < DL < DL 0.5
Equipment, and Systems specifies how nitric acid, or
Si < DL < DL 22 < DL other similar agents, is used to restore the desired
Na 0.015 0.04 0.16 5.4 equilibrium between chromium and iron. By requiring
Sr < DL < DL < DL 0.038 passivation, stainless steel systems must be pitched and
W < DL < DL 0.24 0.15 installed to allow complete drainage. This is the main
reason, as well as those systems requiring Clean In
Zn < DL < DL 0.023 < DL
Place (CIP) or Steam In Place (SIP), beadless and
DL = Detection Limit pitched systems are required. Systems not requiring
Table 4.5 Actual purity comparison of four sample points in systems passivation or CIP (i.e. high performance thermoplastics)
with piping materials in HP PVDF and 316L SS. Measurement type do not require beadless welding and pitched installation.
is Ion Chromotography.

23 APP-02
Thermoplastics offer simplified welding techniques and water treatment operations, many of which do not have
installation. Both PVDF and PP are melt-processable the ability to be steamed, to be required to be drained
polymers. Systems are joined by a variety of thermal- completely free of water (2).
fusion welding techniques. As mentioned, PVDF and PP
1. Lee, Ron; Patterson, Michael, Ph.D.; and Painter, John;
resins are extremely pure and immensely consistent
Semicondutors: The Efffect of Velocity on High-Purity Systems Rinse Up
from lot to lot. This purity and consistency allows for and Requalification; Ultrapure Water Journal; March 2002; pg 41.
dependable welding parameters, which translate into 2. Collentro, Andrew; Pharmaceuticals: Practical Microbial Control
repeatable and reliable welding techniques. Stainless Techniques for Pharmaceutical Water Purification Systems;
steel welding concerns such as sulfur concentration, Ultrapure Water Journel; March 2002; pg 56.
chromium depletion, condition of tungsten electrodes are
not issues for thermoplastics. The result is simplified
welding and installation practices with thermoplastic 4.5 Rouging
systems.
Rouging is a ubiquitous and perhaps a misunderstood
One of the most common high-purity welding methods phenomenon that unfortunately is associated with the
for high performance thermoplastics such as PVDF and pharmaceutical industry. Rouge is an unacceptable
PP is a non-contact method known as Infrared (IR) visible evidence of water contamination by 316L stainless
Fusion. IR Fusion is accomplished by bringing the pipe steel with corrosion by-products, primarily heavy metals.
components into close proximity with a heating element. Regardless of cause, rouging is a serious issue, which
Direct contact with the heater is avoided in order to must be dealt with in every stainless sanitary system.
minimize the risk of material contamination. IR Fusion
Section 4
provides superior weld results in terms of purity, reliability The reason rouge is not well explained lies in part with
and speed of installation. This is evident by the semicon- the ephemeral nature of the effect and its unusual
ductor industries overwhelming preference for this association primarily with the pharmaceutical and dairy
method of joining, even when compared to various industries. A review of the literature also reveals little
beadless systems. study of the matter. There is a lot of contradiction on the
(Please refer to Section Seven for greater details on IR Fusion and causes and treatment. Metallurgists hold a part of the
other available joining techniques.) puzzle, but they do not have experience with hot WFI
systems. Pharmaceutical engineers hold another key,
Many pharmaceutical engineers shy away form IR but they may not have corrosion expertise. Passivation
Fusion because of the presence of an internal bead. It is engineers have their take on the rouging problem, but are
incorrectly assumed the bead presents an area for not very helpful in preventing rouge, only treating it.
microbial proliferation. If this were the case, semiconduc-
tor water systems would have continuous problems with It is interesting to note the following two facts:
microbial levels. This is simply untrue as evident by
actual installations. For example, one leading semicon- Nitric acid passivates stainless steel, but does not
ductor manufacturer has warning levels of 2.5cfu/100ml dissolve ferrous or ferric oxides; therefore it does not
and action limits of 5cfu/100ml for their UPW distributed remove rouge.
in IR fused PVDF piping (1). These levels are well below Acid cleaning removes rouge but does not passi-
the cGMP action levels of 10cfu/100ml for WFI and vate 316L stainless steel.
10,000cfu/ml for PW!
Stainless systems inherently require two timely and
Furthermore, leading process engineers have acknowl- costly operations not required in thermoplastic systems.
edged the fact not all PW systems require pitched
installations with drainage capabilities. [T]he intent of a Nobody can convincingly explain the causes or methods
fully drainable system [in the context current Good to prevent rouge in a stainless system. Having been
Manufacturing Processes for Large Volume Parenterals said, water is truly the universal solvent. Therefore,
(21CFR Part 212)] was to facilitate the draining of stainless steel corrodes in high purity water. The metals
condensate after a system had been steam sterilized. content or rate of stainless steel corrosion can be
The complete drain ability of ambient or chemically determined by direct ICP/MS analysis of high purity
sanitized piping systems that do not have the ability to be water for metals. Experience has documented lower
steamed is not required. Nor is it reasonable for many levels of metal ionic contamination is found in ambient

APP-02
temperature systems than comparable high temperature Storage tanks- Use lined storage tanks for ambient
systems. In other words, stainless systems corrode and temperature storage. Some stainless steel can be
rouge quicker in high temperature operation. High accommodated, and a stainless storage tank alone
temperature systems may be effective in controlling may be acceptable.
microbial activity but contribute to the overall degradation
of water quality. Piping Ideally, piping material should be thermoplas-
tic. Thermoplastic pipe, valves, fittings and measure-
The metal content in these water systems is evidence of ment device will not rouge or corrode. In applications
rouge and its contamination of the water. The heavy absolutely requiring stainless steel, 316L should be
metal contamination by-product of rouge includes: Fe, Al, specified.
Ba, Cr, Cu, Co, Mn, Ni, Mo, W, Zn. For every corrosion
source point, often exhibited by a hard discoloration of
the pipe surface, there can be a deposition including in
extreme cases, visible particles carried in the water.
Rouge may be a self-catalyzing reaction that will reoccur 4.6 Bioadhesion Comparison & Control
some time after treatment.
The control of bacteria as a contaminant in product
The surface area of 316L stainless steel in contact with water should be the primary concern in the design and
UPW should be minimized to avoid rouge and its con- utilization of high purity water systems for Life Sci-
ences applications. It is only recently that scientists
tamination affects. When compared to hot or steam
have begun conceptualizing and treating bacteria not
cleaned systems, ambient systems reduce the speed in as discreet units, but as highly diverse, protected,
Section 4
which rouging spreads its harmful effects. USP25 complex communities, known as biofilm.
guidelines now allow WFI quality water to be achieved
through RO operation instead of traditional distillation. Understanding the formation, properties and behavior
cGMPs also suggest 65C is just as effective as 80C in of the biofilm is required to effectively deal with
controlling microbial activity. Under these guidelines, why bacteria in Life Sciences water systems. This under-
consider water distribution through expensive and standing assists designers and operators in attacking
corrosion susceptible stainless steel? High performance the core issues rather than the symptoms of bacteria
thermoplastics such as PP and PVDF can quickly laden water systems.
become the obvious answer to rouge and its ubiquitous
Biofilm Definitions
and unacceptable industry wide contamination issue.
- A thin layer of bacteria and organic matter that
occurs under the viscous boundary layer, at the
4.4.1 Avoiding Rouge interface between the bulk water phase and solid
Stainless steel can not be completely avoided in high system components such as piping, filters and
purity water systems. In fact, stainless steel may be resins. An immobilized cell thin-film bioreactor.1
the preferred material for certain applications. How-
ever, the best method to avoid rouging is to limit the - A complex and highly diversified community of
usage of stainless steel. viable and nonviable microorganisms, their associ-
ated glycocalyx, adsorbable organics, and en-
Stills- Stills can be a source of rouge and are often trained particles.2
badly corroded when examined. Do not worry about
rouge from main boilers; it will not carry over in the Bacteria cells are present, to some degree, in all
steam. The condenser and all wetted surfaces thereaf- distribution piping systems and adhere to essentially
ter should be 316L stainless steel or Thermoplastic all wetted surfaces. Furthermore, (b)iofilms form
where applicable. expected densities after 2 weeks on all wetted sur-
faces, regardless of flow velocity.3 The presence of
Pumps All pump impellers and wetted surfaces should biofilms in high purity water piping, to some degree, is
be 316L stainless steel, if not coated with high perfor- unavoidable. Once understood, the issue then be-
mance thermoplastic. Erosion due to pump cavitation comes how to best minimize and limit biofilm and it
adverse effects.
will exacerbate rouging episodes.

25 APP-02
The primary source of planktonic (free-floating) Microor-

4.6.1 Methods of Controlling Biofilm ganisms in the bulk phase of the high purity water is
detachment of cells from the interfacial biofilm.2, 4 As
Heat biofilm shearing adds to the overall nutrient levels of
Heat has been proven to be an effective means of water systems, the sheared cells are quickly replaced
controlling overall system biocolonization levels. Hot with new levels of biofilm feeding in the relatively
systems are typically operated at 80C. Purad PVDF nutritious environment. This in turn leads to new layers
systems can easily handle systems designed to of biofilm shearing into the flow stream. A troublesome
operate and sanitize at this temperature. cycle is now possible.
Recently, ISPEs Baseline Guide, Volume IV, Water and Limiting their growth in the high purity environment may
Stream Systems, Jan 02, has recognized 65C as an best control biofilms and system bacteria levels. In
equally effective temperature as 80C. PolyPure and high purity environments, cell proliferation in the biofilm
Proline PP Systems can and should be considered
is severely inhibited by a combination of colonization or
under these circumstances.
inoculation prevention and nutrient deprivation.
In either case, PVDF and PP are excellent thermal
insulators. Hot piping systems (up to 80C+) con- Inoculation Prevention
structed of PVDF and PP do not require external Preventing inoculation of a piping system is a function
insulation for maintaining critical, hot temperatures or of the water system design, not the distribution piping
for protection from injury resulting from burns. design. The water system design must limit and
prevent both viable and nonviable organisms from
However, those who use heat sanitization for ambient proceeding downstream. It is a function of filtration with
temperature systems such as carbon beds, RO mem- RO being one of the more effective means. This
Section 4
branes, distribution loops, etc. should be aware that prevents seeding of a potential biofilm by colonizing
heat sanitization does not remove biofilm, regardless of bacteria and perhaps more importantly prevents live
material of construction. In such systems, failure to and dead organisms from providing a nutrient source to
remove a biofilm may lead to its re-colonization and downstream biofilms.
growth even faster than with bare pipe. The old biofilm
serves as an excellent capture and attachment site with Nutrient Deprivation
nutrients at hand. In extreme nutrient deficient environments, bacteria will
not attach to surfaces. If they do not attach, they
In addition, hot stainless steel water Life Sciences cannot form biofilm. Costerton7
applications have become less attractive due to safety,
cost and quality considerations (i.e. rouging Please TOC control is essential to preventing biofilm prolifera-
refer to Section 4.5 for discussion on rouging) and the tion. Water systems should not operate with TOC over
move towards in-line mixing and the preponderance of 5ppb. Ideally the systems should run at < 0.5 ppb or
ambient temperature applications. In addition, most 500 ppt TOC. This is a far tighter control of TOC than
points of use must be cooled prior to supply. This can the 500 ppb allowed by regulation in Life Sciences
add to sanitation concerns for improperly operated water systems. Water systems with more than 50 ppb
systems. TOC are decidedly nutrient rich, and bacteria problems
can be expected.
Velocity
Powells work showed the average velocity to remove Multiple nutrient restrictions (phosphorous, nitrogen,
biofilm from electropolished pipe is 12 ft/sec. This is potassium) appear to limit growth.4 Water systems
two times (2X) the average maximum velocity of water should target detectable elements at no more than 10
in distribution piping which results in an unacceptable ppt. Borone should be the exception, which, if required,
pressure drop. The minimum thickness of the laminar must be dealt with separately.8 Standard designed RO/
sub layer for cold water is about 0.1 0.2 mm.8 Even DI water systems are capable of routinely and continu-
mature biofilm with films 5 m thick would require 5 ously providing water of this quality. As shown on chart
layers to begin to protrude into the turbulent flow at 8.6 1.A on page two of this guide, thermoplastic piping
ft/sec. As such, high velocity of water in distribution has systems typically operate at extremely lower rates of
been shown to have little or no effect in the control of ion contamination than 316L systems, thus, avoiding
microbiology and biofilm formation.3, 6 In fact, exces- contribution to nutrition level required for the prolifera-
sive flow velocities may actually accelerate biofilm tion of biofilm and bacteria laden systems. This is the
growth.3 basis of biofilm control in the semiconductor industry
where routine decontaminations and sanitation cycles

APP-02
are avoided, as the procedures themselves are consid- There is no correlation between the presence of biofilm
ered a source of contamination. Additionally, it requires and the water quality delivered to Points of Use.7 By
downtime that is neither available nor appreciated. inhibiting biofilm growth, the scant biofilm that may be
Although semiconductor water requirements are differ- present is left virtually irreversibly attached to the
ent than those required for Life Sciences, high quality
substrate (pipe surface) in the laminar sub layer where it
water with controlled biocolonization and endotoxin
levels are issues for both industries. is unable to be sloughed into the bulk flow. This allows
the Semiconductor Industry to achieve total bacteria
Materials of Construction counts (dead and alive) of less than 10 cells/liter.
Thermoplastics are the preferred choice for the materi-
als utilized in UPW systems and distribution piping 4.6.2 Conclusion
where water quality is the primary concern. In conclusion, thermoplastic piping systems should be
specified for exceptionally high quality water systems
The product water from Life Science water systems for the following reasons:
utilizing 316L piping, always demonstrate a distinct
metal ion signature, mirroring the composition of the - 316L systems have been shown to be more
316L distribution piping. Trace metals for 64 elements susceptible than PVDF to excessive biofilm
as measured by ICP/MS are typically negative for high formation.
purity thermoplastic water systems to parts per trillion - Hot water systems, if desired, are compatible
(ppt) levels.8 with thermoplastic systems and do not experi-
ence accelerated corrosion as with stainless
It is clear that 316L stainless steel supports the attach- systems.
ment and apparently promotes the growth of biofilm - High performance thermoplastics do not
when compared side by side with thermoplastics in a contribute to the nutrition (ion contamination)
Section 4
series of tests. Gray states that stainless steel was levels of water systems.
generally concluded to allow more extensive biofilm
growth than plastics.9, 6 Husted found consistently lower The key to controlling microbiology in high purity water
microbial cell densities and biofouling, per unit area, are systems is maintaining exceptionally high water quality.
noted for thermoplastics when compared to stainless Operating higher quality systems than mandated by
steel.9 (See Section 4.2 for more details). USP specifications should not be expensive. The use
of very low TOC water (< 10 ppb TOC recommended)
Surface finish alone does not appear to explain the and thermoplastic distribution piping is conducive to
control microbiology via nutrient deprivation.
disparity between 316L stainless steel and Thermoplas-
tic piping systems. The average wall smoothness for The Semiconductor/Thermoplastic approach to higher
Polypropylene is not as good as mechanical finished water quality is proven effective and reliable and results
316L stainless steel, yet experience indicates bacteria in considerable cost savings in:
counts in the bulk water phase for Polypropylene is very
similar to other thermoplastics reported in the data. - Cost of Installation and Maintenance
This may indicate the biofouling is reduced for Polypro- - No boriscoping, passivation or de-rouging
pylene despite a rougher average pipe wall finish. requirements
Further investigation is ongoing. - No hot water utilities infrastructure and opera-
tional costs
As mentioned above, one possible explanation may be
The Semiconductor Industry routinely operates ambient
the metals in 316L provide a source of scarce limiting
DI water systems with less than one cfu/ liter microbiol-
nutrients that are definitely not present in either PVDF
ogy levels without routine sanitizations being required.
or PP thermoplastic piping systems. However, thermo-
The effective and proven practices of biofilm control in
plastics such as PVC should be avoided for the sol-
this industry, of which thermoplastic piping systems is a
vents required for system joining contribute to contami-
major factor, should be considered as applicable and a
nation concerns and system TOC levels. The fact that
cGMP for Life Sciences. Regardless of industry, low
PVDF may be employed at 65C to 80C and can be
bacteria counts and high quality water systems are
steam sanitized could make it an attractive option to
absolutely required.
replace stainless steel in hot WFI applications and is
being utilized more frequently.

27 APP-02
Section 4.6 Bibliography
1. Costerton, J.W. and Stewart, Philip S.; Battling

Biofilm; Scientific American; (July, 2001)
2. Patterson MK, Husted G. Rutkowski , et al.,

Isolation, Identification, and Microscopic Properties of
Biofilms in High-Purity Water distribution systems,
presented to the UltraPure Water Conference, Santa
Clare, CA. November 1990 and published in UltraPure
Water Journal, 8(4):18-24, 1991
3 Martyak, J.E., Carmody J.E., and Husted G.R.;

Characterizing Biofilm Growth in Deionized UltraPure
Water Piping Systems, MicroContamination; 11(1) pp
39-44 (January 1993)
4. Husted G. Rutkowski AA Couture A, Response

of Oligotrophic Biofilm Bacteria in High Purity Water
Section 4
Systems to Stepwise Nutrient Supplementation,

UltraPure Water Journal September 1994
5. Battling Biofilm; Scientific American; 7/2001
6. Gray, G.; Recirculation Velocities in WFI Distribution

Systems; Pharmaceutical Engineering; Volume 17, #6,
Nov/Dec 1997
7. Riedewald, F.; Biofilms in Pharmaceutical Waters;

Pharmaceutical Engineering; Volume 17, #6, Nov/Dec
1997
8. With the exception of very low levels of boron, which

can often be detected in high purity water systems
regardless of design. Boron is typically the first ion to
breakthrough a water system.
9. Husted, G.; Evaluation of HALAR ECTFE for Sur-

face Properties and Biofilm Formation in Ultrapure
Water Service; Micro Techno Research; Hinesburg, VT,
printed by Ausimont, USA (July 11, 1996)

APP-02
Section Five: Validation Plan Asahi/America Application and Validation Guide
Section Five
Validation Plan and It is extremely important to properly plan the validation of
Sample Validation Protocals the system that is being installed. The plan becomes the
basis of the entire activity and establishes the following
components:
5.0 Generic Validation Plan

1. Scope
Prior to writing and building a validation plan, the es- 2. Facility or Process Description
sence of validation must be understood. The accepted
definition of validation by the FDA is: 3. Systems and Equipment to be Validated
4. Responsibilities:
Documented evidence which provides a high degree of Protocol Preparation
assurance that a specific process will consistently Protocol Execution
produce a product meeting its predetermined specifica-
tions and quality attributes. 5. Acceptance Criteria
6. Protoc0l Format
Note the underlined words. The documented evidence is
prepared with the following industry protocols: 7. Reference Procedures:
Standard Operating Procedures (SOP)
Material Receiving Procedures
Installation Qualification (IQ) Inspection Procedures
Documented verification that the equipment or system Calibration Procedures
has been installed according to plans and specifications.
All the pertinent information is assembled with this 8. Validation Schedule
document. 9. Manpower Requirements
Section 5
The IQ should be written at the conception of a project 10. Change Control Procedures
and followed throughout the installation. In many cases it
11. Re-Validation Requirements
is written as an after thought to comply with regulations.
Asahi/America provides the guideline for the IQ to make 12. Appendices
the document useful to a project. Room Classification and Pressurization
Drawings
Operational Qualification (OQ) Personnel and Material Flow Diagram
Verification that the system operates according to the Process Flow Charts
design drawings and specifications. Failure modes and Discussion
alarms are confirmed.
Process Qualification (PQ) Not all of the above items may be needed for a system
Confirmation that the system will produce the product or which is part of an overall facility project. The two most
material as intended. Various operating configurations important documents in the plan and the subsequent
may require simulation. Analytical procedures must also protocols are a system description and a detailed
be validated and the final test results complete the process and instrumentation drawing. These should be
validation report. prepared as soon as the design has been established.
The final document is a summary report which discusses

the validation and determines that all acceptance criteria
have been met.

29 APP-02
Asahi/America Application and Validation Guide Section Five: Validation Plan
5.1 Schedule
The typical project schedules shown cover the total

validation effort.
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Design
Engineering
Procurement
& Delivery
Construction
StartUp &
Commissioning
Validation Plan
Protocol Preparation
Initial SOP Prep
IQ Execution
OQ Execution
5.2 Sample Protocols
The protocols shown in this section are in a suggested

Section 5
format and have been successfully utilized for many

water systems. Since USP Purified Water Systems are
one of the most common applications, we have chosen
these examples. Similar protocols may be developed for
any of the other applications. The format is not as
important as the content. Each protocol contains all
necessary information.
These protocols are availble in full-sized, eletronic format

per request and can also be tailored to other process
systems. Asahi/America offers this service as part of its
Total Systems Approach to your water system valida-
tion process. Simply email your request to:
ValidationGuide@asahi-america.com
Please be sure to include your name, phone number,

place of employment and a return email address.
Sample protocols will be sent in MS Word Document
format.

APP-02
Section Five: Validation Plan Asahi/America Application and Validation Guide
Sample Protocols:
TAL INDEX
MANUAL AND SUBMIT
6. EQUIPMENT
Piping System
ral Polypropylene
PolyPure Natu
1. Title: Rev. PP-99A
Number: 1999
Installation Qua :
Revision Date lastic Val
lification: INTR istant Thermop
ODUCTIO Corrosion-Res
N Asahi/America
1.1 PURPOSE 2. Title: Rev. V-00/A
Number: 2000
:
To provide a
protocol for the Revision Date Meters
x Flow
System. This Installation Qua Universal Vorte
Insta lifica
system including llation Qualification will defin tion (IQ) of the new High Asahi/America
modifications/ e Purity W 3. Title:
United States upgrades to prod the established high purity
Phar
executed to asse macopoeia (USP) Purified uce the water wate
quality attributes r Rev. FM-98/B
Water. The Insta Number:
verification that mble all the documents and me : 1998
the equipmen background infor llation Qualification Revision Date Cont rols
specifications. t was
Further, this Insta installed in conformance mation pertaining to Actuation and
attributes and llation Qualificat with the draw Asahi/America
operating para ion will estab ings and 4. Title: Re. AC-99/A
meters. lish standards
for qu Number: 1999
1.2 BACKGROUN :
D/SUMMARY Revision Date PVDF
Valve made of
This new High Agru Sampling
Purity Water Title: 6/F
current Good
Man
System is desig
ned to meet the
5. L-MM/TI-Rm2.9
system will mee ufacturing Practice (cGM standards of Number:
:
t the requirem P). The water the FDA
ents of the curre quality Revision Date iaphragm Valv
es
nt USP for Purif produced by this leg (T) Valves/D
The system was ied Water. Agru Zero Dead
designed by:
____________ 6. Title:
____________
The system was ____Date: ____
____ Number:
installed by: ____ :
____________
____________ Revision Date
_Date: ________ s:
/Discrepancie
Observations
Date:
Submitted By:
mentation is
Above Docu
Y/N
Complete:
Section 5
7.2.3Perform
ance Qualific
atio n
Equipment Des
cription:
Protocol Prep
High Purity Wat
ared By er System
ODUCTION:
lification: INTR
Operational Qua
Approved for Date
Execution
____________ By ____________
____________
_______
1.1 PURPOSE
of the new High Approved for Date
ification (OQ) r Execution
Operational Qual enge this wate ____________ By ____________________
protocol for the rational Qualification will chall ates as specified by ________
To provide a Ope m oper ___
System. This lled sub-syste will result in
Purity Water each correctly insta this valid ation protocol
that of to
system to verify In addition, the execution information pertaining
Approved for
Execution Date
urer. nd
the manufact ts and back grou ition. ____________ By ____________________
of all documen its installed cond ___________
the assembly t operates in
the equipmen
verification that ess of the
ate the effectiven to
ence to demonstr ents for maintenance, and Date
e 1 will comm the requirem d with the high
Further, Phas to esta blish asso ciate
monitoring sche
me, es (SOPs)
dard oper ating procedur Equipment Des
support the stan m. cription:
purity wate r syste Practice High Purity Wat
Manufacturing 1.1 PURPOSE er System
for current Good will meet the
ards of the FDA water system will be tested
To meet the stand r quality produced by this points-of-use To provide a
(cGMP). The
wate
s Phar maco epeia 25. All protocol for the
of United State oved procedure. water system. Performance
requirements This Performan Qualification
appr of the new high
ied Water per document and ce
confirm the appr Qualification will be executed purity
for USP Purif operating rang opriateness of to evaluate,
es. In addition, the critical proc
water system this performan ess paramete
and ce r
D/SU MMARY operated in acco water quality reproducibility qualification will demonst
1.2 BACKGROUN standards of
the rdance with appr over a duration rate both
ned to meet the oved standard of one year when
System is desig (cGMP). The water quality operating proc
Purity Water tice USP for 1.2 BACKGR edures.
This new High ufacturing Prac requirements of the current OUND/SUMMA
nt Good Man t the RY
FDA for curre m will mee
this water syste This new High
produced by FDA for curre
Purity Water
System is desig
r. ___
Purified Wate Date: ________ nt Good Man
ufact ned to meet the
____________ produced by
this water syste uring Practice (cGMP). The standards of the
____________
designed by: _______ Purified Wate m will meet the water quality
The system was _____Date: ____
r. requirements
of the current
____________ USP for
m was insta lled by: ________ The system was
The syste designed by:
___________ ____________
____________
_________Dat
e:
The system was
installed by: ____
___________ ____________
____________
______Date:

31 APP-02
Asahi/America Application and Validation Guide Section Five: Validation Plan

Section 5

APP-02
Section Six: Materials and Systems Overview Asahi/America Application and Validation Guide
It is the best material for handling high concentrations of

Section Six sodium hypochlorite. Additionally, E-CTFE has good
Materials and electrical properties, and a broad-use temperature range
from cryogenic to 300F (150 C). E-CTFE is a tough
Systems Overview material with excellent impact strength over its broad-use
temperature range. E-CTFE also maintains useful
6.0 Materials Introduction properties on exposure to cobalt 60 radiation at dosages
of 200 megarands. It is one of the best fluoropolymers
This section is devoted to the discussion of thermoplas- for abrasion resistance.
tics and their properties as they pertain to pharmaceuti-
cal applications. References to polypropylene and Ultra Proline Halar Systems is Asahi/Americas E-CTFE
PVDF are valid for Proline PP, PolyPure PP and Purad Piping System. Ultra Proline Systems are available in
PVDF systems as offered by Asahi/America. Discus- sizes between 32mm and 110mm (1 and 4) with a
sions of PVC and CPVC are relevant to our broad line of basic assortment of fittings and diaphragm valves. Ultra
valving products, as well as a general guide for piping Proline Systems should be considered for aggressive
systems constructed of these materials CIP applications such as high concentrations of sodium
hypochlorite, which have traditionally been difficult for
PVDF (Polyvinylidene Fluoride) other materials to handle.
This high molecular weight fluorocarbon has superior
abrasion resistance, dielectric properties and mechanical Thermoplastic Application Range
strength. These characteristics are maintained over a
temperature range of -40 F (-40 C) to 284 F (140 C). Material Max. Operating Ranges of Application
In piping systems, PVDF is best suited for systems Temperature
operating from 14 F (-10 C) to 250 F (121 C). PVDF
PVDF 284 F / 140 C piping:
is highly resistant to wet or dry chlorine, bromine and - Cold and hot UPW distribution
other halogens, most strong acids, aliphatics, aromatics, - Polishing system
alcohols and chlorinated solvents. Because of its ex- -Cleanroom loop system
tremely low amounts of extractables, PVDF is widely - Hook up system
- Reclaim system
used in the transport of ultra pure water for the semicon- - Drain / waste system
ductor and pharmaceutical industries. - CIP Chemical distribution
Asahi/America offers the Purad PVDF System for high E-CTFE 300 F / 150 C semifinished products:
- Lining of UPW storage tanks
purity applications. Purad is ideal for Pure Water and - Lining of chemical storage tanks
Water for Injection service. It is available in sizes 20mm - Tank construction
to 315mm (1/2 to 12) with a wide assortment of fittings, - Apparatus
Section 6
valves and flowmeters. - Machined components
PolyPure 204 F / 95 C piping:

E-CTFE (Ethylene Tetrafluoroethylene) Proline PP -Cold and hot UPW distribution
E-CTFE fluoropolymer is commonly known by its trade - Reclaim system
name HALAR. E-CTFE is essential a 1:1 alternating - Drain / waste system
- Reclaim system
copolymer of ethylene and CTFE (chlorotrifluoro- - CIP Chemical Distribution
ethylene). It contains about 80% CTFE, one of the most - Ventilation systems (Duct)
chemically resistant building blocks that can be used to
make a polymer. However, CTFE homopolymers are PVC 140 F / 60 C piping:
-Cold UPW feedwater
difficult to fabricate, extrude or mold. By the copolymer- - Drain / waste system
ization with ethylene, E-CTFE displays much of the - Limited Reclaim system
chemical resistance of CTFE with the ease of process- - Ventilation systems (Duct)
ing. It provides excellent chemical resistance, handling
CPVC 195 F / 90 C piping:
applications that almost all other materials can not. In -Cold and hot UPW feedwater
particular, E-CTFE demonstrates effective handling of - Limited Reclaim system
fuming acids and chlorinated bases. - Drain / waste system
- Hot Acid Waste
HALAR is a registered trademark of Solvay Polymers - Ventilation systems (Duct)

33 APP-02
Asahi/America Application and Validation Guide Section Six: Materials and Systems Overview
PP (Polypropylene) should be specified in some instances where hot

A member of the polyolefin family, PP is one of the corrosive liquids are being handled and an extra
lightest plastics known. It possesses excellent chemical margin of safety is required. CPVC is joined using a
resistance to many acids, alkalies and organic solvents. solvent cement process.
PP is one of the best materials to use for systems
exposed to varying pH levels as many plastics do not CPVC valves are available primarily as ball or dia-
handle both acids and bases as well. It is not recom- phragm type with sizes 1/2 through 12 commonly
mended for use with hydrocarbons and aromatics. PP is stocked. As with our PVC offering, our valve depart-
excellent for the transport of caustic cleaning agents ment in available to assist with sizing and selecting the
often used in CIP applications. PP has also been appropriate product for your application.
extensively used in UPW applications because of its cost
effectiveness and good purity performance when com-
pared to PVDF. Its upper temperature limit is 204 F
(95C).
Asahi/America offers two polypropylene piping systems:

PolyPure and Proline. PolyPure is a natural PP produced
primarily for Pure Water applications. Its packaging and
production environment has been selected to ensure pure
quality for UPW systems and is available from 20mm to
110mm (1/2 to 4)
Proline PP is a pigmented PP with a large and versatile

application range. Sizes from 20mm to 1400mm (1/2 to
54) are available in a variety of pressure ratings for
UPW, Chemical or Vent Systems.
PVC (Polyvinyl Chloride)

Asahi/America uses an unplasticized PVC polymer in
all its PVC valves and flowmeters. This material has
excellent chemical resistance, strength, rigidity, and
modulus of elasticity. It resists attack by most acids
and strong alkalies, as well as gasoline, kerosene,
aliphatic alcohols and hydrocarbons, and salt solutions.
Aromatic, chlorinated organic compounds, and lacquer
Section 6
solvents do affect PVC chemical properties. Its low

cost and overall balance of properties make PVC the
material best suited to the widest number of corrosive
applications. Its temperature limit is 140 oF/60 oC. PVC
is joined using a solvent cement process.
Asahi/America has pioneered the application usage of

PVC Valves in the United States. Our valve product
offering is one of the largest available. Depending on
valve type, sizes from 1/2 to 24 are readily available
from stock. Please consult our experienced valve
department to learn more.
CPVC (Chlorinated Polyvinyl Chloride)

The properties of CPVC and its advantages are very
similar to those of PVC; however, its working tempera-
ture range is higher (195oF/90oC) than that of PVC. It

APP-02
6.1 Purad PVDF
6.1.1 Materials PURAD PVDF PHYSICAL CHARACTERISTICS

Purad PVDF pipe, valves and fittings are manufactured
of natural Polyvinylidene Fluoride resin. PVDF is part
Property Test Standard Unit PVDF
of the fluorocarbon family with an alternating fluoride
3
and hydrogen atom. These resins are partially crystal- Specific gravity ISO 1183 g/cm 1.77
line, high molecular weight Water absorption DIN 53495 % < 0.04
polymers of vinylidene fluoride.
Purad is 100% PVDF with H F Permissible service
- C -40 to +140
absolutely no antioxidants, temperature
-C-C-
antistatic agents, colorants, fillers, Tensile strength at yield ISO 527 MPa 50
flame retardants, heat stabilizers, F H
Elongation at yield ISO 527 % 9
lubricants, plasticizers, preserva-
tives, processing aids, UV Tensile strength at break ISO 527 MPa 46
stabilizers or any other additives. Purad is also resis- Elongation at break ISO 527 % 80
tant to the effects of gamma radiation and has V-O
2
rating according to UL-94 vertical flame test. Impact strength ISO 179 kJ/m 124
2
Notch impact strength ISO 179 kJ/m 11
Purad PVDF has been qualified for its inherent purity
through extensive testing performed by internationally Ball ind. hardness Rockwell ISO 2039-1 MPa 80
recognized independent laboratories. The outstanding
performance of Purad material with respect to extreme Flexural strength ISO 178 MPa 80
conditions is well documented and available upon
Modulus of elasticity ISO 527 MPa 2000
request. It is well suited to handle such aggressive
media as ultrapure water and ultrapure, electronic Vicat softening temp
ISO 306 C 140
grade acids. Just as importantly, it conforms to FDA VST/B/50
regulations as outlined in Title 21, Chapter 1, Part 177-
Heat deflection temp HDT/B ISO 75 C 145
2510 for contact with food, of Code of Federal Regula-
tions and is suitable for the safe application of products Coef. of linear therm.
for continuous contact with food stuffs. PVDF corre- DIN 53752 K-1 x 10-4 1.2
Expansion
sponds also to the criteria of the 3A Sanitary Stan-
dards for multiple use plastic materials used as product Thermal conductivity at
DIN 52612 W/(mxK) 0.13
contact surfaces for dairy equipment serial No. 2000. 20 C
Section 6
Volume resistivity VDE 0303 OHM cm > 1013
Due to its material properties, surface finish, purity,
mechanical strength and ease of installation, PVDF Surface resistivity VDE 0303 OHM > 1012
has become the flagship piping product of Asahi/
America and high purity water and chemical applica- Dielectric constant at 1MHz DIN 53483 - 7.25
tions.
Dielectric strength VDE 0303 kV/mm 22
The surface of PVDF components prevents the prolifera- Physiological non-toxic EEC 90/128 - Yes
tion of microorganisms, similar to the surface of glass.
This conclusion is the result of a study carried out be CFR 21.1177-
FDA - Yes
Solvay at the Centre dEnseignement et de Recherches 2510
des Industries Alimentaires et Chimigues, CERIA in Friction coefficient DIN 53375 - 0.34
Brussels, analysis no. 284.321 dated the 14th of May
Flammability UL94 - V-0
1974.
UV stabilization - - Yes*
*PVDF is not suitable for direct connection to UV-Sterilizers. UV light traps can be installed
to eliminate the problem.

35 APP-02
6.1.2 System Overview

The Purad high purity PVDF Pipe System is designed
specifically for use in ultra pure water application. Every
valve, fitting and pipe is designed, produced and pack-
aged for high purity applications. No other system in the
world was designed from the ground up with this inten-
tion.
Purad is produced with the premiere PVDF resin of the

market. It is the only product to exclusively utilize
Solvays high purity Solef resin for all pipe, fittings, valves
and flow meters. Single resin source ensures compo-
nent compatibility and produces reliable, repeatable weld
quality. Utilizing a single resin source also simplifies
validation protocol.
Solvays Solef 1000-0001 Series Resin is 100% pure

PVDF with absolutely no additives or processing agents.
Designed and produced exclusively for high purity
applications, Solef resin provides superior performance
and reliability.
Purad is available in sizes through 12. All compo-

nents are produced in a class 1000 or 100 cleanroom.
Dedicated extrusion and molding equipment eliminates
cross contamination threats. Continuous quality control
measures are in place to ensure the Purad product
meets our stringent qualifications.
Purad Pipe is immediately packaged after production in a

class 100 cleanroom. They are sealed on each end with
a PE film and PE cap. The pipe is then sleeved in the PE
Section 6
and heat sealed on each end. Pipes are shipped in rigid

PE tubes which are non-particle generating and resistant
to moisture and impacts.
Valves and fittings are cleaned after secondary machin-

ing in a 6 basin automated hot UPW bath system (UPW
quality: TOC <10 ppb, conductivity >18 ,
Temperature >70C). After drying with hot clean-air
(class 100) and 100% quality inspection, the valves are
assemblied and all fittings and valves are double bagged
under a cleanroom class 100 environment.

APP-02
The Purad PVDF system offers zero deadleg valves in

over 35 size configurations from 20mm x 20mm to
110mm x 63mm ( x to 4x 2). Specialty fittings
such as instrument fittings allow for the proper installation
of gauges and sample valves, completely eliminating
dead zones in a pipe system. Newly introduced needle
valves now provide an excellent method for drawing off
low volume samples.
System assembly can be conducted utilizing two ap-

proved high purity methods. Beadless smooth surface
fusion is available from to 2. Non contact IR fusion is
available from to 10. Both methods offer consider-
able purity advantages over conventional methods. For
less critical applications, contact butt fusion and socket
fusion are available. Please consult the installation
section of this manual and Asahi/Americas Engineering
Design Guide for further information on joining tech-
niques.
6.1.3 Surface Finish

Purad PVDF is produced with extremely smooth surface
finishes. Depending on size, finish quality tolerances are
held as tight as 7.5 m Ra for both pipe and fittings. The
excellent surface finish helps resist biofilm and
biocolonization. The smooth surface on our high purity
components are achieved by application of specially
designed and designated manufacturing equipment and
tooling. Special materials and surface finishes of tools
used for injection moulding and extrusion have a signifi-
cant influence upon the surface quality of the finished
product.
Section 6
The surface quality is constantly monitored during
production of all high purity components. The surface
roughness (Ra-values) and micropores are measured to
ensure system compliance. These tests are performed
on a statistical basis and provide an excellent indication
of the quality of the manufacturing process. Additionally,
independent labs and interferential microscopy are used
to measure quality in accordance with SEMATECH
9201055 B (SEM).

37 APP-02
6.1.4 Purad Pressure Rating 6.1.4 Purad: The Pure Advantage

As with all thermoplastic materials, Purads pressure While many companies offer PVDF piping, only Asahi/
rating is derated as the operating temperature is in- America offers the Total System Approach. The Purad
creased. Purad has two available system ratings System is more than components, it is a highly engi-
depending on the Standard Dimensional Ratio (SDR). neered system providing the greatest level of purity,
SDR21 is rated for PN16/230psi services and SDR33 reliability and safety.
has a PN10/150psi rating. To determine the rating based
on a systems operating temperature use the table below. Purad systems consist of many individual advantages
when combined provide the most reliable and complete
system on the market. Some of the advantages include:
Temperature Temperature Correction
o
F o
C Factor One resin supplier for all components
One color for all products
68 20 1.00 Largest size range 20mm - 315mm ( 12)
80 27 0.95 Vortex Flow meters from 16mm - 225mm ( 9)
90 32 0.87 More pressure rating options per size
100 38 0.80 Sweep 90 elbows instead of sharp radius
120 49 0.68 All products class 100 or 1000 clean room produced
140 60 0.58 Each fitting and valve hot DI washed for over 1 hour
160 71 0.49 Pipe Packaging includes HDPE outer tube; non-
180 82 0.42 particle generating
200 93 0.36 Fittings in tear-proof double bags
240 115 0.25
280 138 0.18 The Total Systems Approach provides Purad Systems
Table 6.1: Purad PVDF Pressure Rating Table. with the Pure Advantage in high purity flow distribution.
Multiply the Correction Factor times the nominal pipe rating.
Example: SDR21 Pipe (230psi) at 120 oF, 230psi x 0.68 = 156.4 psi
Section 6

APP-02
6.2 HALAR E-CTFE 6.1.3 Surface Finish

Ultra Proline is produced with surface finishes smoother
6.1.1 Materials than that of PVDF. Depending on size, finish quality is
HALAR resin, produced by Solvay Polymers is a better than 7.8 m Ra for both pipe and fittings. The
copolymer of Ethylene and excellent surface finish helps resist biofilm.
chlorotrifluorethylene. Halar
offers superior chemical H H F F HALAR E-CTFE PHYSICAL CHARACTERISTICS
resistance, electrical properties, -C -C-C-C- Property Test Standard Unit E-CTFE
and extremely low permeability.
Halar has a temperature range H H Cl F Specific gravity ISO 1183 g/cm 3
1.68
of 105 F to 300 F. Water absorption DIN 53495 % < 0.1
Permissible service
Severe stress tests have proven that it is not subject to - C -76 to +150
temperature
chemically induced stress cracking from strong acids
and bases, solvents and chlorine. In particular E-CTFE Tensile strength at yield ISO 527 MPa 30
can with stand high concentrations of Sodium Hypochlo-
Elongation at yield ISO 527 % 5
rite and Hydrogen Peroxide, out performing most
available plastic and alloy materials. It is only affected by Tensile strength at break ISO 527 MPa 54
hot amines and molten alkali metals. Elongation at break ISO 527 % 250
Impact strength ISO 179 kJ/m2 no break

HALAR is produced in a variety finished and
semifinished forms. As a semifinished product, Halar is Notch impact strength ISO 179 kJ/m2 no break
commonly used as tank liners, sheet material or rod
stock. Asahi/Americas HALAR systems is martketed Ball ind. hardness Rockwell ISO 2039-1 MPa R 90
as Ultra Proline E-CTFE is the only molded and extruded
HALAR piping system for pressure applications. Flexural strength ISO 178 MPa 47
Modulus of elasticity ISO 527 MPa 1690

Ultra Proline is available in dimensions between 32mm Vicat softening temp
ISO 306 C --
110mm (1 4). Larger sizes can be accommodated on VST/B/50
special request. Fittings are produced as butt fusion
Heat deflection temp HDT/B ISO 75 C 90
style suitable for contact butt fusion and IR non-contact
butt fusion. Halar piping systems can be specified as Coef. of linear therm.
DIN 53752 K-1 x 10-4 0.8
high purity or general grade depending on application Expansion
Section 6
requirement.
Thermal conductivity at
DIN 52612 W/(mxK) 0.15
High purity Ultra Proline Pipe, as with Purad PVDF, is 20 C
immediately packaged after production in a class 100 Volume resistivity VDE 0303 OHM cm > 1016
cleanroom. Pipe ends are sealed with PE film and PE
cap. The pipe is then sleeved in the PE and heat sealed Surface resistivity VDE 0303 OHM > 1014
on each end. Pipes are shipped in rigid PE tubes which
are non-particle generating and resistant to moisture and Dielectric constant at 1MHz DIN 53483 - 2.6
impacts.
Dielectric strength VDE 0303 kV/mm 30-35
Valves and fittings are cleaned after secondary machin- Physiological non-toxic EEC 90/128 - Yes
ing in a 6 basin automated hot UPW bath system (UPW
quality: TOC <10 ppb, conductivity >18 , FDA
CFR 21.1177-
- in prep.
2510
Temperature >70C). After drying with hot clean-air
(class 100) and 100% inspection, the valves are Friction coefficient DIN 53375 - 0.19
assembled and all fittings and valves are double Flammability UL94 - V-0
packaged under a class 100 cleanroom environment.
UV stabilization - - Yes

39 APP-02
Components are produced by application of special maintaining the same SDR. Care should be taken when
design and designated manufacturing equipment and specifying Halar systems to ensure all system compo-
tooling. Special material and finish of tools used for nents are suitable for the application pressure require-
injection molding and extrusion have a significant ments.
influence upon the surface quality of the finished product.
6.2.4 Ultra Proline Advantages
The surface quality is constantly monitored during Asahi/America and Agru are uniquely able to provide
production of all high purity components. The surface Halar piping systems offering the following advantages:
roughness (Ra-values) and micropores are measured to
ensure system compliance. These tests are performed One of the smoothest Surface Finish of any thermo-
on a statistical basis and provide an excellent indication plastic material
of the quality of the manufacturing process. Additionally, Extremely low levels of leachables
independent labs and interferential microscopy are used More cost effective than PFA Pipe
to measure quality in accordance with SEMATECH Superior Chemical Resistance
9201055 B (SEM). Reliable Joining Techniques
6.2.4 Ultra Proline Pressure Rating

As with all thermoplastic materials, Ultra Proline pressure
rating is derated as the operating temperature is in-
creased. All Halar components are produced as a SDR21
system. Halar systems differ from most thermoplastics
in that its pressure rating varies according to OD while
Table 6.3 Halar Pressure System Pressure Rating

PN 10 / ISO S-10 / SDR 21
Operation Permissible system working pressure 1) bar/psi
Temperature
period
[C]/[F] [years] OD 20mm-32mm OD 40mm-50mm OD 63mm-160mm
OD 1/2" - 1" OD 1 1/4" - 1 1/2" OD 2" - 6"
20/68 1 20.2/287.3 15.9/226.1 12.6/179.2

10 18.7/265.9 14.7/209.0 11.6/164.9
25 17.7/251.7 13.9/197.7 11.0/156.4
50 17.2/244.6 13.5/192.0 10.7/152.1
Section 6
60/140 1 13.1/186.3 10.3/146.5 8.2/112.3

10 11.1/157.8 8.7/123.7 6.9/98.1
25 10.6/150.7 8.3/118.0 6.6/93.8
50 10.1/143.6 7.9/112.3 6.3/89.6
70/158 1 9.1/129.4 7.1/100.9 5.6/79.6

10 8.4/119.4 6.6/93.8 5.2/73.9
25 8.1/115.2 6.3/89.6 5.0/71.1
50 7.9/112.3 6.2/88.1 4.9/69.6
80/176 1 6.7/95.2 5.3/75.3 4.2/59.7

10 6.4/91.0 5.1/72.5 4.0/56.8
25 6.2/88.1 4.9/69.6 3.9/55.4
50 6.1/86.7 4.8/68.2 3.8/54.0
90/203 1 4.9/69.6 3.9/55.4 3.1/44.0

10 4.9/69.6 3.9/55.4 3.1/44.0
25 4.9/69.6 3.9/55.4 3.1/44.0
50 4.9/69.6 3.9/55.4 3.1/44.0

APP-02
6.3 PolyPure Natural Polypropylene additional purity benefit of reduced risk of heater element
cross-contamination. If desired, socket fusion is available
6.3.1 Materials for sizes 20mm - 63mm ( - 2).
PolyPure is a natural, random copolymer polypropylene
offering superior mechanical proper-
ties over homopolymer materials. H H
PolyPures flexural modulus is more - C - C- POLYPURE PHYSICAL CHARACTERISTICS
than 30% lower than homopolymer H H- C -H Property Test Standard Unit PP-R
pipe, making it more flexible in H 3
bending applications. Lower crystallin- Specific gravity ISO 1183 g/cm 0.9
ity in the joints also makes PolyPure more reliable. Water absorption DIN 53495 % (-) < 0.01
PolyPure is a pure polypropylene, offering low Permissible service

- C -5 to +95
temperature
extractables and excellent surface finish. PolyPure
production is conducted on Agrus state-of-the-art Tensile strength at yield ISO 527 MPa 25
extrusion and injection molding equipment. Pipe is
Elongation at yield ISO 527 % (-) 12
capped and sealed immediately after production. Fittings
and valves are cleanroom produced, DI rinsed after Tensile strength at break ISO 527 MPa 40
secondary machining and individually packaged. This Elongation at break ISO 527 % 800
production standards helps maintain the purity of the
system. Impact strength ISO 179 kJ/m2 no break
2
Notch impact strength ISO 179 kJ/m 25
The PolyPure system is a viable, cost-effective alterna-
tive to stainless steel and PVDF Pure Water systems. Ball ind. hardness Rockwell ISO 2039-1 MPa 45
Superior resin and production techniques are employed
to maximize the effectiveness of the PolyPure system. In Flexural strength ISO 178 MPa 20
addition, PolyPure conforms to the FDA, CFR, Title 21
Modulus of elasticity ISO 527 MPa (-) 700
(2001) 177.1520 for contact with food stuff.
Vicat softening temp
ISO 306 C 65
6.3.2 System Overview VST/B/50
PolyPure is available in sizes 20mm - 110mm ( 4)
Heat deflection temp HDT/B ISO 75 C (68) 75
with a wide variety of fittings, valves, flow meters and
joining techniques. Coef. of linear therm.
DIN 53752 K-1 x 10-4 1.5
Expansion
Section 6
Produced on dedicated equipment, PolyPure compo-
nents are packaged to protect its purity and quality. Pipe Thermal conductivity at
DIN 52612 W/(mxK) 0.24
ends are immediately sealed with PE film and PE Caps. 20 C
Pipe are then packaged in full length PE bags (quantity Volume resistivity VDE 0303 OHM cm > 1016
dependent) for further protection.
Surface resistivity VDE 0303 OHM > 1013
Valves and fittings are cleaned after secondary machin-
ing in an automated hot UPW bath system (UPW Dielectric constant at 1MHz DIN 53483 - 2.33
quality: TOC <10 ppb, conductivity >18 ,
Temperature >70C). After drying with hot clean-air Dielectric strength VDE 0303 kV/mm (75) 70
(class 100) and 100% inspection, the valves are Physiological non-toxic EEC 90/128 - Yes
assembled and all fittings and valves are double
packaged under a cleanroom class 100 environment. CFR 21.1177-
FDA - Yes
2510
The prefrered methods of system joining are butt or IR Friction coefficient DIN 53375 - 0.3
fusion. Butt and IR fusion methods provides superior Flammability UL94 - HB
weld mechanical properties exceeding the mechanical
properties of socket fusion. IR Fusion provides the UV stabilization - - No

41 APP-02
6.3.3 PolyPure Pressure Ratings

As with all thermoplastic materials, PolyPures pressure
creased. To determine the rating based on a systems
operating temperature use the table below. PolyPure is
an SDR 11 piping system rated at 150 psi at 68 F in all
dimensions.

o o
F C Factor
73 22.7 1.0
100 37.7 0.6
140 60.0 0.4
180 82.2 0.3
200 93.3 0.1
Table 6.2 PolyPure Pressure Rating Correction Chart
Example: SDR11 Pipe (150psi) at 140 oF, 230psi x 0.60 = 90 psi
6.3.4 PolyPure System Advantages:

PolyPure Systems offer many advantages. The
choice of resin, production methods and packaging
specifications combine to provide the highest quality
polypropylene system. Additional advantages
include:
Purity of Material, random copolymer PP resin offers

lower extractables compared to homopolymer PP and
high purity PVC system.
Random copolymer polypropylene offers superior
mechanical properties.
Clean room production insures the purest piping
Section 6
system available
Available in multiple joining techniques, Butt fusion,
Socket Fusion and IR Fusion.
All joints are made using heat fusion, providing
reliability and maintaining purity. No messy cements
which increase TOC levels.

APP-02
6.4 Proline Pigmented Polypropylene
6.4.1 Materials
Proline systems are pigmented PROLINE PHYSICAL CHARACTERISTICS
polypropylene and are manufactured H H
from random copolymer resin. - C - C-
Copolymer materials offer superior Property Test Standard Unit PP-R
H H- C -H
mechanical properties over ho- H Specific gravity ISO 1183 g/cm 3
0.9
mopolymer materials. Prolines Water absorption DIN 53495 % (-) < 0.01
flexural modulus is more than 30% lower than homopoly-
mer pipe, making it more flexible in bending applications. Permissible service
- C -5 to +95
Lower crystallinity in the joints also makes Proline temperature
systems more reliable.
Tensile strength at yield ISO 527 MPa 25
Proline systems have an extremely large application Elongation at yield ISO 527 % (-) 12
range. Equally suited for UPW transport, caustic CIP Tensile strength at break ISO 527 MPa 40
distribution or aggressive vent systems, Proline provides
Elongation at break ISO 527 % 800
maximum system flexibility.
Impact strength ISO 179 kJ/m2 no break
Notch impact strength ISO 179 kJ/m2 25

Proline is readily available in sizes 20mm to 630mm (1/2 Ball ind. hardness Rockwell ISO 2039-1 MPa 45
through 24) and can be supplied in sizes up to 1400mm
(54). The wide size range is supported by a full line of Flexural strength ISO 178 MPa 20
molded fittings and valves up to 400mm (20).
Modulus of elasticity ISO 527 MPa (-) 700
Proline systems are supplied as SDR11 or SDR33 with Vicat softening temp
respected pressure ratings of 150psi and 45psi. Addi- ISO 306 C 65
VST/B/50
tional ratings are available upon request.
Heat deflection temp HDT/B ISO 75 C (68) 75
High Purity Proline pipe is immediately packaged after
Coef. of linear therm.
production and is sealed on each end with a PE film and DIN 53752 K-1 x 10-4 1.5
Expansion
PE cap. The pipe is then sleeved in the PE and heat
Section 6
sealed on each end. Pipes are shipped in rigid PE tubes Thermal conductivity at
DIN 52612 W/(mxK) 0.24
which are non-particle generating and resistant to 20 C
moisture and impacts.
Volume resistivity VDE 0303 OHM cm > 1016
High purity grades of Proline valves and fittings are Surface resistivity VDE 0303 OHM > 1013
cleaned after secondary machining in an automated hot
UPW bath system (UPW quality: TOC <10 ppb, Dielectric constant at 1MHz DIN 53483 - 2.33
conductivity >18 , Temperature >70C). After
drying with hot clean-air (class 100) and 100% Dielectric strength VDE 0303 kV/mm (75) 70
inspection, the valves are assembled and all fittings and
Physiological non-toxic EEC 90/128 - Yes
valves are double packaged under a cleanroom class
100 environment. CFR 21.1177-
FDA - Yes
2510
Proline systems are joined by a variety if methods. For Friction coefficient DIN 53375 - 0.3
PW, IR is commonly specified. Butt and socket fusion
are available options. For vent systems, butt fusion or Flammability UL94 - HB
slip coupling welding can be utilized depending upon UV stabilization - - Limited
system size.

43 APP-02
6.4.3 Proline Pressure Ratings

As with all thermoplastic materials, PolyPures pressure
creased. To determine the rating based on a systems
operating temperature use the table below. PolyPure is
an SDR 11 piping system rated at 150 psi at 68 F in all
dimensions.

o o
F C Factor
73 22.7 1.0
100 37.7 0.6
140 60.0 0.4
180 82.2 0.3
200 93.3 0.1
Table 6.3 Proline Pressure Rating Correction Chart
Example: SDR11 Pipe (150psi) at 140 oF, 230psi x 0.60 = 90 psi
6.4.4 Proline System Advantages:

Proline Systems offer many advantages such as:
Largest assortment of molded polypropylene compo-

nents and fittings.
Available size range of 20mm to 1400mm (1/2 to 54)
Flexible application range.
Available in multiple joining techniques, Butt fusion,
Socket Fusion and IR Fusion.
All joints are made using heat fusion, providing
reliability and maintaining purity. No messy cements
which increase TOC levels.
Section 6

APP-02
6.5 Polymer Purity Data
In the international market different test methods for

leach out behavior are being used . The different test
methods provide different test results, which are not
comparable. For better identification and qualification all
Agru high purity systems have been tested according to
valid international standards.
Static leach tests provide valuable information on a

material purity. They are useful in comparing materials,
Analytical Equipment
but do not simulate an actual installation. When compar-
ing data, ensure the test methods and units of measure-
ment are identical. Results will vary based on the test-
method and unit of measurement used. Results mea-
sured by wetted surface are considered most depend-
able for comparison analysis.
Mesurement Types:
Ion chromatography (IC) According to SEMI draft doc.
2840 (rev 05/14/98)
Total organic carbon Analyses (TOC) According to
SEMI2840B STD (7d;850C)
Sample setup for static leach out test
Test Procedure:
Sample
Sample preparation in class 10,000 Preparation: PVDF-cap
environment
UPW
Test was performed in class 1 (18.1 MWcm)
Precleaning of the sample with UPW

L = 4D
according to SEMASPEC.
Section 6
PVDF
Pipe sample
Soak time 7 days
(to be tested)
Anion analyses by IC with suppressed
conductivity and preconcentration unit PVDF-cap
(Release values are notified)
Transition metals + Cation analyses by IC

with suppressed conductivity and postcolumn
derivation with PAR. D
Cleanroom
( Release values are notified )
Test Set Up:
activated carbon filter
TOC analyses by TAC-502P system
Laminar Flow
Samples
class 1

45 APP-02
Static Leach Out

Test Results:
Test Period Proline PP PolyPure Purad PVDF

Element [Days] [g/m2] [ppb] [g/m2] [ppb] [g/m2] [ppb]
Anions Sulphate 7 < 1.48 < 0.1 10.6 1.28 0.7 0.14
Chloride 7 4.3 0.29 13.17 1.06 11.7 1.9
Nitrite 7 < 1.48 < 0.1 4.43 0.35 < 1.9 < 0.3
Bromide 7 < 1.48 < 0.1 - - < 0.2 < 0.03
Nitrate 7 < 1.48 < 0.1 0.73 0.03 0.51 0.09
Phosphate 7 < 2.96 < 0.2 0.23 0.02 0.51 0.09
Fluoride 7 12.74 0.86 0.49 0.04 1097 174
Cations Lithium 7 < 1.48 < 0.1 - - < 0.19 < 0.04
Sodium 7 29.18 1.97 2.05 0.34 0.68 0.15
Potassium 7 < 2.96 1.48 0.25 0.02 0.62 0.11
Magnesium 7 38.22 2.58 11.96 1.46 0.38 0.07
Calcium 7 32.15 2.17 7.67 0.63 3.52 0.62

Metals Iron 7 3.41 0.23 0.44 0.04 0.97 0.18
Copper 7 < 1.48 < 0.1 0.11 0.02 < 0.91 < 0.17
Nickel 7 < 1.48 < 0.1 0.16 0.01 < 0.91 < 0.17
Zinc 7 5.33 0.36 7.22 0.39 1.57 0.28
Cobalt 7 1.78 0.12 - - < 0.91 < 0.17
TOC Analysis
Results:
Leachout Behavior of Total Organic Carbon

Section 6
100000
90000
80000
Concentration [g/m2]
70000
60000
50000
40000
30000
20000
10000
0
Proline HP PP PolyPure PP Purad PVDF SEMI Spec. E49.new
Polymer Material OD 50 - 63

APP-02
Section Seven: Piping Design Asahi/America Application and Validation Guide
Section Seven tectable levels of metal ions, Purad PVDF is recom-

mended for the service.
Piping Design
High Purity Water Systems For less stringent water quality applications, PolyPure
Natural Polypropylene is an excellent alternative.
PolyPure offers excellent surface smoothness, as well
7.0 Introduction as, low extractable levels as compared to stainless steel.
PolyPure systems are thermally fused together, eliminat-
A pure water system comprised of PVDF or Natural ing the use of glues, which will continue to leach into a
Polypropylene is similar to that of most chemical feed water system for extended periods of time. Polypropy-
systems. The critical difference in a pure system is to lene is an extremely weldable material, making fusion
design it as a continuous recirculating loop with mini- joints that are simple and reliable.
mized dead legs and maintain extremely low TOC levels
in order to inhibit microbial growth. Operating Parameters
Because thermoplastic systems have varying ratings at
Systems should also be sized to have turbulent flow as a different temperatures it is important to design a
part of the strategy of inhibiting bacteria growth. PVDF system around all the parameters it will be subjected
and PP systems are ideally suited for pure water as they to. The following operating parameters should be
have extremely smooth inner surfaces which reduce verified:
particle generation and inhibit sites for bacteria to adhere
to and proliferate. In addition, PVDF and PP systems Continuous operating Temperature
have low extractables, thus not contaminating the water Continuous operating Pressure
being transported. Flow rates
In designing a thermoplastic water system, the following Knowledge of the above parameters is required in order
items need to be considered: to determine the suitability of thermoplastics for your
Material of Construction application. Compare the actual conditions to the
Operating Parameters allowable ratings of the material being selected for the
System Sizing job. It is important to predict elevated temperatures, as
Thermal Expansion/Hanging Methods thermoplastics have reduced pressure ratings at higher
Instrumentation and Controls temperature. Valves should be verified in terms of
Sanitization Methods temperature and pressure separately from a piping
Welding Method system, as certain styles and brands of valves have
Dead Leg Reduction and End-Point Configuration lower ratings than that of the pipe system.
After verifying the standard operating conditions, it is

7.1 Materials of Construction necessary to examine other operations that might effect
the piping. The following is a sample of items to consider,
The Purad High Purity PVDF Piping System is the prior to specifying a material:
premier system for Pure Water applications. PVDF has
been used in Pure Water Systems for over fifteen years. Will there be spikes in temperature or pressure?
Is there a cleaning or sanitization operation that Section 7
Purad combines excellent surface finish with extremely
low extractables to provide the highest quality piping the piping will be exposed to?
material. In addition to purity attributes, Purad also has a If yes, what is the cleaning agent?
wide variety components and welding methods well What temperature will cleaning be conducted at?
suited for HP applications. Purad is a crystalline material Will the system be exposed to Sunlight or employ
that can withstand high pressures. However, all PVDF is other sources of UV radiation?
more brittle than PP and requires special planning and
handling during installation. These requirements are now Each of the above questions should be answered and
commonplace on the market and are accepted as the desired material should be checked for suitability
standard operating methods. For the strictest applica- based on the above factors as well as any others that
tions, requiring low bacteria counts and virtually unde- might be special to the system in question.

47 APP-02
Asahi/America Application and Validation Guide Section Seven: Piping Design
7.2 System Sizing In addition to this approach recent tests results com-
pared the effectiveness of 0.5 and 1.0ft/sec velocities
It is well known that high purity water systems are in rinsing contaminated UPW into specification1. UPW
designed to operate in a continuously flowing loop to samples were exposed to prolonged stagnation (over 8
prevent stagnant water in the system. Stagnant water hours) allowing prolific microbial growth. High-purity, IR
propagates the growth of bacteria and biofilm. The rate Fused, PVDF systems rinsed into specification from
of microbial growth is dependent on numerous factors greater than 90 cfu/100ml to under 2.5 cfu/100ml in 30
including the initial quality of the water. However, after an minutes with 1.0 ft/sec. This clearly suggests maintain-
initial lag phase, exponential growth is likely to begin ing system velocities at 1.0 ft/sec may be sufficient and
within 12 to 24 hours. can effectively limit microbial activity associated with
stagnant water.
Continuous flow is therefore recommended for all areas
of PW and WFI distribution. General guidelines have Sizing Laterals
traditionally suggested flow velocities between 3 to 5 ft/ A Purified Water system may be made of a main loop
second. and branches known as Laterals. It is important in design
to not dead end laterals and ensure that there is always
However, a more sensible approach with high perfor- flow movement in the main and the lateral. Systems are
mance thermoplastics may be to review the Reynolds designed with different loop configurations to accommo-
Number of the system to insure the flow is turbulent. Use date the needs of production. However, all laterals must
of the Reynolds Number may reduce wasteful over sizing be designed for continuous flow and should feed back
of pumps, excessive pressure drops, and unnecessarily unused water into a return line.
high velocities.
1. Lee, Ron; Patterson, Michael, Ph.D.; and Painter, John;
Determination of Reynolds Number
Semicondutors: The Effect of Velocity on High-Purity Systems Rinse
Once the diameter sizes have been selected for a Up and Requalification; Ultrapure Water Journal; March 2002; pg 41.
given piping system, the next step is to determine
whether the flow through the pipes is laminar or
turbulent. The only accepted way of determining this
characteristic through analytic means is by calculating
7.3 Thermal Expansion
the Reynolds Number. The Reynolds Number is a
dimensionless ratio developed by Osborn Reynolds, Purad and PolyPure systems designed for ambient or
which relates inertial forces to viscous forces. Cold DI water that are inside at a constant temperature
building generally do not need to compensate for thermal
To determine type of flow from Reynolds Number expansion. However, thermal expansion is an important
value, use: factor that should be at least reviewed on each and every
installation design.
Nre = (De v) / ( g)
Hot systems, normally operating at temperatures of 65
C to 120 C, require a more complex design. Purad
Where:
PVDF systems can be used in many hot water applica-
Nre = Reynolds Number (dimensionless)
tions and applications where the temperature is cyclical,
De = equivalent diameter (ft = inside diameter
Section 7
it just requires analysis of the thermal expansion effects

fully-filled circular pipe)
and proper design to compensate for those effects.
v = velocity (ft/s)
= fluid density (lb/ft3)
Polypropylene and PVDF will grow significantly with the
= relative viscosity (lb x sec/ft2)
introduction of heat. For example polypropylene will grow
Laminar flow: Nre < 2100 close to 1 inch for every 10 F of temperature increase
Transition region: Nre 2100 to 3000 over 100 feet of straight pipe. The growth of pipe can be
Turbulent flow: Nre > 3000 properly compensated for utilizing expansion loops,
offsets or changes in direction. Figure 7.A depicts one
recommended methods of expansion design. Using the
loops, offsets or changes in direction is ideal since they

APP-02
are homogenous with the pipe system. Other devices Thermal Expansion. Figure 7.B an example of an anchor
such as pistons or bellows can also be used, but are not type fitting with a fixing pipe clamp available from Asahi/
recommended for PW or WFI applications as they rely on America, Inc.
mechanical features and connections that could leak over
time and are not compatible with sanitary design.
7.4 Instrumentation and Controls
Offset
In the proper design of an Ultra Pure Water system it is
important to monitor the quality of the water, tempera-
Ls
ture, pressure and the flow rate.
The following chart outlines recommended instruments

and sample points along with their location in the Pro-
F ... fixpoint or anchors
LP ... pipe support (e.g. pipe clips) cess.
Ls... Minimum straight length Instrumentation Type and Location
Figure 7.A An Example of one Thermal Expansion Design

Options Process Step Measurement Type Readout Location
For a thorough review of thermal expansion and proper Feed Water PVC Vortex Flow Meter Line Mount
design, consult Section C of the Asahi/America Engineer- Totalizer Wall Mount
ing Design Guide.
Pretreatment PVC/PP Vortex Flow Meter Line Mount
Hot DI systems also reduce the rigidity of thermoplastic Supply Water Temperature Line Mount
piping systems, which in turn decreases the support
spacing between pipe hangers. In smaller dimensions it Media Filter Pressure Gauges Line Mount
is recommended to use continuous support made of Purification RO Low Feed Pressure Alarm at RO Panel
some type channel or split plastic pipe.
RO Product Totalizer RO Panel
The use of hangers as guides and anchors becomes
PP/PVDF Product Vortex Flow RO Panel
important. As the design procedures in Section C of the Meter
Engineering Design Guide indicate, certain hangers
should be used as guides to allow the pipe to move back RO Reject Flow Meter/Total RO Panel
and forth in-line, while other hangers shall be anchoring
locations used to direct the expansion into the compen- RO Reject Recirculation RO Panel
sating device. The anchors and hangers should be RO Percent Ion Rejection RO Panel
designed to withstand the end load generated by the
Post Treatment Mix Bed Polish Resitivity Polisher Panel
Point of Distribution Resitivity Polisher Panel
Distribution Loop PP/PVDF Supply Vortex Flow Line / PLC

Meter Section 7
PP/PVDF Return Vortex Flow Line / PLC

Meter
Figure 7.B Fixed Anchor Design

49 APP-02
All devices should be picked on the following criteria

- Accuracy of Indication
- Repeatability
- As unobtrusive to the process as possible
- Cleanliness
- Devices in contact with the Water should be thermo-
plastic. Figure 7.D Vortex Priniciple
- Ease of use
- Operating parameters: Temperature, Pressure,
media compatibility.
7.5 Welding Method
In regards to monitoring flow, it is important to use
devices that do not rely on moving parts to determine the Asahi/America offers several choices for joining Purad
flow rate. Ideally, all thermoplastic construction should PVDF and PolyPure natural Polypropylene. The choice of
exactly match that of the pipe. An ideal Flow measure- a particular method should be based on the following
ment device is the Vortex Meter. A Vortex Meter from concerns:
Asahi/America will provide accurate, repeatable flow Purity of the system
without the use of any moving parts. The features Installation location
translate into the benefit of clean operating design and Size range
long lifetime. With no moving parts, no particles will be System complexity.
generated and there are no parts to wear out. In addi-
tion, Vortex meters are simple to install and wire up. With While the welding method is instrumental in the purity of
all thermoplastic components the device is unobtrusive to a water system, the choice of a welding method is not
the process and provides years of reliable, clean opera- the final factor. The environment that welding takes place
tion. under maybe more important than the actual welding
method. Asahi/America recommends the welding
Vortex meters operate on the vortex principal. A bluff in method be based on the type of installation, rather than
the flow body cause a slight pressure drop behind it as the desire to have the most advanced equipment on site.
the flow passes by. The water turns inward into the
pressure differential causing the formation of small PVDF can be installed using, butt fusion, IR fusion,
eddies or whirl pools. The vortices as they are called socket fusion and beadless HPF fusion. All methods are
alternate from one side to the other in direct proportion to proven in DI water systems, and each has its own
the flow. The frequency is calculated to flow and is advantages. E-CTFE is available as butt or IR fusion and
transmitted as a 4-20mA signal or a digital pulse depend- Polypropylene is weldable using socket, butt or IR fusion.
ing on customer preference.
7.5.1 Socket Fusion
Socket fusion is a simple method for basic, low-cost
systems. In small diameters, 20mm to 40mm ( 1),
socket fusion can be done quite easily with a hand held
Section 7
welding plate and a few inserts. With just a limited

amount of practice an installer can make reliable joints.
For larger dimensions, up to a maximum of 110mm ( 4 ),
bench style socket fusion equipment is available for
keeping joints properly aligned.
Figure 7.C Vortex Flow Meter

APP-02
Figure 7.E Steps of Socket Fusion Figure 7.F Steps of IR Non-Contact Fusion
7.5.3 IR Fusion 7.5.3 Butt Fusion

For systems that have larger dimensions above 110mm Butt fusion is similar to IR fusion, however the compo-
(4), butt and IR fusion make a logical choice. Both nents to be welded are in contact with the heat source.
systems are available for welding all dimensions from Butt fusion is the parent of IR fusion and still maintains its
20mm to 250mm ( to 10). IR fusion has several one advantage; it can be done in a variety of environ-
advantages; during the welding process the material is ments. Wind or a strong breeze can make IR welding
not in contact with the heat source, thus eliminating a troublesome, for these cases butt fusion is preferred.
possible source of contamination. In the course of an IR Additionally, field or in-place welds should be performed
weld there is no force against the heating element like in with butt fusion. A variety of different types of butt fusion
butt fusion, therefore the weld beads are smaller when equipment are available, making location welds possible,
making an IR weld. In a flowing system an IR bead will where an IR would not be.
flush cleaner, due to its round, smoother shape as
compared to a butt weld. 7.5.4 HPF Fusion
HPF Fusion is a welding method that combines a smooth Section 7
IR fusion is neat, clean and reliable. Current day welding internal seam with practical portability. It is available in
equipment is computer controlled making each weld 2 PVDF. The method is simple in use. Pipe is
identical and making the inspection processes more simply inserted into a coupling and locked into place
reliable. IR fusion equipment also allows for complete using a clamp. The tool is set for each weld using a bar
traceability of each weld, by each operator. code scanner to set the parameters. As the coupling is
IR fusion is suited for clean room environments and electrified the heat joins the pipe and coupling together.
bench top type welding. Equipment is highly sophisti- Inside the pipe an internal balloon is used to maintain the
cated and is not generally recommended for making field shape of the pipe. The weld can also be accomplished
or location welds. without an internal balloon. In this case the heat is
stopped prior to reaching the internal pipe diameter. In

51 APP-02
both cases the pipe is completely bead free on the inside, 7.6 Sanitization Methods
but when welded without the balloon a small seam is
present. This seam however is smaller than a gap that Many different methods for the sanitizing of a distribution
would be present between any joint containing a gasket pipe system can be incorporated. If heat or hot water are
such as union or sanitary clamp connection. to be used, the main area of concern is thermal expan-
sion and the temperature/pressure ratings. If a chemical
sanitization method is to be used, the chemical compat-
ibility of the piping material needs to be verified with the
pipe manufacturer.
7.6.1 UV Exposure
All plastics react differently to UV exposure. In addition to
the external exposure of UV lights, it also common for UV
sterilizing lamps to be used to control bacteria levels in a
water system. These lamps, give off high intensity light
to breakup living bacteria in a water. Depending on the
wave length of the lamp, trace amounts of Ozone can be
generated from these lamps. The combination of the
intense UV and Ozone can create stress cracking in
piping components directly in contact with the light
source. To avoid a possible problem it is recommended to
build a light trap from SS components. The use of SS
diaphragm valves or a couple changes in direction will
eliminate the concern altogether. Below is a graphic
Figure 7.G HPF Fusion without and with internal support balloon representation of an efficient light trap.
Figure 7.H UV Light Trap Design

Section 7
7.6.2 Steam Sterilization

Steam In Place (SIP) is considered by many to be the
most reliable method of ensuring sterility and maintaining
microbial control. For effective steam sterilization, the
steam must be saturated, that is, it must be at a tempera-
ture and pressure that falls along the liquid/gas interface
on a phase diagram. SIP must be conducted at 121C
(250F) at the coldest point in the system. Terminal
sterilization or Overkill is generally achieved after 15 to
20 minute exposure to saturated steam. Longer dura-
tions are not necessary and should be curtailed in PVDF

APP-02
systems. A heat penetration study documenting suffi- lines at periods 30 minutes or shorter is perfectly accept-
cient temperature is maintained throughout the piping able. However, care should be taken with use of Ozone
system is critical to validation. in PP systems. Please consult our Engineering Depart-
ment for exact application guidelines concerning the use
Steam sterilized Purad PVDF systems offer several of Ozone.
advantages over those constructed of stainless steel.
Purad PVDFs extremely low thermal conductance factor
of 1.32 Btu-in/hr ft2 minimizes heat loss. Heat penetra-
tion throughout a system is more easily ensured without
7.7 Hanging
the need for pipe insulation. Purad PVDF can safely
transport hot media without risk of serious injury to those Polymer piping systems act differently than metal piping
who may come in contact with it. Additionally, the hot systems and varying hanger styles are required. The
temperatures do not contribute to accelerated corrosion three uses of hangers are as a support, a guide and/or
as is the case in with stainless steels. Clean steam is an anchor. The hanger itself may be used to accomplish
highly corrosive to stainless steels. High grades, such as two of these goals, but all three uses need to be consid-
316L, are not immune to its corrosive effects. The ered when laying out the hanger configuration. The
corrosion can contribute to degradation of the systems designer of a system should specify the exact hanger
overall water quality. Purad PVDF, on the other hand, and location and not leave this up to the installer.
can handle SIP without corrosion and without restorative
passivation requirements. This is an important factor to Support spacing for thermoplastic piping systems differs
consider when selecting system material of construction greatly as compared to metallic piping. It generally
and determining operating and maintenance costs. requires more supports, and the introduction of higher
temps will further increase that support spacing require-
Recommended SIP Parameters for Purad PVDF* ment. For support space requirements by
Temperature 121-130 C
Gauge Pressure 15-25 psig
Duration 15-20 minutes
Frequency As Needed
*Values based on SDR21 Pipe and Fittings. Valves and other

components should also be checked for suitability. SIP necessitates
expansion calculations and compensation.
7.6.3 Ozone Sterilization

Ozone is currently under utilized in Life Science water
applications. Ozone is an extremely effective method of Figure 7.I Recommended Pipe Hanger Design
sanitation. Bacteria are easily destroyed at low concen-
tration levels and with limited exposure. Ozone concen-
trations of 0.2 to 0.5ppm and at contact times as little as Hangers that evenly grip 360 degrees around the pipe
10 minutes are recommended for water sterilization. are preferred. Clamps, such as U-bolts, can tighten down
Ozone can be destroyed downstream of point of injection on the pipe providing a pin point load on the pipe that can
by UV sterilization lights. lead to eventual damage. Thermoplastic clamps are Section 7
recommended when installing a thermoplastic pipe
Ozone is a strong oxidant. As such, material compatibil- system. Above is a detail of a recommended clamp. If a
ity issues need to be considered. Extended exposure metal clamp is to be utilized, a rubber gasket material
may deteriorate gasket materials and some piping should be placed between the pipe and the clamp as a
materials. Purad PVDF is fully resistant to Ozone as cushion to protect the pipe. Clamps should be checked
used for sanitation control. High concentrations of Ozone for sharp or jagged edges that could scrape or penetrate
are harmful to all PP . However, effective levels may be the pipe.
introduced into Proline and PolyPure systems. Weekly
CIP with Ozone at 0.2-0.5ppm in Proline and PolyPure For thorough hanging design recommendations, refer to
Asahi/Americas Engineering and Design Guide.

53 APP-02
7.7 Dead Leg Reduction and End Point

Configuration
and reducers to accommodate the addition of these
The term dead leg refers to a stagnant zone of water in the components into the system. This is often called the
distribution system. Dead legs are often found in the branch Christmas Tree effect, as many reducers can end up
of a tee that is closed off with a valve. This is especially true stacked on top of each other to reduce down to the
in cases where the branch reduces from the main. required thread size
Figure 7.J Improper Dead Leg Design Figure 7. L Dead leg to improper instrument installation
Accepted cGMP design is to keep all dead legs to a Since these tee configurations are narrow in diameter
maximum of 6 internal pipe diameters in length. The they create a dead leg in the branch where microorgan-
turbulent flow in the main trunk line will create significant ism growth can be initiated. The use of instrumentation
amount of movement to keep the leg moving and prevent fittings eliminate dead legs while being a safe adapter for
bacteria from proliferating. However, the Purad system gauges or sample valves. Instrumentation fittings are
allows designers to avoid dead legs altogether with the available in multiple configurations and can accommo-
advent of T-Diaphragm valves and Zero dead leg fittings. date more than one instrument per fitting.
T-valves take the place of a tee, reducer and diaphragm
Figure 7.K Molded T-Valve with significantly reduced dead-leg Figure 7.M Proper instrument installation
Section 7
valve, by combining all three into one component. T- The insert of a resistivity probe can also be a possible
Valves reduce the quantity of welds in a system as well. source for dead legs. Since most probe manufacturers
By using a T-Valve, branch lines can be shut off at any recommend that fluid flows directly at the probe, they are
time without creating a dead leg and turned back on often situated in the leg of a tee and the tee acts as a 90
without an extensive flush procedure. elbow. Since almost all probes are supplied as a or 1
sanitary adapter, there is the necessity to weld
Dead legs in a system can be found in more than just reducers onto the tee leg to accommodate the sensor. A
branch lines. Often times the introduction of a gauge, simple fitting, the probe adapter, conveniently eliminates
measurement device, and/or sampling valve can create a the needs for reducers and shortens the leg of the tee,
dead leg. Standard plastic fittings require the use of Tees see figure 7N. Probe adapters are available in all sizes

APP-02
and pressure ratings. Pressure gauges can also be End Point Configurations
installed utilizing sanitary adapters. Sample valves can Very often, the quality of product water is maintained
also be built into the same fitting to reduce space and the throughout the distribution system, but cannot be utilized
amount of fittings used. Multiple configurations are without contamination. Gooseneck faucets, dead ended
available. drops, needle valves and ball valves are often improperly
utilized as Point of Use fittings. The microbiological
integrity of a Water System should be measured at a
minimum of at least three places:
1) Point of Distribution - the quality of product water

the system is capable of making.
2) Return from Distribution The quality of water
after transport in the piping system.
3) Point of Use The quality of water delivered by
the end point configuration.
All three points are rarely identical with the most impor-
Figure 7.N Instrument probe installation tant, Point of Use, typically the lowest quality of the three.
Connecting a new thermoplastic system to existing or

new equipment is often a concern. New Purad and
PolyPure systems are fully equipped with sanitary
adapter that make transition seamless and hassle free.
Please refer to Section Four for further details concerning
sanitary adapter sizing and selection. Finally, most
purified water systems feed a sink or wet station. The
need for zero dead leg use points is required. There are
many ways of accommodating the need, from recirculat-
ing faucets to simple flow through T-Valves. Recirculation
faucets offer reduced stagnant zones of flow, but in-
crease plumbing complexity. T-Valves are highly recom-
mended as the cleanliest component for a use point
configuration. Multiple end connections are available to
adapt to existing tubing or final connections.
Section 7
Figure 7.O Sample sanitary instrumentation adapter

55 APP-02

Section 7

APP-02
Section Eight: PuradSpecifications Asahi/America Application and Validation Guide
1.6 Submittals
Section Eight Submit the Following:
Product Specifications
A. Product data for the system specified; relative to
Purad High Purity PVDF Piping materials, dimensions of individual components,
profiles and finishes.
B. Product certificates signed by manufacturer of

PART 1 GENERAL Purad PVDF piping product, stating compliance to
stated requirements.
1.1 Summary
Furnish a complete high purity PVDF piping system C. Welder certificates, certifying that welders comply
to include pipe, fittings, anchors, specialty fittings and with the installation procedures as outlined by ASTM
valves. D-2657 & DVS 2207-15. All required training should
be scheduled and completed at job start-up.
1.2 References
The following standards apply to products used within D. Qualification of firms supplying Purad PVDF:
this section. Firms must have a minimum of five years experience
in HP design, installation and operation of thermo-
ASTM D 1598 ASTM D 1599 plastic high purity piping systems.
ASTM D 2122 ASTM D 2657
ASTM D 2837-85 ASTM D 3222-81
DVS 2207-15 1.7 Quality Assurance
Obtain components from a single source having
The system design shall meet the requirements of responsibility and accountability to answer and
ASME/ANSI B31.3 for design criteria where tempera- resolve problems regarding proper installation,
ture and pressure fall within the limits of the code. compatibility, performance, and acceptance.
1.3 Definitions 1.8 Delivery, Storage and Handling

Purad High Purity PVDF A. Deliver all Purad PVDF pipe to arrive on-site inside
Polyvinylidene Fluoride protected hard black PE tubes. Cardboard tubes are
not allowed.
1.4 System Description and Pressure Rating
System shall be a Purad PVDF system made of B. Deliver all Purad PVDF fittings to arrive on-site
uniform pipe and fitting resin. System pressure ratings double bagged in boxes layered with bubble packing
shall be based on continuous use of 50 years. Purad to prevent damage.
Pipe and Fittings shall be based on a Standard
Dimensional Ratio (SDR) of 21, through 9 (20- C. Store products on elevated platforms in a dry
225mm) or 33, 3 through 12 (90-315mm). Pressure location with protection from the environment.
rating for pipe and fittings, unless otherwise noted,
shall be 232 psi (16 bar) for SDR21 material and 150 D. Lift, support and transport Purad PVDF piping per
psi (10 bar) for SDR33 material at 68F. manufacturers recommendations.
1.5 System Performance Requirements 1.9 Warranty

System performance requirements shall handle the Warranty period is one year after date of substantial
following: completion.
Operating Pressure: (TBD by Engineer/Project Owner) 1.10 Extra Material

Section 8
Operating Temp: (TBD by Engineer/Project Owner) Turn over to owner at end of construction necessary
Test Pressure: (TBD by Engineer/Project Owner)
welding equipment as suggested by manufacturer for
Media: Deionized Water
repair, additions and maintenance of Purad PVDF
piping system.

57 APP-02
Asahi/America Application and Validation Guide Section Eight: Purad Specifications
PART 2 PRODUCTS
2.1 Manufacturers Size Surface Finish

Subject to compliance with requirements products mm (inch) m ( inch)
which may be incorporated in the work include: The
20-90 ( - 3) 0.2 7.8
Purad PVDF System as supplied by Asahi/America,
Inc. of Malden, Massachusetts, (781) 321-5409. 110 4 0.35 13.8
Produced by Alois Gruber GmbH AGRU of Bad Hall, 160-315 (6 - 12) 0.5 19.7
Austria.
2.2 Material In addition manufacturer shall conduct continuous

Pipe, valves and fittings shall be made from HP resin checking for micropores. The micropores shall not
produced by one supplier. The resin shall meet or exceed a size of 1 micron.
exceed the requirements outlined for a Type II
suspension grade homopolymer resin in ASTM D- B. Packaging
3222. Resin is approved for contact with foodstuff as All pipes shall have ends sealed with PE bags and
per the FDA CFR, Title 21 (2001) 177.1520. then capped. Pipe shall be sleeved in a PE encase-
ment and heat-sealed. Pipe is then packed into a
Pipe shall be made of Solef 1010/0001 HP resin. hard PE tube for shipping protection. Cardboard
MFR = 4-7 g/10 min. tubes are not acceptable. The following chart desig-
nates quantities of pipe per PE shipping tube:
Fittings 1/2-2 shall be made of Solef 1009/0001
HP resin. Size - inch Size - mm Qty
MFR = 12-16 g/10min.
" 20 Five
Fittings 2-1/2-10 shall be made of Solef 1008/ " 25 Four
0001 HP resin.
1" 32 Three
MFR = 22-27 g/10 min.
1 " 40 One
All resins shall not introduce contaminations into the 1 " 50 One
ultra high purity water. Specifically, all raw materials
2" 63 One
in product manufacturing shall be free of chemical
additives, fillers, property enhancers and reinforce- 2 " 75 One
ments, such as antioxidants, anti static agents, 3" 90 One
colorants, flame retardants, heat stabilizers lubricants,
4" 110 One
mold release agents, pigments, plasticizers, process-
ing aids, ultraviolet stabilizers and viscosity depres- 6" 160 One
sants. 8" 200 One
In addition, manufacturer shall test all lots to ensure 9" 225 One
the melt flow index is within allowable range. 10" 250 One
12" 315 One
2.3 Pipe
A. Production
All pipe shall be produced on a dedicated extruder
completely within a class 100 cleanroom and shall be C. Pressure Rating
packaged within a class 100 section of the All pipe shall meet the requirements of Section 1.4.
cleanroom. Pipe shall be stress relieved on line as it
Section 8
is extruded. Post extrusion annealing is not allowed. D. Production Control

Surface finish smoothness is as follows: During pipe production continuous quality controls are
performed and monitored. Minimum required produc-
tion control:

APP-02
2.5 Valves and Flow Meters

All valves shall be produced in the same manner as
Criteria Test standard Test interval
High Purity Fittings
Measurement ISO/DIS 10931-2 every hour
Surface visual each pipe Type 342 Spigot Diaphragm Valves:
Color visual each pipe - 4 (20mm 110mm) shall be the type 342 of the
Marking visual each pipe
Micropores microscope 1x/shift PURAD system. The Valves shall have a PVDF body
Inner surface DIN 4768 1x/shift (Solef Resin) and a PTFE diaphragm with EPDM
Packaging visual each pipe backing. Valves will be spigot single body design. Top
Labels visual each pipe Works must include integral lockout device on the
handle and position indicator.
2.4 Fittings
A. Production Type 342 Flanged Diaphragm Valves:
All standard fittings through 12 (315mm) shall be 2 shall be type 342 with stub end and
injection molded. All fittings are to be molded with backing ring IR welded onto both sides. Top Works
equipment in a class 100 cleanroom environment. After must include locking device on the handle and
secondary machining, all molded fittings shall be cleaned position indicator.
for a minimum of 1 hour in an automated 6-basin Hot
DI rinse stations. The DI rinse water specification Flanged Diaphragm Valves:
shall be 70 C with resistivity above 18M and TOC 3 - 4 shall be type 342 single PVDF body design
less than 10PPB. with flanges molded as part of the body. Diaphragm
shall be PTFE with EPDM backing. Top Works must
B. Packaging include locking device on the handle and position
All fittings are to be packaged in a class 100 cleanroom indicator.
immediately after the cleaning process. Fittings are to be
double bagged, purged with clean dry class 100 air in Flanged Diaphragm Valves:
PE/Nylon composite bags. Bags are to be silicone free 6 - 8 shall be type 15 or G single PVDF body with
and antistatic. flanges molded as part of the body. Diaphragm shall
be two piece style with PTFE and separate EPDM
C. Specialty Fittings backing. Top works shall include a position indicator
Specialty fittings are to include restraint fittings, butt and travel stop.
fusion instrumentation fittings, instrumentation donuts,
etc. Specialty fittings shall be machined or molded of the Type 343 Reduced Dead Leg Valve:
same PVDF resin as the pipe and fittings. x through 4 x 2 (20mm x 20mm through
110mm x 63mm) reduced dead leg (zero dead leg)
D. Pressure Rating valves shall be Type 343 Style from the PURAD
All fittings, unless otherwise noted, shall meet the System. Valves shall be made of PVDF Solef resin.
requirements of Section 1.4. Valve bodies are to be unibody, molded design with a
full 150 psi rating at 70F. All metal nuts and bolts
E. Production Control must be capped or covered to reduce metal expo-
During fitting production continuous quality controls are sure. Top Works must include integral lockout device
performed and monitored. Minimum required production on the handle and position indicator.
control:
Check Valves:
Criteria Test standard Test interval All sizes class 150, ball type PVDF body with FPM
seat and seals. 150PSI at 73.4F for sizes through
Measurement ISO/DIS 10931-3 every 2 hours
Condition visual each fitting 2 nominal 100 PSI at 73.4F for sizes 3 and 4.
Color visual each fitting
Section 8
Markings visual each fitting Pressure RatingValves

Inner surface DIN4768 1x/shift Pressure rating of valves shall be per manufacturers
Packaging visual each fitting
X-ray test visual every 2 hours recommendations based on materials, valve type and
size.

59 APP-02
Flowmeters: welded joints, tools will utilize and measure the

All Flowmeters shall be Vortex Style from the PURAD welding pressures to join material and not me-
system. All Vortex Meters shall be made of PVDF and chanical stops. All IR fusion equipment shall
free of all seal materials. Supplier shall be capable of possess a minimum of the following capabilities:
supplying all sizes - 9 (20mm 225mm) and have
a replacable electronics module. 1. Computer control of the welding process.
2. Ability to store welding data internally on
All Vortex Meters shall be wet bench calibrated and computer memory - up to 1000 welds.
supplied with Calibration Records from the manufac- 3. Full alignment capabilities (vertical and
turer. horizontal).
4. All metal components coated to prevent any
2.6 Joining Equipment particle generation from metals.
Purad PVDF installation shall be performed by factory 5. Ability to download all data to a personal
certified and trained installers in accordance with computer.
manufacturers ISO procedures, ASTM D 2657 and
DVS 2207-15. Date of certification or recertifications IR equipment shall also have the capability of
shall not exceed two years from the beginning of following options incorporated into the tool for
project. Available joining techniques are as follows: special demands:
1. Protective hood over welding area up to 2
A. Butt Fusion (63mm).
Proper equipment selection should be based on pipe 2. Nitrogen purge of the welding area.
size and site conditions. Butt fusion equipment 3. Automatic nitrogen purge of the pipeline.
should be designed and tested to provide reliable 4. Security card entry.
welds. All equipment should utilize electronically 5. Printer labels for each weld automatically.
controlled heating elements for accurate welding
temperatures. Tools should also incorporate planing SP Series:
units to face ends prior to heating. Butt fusion Tool shall be made available in 4 (20mm
equipment supplied shall weld joints based on force or 110mm) and 2 10 (75mm 250mm) size
pressure and not mechanical stops. ranges. Tools shall possess electronic planar and
infra heating element. Tools will utilize and
B. Socket Fusion measure the welding pressures to join material
Proper equipment selection should be based on pipe and not mechanical stops. To avoid improper
size and site conditions. Socket fusion tools shall be welded joints, tool shall automatically operate
available in two styles; one portable style capable of clamps and control joining force. Tools shall
welding 1/2- 2 (20mm 63mm) and a bench style possess the following features:
capable of welding 3/4- 4 (25mm 110mm).
Heating elements are to be electronically controlled 1. Computer control and automatic fusion.
for accurate welding temperatures. Tools should also 2. Touch screen for tool operation and parameter
incorporate male and female heater inserts with selection.
Teflon coating. 3. Restricted access through use of PCMCIA
cards.
C. Non-Contact Butt Fusion 4. Automatic label printouts after each weld.
Proper equipment selection should be based on 5. Ability to display and graph weld status while
installation requirements and line sizes. Tool shall be weld is in process.
either semi automatic (UF2000 style) or fully auto- 6. Memory storage of welds.
matic (SP series). 7. Magnetic clamps to reduce change out time
from one size to another.
UF2000 Style: 8. Vertical and horizontal adjustment for pipe
Section 8
Tool shall be made available in - 2 (20mm alignment.

63mm) and 2 10 (75mm 250mm) size
ranges. Tools shall possess electronic planer and
non-contact heating element. To avoid improper

APP-02
D. Beadless Fusion 3.2 Testing

High Performance Fusion (HPF) equipment should be A. Inspection
designed to weld all PVDF pipe valves and fittings 1/2-2 Prior to pressure testing, the system shall be exam-
(20mm 62mm). Equipment shall incorporate a bar ined for the following items:
code scanner to set all weld parameters. An internal
balloon shall be used to eliminate a bead formation. 1. Pipe shall be completed per drawing layout with all
Where usage of the balloon is not possible, weld will be pipe and valve supports in place.
conducted without balloon. Each weld will be done 2. Pipe, valves and equipment shall be supported as
utilizing a HPF coupling. specified, without any concentrated loads on the
system.
3. Pipe shall be in good conditions void of any cracks,
PART 3 EXECUTION gouges or deformation.
4. Pipe flanges shall be properly aligned. All flange
3.1 Installation bolts should be checked for correct torques.
A. Facilities 5. All diaphragm valve bonnet bolts shall be checked
Subassembly and fabrication work should be con- for correct torques.
ducted in a separate, temporary cleanroom located 6. All joints should be reviewed for appropriate
within the building. Cleanroom should be equipped welding technique:
with the following to provide a clean installation:
Butt: To have two beads, 360 around the joint.
1. Provide Laminar flow Hepa filters in room ceiling to
reach a level of class 10,000. Socket: To have two beads on the end of the
2. The quantity of filters should be determined by fitting and on the outside of the pipe in contact.
providing a minimum of 60 room air changes per
hour. Non-Contact: Identity labels shall identify weld
3. Ideal set up is to place welding equipment directly certification by the print welding parameters
under a filter. In addition nitrogen should be available OK. Joints should have two beads 360 around
for purging the pipelines with a positive pressure if the the joint.
assemblies expand beyond the bounds of the room.
Manufacturer to supply inspection procedures beyond
B. Tools the above recommendations. If any deficiencies
All fusion tools utilized are to be dedicated for clean appear, the quality control manager shall provide
build only, and should be kept separate. Special directions for repair.
attention should be given to the fusion tools to prevent
the possibility of contaminating a weld. The contractor B. Pressure Test
shall lease or purchase all necessary welding equip- 1. Test fluid should be deionized water, with quality
ment from the manufacturer. At the end of the level set by Quality Control Engineer. In all cases test
installation, any necessary equipment needed on-site must be done hydrostatically. Air test is not allowed
should be sold to the owner. Contractor is respon-
sible for proper maintenance and care of the fusion 2. Filling the systemOpen all valves and vents to
tools during construction. purge the system of air. Slowly inject the water into
the system, making sure that air does not become
C. Certification trapped in the system.
Installers shall be pre-qualified as per section 2.6.
Manufacturer shall provide on-site training in the 3. Begin pressurizing the system in increments of 10
assembly and installation of the Purad PVDF piping PSI. Bring the system up to 100 PSI and hold. Allow
system as needed. system to hold pressure for a minimum of two hours
and up to a recommended 12 hours. Check pressure
Section 8
gauge after one hour. Due to natural creep effects on

plastic piping the pressure will have decreased. If
drop is less than 10% pump the pressure back up. At
this time the system may be fully pressurized to

61 APP-02
desired test pressure.
4. If after one hour the pressure has decreased more

than 10%, test is consider a failure. Note the 10%
value may need to be greater for larger systems, or
systems experiencing significant thermal changes.
5. Test is to be witnessed by Quality Control Engineer

and certified by the contractor.
3.3 Cleaning of HP-PVDF Piping System

System shall be cleaned at completion of project
according to requirements set by owner.
Section 8

APP-02
Section Eight: PolyPureTM Specifications Asahi/America Application and Validation Guide
1.6 Submittals
PolyPure, Natural Polypropylene materials, dimensions of individual components,
PART 1 GENERAL B. Product certificates signed by manufacturer of

Purad PVDF piping product, stating compliance to
1.1 Summary stated requirements.
Furnish a complete high purity natural PP piping
system to include pipe, fittings, anchors, specialty C. Welder certificates, certifying that welders comply
fittings and valves. with the installation procedures as outlined by ASTM
D-2657 & DVS 2207-11. All required training should
1.2 References be scheduled and completed at job start-up.
The following standards apply to products used within
this section. D. Qualification of firms supplying PolyPure: Firms
must have a minimum of five years experience in HP
ASTM D 1598 ASTM D 1599 design, installation and operation of thermoplastic
ASTM D 2122 ASTM D 2657 high purity piping systems.
ASTM D 2837-85 ASTM D 4101
DVS 2207-11
1.7 Quality Assurance
The system design shall meet the requirements of Obtain components from a single source having
ASME/ANSI B31.3 for design criteria where tempera- responsibility and accountability to answer and
ture and pressure fall within the limits of the code. resolve problems regarding proper installation,
compatibility, performance, and acceptance.
1.3 Definitions
PolyPure 1.8 Delivery, Storage and Handling
Natural Polypropylene A. Deliver all PolyPure pipe to arrive on-site inside
protected for shipment.
System shall be a PolyPure system made of uniform B. Deliver all PolyPure fittings to arrive on-site single
pipe and fitting resin. System pressure ratings shall bagged in boxes layered with bubble packing to
be based on continuous use of 50 years. PolyPure prevent damage.
110mm). Pressure rating for pipe and fittings, unless location with protection from the environment.
otherwise noted, shall be 150 psi (10 bar) for all
SDR11 material. D. Lift, support and transport PolyPure piping per
manufacturers recommendations.
1.5 System Performance Requirements
System performance requirements shall handle the 1.9 Warranty
following: Warranty period is one year after date of substantial
completion.
Operating Pressure: (TBD by Engineer/Project Owner)
Operating Temp: (TBD by Engineer/Project Owner) 1.10 Extra Material
Turn over to owner at end of construction necessary
Section 8

repair, additions and maintenance of PolyPure piping
system.

63 APP-02
Asahi/America Application and Validation Guide Section Eight: PolyPureTM Specifications
C. Pressure Rating
PART 2 PRODUCTS All pipes shall meet the requirements of Section 1.4.
2.1 Manufacturers D. Production Control

Subject to compliance with requirements products During pipe production continuous quality controls are
which may be incorporated in the work include: The performed and monitored. Minimum required produc-
PolyPure tion control:
2.2 Material
Pipe, valves and fittings shall be made from resin
produced by one supplier. The resin shall meet or Measurement ISO/DIS 10931-2 every hour
exceed the requirements outlined for a random Surface visual each pipe
copolymer resin according to ASTM D 4101-96a and Color visual each pipe
DIN 16774. MFI shall be 0.30 g/10min per 230/2.16 Micropores microscope 1x/shift
according to ASTM D 792. Resin is approved for Inner surface DIN 4768 1x/shift
contact with foodstuff as per the FDA CFR, Title 21 Packaging visual each pipe
(2001) 177.1520. Labels visual each pipe
In addition, manufacturer shall test all lots to ensure

the melt flow index is within allowable range. 2.4 Fittings
A. Production
2.3 Pipe All standard fittings through 4 (110mm) shall be
A. Production injected molded. All fittings are to be molded with
All pipe shall be produced on a dedicated extruder equipment in a clean environment. After secondary
completely within a dedicated clean area. Surface machining all fittings shall be cleaned for a minimum
finish smoothness is as follows: of 1 hour in an automated Hot DI rinse. The DI rinse
water specification shall be 70 C with resistivity
Size Surface Finish above 18M and TOC less than 10PPB.
mm (inch) Ra Rt
B. Packaging
20-40 ( - 1") > 1.5 m > 6 m
All fittings are to be packaged in a class 100
50-110 (1" -4") > 0.8 m > 3 m cleanroom immediately after the cleaning process.
Fittings are to be single bagged in PE/Nylon compos-
B. Packaging ite bags. Bags are to be silicone free and antistatic.
All pipes shall have ends sealed with PE bags and
then capped. Pipe shall be sleeved in full length PE C. Specialty Fittings
bag (qty dependent). The following chart designates Specialty fittings are to include restraint fittings, butt
quantities of pipe per PE bag: fusion instrumentation fittings, instrumentation donuts,
etc. Specialty fittings shall be machined or molded of
the same PP resin as the pipe and fittings.
Size - Inch Size - mm Qty
" 20 Five D. Pressure Rating

All fittings, unless otherwise noted, shall meet the
" 25 Four
requirements of Section 1.4.
1" 32 Three
1 " 40 One E. Production Control

During fitting production continuous quality controls are
1 " 50 One
performed and monitored. Minimum required production
Section 8
2" 63 One control:

3" 90 One
4" 110 One

APP-02
Pressure RatingValves
Criteria Test standard Test interval Pressure rating of valves shall be per manufacturers
recommendations based on materials, valve type and
Measurement ISO/DIS 10931-3 every 2 hours size.
Condition visual each fitting
Markings visual each fitting Flow Meters:
Inner surface DIN4768 1x/shift All Vortex Meters shall be made of PolyPure and free
Packaging visual each fitting of all seal materials. Supplier shall be capable of
X-ray test visual every 2 hours supplying all sizes - 3 (20mm 90mm) and have
a replace electronics module.
2.5 Valves All Vortex Meters shall be wet bench calibrated and
All valves shall be produced in the same manner as supplied with Calibration Records from the manufac-
High Purity Fittings turer.
Type 342 Spigot Diaphragm Valves: 2.6 Joining Equipment

- 2 (20mm 63mm) shall be the type 342 of the PolyPure installation shall be performed by factory
PURAD system. The Valves shall have a PolyPure certified and trained installers in accordance with
body and a diaphragm of PTFE with EPDM backing manufacturers ISO procedures, ASTM D 2657 and
or EPDM. Valves will be spigot single body design. DVS 2207-15. Date of certification or recertification
Top Works must include integral lockout device on the shall not exceed two years from the beginning of
handle and position indicator. project. Available joining techniques are as follows:
Type 342 Flanged Diaphragm Valves: A. Butt Fusion

2 shall be type 342 with stub end and backing Proper equipment selection should be based on pipe
ring IR welded onto both sides. Top Works must size and site conditions. Butt fusion equipment
include locking device on the handle and position should be designed and tested to provide reliable
indicator. welds. All equipment should utilize electronically
controlled heating elements for accurate welding
Flanged Diaphragm Valves: temperatures. Tools should also incorporate planing
3 - 4 shall be type 14 single Proline PP body design units to face ends prior to heating. Butt fusion
with flanges molded as part of the body. Diaphragm equipment supplied shall weld joints based on force or
shall be PTFE with EPDM backing or EPDM. Top pressure and not mechanical stops.
Works must include locking position indicator.
B. Socket Fusion
Type 343 Reduced Dead Leg Valve: Proper equipment selection should be based on pipe
x through 2 x 2 (20mm x 20mm through size and site conditions. Socket fusion tools shall be
110mm x 63mm) reduced dead leg (zero dead leg) available in two styles; one portable style capable of
valves shall be Type 343 Style from the PolyPure welding 1/2- 2 (20mm 63mm) and a bench style
System. Valves shall be made of PolyPure resin. capable of welding 3/4- 4 (25mm 110mm).
Valve bodies are to be unibody, molded design with a Heating elements are to be electronically controlled
full 150 psi rating at 70F. All metal nuts and bolts for accurate welding temperatures. Tools should also
must be capped or covered to reduce metal expo- incorporate male and female heater inserts with
sure. Top Works must include integral lockout device Teflon coating.
on the handle and position indicator. (Consult Factory
for Availability of Molded T-343) C. Non-Contact Butt Fusion
Proper equipment selection should be based on
Check Valves: installation requirements and line sizes. Tool shall be
Section 8
All sizes class 150, ball type Proline PP with FPM or either semi automatic (UF2000 style) or fully auto-
EPDM seat and seals. 150 PSI at 73.4F for sizes matic (SP series).
through 4.

65 APP-02
UF2000 Style: PART 3 EXECUTION

Tool shall be made available in - 2 (20mm
63mm) and 2 10 (75mm 250mm) size 3.1 Installation
ranges. Tools shall possess electronic planer and A. Facilities
non-contact heating element. To avoid improper Subassembly and fabrication work should be con-
welded joints, tools will utilize and measure the ducted in a separate, temporary cleanroom located
welding pressures to join material and not me- within the building. Cleanroom should be equipped
chanical stops. All IR fusion equipment shall with the following to provide a clean installation:
possess a minimum of the following capabilities:
1. Computer control of the welding process. reach a level of class 10,000.
2. Ability to store welding data internally on computer 2. The quantity of filters should be determined by
memory - up to 1000 welds. providing a minimum of 60 room air changes per
3. Full alignment capabilities (vertical and horizontal) hour.
4. All metal components coated to prevent any 3. Ideal set up is to place welding equipment directly
particle generation from metals. under a filter. In addition nitrogen should be available
5. Ability to download all data to a personal computer. for purging the pipelines with a positive pressure if the
assemblies expand beyond the bounds of the room.
IR equipment shall also have the capability of
following options incorporated into the tool for special B. Tools
demands: All fusion tools utilized are to be dedicated for clean
1. Protective hood over welding area up to 2 (63mm) build only, and should be kept separate. Special
2. Nitrogen purge of the welding area. attention should be given to the fusion tools to prevent
3. Automatic nitrogen purge of the pipeline. the possibility of contaminating a weld. The contractor
4. Security card entry shall lease or purchase all necessary welding equip-
5. Printer labels for each weld automatically. ment from the manufacturer. At the end of the
installation, any necessary equipment needed on-site
SP Series: should be sold to the owner. Contractor is respon-
Tool shall be made available in 4 (20mm sible for proper maintenance and care of the fusion
110mm) and 2 10 (75mm 250mm) size tools during construction.
ranges. Tools shall possess electronic planar and
infra heating element. Tools will utilize and measure C. Certification
the welding pressures to join material and not Installers shall be pre-qualified as per section 2.6.
mechanical stops. To avoid improper welded joints, Manufacturer shall provide on-site training in the
tool shall automatically operate clamps and control assembly and installation of the PolyPure piping
joining force. Tools shall possess the following system as needed.
features:
1. Computer control and automatic fusion. 3.2 Testing

2. Touch screen for tool operation and parameter A. Inspection
selection. Prior to pressure testing, the system shall be exam-
3. Restricted access through use of PCMCIA cards. ined for the following items:
4. Automatic label printouts after each weld.
5. Ability to display and graph weld status while 1. Pipe shall be completed per drawing layout with all
weld is in process. pipe and valve supports in place.
6. Memory storage of welds 2. Pipe, valves and equipment shall be supported as
7. Magnetic clamps to reduce change out time from
Section 8
specified, without any concentrated loads on the

one size to another. system.
8. Vertical and horizontal adjustment for pipe align- 3. Pipe shall be in good conditions void of any cracks,
ment. gouges or deformation.

APP-02
bolts should be checked for correct torques.

5. All diaphragm valve bonnet bolts shall be checked
for correct torques.
6. All joints should be reviewed for appropriate
welding technique:
Socket: To have two beads on the end of the

fitting and on the outside of the pipe in contact.
Non-Contact: Identity labels shall identify weld

certification by the print welding parameters
OK. Joints should have two beads 360 around
the joint.
Manufacturer to supply inspection procedures beyond

the above recommendations. If any deficiencies
appear, the quality control manager shall provide
directions for repair.
B. Pressure Test
1. Test fluid should be deionized water, with quality
level set by Quality Control Engineer. In all cases test
must be done hydrostatically. Air test is not allowed
2. Filling the systemOpen all valves and vents to

purge the system of air. Slowly inject the water into
trapped in the system.
3. Begin pressurizing the system in increments of 10

PSI. Bring the system up to 100 PSI and hold. Allow
system to hold pressure for a minimum of two hours


Section 8
3.3 Cleaning of PolyPure Piping System


67 APP-02

Section 8

APP-02
Section Eight: Proline Specifications Asahi/America Application and Validation Guide
1.6 Submittals
Proline, High Purity PP materials, dimensions of individual components,

Proline PP piping product, stating compliance to
Furnish a complete high purity pigmented PP piping
system to include pipe, fittings, anchors, specialty C. Welder certificates, certifying that welders comply
fittings and valves. with the installation procedures as outlined by ASTM
D-2657 & DVS 2207-11. All required training should
1.2 References be scheduled and completed at job start-up.
The following standards apply to products used
within this section. D. Qualification of firms supplying Proline: Firms
ASTM D 2837-85 ASTM D 4101
DVS 2207-11
1.3 Definitions
Proline 1.8 Delivery, Storage and Handling
Pigmented Polypropylene A. Deliver all Proline pipe to arrive on-site inside
protected for shipment.
System shall be a Proline system made of uniform B. Deliver all Proline fittings to arrive on-site single
pipe and fitting resin. System pressure ratings shall bagged in boxes layered with bubble packing to
be based on continuous use of 50 years. Proline prevent damage.
315mm). Pressure rating for pipe and fittings, unless location with protection from the environment.
otherwise noted, shall be 150 psi (10 bar) for all
SDR11 material. D. Lift, support and transport Proline piping per
completion.
Operating Temp: (TBD by Engineer/Project Owner) 1.10 Extra Material
Section 8

welding equipment as suggested by manufacturer
for repair, additions and maintenance of Proline
piping system.

69 APP-02
Asahi/America Application and Validation Guide Section Eight: Proline Specifications
PART 2 PRODUCTS
C. Pressure Rating
2.1 Manufacturers All pipe shall meet the requirements of Section 1.4.
Subject to compliance with requirements products
which may be incorporated in the work include: The
Proline System as supplied by Asahi/America, Inc. of D. Production Control
Malden, Massachusetts, (781) 321-5409. Produced During pipe production continuous quality controls are
by Alois Gruber GmbH AGRU of Bad Hall, Austria. performed and monitored. Minimum required production
control:
2.2 Material
Pipe, valves and fittings shall be made from resin Criteria Test standard Test interval
produced by one supplier. The resin shall meet or
exceed the requirements outlined for a random Measurement ISO/DIS 10931-2 every hour
copolymer resin according to ASTM D 4101-96a and Surface visual each pipe
Color visual each pipe
DIN 16774. MFI shall be 0.30 g/10min per 230/2.16 Marking visual each pipe
according to ASTM D 792. Micropores microscope 1x/shift
Inner surface DIN 4768 1x/shift
In addition, manufacturer shall test all lots to ensure Packaging visual each pipe
Labels visual each pipe
the melt flow index is within allowable range.
2.3 Pipe 2.4 Fittings

A. Production A. Production
All pipe shall be produced on a dedicated extruder All standard fittings through 12 (315mm) shall be
completely within a dedicated clean area. Surface injected molded. All fittings are to be molded with
finish smoothness is as follows: equipment in a clean environment. After secondary
machining all fittings shall be cleaned for a minimum
of 1 hour in an automated Hot DI rinse. The DI rinse
water specification shall be 70 C with resistivity
Size Surface Finish
above 18M and TOC less than 10PPB.
mm (inch) Ra Rt
20-40 ( - 1") > 1.5 m > 6 m B. Packaging
All fittings are to be packaged in a class 100
50-110 (1" -4") > 0.8 m > 3 m
cleanroom immediately after the cleaning process.
Fittings are to be double bagged, purged with clean
B. Packaging dry class 100 air in PE/Nylon composite bags. Bags
All pipes shall have ends sealed with PE bags and are to be silicone free and antistatic.
then capped. Pipe shall be sleeved in a PE encase-
ment and heat-sealed. Pipe is then packed into a C. Specialty Fittings
hard PE tube for shipping protection. Cardboard Specialty fittings are to include restraint fittings, butt
tubes are not acceptable. The following chart fusion instrumentation fittings, instrumentation
designates quantities of pipe per PE shipping tube: donuts, etc. Specialty fittings shall be machined or
molded of the same PP resin as the pipe and fittings.
D. Pressure Rating
Size - Inch Size - mm Qty All fittings, unless otherwise noted, shall meet the
" 20 Five requirements of Section 1.4.
" 25 Four
E. Production Control
Section 8
1" 32 Three During fitting production continuous quality controls are

1 " - 12" 40 - 315 One performed and monitored. Minimum required production
control:

APP-02
Pressure RatingValves
Criteria Test standard Test interval Pressure rating of valves shall be per manufacturers
recommendations based on materials, valve type
Measurement ISO/DIS 10931-3 every 2 hours
Condition visual each fitting and size.
Markings visual each fitting Flow Meters:
Inner surface DIN4768 1x/shift All Vortex Meters shall be made of PolyPure and free
Packaging visual each fitting
X-ray test visual every 2 hours of all seal materials. Supplier shall be capable of
supplying all sizes - 3 (20mm 90mm) and have
a replace electronics module.
2.5 Valves
All valves shall be produced in the same manner as All Vortex Meters shall be wet bench calibrated and
High Purity Fittings supplied with Calibration Records from the manufac-
turer.
Type 342 Spigot Diaphragm Valves:
- 2 (20mm 63mm) shall be the type 342 of the 2.6 Joining Equipment
PURAD system. The Valves shall have a PolyPure Proline installation shall be performed by factory
body and a diaphragm of PTFE with EPDM backing certified and trained installers in accordance with
or EPDM. Valves will be spigot single body design. manufacturers ISO procedures, ASTM D 2657 and
Top Works must include integral lockout device on DVS 2207-15. Date of certification or recertifications
the handle and position indicator. shall not exceed two years from the beginning of
project. Available joining techniques are as follows:
Type 342 Flanged Diaphragm Valves:
2 shall be type 342 with stub end and backing A. Butt Fusion
ring IR welded onto both sides. Top Works must Proper equipment selection should be based on pipe
include locking device on the handle and position size and site conditions. Butt fusion equipment
indicator. should be designed and tested to provide reliable
welds. All equipment should utilize electronically
Flanged Diaphragm Valves: controlled heating elements for accurate welding
3 - 4 shall be type 14 single Proline PP body design temperatures. Tools should also incorporate planing
with flanges molded as part of the body. Diaphragm units to face ends prior to heating. Butt fusion
shall be PTFE with EPDM backing or EPDM. Top equipment supplied shall weld joints based on force
Works must include locking position indicator. or pressure and not mechanical stops.
Type 343 Reduced Dead Leg Valve: B. Socket Fusion

x through 2 x 2 (20mm x 20mm through Proper equipment selection should be based on pipe
110mm x 63mm) reduced dead leg (zero dead leg) size and site conditions. Socket fusion tools shall be
valves shall be Type 343 Style from the PolyPure available in two styles; one portable style capable of
System. Valves shall be made of PolyPure resin. welding 1/2- 2 (20mm 63mm) and a bench style
Valve bodies are to be unibody, molded design with a capable of welding 3/4- 4 (25mm 110mm).
full 150 psi rating at 70F. All metal nuts and bolts Heating elements are to be electronically controlled
must be capped or covered to reduce metal expo- for accurate welding temperatures. Tools should
sure. Top Works must include integral lockout device also incorporate male and female heater inserts with
on the handle and position indicator. (Consult Teflon coating.
Factory for Availability of Molded T-343)
C. Non-Contact Butt Fusion
Check Valves: Proper equipment selection should be based on
Section 8
All sizes class 150, ball type Proline PP with FPM or installation requirements and line sizes. Tool shall be
EPDM seat and seals. 150PSI at 73.4F for sizes either semi automatic (UF2000 style) or fully auto-
through 2 nominal 100 PSI at 73.4F for sizes 3 matic (SP series).
and 4.

71 APP-02
UF2000 Style: PART 3 EXECUTION

Tool shall be made available in - 2 (20mm
63mm) and 2 10 (75mm 250mm) size 3.1 Installation
ranges. Tools shall possess electronic planer and A. Facilities
non-contact heating element. To avoid improper Subassembly and fabrication work should be con-
welded joints, tools will utilize and measure the ducted in a separate, temporary cleanroom located
welding pressures to join material and not within the building. Cleanroom should be equipped
mechanical stops. All IR fusion equipment shall with the following to provide a clean installation:
possess a minimum of the following capabilities:
1. Computer Control of the welding process. reach a level of class 10,000.
2. Ability to store welding data internally on computer 2. The quantity of filters should be determined by
memory - up to 1000 welds. providing a minimum of 60 room air changes per
3. Full alignment capabilities (vertical and horizontal) hour.
4. All metal components coated to prevent any 3. Ideal set up is to place welding equipment directly
particle generation from metals. under a filter. In addition nitrogen should be available
5. Ability to download all data to a personal com- for purging the pipelines with a positive pressure if
puter. the assemblies expand beyond the bounds of the
room.
IR equipment shall also have the capability of
following options incorporated into the tool for special B. Tools
demands: All fusion tools utilized are to be dedicated for clean
1. Protective hood over welding area up to 2 build only, and should be kept separate. Special
(63mm) attention should be given to the fusion tools to
2. Nitrogen purge of the welding area. prevent the possibility of contaminating a weld. The
3. Automatic nitrogen purge of the pipeline. contractor shall lease or purchase all necessary
4. Security card entry welding equipment from the manufacturer. At the
5. Printer labels for each weld automatically. end of the installation, any necessary equipment
needed on-site should be sold to the owner. Con-
SP Series: tractor is responsible for proper maintenance and
Tool shall be made available in 4 (20mm care of the fusion tools during construction.
110mm) and 2 10 (75mm 250mm) size
ranges. Tools shall possess electronic planar and C. Certification
infra heating element. Tools will utilize and measure Installers shall be pre-qualified as per section 2.6.
the welding pressures to join material and not Manufacturer shall provide on-site training in the
mechanical stops. To avoid improper welded joints, assembly and installation of the Proline piping
tool shall automatically operate clamps and control system as needed.
joining force. Tools shall possess the following
features:
3.2 Testing
1. Computer control and automatic fusion. A. Inspection
2. Touch screen for tool operation and parameter Prior to pressure testing, the system shall be exam-
selection. ined for the following items:
3. Restricted access through use of PCMCIA cards.
4. Automatic label printouts after each weld. 1. Pipe shall be completed per drawing layout with all
5. Ability to display and graph weld status while pipe and valve supports in place.
weld is in process. 2. Pipe, valves and equipment shall be supported as
6. Memory storage of welds
Section 8
specified, without any concentrated loads on the

7. Magnetic clamps to reduce change out time from system.
one size to another. 3. Pipe shall be in good conditions void of any
8. Vertical and horizontal adjustment for pipe cracks, gouges or deformation.
alignment. 4. Pipe flanges shall be properly aligned. All flange

APP-02
bolts should be checked for correct torques. 3.3 Cleaning of Proline Piping System
5. All diaphragm valve bonnet bolts shall be checked System shall be cleaned at completion of project
for correct torques. according to requirements set by owner
6. All joints should be reviewed for appropriate
welding technique:
Socket: To have two beads on the end of the

fitting and on the outside of the pipe in contact.
Non-Contact: Identity labels shall identify weld

OK. Joints should have two beads 360 around
the joint.
Manufacturer to supply inspection procedures

beyond the above recommendations. If any deficien-
cies appear, the quality control manager shall
provide directions for repair.
B. Pressure Test
level set by Quality Control Engineer. In all cases
test must be done hydrostatically. Air test is not
allowed
2. Filling the systemOpen all valves and vents to

purge the system of air. Slowly inject the water into
trapped in the system.

and up to a recommended 12 hours. Check pres-
sure gauge after one hour. Due to natural creep
effects on plastic piping the pressure will have
decreased. If drop is less than 10% pump the
pressure back up. At this time the system may be
fully pressurized to desired test pressure.

5. Test is to be witnessed by Quality Control Engi-

Section 8
neer and certified by the contractor.

73 APP-02

Section 8

APP-02
Section Eight: Ultra Proline Specifications Asahi/America Application and Validation Guide
1.6 Submittals
Ultra Proline, High Purity E-CTFE materials, dimensions of individual components,

Ultra Proline piping product, stating compliance to
Furnish a complete high purity E-CTFE piping system
to include pipe, fittings, anchors, specialty fittings and C. Welder certificates, certifying that welders comply
valves. with the installation procedures as outlined by ASTM
D-2657. All required training should be scheduled
1.2 References and completed at job start-up.
The following standards apply to products used within
this section. D. Qualification of firms supplying Ultra Proline: Firms
ASTM D 2837-85

1.3 Definitions
Ultra Proline Halar 1.8 Delivery, Storage and Handling
Ethylene Tetrafluoroethylene (E-CTFE) A. Deliver all Ultra Proline pipe to arrive on-site inside
protected hard black PE tubes. Cardboard tubes are
1.4 System Description and Pressure Rating not allowed.
System shall be an Ultra Proline System made of
uniform pipe and fitting resin. System pressure ratings B. Deliver all Ultra Proline fittings to arrive on-site
shall be based on continuous use of 50 years. Ultra double bagged in boxes layered with bubble packing
Proline Pipe and Fittings shall be based on a Stan- to prevent damage.
dard Dimensional Ratio (SDR) of 21, 1 through 4
(20-225mm). Pressure rating for pipe and fittings, C. Store products on elevated platforms in a dry
unless otherwise noted, shall be 150 psi (10 bar) for location with protection from the environment.
sizes up to 1 and 120 psi (8.3 bar) for sizes 2
(63mm) and above. D. Lift, support and transport Ultra Proline piping per
completion.
Operating Temp: (TBD by Engineer/Project Owner)
1.10 Extra Material
Section 8

repair, additions and maintenance of Purad PVDF
piping system.

75 APP-02
Asahi/America Application and Validation Guide Section Eight: Ultra Proline Specifications
PART 2 PRODUCTS
B. Packaging
2.1 Manufacturers All pipes shall have ends sealed with PE bags and
Subject to compliance with requirements products then capped. Pipe shall be sleeved in a PE encase-
which may be incorporated in the work include: The ment and heat-sealed. Pipe is then packed into a
Ultra Proline System as supplied by Asahi/America, hard PE tube for shipping protection. Cardboard
Inc. of Malden, Massachusetts, (781) 321-5409. tubes are not acceptable. The following chart desig-
Produced by Alois Gruber GmbH AGRU of Bad Hall, nates quantities of pipe per PE shipping tube:
Austria.
2.2 Material Size - Inch Size - mm Qty

Pipe, valves and fittings shall be made from Halar 1" 32 Three
resin produced by Solvay Polymers. MFI shall be 3.0
1" - 4" 32 - 110 One
6.0 g/10min per 275/2.16 according to ASTM D
792.
All resins shall not introduce contaminations into the C. Pressure Rating
ultra high purity water. Specifically, all raw materials All pipe shall meet the requirements of Section 1.4.
in product manufacturing shall be free of chemical
additives, fillers, property enhancers and reinforce- D. Production Control
ments, such as antioxidants, anti static agents, During pipe production continuous quality controls are
colorants, flame retardants, heat stabilizers lubricants, performed and monitored. Minimum required produc-
mold release agents, pigments, plasticizers, process- tion control:
ing aids, ultraviolet stabilizers and viscosity depres-
sants.
In addition, manufacturer shall test all lots to ensure Measurement ISO/DIS 10931-2 every hour
the melt flow index is within allowable range. Surface visual each pipe
Color visual each pipe
2.3 Pipe Micropores microscope 1x/shift
A. Production Inner surface DIN 4768 1x/shift
All pipe shall be produced on a dedicated extruder Packaging visual each pipe
Labels visual each pipe
completely within a class 100 cleanroom and shall be
packaged within a class 100 section of the
cleanroom. Pipe shall be stress relieved on line as it
2.4 Fittings
A. Production
Size Surface Finish All standard fittings through 4 (110mm) shall be injection
mm (inch) m ( inch) molded. All fittings are to be molded with equipment in a
32 - 90 (1 - 3) 0.2 (7.8) class 100 cleanroom environment. After secondary
machining, all molded fittings shall be cleaned for a
110 (4) 0.35 (13.8) minimum of 1 hour in an automated 6-basin Hot DI
rinse stations. The DI Rinse water specification shall
is extruded. Post extrusion annealing is not allowed. be 70 C with resistivity above 18M and TOC less
Surface finish smoothness is as follows: than 10PPB.
In addition manufacturer shall conduct continuous
checking for micropores. The micropores shall not B. Packaging
exceed a size of 1 micron. All fittings are to be packaged in a class 100
Section 8
cleanroom immediately after the cleaning process.

Fittings are to be double bagged, purged with clean
dry class 100 air in PE/Nylon composite bags. Bags
are to be silicone free and antistatic.

APP-02
C. Specialty Fittings certified and trained installers in accordance with

Specialty fittings are to include restraint fittings, butt manufacturers ISO procedures and ASTM D 2657.
fusion instrumentation fittings, instrumentation donuts, Date of certification or recertifications shall not
etc. Specialty fittings shall be machined or molded of exceed two years from the beginning of project.
the same PVDF resin as the pipe and fittings. Available joining techniques are as follows:
D. Pressure Rating A. Butt Fusion

All fittings, unless otherwise noted, shall meet the Proper equipment selection should be based on pipe
requirements of Section 1.4. size and site conditions. Butt fusion equipment
should be designed and tested to provide reliable
E. Production Control welds. All equipment should utilize electronically
During fitting production continuous quality controls are controlled heating elements for accurate welding
performed and monitored. Minimum required production temperatures. Tools should also incorporate planing
control: units to face ends prior to heating. Butt fusion
equipment supplied shall weld joints based on force or
2.5 Valves pressure and not mechanical stops.
C. Non-Contact Butt Fusion

Proper equipment selection should be based on
Measurement ISO/DIS 10931-3 every 2 hours installation requirements and line sizes. Tool shall be
Condition visual each fitting either semi automatic (UF2000 style) or fully auto-
Color visual each fitting matic (SP series).
Markings visual each fitting
Inner surface DIN4768 1x/shift
Packaging visual each fitting UF2000 Style:
X-ray test visual every 2 hours Tool shall be made available in - 2 (20mm
63mm) and 2 10 (75mm 250mm) size ranges.
All valves shall be produced in the same manner as Tools shall possess electronic planer and non-contact
High Purity Fittings heating element. To avoid improper welded joints,
tools will utilize and measure the welding pressures to
Type 342 Spigot Diaphragm Valves: join material and not mechanical stops. All IR fusion
1 - 4 (32mm 110mm) shall be the type 342 of the equipment shall possess a minimum of the following
PURAD system. The Valves shall have a E- capabilities:
CTFEbody (Halar Resin) and a PTFE diaphragm with
EPDM backing. Valves will be spigot single body 1. Computer control of the welding process.
design. Top Works must include integral lockout 2. Ability to store welding data internally on computer
device on the handle and position indicator. memory - up to 1000 welds.
3. Full alignment capabilities (vertical and horizontal)
Type 342 Flanged Diaphragm Valves: 4. All metal components coated to prevent any
1 2 (32mm 63mm) shall be type 342 with stub particle generation from metals.
end and backing ring IR welded onto both sides. Top 5. Ability to download all data to a personal computer.
Works must include locking device on the handle and
position indicator. IR equipment shall also have the capability of follow-
ing options incorporated into the tool for special
Pressure RatingValves demands:
Pressure rating of valves shall be per manufacturers
recommendations based on materials, valve type and 1. Protective hood over welding area up to 2 (63mm)
size. 2. Nitrogen purge of the welding area.
3. Automatic nitrogen purge of the pipeline.
Section 8
2.6 Joining Equipment 4. Security card entry

Ultra Proline installation shall be performed by factory

77 APP-02
5. Printer Labels for each weld automatically. installation, any necessary equipment needed on-site
SP Series: should be sold to the owner. Contractor is responsible
Tool shall be made available in 4 (20mm for proper maintenance and care of the fusion tools
110mm) and 2 10 (75mm 250mm) size during construction.
ranges. Tools shall possess electronic planar and
infra heating element. Tools will utilize and measure C. Certification
the welding pressures to join material and not Installers shall be pre-qualified as per section 2.6.
mechanical stops. To avoid improper welded joints, Manufacturer shall provide on-site training in the
tool shall automatically operate clamps and control assembly and installation of the Ultra Proline piping
joining force. Tools shall possess the following system as needed.
features:
1. Computer control and automatic fusion. 3.2 Testing

2. Touch screen for tool operation and parameter A. Inspection
selection. Prior to pressure testing, the system shall be exam-
3. Restricted access through use of PCMCIA cards. ined for the following items:
4. Automatic label printouts after each weld.
5. Ability to display and graph weld status while weld 1. Pipe shall be completed per drawing layout with all
is in process. pipe and valve supports in place.
6. Memory storage of welds 2. Pipe, valves and equipment shall be supported as
7. Magnetic clamps to reduce change out time from specified, without any concentrated loads on the
one size to another. system.
8. Vertical and horizontal adjustment for pipe align- 3. Pipe shall be in good conditions void of any cracks,
ment. gouges or deformation.
bolts should be checked for correct torques.
PART 3 EXECUTION 5. All diaphragm valve bonnet bolts shall be checked
for correct torques.
3.1 Installation 6. All joints should be reviewed for appropriate
A. Facilities welding technique:
Subassembly and fabrication work should be con-
ducted in a separate, temporary cleanroom located Butt: To have two beads, 360 around the joint.
within the building. Cleanroom should be equipped
with the following to provide a clean installation: Non-Contact: Identity labels shall identify weld
1. Provide Laminar flow Hepa filters in room ceiling to OK. Joints should have two beads 360 around
reach a level of class 10,000. the joint.
2. The quantity of filters should be determined by
providing a minimum of 60 room air changes per Manufacturer to supply inspection procedures beyond
hour. the above recommendations. If any deficiencies
3. Ideal set up is to place welding equipment directly appear, the quality control manager shall provide
under a filter. In addition nitrogen should be available directions for repair.
for purging the pipelines with a positive pressure if the
assemblies expand beyond the bounds of the room. B. Pressure Test
B. Tools level set by Quality Control Engineer. In all cases test
All fusion tools utilized are to be dedicated for clean must be done hydrostatically. Air test is not allowed
Section 8
build only, and should be kept separate. Special

attention should be given to the fusion tools to prevent 2. Filling the systemOpen all valves and vents to
the possibility of contaminating a weld. The contractor purge the system of air. Slowly inject the water into
shall lease or purchase all necessary welding equip- the system, making sure that air does not become
ment from the manufacturer. At the end of the trapped in the system.

APP-02



3.3 Cleaning of Ultra Proline Piping System

Section 8

79 APP-02

Section 8

APP-02
Asahi/America Application and Validation Guide

www.asahi-america.com APP-02
ASAHI/AMERICA, INC.
35 Green Street
P.O. Box 653
Malden, MA 02148
Tel: 800-343-3618; 781-321-5409
Fax: 800-426-7058
Email: pipe@asahi-america.com
Website: www.asahi-america.com

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ASAHI/AMERICA

High Purity Piping

Application and Design: Purad PVDF

Material Comparisons PolyPureTM, Natural PP

Validation Plan and

Section Six Proline Pigmented PP

SDR11, PN11/150psi, Sizes 20-500mm

Systems Overview pg. 33

Piping Design: High Purity

Section Eight Ultra Proline E-CTFE

SDR21, PN10/150psi, Sizes 32, 50, 63, 90 and110mm

35 Green Street - Malden, MA

Hot WFI water can be 10X more expensive than

35 Green Street - Malden, MA

approach provides high quality water on demand with

HP PVDF vs. 316L SS Pipe

High Purity PVDF

35 Green Street - Malden, MA

Asahi/America is prepared to assist you in all phases

1.2 HOW TO USE THIS GUIDE

The following is a suggested approach to a typical

2. Refer to our generic designs which are shown in

35 Green Street - Malden, MA

This Page Intentionally Left Blank

35 Green Street - Malden, MA

Section Two Classification Purified WFI

2.1 USP Purified Water (USP 25) 2.2.1 Design Philosophy

35 Green Street - Malden, MA

2.2.2 System Sizing 2.3.1 Process Design: Feed Water

35 Green Street - Malden, MA

FIGURE 2.A SAMPLE PROCESS PIPING P&ID

2.3.2 Process Design: Pretreatment Water Softening

35 Green Street - Malden, MA

TABLE 2.3 ACTIVE CARBON COMPARISON Source: Henry G.

35 Green Street - Malden, MA

2.3.3 Process Design: Purification

The Purification phase of treatment deals with dissolved

purification for standard DI water systems when the

35 Green Street - Malden, MA

2.3.4 Process Design: Post Treatment

Post Treatment design typically involves pumps, mixed

standard Post Treatment configuration is responsible for

35 Green Street - Malden, MA

2.4 Materials of Construction filtration. PVC contains an enormous amount of process-

2.4.1 MATERIAL PURITY

35 Green Street - Malden, MA

This Page Intentionally Left Blank

35 Green Street - Malden, MA

Section Three 3.1 Water for Injection (WFI)

Material Ambient Pressure

Fermentation and cell 316/316L SS N.A. - -

Table 3.1 Material Selection Guide by System Application

35 Green Street - Malden, MA

Clean Steam 45 to 75 psig. (optional)

Purified Water Feed

Cooling Water Supply

To Drain * = Please Consult Factory for exact pressure vs. temperature

35 Green Street - Malden, MA

The temperature and pressure in the distribution loop are

35 Green Street - Malden, MA

STEAM Vent to Safe Place

CIP PREP COND

PVDF PVDF PVDF Sterile