ASTM A967 / A967M - 13 Standard Specification for Chemical Passivation

Treatments for Stainless Steel Parts

We just have finished install a new purity water system in site, and before the first
commission of this system, also to meet requirement of QA or cGMP compliance, we
must clean and disinfect the system pipe/valves according to necessary procedure. So I
want to know if we have a standard SOP about this operation?

Thanks and Regards

zhangbd

Janssen China

greg87 (Chemical)25 Jun 03 11:59

Sanitization can be performed with chemicals: hydrogen peroxide or peracetic acid

solutions. Makeup a dilute solution in the tank and circulate through the system. Draw
off at each use point to ensure exposure to all piping. After a period of time,
flush. Sample to ensure no residual.
Concentration and time are the two variables. For hydrogen peroxide, a 10% solution
circulated for 12 hours is very conservative. A solution of Minncare by Minntech is a
good choice for a peracetic acid solution, and preferable to hydrogen peroxide. A 1%
solution circulated for an hour (after you are sure it has reached all parts of the system)
will do it. Minntech can provide you info and test strips.

I am assuming that the pipe has been installed clean, and if it is stainless steel, it has
been passivated.

MedicineEng (Industrial)3 Jul 03 03:36

Zhangbd:

Greg87 is right but this only applies to the PW production plant, not to the PW
distribution loop.
For the loop, before you do the sanitization you will have to make some other steps:

I assume that the pipe and tank are SS316L internal polish, food grade (<0.51uRa if I
am not mistaken);
1.After the weldings and the pipe all manufactured and put in place you will have to
degrease it. As you know, pipes are quite dirty and also welding releases some "greasy"
material. You can do this with a normal washing powder. Charge the tank around 10-
20% and then add the washing powder. Be very careful with the quantity, due to the
foam formation when you put the loop pump working. So, I recomend that you use a low
foam detergent;
2.You recirculate this solution for 30minutes, one hour, discahrge and rinse the tank and
pipes with fresh water several times.
3.Then, you need to passivate the tank and the distribution loop. As you know, PW has a
pH acid, so you need to passivate the SS to increase it's resistance. For that, you use a
solution of nitric acid at 5%.
Charge the tank about 8-12%. Then, you need to heat up the system up to 80C and
recirculate the solution 30 minutes. After that, cool dowm and make the neutralization
with sodium hodroxide. VERY IMPORTANT!!! Be careful with the addition of NaOH to the
solution of nitric acid. The reaction is highly exotermic. As such you will have to add the
NaOH very slowly if possible with the recirculation pump switch on. After Ph=7 is
achieved (you have to control with a Ph papaer indicator), let the neutral solution
circulate for about 30 minutes. Discharge the tank and fill up to 10-15%with PW water.
Then recirculate for about 2 hours. Repeat this step until you don't have traces of nitric
acid or NaOH.
4. Now you can sanitize the tank and the loop. Usually in this sanitization we don't use
any chemical it is just a thermic sanitization that is controlled by the PLC program of the
PW skid. Usually you have two types of thermic sanitization: one at 80C that is
recirculating for 2 hours, and other at 121C (a kind of sterilization) that recirculates for
30 minutes.

For both you have to have the PW level in the tank of about 15%.

All this is for the PW storage and distribution loop.

For the PW production plant you can use Greg's suggestion. Usually, for microbiological
contamination, we use also formaldehyde solution.
I suggest to you that you contact the supplier to give you some support, otherwise you
might have big headaches with the system.
PW systems are very sensitive and a permanent attention has to be given to it.
Just as an example, in my actual PW system and since the area where my actual
company is installed (Southeast China)is very hot and humid we had to install a system
that permanently cools down the water below 23C because as you know, above 25-27C
the probabilities of having microbiological contamination increase very much.

PauloRibeiro is correct that if the system is stainless steel, then it must be passivated
prior to sanitization, as I stated. The actual water spec for your high purity system
may impact what really needs to be done. Stainless steel high purity water systems
would normally use stainless tubing, sanitary fittings, would be welded (either by
machine or manual) without filler rod, and would be installed clean by trained
personnel. With this approach, there would not be grease or welding spatter. Since the
installed system is still not perfectly clean, standard passivation procedures include
cleaning as a first step, usually with hydroxide, prior to the passivation
steps. Passivation is best be contracted to a company who does it regularly. Most
companies that perform passivation use chelated chemicals rather than nitric acid.

If you have the equipment set up to heat sanitation, that is best. Systems at
pharmaceutical facilities and labs that do not have the heat exchangers etc, use
hydrogen peroxide or peracetic acid to sanitize the entire distribution system, as well as
the production system. Both of these chemicals are effective and, more importantly,
are non-contaminating. These chemicals are also appropriate for plastic systems. I do
think formaldehyde should be added to any pure water system.

You will need to sanitize the system (production and distribution) periodically. How
often will depend on the quality of the installation. You will need to sample every day to
determine when the microbial load on the system is starting to get close to your limit.

MedicineEng (Industrial)10 Jul 03 00:27

Zhang:
Greg is right. The use of formaldehyde in a PW system should be avoided, specially
because it is dangerous for the health and some special cares have to be taken when
you are handling it. If you use it, you have also to have a kit to detect in order to check
if you still have formaldehyde after the rinsing of the system (you can use a Merck kit
1.08028.0001-Formaldehyd Test).
Formaldehyde is very hard to remove from the system. Just for you reference, every
time that we use it, we need to make a 16/20hours rinsing to assure that no
formaldehyde is in the system.
Some systems replaced formaldehyde by peracetic acid, but as far as I was told, there
are some old versions of reverse osmosis membranes that cannot withstand with the
peracetic acid.

Please give us your feedback on how are the things going with your PW system.

PR

dtreacy (Bioengineer)23 Oct 03 11:23

Hi,
I agree with the above, Formaldehyde should be definitely avoided when it comes to
purified water system.
For degreasing a caustic based solution should be used. Detergents should be avoided,
as it may be impossible to prove to the regulatory authority or your own QA department
that they have been effectively removed by rinsing.
Nitric acid or chelated chemicals can be used for passivation. The function of the
passivation is to re-establish the protective layer on the surface of the steel, which was
removed by welding. (Its also good if you have a rouging problem).
Sanitisation can be carried out either chemically (Hydrogen Peroxide / Peracetic acid
mixes such as Oxonia), thermally 85 degC or through the use of Ozone generators and
injectors.
If you are using chemical or ozone sanitisation. Turn off your UV lamps during
sanitisation and turn them back on during rinsing (this will degrade the Ozone /
hydrogen peroxide.
Also make sure that your UV lamps are off when thermally sanitising as the heat will
damage the UV lamps.
Periodically monitor chemical concentrations during sanitisation as the sanitant may be
used up doing its job.

HOMEINDUSTRIES SERVEDFOOD / DAIRY / BEVERAGEORBITAL WELDING OF STAINLESS STEEL TUBING

Orbital welding has been proven to be a very effective method for joining of stainless
steel tubing for systems in which the products flowing through them must be
maintained in a clean and/or sterile condition. The capability of making smooth,
crevice-free welds that maintain uniformity and consistency for thousands of joints
have made orbital welding technology the accepted joining technology for the
semiconductor and biopharmaceutical industries in the United States. Crevice-free
welds are essential for controlling the growth of microorganisms in hygienic piping
systems.

The food and dairy industries in the United States, which have been slow to adopt
orbital welding, have shown an increasing awareness during the past year or so that
the joining technology used for the fabrication of sanitary piping systems is
fundamental to achieving and maintaining cleanability and sterilizability and are Welding of stainless
steel assemblies at the
taking steps to improve the hygienic condition of their piping systems. "Quilmes" brewery in
Argentina with an Arc
Machines Model 79-
The food and dairy industry is following the lead of the bioprocess industry which 6625 orbital weld
introduced a new standard for the design and fabrication of bioprocessing head. Photo Courtesy
of Soldadura-
equipment, including piping, (ASME Bioprocessing Equipment Standard BPE 97) in Mendoza.
November, 1997. The 3-A Sanitary Standards Committee in collaboration with the American Welding
Society (AWS), has just published the AWS D18.1 Standard for welds in stainless steel piping systems
which come in contact with the product.

This standard is more precise and well defined than previous standards used by the food and dairy
industry. However, breweries, both in the USA and abroad, have long recognized the advantages of
orbital welding for achieving a high level of cleanliness in their piping systems. The demand for higher
standards is driven by new technologies including bioprocessing and advanced food processing
technologies, as well as by the global marketplace. International trade in biopharmaceutical as well as
food and dairy products has led to improvements in plant construction methods abroad, including the
introduction of orbital welding, to meet the more exacting requirements for export, particularly to the
USA.

The standards writing groups have had to deal with defining weld acceptance criteria and related
issues including metallurgical considerations, such as the optimal sulphur content of 316L stainless
steel, and the amount of permissible discoloration of the weld and heat-affected zone. These issues
will be examined as well as orbital welding standard operating procedures (SOPs) that have been
shown to result in high productivity and excellent weld quality.

Figure 1. Water for

injection (WFI) is one
of the most common
applications of orbital
welding in the
pharmaceutical
industry. Welds must
be smooth and
crevice-free in order
to meet WFI
standards for injection
into the human body.
Photo courtesy of
Pfizer Animal Health.
 Figure 2. An Arc
Machines Model 9-
2500 weld head
(arrow) mounted on 2
inch OD critical
piping on a bioreactor
skid. Photo courtesy
of B.Braun Biotech

Industry Applications

Biopharmaceutical. Orbital welding has been used for DI (deionized) and WFI (water for injection)
piping systems throughout the pharmaceutical industry since the 1970s. For example, Figure 1 shows
a WFI system at the Pfizer Animal Health facility in Missouri. Orbital welding has now been used for
several pharmaceutical installations in Latin America.

One example is the Fiocruz Instituto de Technologia em Immunobiologicos in Rio de Janeiro, Brazil
which used orbital welding for joining piping systems for cold water, WFI, hot DI water and
compressed air at a state-of-the art R&D and production facility for the manufacture and production of
vaccines. Orbital welding is frequently used for installing process equipment on-site such as the large
fermenter for antigen production which was installed in a class 100,000 clean room at the Fiocruz
facility. Welding standards at this facility had to meet exacting criteria required for export of the
vaccines to countries outside of Brazil. Orbital welding is used by equipment manufacturers (OEMs)
such as the Paul Mueller Co. in Springfield, Missouri who use orbital welding to fabricate their multi-
effect stills which are used to distill water for high-purity pharmaceutical applications.

Another common application of orbital welding is the installation of skid- mounted equipment.
Biopharmaceutical equipment is frequently installed on "skids" with associated equipment and
connecting piping which are fabricated off-site. This offers flexibility in locating the equipment on-site
and facilitates installation, eg, orbital welding is used for joining the critical piping which delivers gases
to the bioreactor on the bioreactor skids made by B.Braun Biotech in Allentown, Pennsylvania as
shown in Figure 2.
Food Industry. Several of the major food industry suppliers have begun to use orbital welding. Kraft
Foods has purchased orbital welding systems for several of its plants including Springfield, Missouri,
Allentown, Pennsylvania, and New Ulm, Minnesota. They find it practical to have an orbital welder on-
site for maintenance jobs and for small installations they can do themselves without having to hire a
contractor.

Procter and Gamble has installed piping systems in several of its plants including food and chemical
plants. Procter and Gamble has now specified that orbital welding be used in all new construction
wherever practical. Several fabricators including APV Crepaco and Central States Industrial have been
using orbital welding to manufacture equipment and fittings for food and dairy applications for at least
10 years.

Figure 3. A manual
weld taken from an
operating
pharmaceutical plant.
This weld has defects
which include lack-
of- penetration,
misalignment, a huge
crevice, and
discoloration due to
poor ID purge. This
weld would be
considered
unacceptable by any
sanitary standard.
 Figure 4. An orbital
weld on 316L
electropolished
stainless steel. The
weld is fully
penetrated with a
uniform crevice-free
inner weld bead with
good alignment. The
ID was purged with
argon containing 8
ppm of oxygen which
resulted in slight
discoloration of the
HAZ. This weld
would be acceptable
for most food, dairy
and pharmaceutical
applications

NAFTA (North Atlantic Free Trade Agreement) has spiked an interest in orbital welding in Mexico to
meet new specifications for export to the USA and Canada. More food industry end users in Mexico are
now specifying orbital welding. Jumex, (Jugos de Mexico), uses orbital welding to weld 316L
electropolished tubing in sizes from 2 to 4 inches OD for pulp, fruit juice and dairy applications. In
India, a country where skilled manual welders are scarce, the Dynamix Dairy successfully orbitally
welded the stainless steel piping systems in a cheese plant making process cheese slices for
McDonalds.
 Figure 5. A valve
manifold to control
CIP and product flow
in a brewery
fabricated by orbital
welding.

Breweries. Breweries have recognized from the beginning the need to control microbial growth in
their process piping. The Anheuser Busch Brewery in Van Nuys, California which orbitally welded about
11 miles of 4 and 6 inch schedule pipe was one of the first orbital welding applications. Orbital welding
is particularly important for making cold filtered and draft beer that are not pasteurized such as Miller
Genuine Draft and Rainier cold filtered beer. Most of the major breweries in the USA and several in
Latin American countries including Mexico, Nicaragua, Argentina and Brazil have done successful
orbital welding installations. The Kaiser Brewery in Sao Paulo recently replaced 3,000 manual welds
with orbital welds.

CIP Systems. An Arc Machines Model 95-6625, an open-frame type weld head with wire feed
capabilities, was recently used in Nicaragua to install product lines, CIP (clean-in-place) and related
piping at "La Victoria" brewery. A complex system of valves, typically computer controlled, are used to
direct either cleaning solutions, rinse water, or product through the process lines. A manifold (shown
above) consisting of 10 valves for control of CIP and product flow was fabricated by orbital welding
using a standard weld head. It was determined that this assembly could be made even more compact
by using a narrower weld head such as Arc Machines Model 8-4000 so that spacers placed between
the valves to allow access for the standard head could be eliminated. This would not only make the
assembly more compact but would also would reduce the total number of welds in the manifold.
Weld Heads and Power Supplies

Orbital welding done with the GTAW process can be done as an autogenous (fusion) weld in which the
tube ends being welded are simply melted by the arc and fused together, or filler, usually in the form
of wire, can be added to the weld. An inert gas is used to protect the molten weld puddle and tungsten
electrode from oxidation. Orbital welds are usually done in-place with the tube or pipe remaining
stationary and the electrode or torch "orbiting" around the weld joint to complete the weld.
Pharmaceutical and other hygienic welds in the United States are typically done as welds square butt
weld without filler. However, in Europe and Latin America, the addition of filler may be required for
some sanitary applications. For fusion welding the power supply controls weld parameters including
primary and background pulsed current, pulse times, travel speed (RPM), level times, etc. Fusion
welds are normally done in a single pass with the current reduced in a series of timed steps called
levels. After the weld is finished or "tied-in", the current is gradually reduced in a timed downslope
until the arc is extinguished. The purge is continued until the weld metal is cooled enough to prevent
oxidation which is typically about 30 seconds.

If filler is to be used, the power supply must have additional controls for feeding wire into the weld,
and may also have controls for torch oscillation and electronic control of the arc gap (AVC), which is
the distance between the end of the electrode and the tube or pipe. This is important because the arc
gap affects the arc voltage and thus the heat input into the weld and should be as consistent as
possible to achieve repeatability of results.
Weld Parameters

Actual values of weld parameters vary with tube and pipe dimensions. For fusion tube welds, weld
current is based on wall thickness with about 1 ampere of weld current for each 0.001 inch. RPM of
the weld head rotor is based on tube diameter to arrive at a typical travel speed of 5 inches per
minute. This would be 1.6 RPM for a 1.000 inch tube or 0.8 RPM for a 2 inch tube. Weld parameters
are recorded on a weld schedule sheet for each size of tube or pipe and stored in the power supply
memory.

Weld heads for fusion welding are typically enclosed. Enclosed weld heads are filled with inert gas
during welding and provide optimal protection from oxidation for the outside of the weld. Since there
may be some separation of tube ends during welding which allows the mixing of gases between the ID
and OD of the tubing, enclosed heads help to maintain a better purge on the inside of the tube as
well.

The size range of orbital fusion welding with enclosed weld heads is from 1/8 inch to 7 inches OD.
Weld heads come in a range of sizes with each size head accommodating several tube sizes. For
example, the Model 8-4000 narrow weld head can weld the sizes from 1 to 4 inches which is the range
most commonly seen in biopharmaceutical applications. Tube clamp inserts of the appropriate size are
installed on both sides of the weld head to hold the tubing in place for welding. The standard electrode
position is in the center of the weld head, but the electrode can be positioned to accommodate fittings
or components having "stick out" too short to reach the center of the head.
Figure 6. The manual
GTAW process. The
welder holds the torch
and is shown adding
filler to the weld.
Inert gas is used to
protect the weld metal
and electrode from
oxidation.

Industry standards are probably the most important determinant of weld quality. This is because
installers are reluctant to spend money or time to achieve results that are not transparent to the end
user. The 3-A Sanitary Standards were published in the 1950s by the dairy industry as a guideline for
material selection and fabrication techniques appropriate for sanitary systems. The 3-A Accepted
Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems was used by the
food and dairy and, until just recently, by the pharmaceutical industry as a guideline for the fabrication
of sanitary piping systems. 3-A selected 300 series stainless steel for equipment and piping having
contact with the product and established guidelines for welding in recognition that fabrication
techniques would have an impact on performance of the system.

At the time it was published, the 3-A standard applied only to manual welding. Nevertheless, some of
their recommendations are still appropriate today for orbital welding. For example, they specified the
Tungsten Shielded Arc Method which is the same process (gas tungsten arc welding or GTAW) that is
used in most orbital welding equipment. Both manual and orbital GTA welding can be done either as a
fusion process or with the addition of filler. 3-A also required that all sanitary welds be fully penetrated
to the ID, and that all welds having "pits, craters, ridges, or embedded foreign materials" be removed
and properly rewelded.

3-A also insisted that an inert back-up gas be used on the tube ID to protect the weld from oxidation,
and that a borescope be made available to inspect the interior of the weld. Current
standards are more specific regarding the level of purge required, the number of
welds to be examined with a borescope, and the inspectors qualifications. 3-A called
for acceptable sample welds to be provided at the beginning of each day. For a
manual weld, a test sample or test coupon demonstrates that the welder has the skill
to make an acceptable weld. For orbital welding, the repeatability of the process
offers some assurance that the test coupon will be representative of the quality level
of subsequent welds on that material. Recent standards for sanitary welding all
require preconstruction weld samples and daily test coupons.
Several industry groups in the USA are currently writing or have recently published
standards for welding of stainless steel tubing which have direct or indirect contact
with the products. Leaders in the nascent bioprocess industry recognized in 1988
that existing standards were not adequate to meet the needs of this very specialized
technology which requires growing cells or microorganisms in culture without
contamination by unwanted microorganisms.

In response to the need for improved standards, the bioprocess industry developed
the ASME Bioprocessing Equipment Standard (BPE-97) which was released in
November, 1997. The ASME BPE-97 standard offers guidelines for the hygienic
design of equipment and piping systems for improved cleanability and sterilizability.
The ISPE is currently writing a series of guidelines for the design and fabrication of
pharmaceutical facilities and equipment. Both ASME and the ISPE Baseline
Pharmaceutical Engineering Guides recognize orbital welding as the preferred joining
technology for piping systems having contact with the product. Recognizing that
visual weld criteria will have an important effect on maintaining the hygienic
condition of the piping system, the BPE -97 standard includes drawings showing
acceptable weld profiles and sets limits for welding defects such as concavity,
convexity, misalignment, discoloration, etc.

The AWS D18.1 1998 Standard, which has just been published by the American
Welding Society in cooperation with 3-A, covers welding standards for use in the
manufacture and construction of dairy product processing plants. This standard will
allow the owner and contractor the choice of manual, mechanized, or automatic
processes, and has weld criteria and inspection protocol that are more stringent than
previous standards used by the food and dairy industries for hygienic applications.
Effects of Sulphur

Since the introduction of orbital welding, two major issues affecting weld quality
have persistently arisen. These are the issue of the ideal sulphur content of 316L Figure 7. Weld
profiles showing
stainless steel and the issue of the level of ID purge that should be required.
limits for concavity,
Elemental sulphur is present as a contaminant and is largely removed by modern convexity,
misalignment, etc.
steel refining processes. AISI/ ASTM specifications for 316 and 316L stainless steel
From ASME-BPE 97
permit a maximum concentration of 0.030% sulphur since sulphur in higher
concentrations promotes hot cracking of welds.

The sulphur content of stainless steel has a pronounced effect on both the surface finish of the
material and on the weldability. The surface finish is affected when sulphur and manganese in the
base metal combine to form manganese sulphide "stringers." These non-metallic inclusions are in the
micron size range and may be removed during passivation or electropolishing leaving pits. The
presence of pits makes it difficult for tubing suppliers to the high-purity industries, particularly the
semiconductor industry, to meet their surface finish specifications. This has driven the semiconductor
industry to specify very low levels of sulphur for tubing used in gas distribution systems.

Trace elements present in stainless steel affect weldability to a varying extent, but sulphur has by far
the most dramatic effect. When the sulphur content of stainless steel is above 0.008%, the application
of heat to the weld is transferred from the outside of the weld puddle towards the center carrying the
heat towards the inside surface of the weldment. This provides good penetration of the weld joint and
a good depth-to-width ratio. When sulphur is eliminated or reduced to very low levels the fluid
dynamics of the weld puddle changes.
Importance of Purging

Purging of both the OD and ID of the weld joint with inert gas during welding is done to protect the
molten weld puddle from oxidation. If oxygen is present in the gas, which is usually argon,
discoloration or "heat tint" occurs on the weld and heat-affected zone (HAZ) next to the weld. Heat
tint ranges in color from black and crusty, if no purge is applied, to bluish brown to pale blue or light
tan or "straw color" depending on the amount of oxygen, moisture or other contaminants in the gas,
on the tubing or in the base material. Discoloration is undesirable, not only because it is unattractive
from a cosmetic point of view, but because its presence has been shown to have a detrimental effect
on the corrosion resistance of stainless steel in direct proportion to the amount of oxygen in the purge
gas.
Corrosion Resistance

Corrosion resistance. For the biopharmaceutical and food and dairy industries, the downside of
discoloration caused by welding is not particulates, but the loss of corrosion resistance. It has been
shown that the loss of corrosion resistance is fairly minimal for straw-coloured welds, but the loss can
be reduced even further when highly purified purge gas is used.

These industries produce products that may be high in chlorides or be acidic, challenging the corrosion
resistance of even 316L stainless steel. Rouging, a form of corrosion common in pharmaceutical piping
systems has sometimes been traced to the HAZ of welds, although other locations, such as pump
impellers and small carbon steel equipment components are more likely to show this effect.

Passivation. Passivation, which is typically done on welded piping systems to remove iron
contaminants left by fabrication and to restore the passive layer on the surface of the welds and HAZ,
has been shown to increase the pitting potentials and hence the corrosion resistance of both welded
and unwelded tubing. However, passivation does not remove heat tint which extends well below the
surface layer. Discoloration and corrosion of the HAZ was apparent on even passivated weld samples
purged with only 108 ppm oxygen in the ID purge even though the pitting potential indicated a high
level of corrosion resistance. Since stainless steel is not inexpensive, and since the cost of replacing it
is high, it would seem advisable to use the best purge possible for any application where the service
environment is aggressive.

AWS D18.2. To help owners, installers, and quality control personnel in specifying the permissible
levels of weld discoloration for specific sanitary food and dairy applications, the AWS, in cooperation
with 3-A, has produced the D18.2 standard which includes a color photo of a series of orbital welds
purged with varying amounts of oxygen added to the argon ID purge. The ASME BPE-97 standards
group intends to reference D18.2 in their next revision. This standard should go a long way towards
helping specifiers select realistic purge levels for their applications.

Figure 8. Orbital
welding of assemblies
which are part of the
filtration loop
between tanks and
pasteurization at the
"Quilmes" brewery in
Buenos Aires,
Argentina. By
standardizing their
fabrication procedures
(SOPs) they were able
to weld at 3 times the
rate for the same
application done with
manual TIG welding.
They were all sanitary
quality welds with
100% visual
inspection of the ID
and zero rejects!

Effect of Welding SOPs on weld quality and productivity

SOPs. Kinetic Systems, Inc., a high-purity mechanical contractor in the USA, presented data at a local
ISPE meeting summarizing results from 100,000 orbital welds in biopharmaceutical facilities during
the period from 1991 to 1994. During this time they were able to reduce the reject rate of their orbital
welds from a very respectable 1.8% to a remarkable 0.2%.

The company attributed this improvement in weld quality to increasing proficiency in executing their
standard operating procedures (SOPs). SOPs are written procedures for fabrication and welding which
include materials handling, cleaning, end-preparation of tubing, pre-tacking of weld components,
purging, use of test coupons, standardization of electrode type and geometry, and many other small
details that have a bearing on weld quality.

Soldaduras-Mendoza, a mechanical contractor in Buenos Aires, did a recent orbital welding installation
at the "Quilmes" brewery at which they were able to establish SOPs resulting in a high level of both
productivity and quality. They had to weld a large number of assemblies that comprise part of the
filtration loop between the tanks and pasteurization. One end of the assembly required a weld of an
elbow to a 4 inch OD tube, while the other end of the tube was welded to an elbow which was joined
to a reducer welded to a 2-1/2 inch tube for a total of 4 welds per assembly.

An Arc Machines Model 95-6625 weld head was used to weld the assemblies. This head has wire feed
capabilities and features a clamping device that clamps directly on to the weld joint without the need
for changing tube clamp inserts. Thus the change from 4 inches to 2-1/2 inches could be accomplished
nearly instantaneously with only a small adjustment of the tungsten and a change of weld programs
accomplished by calling up the weld program number from the memory of the Model 227 Power
Supply.

Pipefitters on the night shift were responsible for cleaning, tacking, and making the purge connections.
The pre-tacked assemblies were placed on racks in groups of 5 which they called cassettes. During the
day, the welding operator did the welds in a predetermined order. As each set was completed, a new
cassette was presented while the welder cleaned the tungsten in preparation for welding the next set
and then continued with production.

Orbital welding done in this way was found to be 3 times as productive as manual TIG welding for the
same application with an average production rate of 58-62 welds per day with one welding operator
and one welding system. All of these were sanitary quality welds. Since the welds were on the ends of
the tubes it was possible to inspect 100% of the welds on the ID. There were zero rejects!
Conclusions

There is evidence of an increased interest in improving standards in the food, dairy, and beverage as
well as the pharmaceutical industry, not only in the United States, but in Latin America and other
countries as well. This is demonstrated by an increase in the use of 316L EP tubing, the demand for
better purge gas quality, the use of higher purity valves, and greater interest in the FDA (Food and
Drug Administration) and cGMPs (current Good Manufacturing Practices). All of these industries are
under pressure for improved product safety, at a lower cost and at higher quality standards than ever
before.

When end-users examine the cost-benefit ratios of new technologies, they find that orbital welding
offers higher quality welds with better corrosion resistance, and in many applications higher
productivity, at a reasonable cost. As these industries continue to improve their fabrication practices,
the use of orbital welding technology will be at the forefront.

Acknowledgement: The author acknowledges the contribution of Angel Brond, Director of Latin
American Sales for Arc Machines, Inc., whose technical support and kind assistance made this
presentation at the Octavo Congreso Argentino de Farmacia Y Bioqumica Industrial, Buenos Aires,
Argentina, June 1999, possible.