Validation Presentation SRP

Clean Room Validation
From
RAMAKRISHNA A R
SRP ENVIRO SERVICES PVT. LTD

Contents
Basics of Clean Room
Types of Clean Room
Clean Room Validation

Definition
Clean Room
A room in which the concentration of airborne particles is
controlled and which is constructed and used in a manner to
minimize the introduction, generation and retention of particles
inside the room and in which other relevant parameters, e.g.
temperature, humidity and pressure, are controlled as
necessary.
Clean Zone
Dedicated place in which the concentration of airborne
particles is controlled, and which is constructed and used
in a manner to minimize the introduction, generation and
retention of particles inside the room and in which other
relevant parameters, e.g. temperature, humidity and
pressure, are controlled as necessary.
Types of Cleanroom
* Unidirectional airflow
* Non Unidirectional airflow
* Mixed airflow
Unidirectional Airflow Clean Room
It is a clean room in which the filtered air entering the room makes a
single pass through the work area in a parallel flow pattern
Non unidirectional Airflow
Clean Room
It is a clean room in which the filtered air entering the room or
passing through the work zone is characterized by non uniform
velocity or turbulent flow
Mixed Airflow Clean Room
It is a clean room which containing both unidirectional and non
unidirectional types of airflow within the same enclosure
Particle
 Solid or Liquid object which, for purposes of
classification of air cleanliness, falls within a
cumulative distribution that is based upon a
threshold( Lower Limit ) size in the range from 0.1Mic
to 5 Mic
 Particle Concentration
Number of Individual Particles per unit volume of air
 Ultrafine Particle
Particles with an equivalent diameter less
than 0.1 Mic
 Macro Particle
Particles with an equivalent diameter greater than
5 Mic
WHERE DO ALL THESE
PARTICLES COME FROM?
WE ARE THE
BIGGEST SOURCE
OF
CONTAMINATION!
How to minimize these
particles in a clean room?
•By using specified material for clean room
construction
•By Proper Clean room Entry Exit Procedures
•By using Proper material for Clean room

clothing and procedures to wear the same
•Personnel working inside the clean room

should have proper training
•By strictly Following SOP’s & Preventive

Maintenance Procedures
How to evaluate the quality of
cleanliness in a clean room?
By Validation
Validation is Establishing documented

evidence which provides a high degree
of assurance that a specific process will
consistently produce a product,
meeting its predetermined
specifications and quality attributes
VALIDATION - Essential Part of GMP
 Predetermined protocols
 Written reports
 Processes and procedures
 Periodic revalidation
 Specific attention:
processing
testing
cleaning
Why Validation is required?
. To ensure that all the systems will have a
high level of assurance and produce a
product that meets its designed
specifications.
• It gives the company a control system that

is consistent and reproducible
• It is credible and stable, because the

acceptance criteria have already been
specified in the qualification stages of
validation
When Should We validate
clean room system?
• At initial installation.
• At regular intervals and thereafter.
• If damage to filters is suspected.
• If filters have been moved or disturbed
• If filters have been subjected to unusual

environmental conditions
Validation Guidelines
Clean rooms, controlled environments, and
environmental chambers are tested and
certified in accordance with
• FED-STD-209 (US FEDERAL STANDARD)
• IEST-RP-CC006.2 – Testing Clean Rooms

(INSTITUTE OF ENVIRONMENTAL SCIENCE AND TECHNOLOGY – RECOMMENDED PRACTICE
– CONTAMINATION CONTROL)
• ISO-14644 (INTERNATIONAL STANDARD ORGANIZATION)
 WHO 2002
• EUROPEAN UNION GUIDE TO GOOD
MANUFACTURING PRACTICE.
• SCHEDULE M
IEST GUIDELINES
 IEST-RP-CCOO1.3. - HEPA AND ULPA FILTERS (1993)
 IEST-RP-CC002.2 - UNIDIRECTIONAL FLOW CLEAN-
AIR DEVICES (1999)
 IEST-RP-CC006.2. - TESTING CLEAN ROOMS. (1993)
 IEST-RP-CC022.1 - ELECTROSTATIC CHARGE IN
CLEANROOMS AND OTHER CONTROLLED
ENVIRONMENTS. (1992)
 IEST-RP-CC023.1. - MICROORGANISMS IN
CLEANROOMS. (1993)
 IEST-RP-CCOO26.1. - CLEANROOM OPERATIONS.
(1995)
 IEST-RP-CCOO34.1. - HEPA AND ULPA FILTER LEAK
TESTS (1999)
Tests Recommended for Clean room Performance (Ref: IEST-RP)
Non
Uni directional
Section Tests Unidirection Mixed Airflow
Airflow
al Airflow
Airflow Volume &
1,2,3 1,2,3, 1,2,3
Uniformity
6.1
Airflow Velocity &
1,2,3 OPT OPT
Uniformity
6.2 Filter Integrity 1,2 1,2 1,2
6.3 Particle Count 1,2,3 1,2,3 1,2,3
6.4 Pressurization 1,2,3 1,2,3 1,2,3
6.5 Air Flow Visualization 1,2 NA OPT (1,2 Only)
6.7 Recovery 1,2 1,2 1,2
6.8 Particle Fall Out 1,2,3 1,2,3 1,2,3
6.9 Lighting Level 1, OPT (2.3) 1, OPT (2.3) 1, OPT (2.3)
6.10 Noise Level 1,2,3 1,2,3 1,2,3
6.11-6.13 Temp & RH Uniformity 1,2,3 OPT 1,2,3 OPT 1,2,3 OPT
6.14 Vibration OPT OPT OPT
The order in which tests are performed is optional, but some sequences are optimal.
N/A: Not applicable to this situation

1: Test is suited to as-built phase
2: Test is suited to at-rest phase
3: Test is suited to operational phase
OPT: Test is optional, depending on process requirements
Clean Room Classification as per US
Federal Standard 209D (class limits)
Class Number of Particles / Cubic Foot
≥0.1µm ≥0.2µm ≥0.3µm ≥ 0.5µm ≥5µm
1 35 7.5 3 1 ***
10 350 75 30 10 ***
100 *** 750 300 100 ***
1000 *** *** *** 1000 7
10,000 *** *** *** 10,000 70
100,000 *** *** *** 100,000 700
ISO 14644 consists of the following parts, under the
general title Clean rooms and associated controlled
environments
14644-1:1999 Classification of air cleanliness
Specifications for testing and monitoring to
14644-2:2000
prove continued compliance with -1
14644-3:2005 Metrology and test methods
14644-4:2001 Design, construction & start-up
14644-5:2005 Operations
14644-6:2007 Vocabulary/terminology
Separative devices (clean air hoods, glove boxes,
14644-7:2004 isolators and mini-environments)
Classification of Airborne Molecular
14644-8:2006
Contamination
14644-9: UD Classification of surface particle cleanliness

Clean Room Classification as per ISO
14644 Part-1 (class limits)
ISO
Classificati Maximum concentration limits( Particles/m3 of air)
on for particles equal to and larger than the considered sizes
Number shown below
≥5.0µ
≥ 0.1µm ≥0.2m ≥0.3µm ≥0.5µm ≥1µm m
ISO Class 1 10 2
ISO Class 2 100 24 10 4
ISO Class 3 1000 237 102 35 8
ISO Class 4 10000 2370 1020 352 83
ISO Class 5 100000 23700 10200 3520 832 29
ISO Class 6 1000000 237000 102000 35200 8320 293
ISO Class 7 352000 83200 2930
ISO Class 8 3520000 832000 29300

ISO Class 9 35200000 8320000 293000
Airborne Classification in the European Union
guide to Good Manufacturing Practice
Maximum Permitted Number of Particles /m3

Grade at rest in operation
≥0.5µm ≥5.0µm ≥0.5µm ≥5.0 µm
A 3500 0 3500 0
B 3500 0 350000 2000
C 350000 2000 3500000 20000
D 3500000 20000 not defined not defined
Note
Grade A and B correspond to with class 100, ISO Class 5
•Grade C correspond to with class 10000, ISO class 7
•Grade D correspond to with class 100000, ISO Class 8
Airborne Classification as per SCHEDULE M
Comparison between selected equivalent classes of
Federal Standard 209 and ISO 14644-1
ISO
Class 3 Class 4 Class 5 Class 6 Class 7 Class 8
14644-1
Classes
Federal Class Class Class

Class 1 Class 10 Class 100
Standard 1000 10000 100000
Comparison of International Standards
France Germany
Country and U.S.A. U.S.A. Britain BS Australia ISO
AFNOR VD
standard 209D 209E 5295 AS 1386 standard
X44101 I.2083
Date of
1990
current 1988 1992 1989 1989 1972 1997
onwards
issue
- 0
1 M1.5 C 0.035 - 1 3
10 M2.5 D 0.35 - 2 4
100 M3.5 E or F 3.5 4 000 3 5
1 000 M4.5 G or H 35 - 4 6
10 000 M5.5 J 350 400 000 5 7
100 000 M6.5 K 3500 4 000 000 6 8

Required Testing ( ISO 14644-2) Schedule of Tests to
Demonstrate Continuing Compliance
The Mandatory Tests

Max.
Cleanroo
Test Parameter Time Test Procedure
m Class
Interval
< ISO 5 6 Months
Particle Count Test ISO 14644-1 Annex A
12
> ISO 5
Months
12
Air Pressure Difference All Classes ISO 14644-1 Annex B5
Months
12
Airflow Measurement All Classes ISO 14644-1 Annex B4
Months
The User Optional Tests
Optional Tests ( ISO 14644-2)

Max.
Cleanroom
Test Parameter Time Test Procedure
Class
Interval
Installation Filter 24
All Classes ISO 14644-3 Annex B6
Leakage Months
24 ISO 14644-3 Annex
Recovery Test All Classes
Months B12
Containment Leakage 24 ISO 14644-3 Annex
All Classes
Test Months B13
24
Air Pressure Difference All Classes ISO 14644-3 Annex B5
Months
24
Airflow Visualization All Classes ISO 14644-3 Annex B7
Months
Recommended Tests by Cleanroom Type based
on type of Cleanroom certification and IEST RP-
CC006.2.
Level III: USER-OPTIONAL ENVIRONMENTAL
TESTS
a) Lighting level and uniformity test
b) Noise level test
c) Temperature and moisture uniformity test
d) Vibration test
CLEANROOMS CAN BE TESTED
IN THREE PHASES:
As-built (A cleanroom facility that is complete and

ready for operation, but without operating personnel or
equipment installed.)
At-rest (An operational cleanroom facility without

operating personnel)
In-Operation (An operational cleanroom facility with

operating personnel and equipment in place and
handling their normal functions.)
Airflow Velocity Test
Ref: ISO 14644-3 Section B.4.1
 This test is performed to determine the airflow velocity, uniformity of
air flow velocity and supply air volume in clean rooms and clean zones
 Airflow velocity is the measurement of the speed of the airflow in feet
per minute or liters per second.
 This Test is applicable in all three of designated occupancy states
Apparatus required for the Airflow Test:
a)
Airflow Velocity: Thermal anemometer,
vane-type anemometer, or equivalent
Airflow Volume: Electronic micro-
b) manometer with appropriate airflow hood, or
equivalent
Airflow Velocity Measuring Units
1. Feet per Minute (FPM)
2 Meter per Second (MPS)
Airflow Volume Measuring Units
1. Cubic Feet per Minute ( CFM )
2 Cubic Meter per Hour (CMH)

Flow Hood
testo 425
Test Procedure for Air Flow Velocity Measurement in

Unidirectional Airflow Clean room/Clean Zone
(Ref: ISO 14644-3 Section B.4.2.1.2)
1. Define the Measuring plane perpendicular to Supply airflow and divide
the measuring plane into grid cells of equal Area
2. Measuring Points should be defined at a distance of between 150

mm and 500 mm from the face of the supply source.
3. For measuring the filter face velocity, the distance should be about
150 mm and for checking the uniformity, it should be more than 300 mm
Test procedure for Air Flow Velocity Measurement
in Unidirectional Airflow Clean room/Clean Zone
(Ref: ISO 14644-3 Section B.4.2.1.3)
 The Number of measuring points should be

more than the square root of the measuring
plane area in square meters ans should be not
less than 3 points
 Measurements should be taken at the centre

of each grid cell
 Measuring time at each position should be at

least 10 seconds and average minimum and
maximum values should be recorded
Procedures for airflow volume evaluation
(Ref: ISO 14644-3 Section B.4.3.1.2)
 The Supply airflow should be measured by using a flow
hood in a manner that includes all the air issuing from each
final filter or supply air diffuser
 The supply airflow volume (Va) in each final filter/diffuser
is measured as velocity multiplied by effective area
 The flow hood opening should be placed completely over
the filter/diffuser and the face of the hood should be sealed to
prevent the bypass air leakage
 The measuring plane is divided into grid cells of equal
areas. Airflow should be measured at the center of the each
cell. Each cell dimensions should be 600 mm x 600 mm or
smaller
Number of Air Changes/ Hour
Calculation in the Cleanroom
• From filter velocity, volume of air through the
filter/diffuser is calculated by multiplying obtained velocity
by effective filter area
• The total airflow volume (Vt) in a clean room is the addition
of volume of air through all the filters/diffusers located in
the clean room
• Room Volume (Rv) of the clean room will be calculated by
multiplying room dimensions (Length x Width x Height)
Air changes per hour is calculated using the

formula
AC / HR = Vt x 60 / Rv
Where
AC / HR = Air changes per hour
Vt = Total Airflow volume in the clean room in cfm
Rv = volume of the room in Cubic feet
Acceptance Criteria for Air Flow Velocity Test

a) The average airflow velocity (for unidirectional airflow) for the
clean room or clean zone should be within + 5% of the value
specified for the clean room or clean zone, or within other tolerance
limits agreed upon by the buyer & the seller.
b) The air changes per hour (for non unidirectional airflow) for the
clean room or clean zone should not be less than the value specified
for the clean room or clean zone, or within other tolerance limits
agreed upon by the buyer & the seller.
Test Report Should have the following details
1. Identification of Apparatus Operator & Data collecting System
2. Identification of Apparatus and calibration status
3. Type of Tests and measurements, and measuring conditions
4. Measurement Locations
5. Temperature, Humidity & Environmental Data
6. Occupancy State
Typical Format – Air Velocity Test & ACPH Test
HEPA Filter Installation Leak Test
This test is performed o confirm that the HEPA & ULPA filter system
is properly installed by verifying the absence of bypass leakage in the
installation and that the filters are free from defects and small leaks.
The test is performed by introducing an aerosol challenge upstream

of the filter and scanning immediately downstream of the filter and the
filter housing frames
The test is a leak test of the installed filter system to detect small
holes and other damage in the filter medium and the frame sealant as well
as the bypass in the filter frame and in the grid system
The installed filter system leak test should not be confused with the
efficiency test of individual filters at the place of manufacture
This test will be applied to clean rooms in “As built” or in “At Rest”
occupancy states
Reasons for HEPA/ULPA Installation

Leak Test
1 Poor Design in Filter Housing
2 Poor workmanship & in-adequate quality control by filter
manufacturer
3 Leaks in the Filter Media itself
4 Leaks due to the failure of the adhesive bond between the
filter medium and its frame
5 Leaks between the cabinet sealing frame and the cabinet
Housing
6 Leaks in the cabinet or housing due to damage in the transit or
handling
7 Leaks from Misalignment or misassembly of filter
housing and HEPA Filter
Types of Leaks identified by on-site testing of HEPA Filters

Instruments Used
Cold Aerosol Hot Aerosol

Photometer
Photometer Generator Generator
TDA 2H
TDA 2G TDA 4B TDA 5B
Aerosol Photometer with a nominal sampling flow rate of 28.3 L/min

( 1 CFM) with a sampling probe of square or rectangular configuration, whose
inlet air velocity approximates the velocity of the air exiting the filter
Aerosol Generator which produces aerosol that results when a high

velocity of stream of air (Laskin Type) breaks up a liquid into droplets. The liquid
used at room temparature, is Di-octyl phathalate (DOP) or Para Alfa Olifin(PAO)
or a specified alternative.
The Concentration of the aerosol challenge upstream of the

filter should be between 20mg/ and 80mg/m3
Test Procedure By Cold DOP Method
1. Airflow velocity should be established within + 20% of the
specified velocity and uniformity should be confirmed prior to
performing this test
4. Introduce the aerosol through the return air riser or in the air
handling unit in a manner that will produce a uniform challenge
concentration over each filter's surface (upstream of the filter).
5. Measure the concentration of the challenge aerosol immediately
upstream of the filters under test, using a photometer whose
sensitivity is adjusted to a baseline of 10-100ug/m3
6. Once the Photometer is set to 100% Immediately scan the down
stream of the filter for leaks through out the filter face area using
the probe should be held approximately 5cm (2 inch) from the
filter face during scanning also the area scan rate should not
exceed 5cm / sec or ( 2 inch/sec)
7. Record the readings displayed in the Photometer, if required size
and location where the maximum leak is identified to be recorded
in a diagram
Aerosol
Challenge is introduced upstream of the HEPA

filter.
A good mixture is assured calibration of

photometer is made to read 100%.
To Photometer
Airflow
Acceptance Criteria
Obtained Leaks should be with 0.01% of the upstream
challenge aerosol concentration, otherwise mutually agreed
between the customer & Supplier
The following information and data to be
reflected in the test report
1. Title of the test method
2. The Measuring Apparatus & its calibration status
3. The ISO Class of the clean room & its operational status
4. The calculated average upstream aerosol concentration and
its distribution
5. The sample flow rate of photometer
6. The acceptance criteria applied for the downstream
measurements
7. The result of downstream measurement for each clearly
identified filter with location
8. Filter Grade
9. The final result of the test for each defined location
Typical Report Format – ON SITE HEPA FILTER
INSTALLATION LEAK INTEGRITY TEST
Room Pressurization Test
The purpose of this test is to verify the capability of the cleanroom system to
maintain the specified pressure difference between installation and its surroundings.
This test is applicable in each of the designated occupancy states,
Apparatus required for pressure difference test

An Electronic Micromanometer, inclined manometer, or mechanical differential
pressure gauge
Pre Test Conditions
The Supply air and exhaust air volumes of the cleanroom should be tested and certified to
meet the specified volumes
Test Procedure
1. Make sure that al the related doors of the clean room closed
2. The pressure difference between the enclosure cleanroom with respect to surrounding
room should be measured and recorded
3. If no surrounding room is present, the pressure difference between the enclosure

clean room and the external environment should be measured and recorded
4. If the installation is subdivided into more than one sub-enclosure or room, the
pressure difference between the innermost room and the next adjacent room should
be measured
5. The measurement should be continued until the pressure difference between the last
enclosure and the surrounding room and against the external environment is
measured
Acceptance Criteria
The pressure difference between the enclosure room and the adjacent rooms should be as
per the specified data or else mutually agreed between the buyer and the seller
Test Report should have the following data

1. Identification of apparatus operator and data collection system
2. Identification of apparatus and their calibration status
3. Type of tests and measurements, and measuring conditions
4. Cleanliness classes of the rooms considered
5. Measuring point locations
6. Occupancy state(s)
Acceptance Criteria
The pressure difference between the
enclosure room and the adjacent
rooms should be as per the specified
data or else mutually agreed between
the buyer and the seller
Test Report should have the

following data
1. Identification of apparatus operator and
data collection system
2. Identification of apparatus and their
calibration status
3. Type of tests and measurements, and
measuring conditions
4. Cleanliness classes of the rooms
considered
Airborne Particle Count Test
:
OBJECTIVE/PURPOSE
To determine the actual Airborne concentration

with the size distributions having a threshold size
between 0.1um to 5um in defined occupancy
states "as built ", "at rest" and "in operational"
Guideline followed for Airborne Particle count Test
ISO 14644-1
CLEANROOMS AND ASSOCIATED CONTROLLED
ENVIRONMENTS
PART 1: CLASSIFICATION OF AIRBORNE PARTICULATES

ISO 14644-1
 INTERNATIONAL STANDARD.
 PROVIDES AIR CLEANLINESS CLASSES FOR
CLEANROOMS AND CLEAN ZONES.
 DOES NOT ADDRESS VIABLE PARTICULATES.
 DOES NOT ADDRESS EQUIPMENT OR SUPPLIES.
 REQUIRES SPECIFIC PROCEDURES BE
EMPLOYED.
 ALL UNITS ARE METRIC.
ISO 14644-1 section 3

3.1 Occupancy state(s)
3.2 Classification number
3.3 Designation
3.2 Classification number (ISO 14644-1 section 3.2)
Airborne particulate cleanliness is designated by a classification number N
The maximum permitted concentration of particles Cn for each considered
particle size D calculated by the formula
Cn = 10N x (0.1/D)2.08
Where
Cn is the maximum permitted concentration (particles/cubic meter) of
airborne particles that are equal to or larger than the considered size
N is the ISO classification number
D is the considered particle size
0.1 is a constant, with a dimension of micrometer
Note: If measurements are to be made at more than one considered particle size, each particle diameter
(e.g. D2) shall be at least 1.5 times the next smaller particle diameter (e.g. D1)
D2 > 1.5 x D1
Selected airborne particulate cleanliness classes
for clean rooms and clean zones as per ISO
14644-1: 1999(E)
ISO Maximum concentration limits (particles/m3 of air) for particles equal to and
Classification
Number
larger than the considered sizes
0.1m m 0.2 mm 0.3 mm 0.5m m 1 mm 5m

ISO Class 1 10 2
ISO Class 2 100 24 10 4
ISO Class 3 1000 237 102 35 8
ISO Class 4 10000 2370 1020 352 83
ISO Class 5 100 000 23 700 10200 3520 832 29
ISO Class 6 1 000 000 237 000 102 000 35 200 8320 293
ISO Class 7 352 000 83200 2 930
ISO Class 8 3 520 000 832 000 29 300
ISO Class 9 35 200 000 8 320 000 293 000
Note: Uncertainties related to the measurement process require that concentration data with no more than three
significant figures be used in determining the classification level
Apparatus Required
Discrete particle counter, a light scattering device
having means of displaying or recording the count
and size of the discrete particles in air with size
discrimination capability to detect the total particle
concentration in the appropriate particle size ranges MetOne Make
for the class under consideration
Discrete particle counter having a minimum

sampling flow rate of one cfm and lower particle size
discrimination capability of particles 0.5 µm or smaller
The Instrument should have the calibration

certificate, the frequency of calibration and method of
calibration should be based on the current accepted Lasair Make
practice
Pre Test Conditions for Particle Count Test
Ref: ISO 14644-1 Section B.3.1
Prior to the Particle count Test, the following aspects of the

clean room are complete with respect to the operational
integrity and functioning
a) Airflow Velocity or volume Test

b) Air Pressure difference Test
c) Containment Leakage Test
d) Installed Filter Leakage Test
Establishment Sampling Locations
Ref: ISO 14644-1 section B.4.1.1
Minimum number of Sampling locations can be derived by the
following formula
NL = SQRT( A )
Where
NL is the minimum number of sampling locations
A is the area of the cleanroom or clean zone in square
metres
Note: sample to be taken in minimum two locations in a
clean room
Establishment of single sample volume per location
Ref: ISO 14644-1 section B.4.2.1
The single sample volume (Vs) per location is determined by using
equation
Vs = (20/Cn.m) X 1000
Where
Vs is the minimum sample volume per location expressed in litres
Cn.m is the class limit (No. of particles/m3) for the largest
considered particle size specified for the relevent class
20 is the defined number
Sampling Procedure (Ref: ISO 14644-1 section B.4.3.1)
1. The sampling probe shall be positioned at the working height level pointing
into the airflow
2. If the direction of the airflow being sampled is not controlled (e.g. non
unidirectional airflow), the inlet of the sampling probe shall be directed
vertically upward
3. Where only one sample is required, take minimum of three single samples at that
location
4. Record the result of each sample measurement as the concentration of each

of the considered particle sizes appropriate to the relevant classification of
air
5. Compute the average particle concentration from the single sample volumes
taken at a location for each considered particle size from the individual
particle concentrations
Reports should Have the following details
1. Identification and location of the cleanroom or cleanzone
2. Identification of discrete particle counter and its calibration status
3. Type of measurement: classification or monitoring test
4. Cleanliness classification of installation
5. Particle size range(s)
6. Particle counter’s inlet sampled flow rate through the sensing chamber volume
7. Sample location with necessary drawing
8. Sampling protocol for classification or sampling plan for monitoring
9. Temperature, Humidity and environmental data

10. Occupancy State(s)
Typical Report Format – Particle Count Test
Computing maximum permitted airborne particle concentration are
calculated as follows (Ref ISO 14644-1 Section D.1.3)
If we consider the particulate
cleanliness class as ISO 5 Cn = (0.1/0.3)2.08 x 105
For Particles > 0.3 Mic (D1)

= 10176
rounded 10200 particles/m3
0.5 Mic (D2) > 1.5 x 0.3 Mic (D1)
Cn = (0.1/0.5)2.08 x 105
For Particles > 0.5 Mic (D2)

= 3517
rounded 3520 particles/m3
Computing the single sample volume (Vs)
Vs = (20/3517) x 1000
= 5.69 litres
Since the obtained sample volume is less than 28 litres, the single sample
volume will be 1 cfm as the flow rate of typical particle counter is 1 cfm
Computing number of sampling point locations (NL)

If the size of the clean room (L x W) is 10m x 8m
Then
NL = SQRT(80) = 8.94 rounded to 9

For Example the counts obtained from the measurements
are as below
The mean value for 0.3 Mic size particles
Sampling Number of Particles Number of Particles
Location > 0.3 Mic > 0.5 Mic
X =(8750+6607+2107+3786+5857+7000+8071+8000+6964)/9
1 8750 750
= 57142/9 2 6607 857
= 6349.1 rounded to 6349 particles/m3 3 2107 0
4 3786 250
The mean value for 0.5 Mic size particles 5 5857 786
6 7000 893
X = (750+857+0+250+786+893+821+1321+679)/9
7 8071 821
= 6357/9
8 8000 1321
= 706.3 rounded to 706 particles/m3
9 6964 679
To calculate standard deviations of the location averages
For 0.3 Mic
s2 ={(8750-6349)2 + (6607-6349)2 + (2107-6349)2 + (3786-6349)2 + (5857-6349)2 + (7000-
6349)2 + (8071-6349)2 + (8000-6349)2 + (6964-6349)2 } / 8
= 37130073/8 = 4641259.1 rounded to 4641259
S = SQRT(4641259) = 2154.4 rounded to 2154 particles/m3

For 0.5 Mic
s2 ={(750-706)2 + (857-706)2 + (0-706)2 + (250-706)2 + (786-706)2 + (893-706)2 + (821-

706)2 + (1321-706)2 + (579-706)2 } / 8
= 1164657/8 = 145582.1 rounded to 145582
S = SQRT(145582) = 381.6 rounded to 382 particles/m3

To calculate 95% UCL

For 0.3 Mic
95% UCL ( > 0.3 Mic) = 6349 + 1.9 [ 2154/SQRT(9) ]
For 0.5 Mic
95% UCL ( > 0.5 Mic) = 706 + 1.9 [ 382/SQRT(9) ]

To calculate 95% UCL

For 0.3 Mic
95% UCL ( > 0.3 Mic) = 6349 + 1.9 [ 2154/SQRT(9) ]
For 0.5 Mic
95% UCL ( > 0.5 Mic) = 706 + 1.9 [ 382/SQRT(9) ]

Recovery Test
The recovery test is performed to determine whether the cleanroom or
cleanzone is capable of returning to its specified cleanliness class within
a finite time, after being exposed briefly to a source of airborne
particulate challenge in the from of a smoke or optional aerosol.
This test is not recommended for unidirectional flow rooms.
This test should be carried out in the as built or at rest occupancy state
Apparatus required for Recovery Test

Aerosol Generator & air-generated aerosol
Discrete Particle counter which is having flow rate of 1 cfm and

efficiency of measuring particles from 0.3mic to 5 mic range
Recovery Test
Test Procedure
1. Adjust the single sample volume, number of cycles and delay
time of the counter should be adjusted to no more than 10
seconds
2. Particle size used in this test should be same as that used for the
determination of cleanliness class.
3. Measure the particle counts at a room air return outlet to
establish the existing particle concentration level.
4. Generate the smoke at the air inlet to the room until a particle
count in the room becomes approximately 100 times the target
cleanliness level. Turn off the smoke.
5. Measure & record the particle count each minute, until the
cleanliness level in the room is restored to the original condition
recorded & record the recovery time. Record
Acceptance Criteria
Acceptable recovery times are a matter for agreement between the
buyer and the seller.
Recovery Test
Acceptance Criteria
Acceptable recovery
times are a matter for
agreement between the
buyer and the seller.
Test Report
1. Identification of apparatus
operator and data collection
system
2. Identification of apparatus
and their calibration status
4. Occupancy state (s)

Acceptance Criteria
The pressure difference between the
enclosure room and the adjacent
rooms should be as per the specified
data or else mutually agreed between
the buyer and the seller
Test Report should have the

following data
1. Identification of apparatus operator and
data collection system
2. Identification of apparatus and their
calibration status
3. Type of tests and measurements, and
measuring conditions
4. Cleanliness classes of the rooms
considered
Air Flow Visualization Test
This test is performed to verify the direction of the supply & return airflow through
the Filter/Diffuser in a clean room and whether the clean room is capable of
limiting the dispersion of internally generated contamination
Apparatus for the airflow parallelism test:

Dry Ice Fog Generator
Digital Video Camera
Pre Test Conditions:

This test is to be performed after the airflow velocity, uniformity Test &
Air Flow Visualization Test
Test Procedure
1. Set up a smoke generator with the outlet tube pointing in the direction of
airflow and located at the center of the filter/diffuser area and at a distance of
6 inches from the filter/diffuser face
2. Insert a little bit of water inside the generator, then heat the smoke generator
gently for 4-5 minutes. Immediately insert the pieces of dry ice inside the
generator.
3. As the dry ice exposes to the air flow, it generates volume of smoke, hold the
hose pipe below the HEPA/ULPA Filter which is to be tested for air flow
direction and the smoke moves in the direction of airflow. Record the air flow
pattern by videography
4. Repeat the procedure for other HEPA Filters also
Test Report
• Identification of the apparatus operator
• Identification of the test apparatus
• Type of test, method of visualization and test conditions
• visualization point locations

Validation Presentation SRP

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Clean Room Validation

SRP ENVIRO SERVICES PVT. LTD

Basics of Clean Room

Types of Clean Room

Clean Room Validation

* Non Unidirectional airflow

•By using Proper material for Clean room

•Personnel working inside the clean room

•By strictly Following SOP’s & Preventive

Validation is Establishing documented

• It gives the company a control system that

• It is credible and stable, because the

• At regular intervals and thereafter.

• If damage to filters is suspected.

• If filters have been moved or disturbed

• If filters have been subjected to unusual

• IEST-RP-CC006.2 – Testing Clean Rooms

• ISO-14644 (INTERNATIONAL STANDARD ORGANIZATION)

N/A: Not applicable to this situation

14644-9: UD Classification of surface particle cleanliness

ISO Class 2 100 24 10 4

ISO Class 3 1000 237 102 35 8

ISO Class 4 10000 2370 1020 352 83

ISO Class 5 100000 23700 10200 3520 832 29

ISO Class 6 1000000 237000 102000 35200 8320 293

ISO Class 7 352000 83200 2930

ISO Class 8 3520000 832000 29300

Maximum Permitted Number of Particles /m3

Federal Class Class Class

100 M3.5 E or F 3.5 4 000 3 5

10 000 M5.5 J 350 400 000 5 7

100 000 M6.5 K 3500 4 000 000 6 8

The Mandatory Tests

Optional Tests ( ISO 14644-2)

a) Lighting level and uniformity test

b) Noise level test

c) Temperature and moisture uniformity test

As-built (A cleanroom facility that is complete and

At-rest (An operational cleanroom facility without

In-Operation (An operational cleanroom facility with

Apparatus required for the Airflow Test:

1. Feet per Minute (FPM)

2 Meter per Second (MPS)

Airflow Volume Measuring Units

1. Cubic Feet per Minute ( CFM )

2 Cubic Meter per Hour (CMH)

Test Procedure for Air Flow Velocity Measurement in

2. Measuring Points should be defined at a distance of between 150

 The Number of measuring points should be

 Measurements should be taken at the centre

 Measuring time at each position should be at

Air changes per hour is calculated using the

Acceptance Criteria for Air Flow Velocity Test

1. Identification of Apparatus Operator & Data collecting System

2. Identification of Apparatus and calibration status

3. Type of Tests and measurements, and measuring conditions

5. Temperature, Humidity & Environmental Data

The test is performed by introducing an aerosol challenge upstream

Reasons for HEPA/ULPA Installation

Types of Leaks identified by on-site testing of HEPA Filters

Cold Aerosol Hot Aerosol

Aerosol Photometer with a nominal sampling flow rate of 28.3 L/min

Aerosol Generator which produces aerosol that results when a high

The Concentration of the aerosol challenge upstream of the