BASIC DESIGN OF THE CLEAN ROOM

1- Introduction

2- Sources of contamination:

Contents 3- Important design considerations for HVAC Systems:

4- Filtration (HEPA & ULPA Air Filtres)

5- Air Flow Distribution and Control

6- Room Pressurization

7- Architectural Issues

8- Mechanical Considerations

9- Certification Requirements
Session Objective

1. To describe the fundamental design of the clean room

requirements.
2. Gaining a better understanding of how to maintain and deal
with the clean room air conditioning system.
3. Determine the most common tests necessary to confirm the
validity of the clean rooms.
Introduction

Clean rooms are defined as specially constructed,

environmentally controlled enclosed areas with respect to
airborne particulate (viable and/or non-viable), temperature,
humidity, air pressure, and airflow pattern.
In Pharmaceutical industries, clean rooms control living
particles that would produce an undesirable effect on patients.
Source Of Contamination

The source of contamination is categorized as the external source

and internal source
External source:
External contamination is brought in primarily through the air
conditioning system through makeup air. Also, external
contamination can infiltrate through building doors, cracks, and
wall penetration for pipes, cables, and ducts. This contamination is
controlled primarily by:
High-efficiency filtration
Area pressurization
Sealing of area penetration
Source Of Contamination

 Internal sources:
the potentially largest source is from people in a cleanroom, plus
the shedding of surfaces, process equipment, and the process itself.
People in the workspace generate particles in the form of skin
flakes, lint, cosmetics, and respiratory emissions. Other sources of
internal contamination are generated through manufacturing
processes.
Source Of Contamination

Control is primarily through airflow design. Although airflow design

is critical, alone does not guarantee that clean room conditions will be
met. Construction finishes, personnel and garments, materials, and
equipment are sources of particulate contamination that must be
controlled,
Source Of Contamination

Important control precautions include:

1. Wall, floor, ceiling tile, lighting fixtures, and doors should be
constructed from materials that must be carefully selected to meet
clean room standards.
2. People must wear garments to minimize the release of particles
into the area. The type of garments depends on the level of
cleanliness required by a process.
3. Materials and equipment must be cleaned before entering the
clean room.
Source Of Contamination

4. Room entrance such as airlocks and pass box is used to

maintain pressure differentials and reduce contamination.
5. Air showers are sometimes used to remove contaminants
from personnel before entering the clean area.

We differentiate between the cleanliness of rooms by

referring to class numbers.
Source Of Contamination

Clean Room Class Limits “not to exceed” particles per cubic meter (m3)
Class equal to or greater than the tabulated size
At rest* In operation**
Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm
A 3,520 20 3,520 20
B 3,520 29 352,000 2,900
C 352,000 2,900 3,520,000 29,000
D 3,520,000 29,000 Not defined Not defined
Source Of Contamination

* At rest: a term used to describe a cleanroom with

equipment in operating condition but without any
operator.

** In operation: A term used to describe a cleanroom in

normal operation with all services functioning and with
production equipment and personnel present and
performing their normal work functions.
Important design considerations for HVAC Systems

The four important air-conditioning design considerations for

cleanroom system design are:
1) Supplying airflow in sufficient volume and cleanliness to
support the classification of the room
2) Introducing air in a manner to prevent stagnant areas
where particles could accumulate.
Important design considerations for HVAC Systems

3) Conditioning air to meet clean room temperature, humidity,

and filtration requirements.
4) Ensuring enough conditioned makeup air to maintain the
specified positive pressurization.

Besides the room preparation in terms of materials and finishes

plays an equally important role in meeting these requirements.
The goal behind that is to minimize the internal generation of
contaminants from the surfaces.
 Important design considerations for HVAC Systems

Clean rooms differ from an ordinary ventilated/conditioned room

mainly in three ways:
1) Increase air supply: the increased air supply is an important
aspect of particle control. Normal air conditioning systems are
designed for 0.5 to 2 air changes per hour. A clean room would
have at least 10 air changes per hour and could be as high as 600
for absolute cleanliness. The large air supply is mainly provided
to eliminate the settling of particulate and dilute contamination
produced in the room to an acceptable level.
Important design considerations for HVAC Systems

2) The use of high-efficiency particulate filter: High-efficiency

filters are used to filter the supply air into a clean room to ensure
the removal of small particles. These filters are installed at the
point of air discharge into the room.
3) Room pressurization: the clean room is positively pressurized
with respect to the adjacent areas. This is done by supplying
more air and extracting less air from the room than is supplied to
it. Room pressurization is mainly provided to ensure that
untreated air does not pass from the dirtier adjacent area into the
clean room.
Important design considerations for HVAC Systems

Before any methods of contamination control of airborne

particles can be applied, a decision must be made as to how
critical this particulate matter is to the process or products. This
is done by the classification of rooms to the requisite class
level.
The classification of the room depends on the type of filtration,
efficiency, airflow distribution and patterns, amount of
pressurization, etc.
Important design considerations for HVAC Systems

1) Filtration (HEPA & ULPA Air Filtres):

Filtration is an important aspect of clean rooms. Most filters
are defined by their particle removal efficiency and air flow
rate. Clean rooms require very high-efficiency filters and for
class 100 (A) in WHO Guideline) 100% HEPA filter coverage
is recommended.
Important design considerations for HVAC Systems

Clean room air filtration technology centers around two types:

 High-Efficiency Particulate Air (HEPA):
HEPA filters are replaceable extended media dry-type having
a minimum particle collection efficiency of 99.97 to 99.997%
for a 0.3-micron particle, and maximum clean filter pressure
drop of 2.54 cm (1”) water gauge when tested at rated airflow
capacity.
 Ultra Low Penetration Air (ULPA):
Important design considerations for HVAC Systems

Most ULPA filters are replaceable extended media dry filters

that have a minimum particle collection efficiency of 99.9997%
efficient for particles greater than or equal to 0.12 microns in
size.
The high-efficiency filters belong to the interception (filtration.
mechanism) family of filters and are referred to as absolute
super interceptors. Absolute filters are used only where an
extremely high level of cleanliness or purity is required. Both
HEPA & ULPA types fall in this category.
Filtration Mechanism

There are four basic mechanisms by which fibrous air

filters remove contamination from the airstream.
1) Straining or sieving: Particles larger than the clearances
between fibers cannot pass through and are collected on
the media.
2) Inertial or Impaction: Particles due to their inertia leave
the airstream around filters and impact the fiber directly.
Adhesives usually retain the particles.
 Filtration Mechanism

3) Interception: Particles small enough follow the airstream line

around the filter fiber but are intercepted by the filter due to
the dimensions of the fiber and the particles.
4) Diffusion: Particles are small enough and have sufficiently
low mass so that air molecules, which are continually in
motion and are bombarding the particle, cause the particle to
acquire a vibration mode. Because of this vibration mode, the
particles have a good chance of coming in contact with the
fibers.
Filtration Mechanism

The mechanisms are increasingly important for decreasing

particle sizes. The most critical areas lie between interception
and diffusion.
All air handling systems serving clean room areas are
provided with pre-filters to remove gross contamination and
protect the cooling coil and final filter from environmental
conditions. The pre-filters have a lower efficiency than the
ones they protect. The system employing outside air and
return air should have an additional filter of 95% minimum
efficiency.
Filtration Mechanism

The HEPA filters are housed in units known as “Filter

Modules”. The module units are mounted into clean room
ceilings, walls, or workstation benches. Filter modules are
perfectly sealed to prevent contamination. Filters must be
handled and installed with the greatest care by trained
personnel. Incorrect handling and installation are often the
cause of leakage in new filters. The filter housing must be
compatible with the filter assembly.
Filter effectiveness

Filter effectiveness:
The ability of the filter to remove particles from the air is
reflected by its efficiency rating. The American Society of
Heating, Refrigerating, and Air Conditioning Engineers
(ASHRAE) has developed a standard for measuring filter
effectiveness. The standard describes test procedures to
classify filters in terms of arrestance and efficiency. Two terms
are commonly used.
Filter effectiveness

1) Arrestance is the amount of dust removed by the filter,

usually represented as a percentage. Since large particles
make up most of the weight in an air sample, a filter could
remove a fairly high
percentage of those particles while having no effect on the
numerous small particles in the sample. Thus, filters with
an arrestance of 90% have little application in clean rooms.
 Filter effectiveness

2) Efficiency measures the ability of the filter to remove fine

particles. ASHRAE efficiencies between 10% and 40% should
remove 20 to 40% of the 1 –micron particles in the air, but
hardly any of the 0.3 to 0.5-micron particles. ASHRAE
efficiencies of 80% to 95% can remove 50% to 70% of 0.3-
micron particles. The efficiency of 99.97% and 99.997% of
HEPA filters look similar but in reality, the difference is not
insignificant. A 99.97% efficient filter has a fractional
penetration of 0.0003, while a 99.997% filter’s fractional
penetration is 0.0001. this means that a 99.997% filter is three
times more efficient in removing 0.3-micron particles.
Types of Filters

Air Filters and Efficiency

Classification Arres. or Eff. ASHRAE EN779 Typical Controlled Contaminant Application

AFI <65 % MERV 1 G1 Am< 65% Particles bigger than 10.0µm

(Pollen)
AFI 65%-70% MERV 2 (Spanish moss)
Gross filter, domestic
(Dust mites)
and commercial
AFI 70%-75% MERV 3 G2 65%≦Am< 80% (Sanding dust)
(Spray paint dust)
AFI 75%-80% MERV 4 （ Textile fibers ）
PRE Filter
(G Class)
AFI 80%-85% MERV 5
G3 80%≦Am<90%
AFI 85%-90% MERV 6 Particle size within 3.0µm-10.0µm
(Mold, (Spores), (Hair spray ） Commercial,
(Cement dust, (Snuff ） , (Powdered industrial, paint shop
NBS 25%-30% MERV 7 milk ）
G4 90%≦Am
NBS 30%-35% MERV 8
Types of Filters

Classification Arres. or Eff. ASHRAE EN779 Typical Controlled Contaminant Application

NBS 40%-45% MERV 9

F5 Particle Size within 1.0µm-3.0µm
40%≦Em< 60% (Lead dust)
NBS 50%-55% MERV 10 IAQ
(Milled flour) concerned
(Coal dust ） commercial &
NBS 60%-65% MERV 11 (Auto-emissions ）
industrial,
F6 60%≦Em< 80% (Nebulizer drop) medical
MEDIUM NBS 70%-75% MERV 12 (Welding fumes ）
Filter
(F Class) NBS 80%-85% MERV 13 F7 80%≦Em< 90% Particle size within 0.3µm-1.0µm
(All bacteria)
NBS 90%-95% MERV 14 F8 90%≦Em< 95% (cooking oil) IAQ concerned
(Most smoke) commercial,
(Copier toner ） industrial,
MERV 15
NBS>95% F9 (Most face powder ） medical, food
95%≦Em etc.
MERV 16 (Most paint pigments ）
Types of Filters

Mean Fractional IEST European Union Typical Controlled

Classification Application
Efficiency RP-CC001.3 EN1822 Class Contaminant

≧95% at 0.3µm H10 ≧85% at MPPS

n/a
≧98% at 0.3µm

≧95% at MPPS Particle size bigger than

H11
0.3µm
≧99.97% at 0.3µm TYPE A
HEPA (Virus [unattached] ）
All types of
Filter (Carbon dust ）
cleanrooms
(H Class) (Sea salt ）
≧99.99% at 0.3µm H12 ≧99.5% at MPPS
(All combustion smoke ）
TYPE C (Radon progeny ）
≧99.995% at 0.3µm H13 ≧99.95% at MPPS

≧99.999% at 0.3µm TYPE D H14 ≧99.995% at MPPS

 Types of Filters

Mean Fractional IEST European Union Typical Controlled

Classification Application
Efficiency RP-CC001.3 EN1822 Class Contaminant

≧99.9995% at 0.12µm U15 ≧99.9995% at MPPS

ULPA Particle size bigger Super

≧99.99995% at 0.12µm TYPE F ≧99.99995% at than 0.12µm
Filter U16 Cleanroom
(U Class) MPPS

≧99.999995% at 0.12µm ≧99.999995% at

U17 MPPS

Note :
1. AFI: American Filter Institute
2. NBS: National Bureau of Standards
3. ASHRAE: American Society of Heating Refrigerating & Air-conditioning Engineers
4. MERV: Minimum Efficiency Reporting Value 8. Am: Average Arrestance Efficiency for Coarse Filters
5. MPPS: Most Penetrating Particle Size 9. Em: Average Efficiency for Fine Filters
6. HEPA: High-Efficiency Particulate Air Filter 10. IEST: Institute of Environmental Sciences and Technology
7. ULPA: Ultra Low Penetration Air Filter
Filter testing

Filter testing:
The efficiency of the filter is of paramount importance and must be
measured in an appropriate way; the common methods of filter
testing include:
Filter testing

DOP test or PAO oil test: a synthetic contaminant often used to

test high-efficiency filters is composed of an atomized droplet
of hot di-octyl-phthalate (DOP) or Polyalphaolefin (PAO)
which replace DOP as it is carcinogenic to human). High-
efficiency filters used in the clean room are subjected to a
DOP or PAO penetration test to determine the percentage of
particles passing through the filter.
DOP has a fairly consistent average particle size of about 0.2
to 0.3 microns while PAO is about 0.1 to 1.0 microns.
Filter testing

The penetration or efficiency of a filter is strongly affected

by the particle size of the challenging aerosol. A small
change in particle size can have a significant effect on the
penetration. The smaller the particle, the lower the efficiency
until the maximum penetrating particle size is reached.
Penetration is also affected by air flow rate. The greater the
air flow rate, the greater the penetration.
Filter testing

Leak testing: A leak is defined as a hole, which would produce

local penetration of 0.01% on the photometer with an upstream
concentration of 100% and sampling of 1 CFM with the air
flowing through the filter at a face velocity of 0.5 meter per
second. Typically cold DOP or PAO is used for leak testing.
Every square inch of the filter surface and its gasket and
framing system are scanned for leaks using a 1 CFM sampling
rate and 0.5 meter per second face velocity and 0.01%
penetration level as a leak.
 Filter testing

In general certification and testing of HEPA filters include leak

testing, scanning, electrical testing, particle count surveys, sound
level measurement, vibration measurement, and temperature and
humidity measurement, airflow balancing.
Air Flow Distribution and Control

Depending on the degree of cleanliness required, it is common for

the air system to deliver considerably more air than would be
needed solely to meet temperature and humidity design. Airborne
particles can be organic or inorganic.
Most contamination control problems concern the total
contamination within the air.
Air Flow Distribution and Control

Particles of different sizes behave differently as air moves

through a room. The selection of airflow patterns is a major
step in clean room design. Because airflow is such an
important aspect of particle control, the design of a clean
room requires careful consideration of air motion and
airflow patterns. The general air patterns are:
 Air Flow Distribution and Control

 Unidirectional (sometimes referred to as Laminar flow) is an

airflow pattern in which essentially the entire body of air
within a confined area moves with uniform velocity and in a
single direction with generally parallel airstreams. Clean room
class 100(A) has a unidirectional airflow pattern.
 Non-unidirectional airflow is not unidirectional by having a
varying velocity, multiple pass circulation, or non-parallel flow
direction. Conventional flow clean rooms (Class 1000 (B) and
10,000 (C) have non-unidirectional or mixed airflow patterns.
 Air Flow Distribution and Control
 Mixed patterns combine some of each flow type.
Common practices of cleanroom design
Clean room airflow design conventionally follows the table below to
decide on the airflow pattern, average velocities, and air changes per
hour. Firstly we have to identify the level of cleanliness required and
apply the table below.
Clean room Class Airflow Type Average Airflow velocity mps Air Changes/Hr

A Unidirectional 0.25-0.45 NLT 100

B Mixed 0.20-0.45 NLT 60

C Mixed 0.12-0.20 NLT 40

D Mixed 0.05-0.15 NLT 20

Air Flow Distribution and Control

A unidirectional airflow pattern is a requirement for absolute

cleanliness and is conventionally applied to spaces demanding
class A. the principle underlying cleanliness for a unidirectional
airflow pattern is air velocity. Higher air velocity is advantageous
in particle removal/settlement.
Differences between unidirectional the non-unidirectional flow
design:
 Air Flow Distribution and Control

1) A unidirectional airflow pattern is in one direction, usually

horizontal or vertical at a uniform speed. Throughout the entire
space. The air velocity is sufficient to remove particles before
they settle onto surfaces. The non-unidirectional turbulent
airflow ventilation system relies on mixing and dilution to
remove contamination.
Air Flow Distribution and Control

2) Unidirectional airflow tends to remain parallel until it

encounters obstacles such as people, process equipment, and
workbenches where it tends to become turbulent. The use of
workstations with perforated tabletops allows the air to pass
Air Flow Distribution and Control
through them uninterrupted. Turbulent areas can have
countercurrents of higher velocity, reverse flow, or even
stagnant or no flow. A small cluster of particles can cluster in
stagnant areas and finally settle on the product.
Air Flow Distribution and Control

3) Unidirectional airflow is used when low airborne

concentrations of particles or bacteria are present. Non-
unidirectional flow is used where particle sizes are relatively
large.
Air Flow Distribution and Control
4) Air changes per unit of time are related to the volume of the
room and are many times greater in unidirectional flow design
than those supplied to a turbulent airflow clean room.
 Air Flow Distribution and Control

5) The non-unidirectional or mixed airflow patterns differ in the

location of the supply and return air registers and air filter
locations. In a non-unidirectional arrangement, the airflow is
typically supplied through diffusers with HEPA filters in them, or
in the ductwork or air Distribution
Air Flow handler. andUnidirectional
Control airflow requires
greater attention to strict design guidelines. A vertical flow room
would have air supplied through a perforated ceiling with HEPA
filters and returned through a raised floor, producing nominally
parallel airflow. Where grated or perforated floors are not suitable
for pharmaceutical application. Low-level sidewall returns are
used.
Air Flow Distribution and Control

6) In a unidirectional arrangement, HEPA filter banks must be

pinhole tight and checked for any pinhole leaks in the media,
sealants, frame gaskets, and supporting frames.
Air Flow Distribution and Control
Unidirectional design configuration:
The unidirectional design is available typically in one of the
three major configurations:
 Air Flow Distribution and Control
Unidirectional flow system designs
1) Single pass system (100% fresh air): Filtered air enters the room, exits
through the louvers, and is not re-circulated. The system is ideal for
100% makeup air or when the ambient temperatures are favorable and
acceptable or there are
Airany hazardous
Flow Distribution andmaterials.
Control
2) Re-circulated system: Filtered air enters the room, exits through plenum
walls, and is re-circulated through a sealed plenum using motorized fan
modules with HEPA filters. This is the most popular design.
3) Ducted plenum system: Filtered air enters the room, exits through
plenum walls, and is re-circulated through air ducts directly to the HEPA
filters.
Room Pressurization

A clean room facility may consist of multiple rooms with different

requirements of cleanliness. Room in a clean facility should be
maintained at static pressures higher than atmospheric to prevent
infiltration by wind. Positive differential pressures should be
Air Flow Distribution and Control
maintained between the rooms to ensure airflow from the cleanest
area to the least clean area. The only exception to using a positive
differential pressure is when dealing with specific hazardous
materials where the statutory health & safety agencies require a
room to be at a negative pressure.
Room Pressurization

Pressurizing Limits:
Positive pressure must be maintained to ensure airflows from the
cleanest area to the less clean area. The idea is to inhibit the
infiltration of unfiltered air. The cleanest room is kept at higher
Air Flow Distribution and Control
pressure, with pressure levels decrease as cleanliness level
decrease. A differential pressure of 0.03 to 0.05
inches water gage (wg) is recommended between areas. Static or
active pressure control methods are used depending on tolerance.
Typical tolerance is ± 0.01 inches wg.
 Room Pressurization
Makeup Air and Building Pressurization:
Many of the critical clean rooms have their own dedicated air conditioning
systems. While this is good design strategy, many of the installation rely
purely on the re-circulated system without paying much attention to
pressurization. Without Air
pressurization contaminant
Flow Distribution and Control can seep into these
sensitive rooms through cracks in wall and ceiling joints, cable and utility
penetrations, and space above drop ceilings and below raised floors.
Positive pressurization is the basis of assuring that uncontrolled and
untreated does not infiltrate the protected area. The ambient air (makeup
air) used to provide the positive pressurization must be treated to ensure
environment free of contaminants.
Room Pressurization

Optimizing Makeup Air Requirements:

Careful attention need to be paid not to over pressurizing the
area. With pressurization, the requirements for makeup air and
the treatment cost Air Flowdue to andcooling/dehumidifying
Distribution Control and
contaminant filtration increases. The cost of treating the makeup
air shall be very high, particularly for the extreme ambient
environment conditions.
 Room Pressurization

The amount of outside air required is a function of:

 Equipment exhaust
 Leakage through pass-through, conveyor openings, strip
curtains, airlocks, etc.
Air Flow Distribution and Control
 Duct leakage, wall, and ceiling leakage.
 Level of positive pressurization required.
The HVAC design must optimize the use of makeup air and
shall minimize uncontrolled leakages while maintaining
controlled ventilation.
Architectural Issues

4.11.5 Architectural, Electrical, and Noise Issues:

Most clean rooms are designed for year-round cooling.
Temperature control is required to provide stable conditions for
materials, instruments, and
Air Flow personnel
Distribution comfort. Humidity control
and Control

is necessary to prevent corrosion, and condensation on work

surfaces, eliminate static electricity and provide personnel
comfort.
Architectural Issues

In addition to high-end HVAC systems designed for effective

filtration, pressure, temperature, and humidity control, the
other design considerations include the room finishes,
electrical distribution, noise control, etc.
Air Flow Distribution and Control
The room preparation plays an important role in meeting these
requirements, some of the key areas for clean room acceptance
include:
Architectural Issues

1) Room Construction:
 Rooms should be constructed using smooth, monolithic,
cleanable, chip resistant materials with a minimum of joints and
seams, and no crevices
Air Flow or moldings.
Distribution and Control
 Sheet vinyl and plastic or epoxy coated products shall be used.
 All doors, panels, etc. should be flush mounted or use sloped
tops.
 Architectural Issues
2) Flooring
Various types of flooring are used in clean rooms, depending on
cleanliness levels
 Contamination control flooring may have a tacky finish to trap
dust and other debris from
Air Flow wheelsand
Distribution and shoes.
Control
 Access flooring consists of solid or perforated panels or raised
pedestals. Air can flow through perforated panels and can be
exhausted in a subfloor area.
 Vinyl flooring features sealed seams to prevent the accumulation
of contamination. This material is considered suitable for high-
quality manufacturing sites: class 100,000 thru class 10,000.
 Architectural Issues

 Sheet vinyl is most common in clean rooms of higher control. Homogenous

material which is solid vinyl is preferred. Basically, this material is supplied
in rolls and serves to reduce the joints, cracks, and crevices.
 Control of electrostatic discharge damage can be addressed by the use of
static dissipative or conductive materials
Air Flow Distribution andsuch
Controlas chemical-resistant rubber

floors free of PVC, asbestos, and halogen.

 In general, the number of joints, cracks, and crevices should be reduced.
Appropriate floor coatings could be applied to fill the joints/cracks/crevices.
It is critical to avoid selecting a poured floor or coating that will deteriorate
with use and subsequently contribute to contamination- particle control.
 Architectural Issues

3) Raised Access Floors

 Raised access floors are most suitable for application in Class
100 (A) or below. Primary benefit is achievement of
unidirectional flow of filtered air entering the clean zone.
Air Flow Distribution and Control
These systems are available in steel, aluminum and composite
materials.
 Architectural Issues
4) Ceiling Grid Systems
 Frame works of parallel and perpendicular bars used to house filter
and light fixtures in clean room ceiling.
 Some companies using gel seal grid system with100% filtration
coverage, other using heavy
Air Flow dutyandgasket
Distribution Control grid system using mixed

flow design.
 The traditional gel grid approach, which is usually associated with a
pressurized plenum system or fan filter modules minimize and is
therefore a relatively low risk solution. The cost however is
prohibiting due to the extensive air delivery system (full coverage
filters, AHU’s, chilled water, etc.).
Architectural Issues

 The gasket grid approach to airflow utilizes less filter coverage

(25-30%) with a concentration of filtration in some of the more
critical areas. By introducing turbulence-inducing devices
downstream of the filter media we can improve the
Air Flow Distribution and Control
classification by mixing the air to create a “Turbulent Flow”.
 The ceiling should be pinhole airtight sealed around the filters.
Sealants are used to seal HEPA filters into ceiling grids. Plastic,
silicone, and gel sealant are commonly used.
 Architectural Issues

5) Vacuum Systems (House Keeping)

 A comprehensive clean room design shall include vacuum system
for routine housekeeping. Sealed convenience receptacles for
hose attachment can be placed on the raised floor walls to
Air Flow Distribution and Control
achieve full accessibility and coverage. PVC piping is used to
direct particulate to the vacuum collection system. Canister,
motor and filter can be located in a less sensitive area outside the
clean rooms to prevent contamination.
 Architectural Issues
6) Procedural Considerations (Air Showers, Gowning etc.).
It is important to adapt a proper procedure for personnel entering and
exiting from the clean room.
 In absolute cleanliness requirements the personnel are required to wear a
special purpose clothing (gown) to cover and
Air Flow Distribution them.
Control
 Air showers are sometimes provided at the entry points that remove
particulate contamination from clean room garments as personnel pass
through. The chamber may include HEPA filters, interlocking doors, a re-
circulating air system, and air nozzles in various patterns through which
filtered air is blown onto personnel in the shower. The air is moved over the
worker, removing particulate contamination from the worker’s garments.
Architectural Issues

7) Minimize Contamination from Clean-room Personnel

The additional measures needed are:
 Adhesive floor mats
 Air pressure
Air Flow Distribution and Control
 Air showers/curtains/doors
 Service bays
 Double door pass-through
Architectural Issues

 Static control
 Shoe and glove cleaners
 Appropriate gowning (type of clothing, proper changing rooms)
 Validated sanitation
Air Flow Distribution and Control
 Adequate transfer procedures for materials and personnel.
 Mechanical Considerations
Other important HVAC considerations
 Humidity Control: Clean room service is intended for critical application and
therefore humidity control is critical and takes precedence over temperature
control. The clean room HVAC design for latent’s load should consider the
high operational ambientAirwet bulb
Flow data, not
Distribution mean coincident dry-bulb data as
and Control
conventional HVAC designs.
The reliability and availability of the HVAC system is critical to the success
of the clean room manufacturing application. Typical design criteria is
 Temperature: 18 to 24°C
 RH: 50 to 60%
 Fresh Air: 20% to 100% fresh air.
Mechanical Considerations

 Redundancy: Some clean rooms operate around the clock

every day. The cost of shutting down critical
manufacturing processes can be significant in these
applications. Here the
Air Flow cost and
Distribution of Control
appropriate levels of
redundancy could be paid off many times over.
Mechanical Considerations

 Equipment: Equally strict measures fall upon the air

handling equipment, drip pan, and ductwork systems. For
clean room projects all air distribution system must be
constructed and finished to the highest
Air Flow Distribution of standards and shall
and Control

be specifically designed to minimize the possibility of dirt

and bacteria build-up. The equipment must ensure that on-
going maintenance is made as simple as possible to achieve
continued cleanliness.
Mechanical Considerations

Noise Criteria
Noise is one of the major issues in clean room and the
design usually require high degree attenuation and use of
acoustic silencers.Air Flow Distribution and Control
Clean room design due to large requirements of airflow is
inherently noisy and requires a close attention to noise
control. Clean room noise can be attributed to three
primary sources:
Mechanical Considerations

 Fan noise
 Air flow turbulence
 Process equipment
The first two sources may be addressed by the noise-control
Air Flow Distribution and Control
engineer during the design of the facility. The manufacturer
of equipment must handle reduction of the noise from
process equipment.
 Acceptance Criteria

Additional criteria to be considered which affect room cleanliness should include:

 building finishes and structure
 air filtration
 location of air terminals and directional airflow
 material flow
Air Flow Distribution and Control
 personnel flow
 gowning procedures
 equipment movement
 the process is carried out (open or closed system)
 outside air conditions
 occupancy
 type of product
 cleaning standard operating procedures (SOPs).
Certification Requirements

The clean room certification and acceptance procedures

shall be in accordance with ISO 14664 Procedural Standards
for Certified Testing of Clean rooms.
Qualified cleanrooms performance testing (CPT) Firms shall
Air Flow Distribution and Control
undertake the following tests for certification:-
1) Air flow velocity & uniformity tests.
2) HEPA Filter installation leak tests.
3) Room particle count tests.
Certification Requirements

4) Closure pressurization tests.

5) Temperature & humidity uniformity tests.
6) Sound & vibration tests.
7) Light level and uniformity tests.
Air Flow Distribution and Control
8) Recovery tests.
9) Conductivity tests.
10) Electrostatic tests.
Group Discussions

HEPA Filter Testing:

How and When to Test and

Replace Your HEPAAirFilter?
Flow Distribution and Control

What is the lifespan of the HEPA

filter?
What are the signs that the
HEPA filter needs to be
replaced?
Group Discussions

HEPA filters don’t last forever. Even ones that are supposedly
“permanent” will still need cleaning to remain effective, and it’s
possible to damage them during the cleaning process. To keep the air
clean, HEPA filters need to be replaced from time to time. How do
you know how muchAirtime each filter
Flow Distribution andhas? Well, there’s no specific
Control
time limit for HEPA filter life. They could last months or years. It’s all
about the environment they are in and how much cleaning they do.
Since lifespan isn’t based on time, to know when to replace your filter
you’ll have to have some HEPA filter testing done. First, let’s discuss
some basic signs you need new HEPA filters, then we’ll analyze how
the pros do the testing.
Group Discussions
What are the signs that the HEPA filter needs to be replaced?
Knowing the condition of your HEPA filters can be determined by
performing some basic inspection.
1. The Filter is Damaged
This seems fairly obvious, but it’s not something you’d see unless you
were looking for it. You might have noticed strange sounds coming
from the area around the filter, such as a high-pitched whistle. If your
HEPA filters are remotely located, you might not ever notice the sound.
A quick visual inspection can reveal whether your filters still have their
structural integrity, so it would be a good idea to set up a routine
schedule to check them out.
Group Discussions

2. Power Consumption Rises

The motors in your filtration unit or HVAC system will have to

work much harder to pump air through the filter when it gets
clogged. You’ll notice the
Air Flow effectsand
Distribution of Control
this when you check your
energy bills. The other issue is that this will cause more wear and
tear on your system, so you can look forward to a repair bill
sooner than you expected, too.
Group Discussions

3. The microbial limit test is failed

The job of a HEPA filter is to filter. When it’s clogged or
torn, then it’s not doing the one job it has anymore. Microbes
and allergens willAir
not beDistribution
Flow filtered andoutControl
anymore and the clean
room will fail the viable particle test.
Group Discussions

4. Dust and Dirt Build Up

This is most likely the most obvious visual indicator. Dust

and dirt will accumulate in the vents of your HVAC system
or on your filtration unit.Distribution
Air Flow So, in addition
and Controlto replacing the
HEPA filters, you will need to clean the vents.
Group Discussions

How To Test Your HEPA Filter

The Aerosol Test:

The most common HEPA filter testing method is the “aerosol
photometry test.” This test has existed since the 50s and is highly
Air Flow Distribution and Control
accurate. The way it works is a technician will spray a dispersed
oil particulate (DOP) over the surface of the filter. The DOP must
be sprayed in a perfectly uniform layer over the filter’s upstream
side.
Group Discussions

Before the aerosol test can begin, however, the filter must have
an established “flow rate.” That way, it’s possible to tell whether
the airflow is too high or too low. Without that baseline rate, the
test is no better than guesswork. Once the baseline is established
and the test is complete,
Air Flowthe tech can
Distribution determine how large the
and Control
leak is. The FDA says that a penetration of just 0.01% is
a significant leak.
Group Discussions

What Aerosol is Used?

There are three aerosols generally used in HEPA filter testing, and
they are:
 Cold aerosols: These aerosols are largely a product of necessity,
Air Flow Distribution and Control
being made at the location of testing. The problem with cold
aerosols is that it’s difficult to determine how many particulates
reach the HEPA level of 0.3 microns. It’s still a useful test,
especially for installations, but it’s not as accurate as a hot aerosol
test. Because particles are of many different sizes, this process is
called “polydisperse.”
Group Discussions

 Hot aerosols: Made from heated dioctyl phthalate oil. This

process is excellent at creating a high number of 0.3-micron
particles. Because the size distribution of the particles is so
small, this process is called “monodisperse.”
Air Flow Distribution and Control
 Microspheres: Polystyrene latex spheres (PSLs)
are increasingly popular for testing because they don’t have
any carcinogenic effects, while oil-based aerosols do. They
can be manufactured to have specific particle sizes for
extremely accurate testing.
Group Discussions

Air Flow Distribution and Control