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Joint Confere.nce on
Cleanrooms and
Microenvironments
RECEIVED
JUL 0 1 1996
Proceedings
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Sponsored by the Institute of Environmental Sciences and the Parenteral Drug Association
February 3 6 , 1992 Arlington, Virginia
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ISBN: 1-877862-17-7
4
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TABLE OF CONTENTS
Test ikfethods
PROPOSED CHANGES TO FED-STD-209 AND IES-RP-CCOO6
Robert L. Mielke .._____.____....___.I__.L.____________._ -----------..--------- ....
1
NEW METHODS FOR CHALLENGING HEPA FILTERS
CharlesE
......Rose.
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..--I..----..-L....----------- .
4
LIFE CYCLE OF HEPA FILTERS AND FILTER TEST METHODS
Dan c Milhouand.. .................................................
-...-.-................................................. 10
TEST METHODS FOR MEASURING AEROSOL PARTICLE EMISSION RATE FROM
CLEANROOM EQUIPMENT
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Cleanroom Design and Robotics
VALIDATION OF THE ‘HVAC SYSTEM-PHARMACEUTICAL
VIEWPOINT
HaroldS.Baseman ...........................................................................................................
VALIDATION OF TKE W A C SYS’IEM-SEMICONDUCTOR VIEWPOINT
Phil Naughton ....................................................................................................................
MODULAR ROBOTIC SYSTEMS
Gary DelVecChio...........................................................................................................................................
ISOLATION TECHNOLOGY
:................................... ..........................................................
Patrick Oles ..........................................................
.
Monitoring
VALIDATION OF ELECTRONIC PARTICLE COUNTER COUNTING ACCURACY
1.........................
Julius 2. Knapp and Lee R. Abnmson ............................................................
FACILITY MONITORING SYSTEMS
Wayne P. KeUy,James A. Blesener, David B. Blackford, and Georg Schiirmann..........................................
A NEW METHOD FOR MONITORING THE LEVEL OF PARTICLE CONTAMINATION
SURFACES
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Donald G. Lulz and Gene J. Sullivan..........................................................................................................................
ENVIRONMENTAL MONITORING’OF VIABLES: SURFACE TESTING
Pam& D. Deschenes................................................................................................................................................
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37
47
52
55
72
OF
76
79
Regulation
RESPONSE TO THE NEW USP PROPOSAL: MICROBIAL EVALUATION AND
CLASSIFICATION OF CLEANROOMS
92
M c h I S. Korczynski. ....................................................................... ...............................................
ESTABLISHING A CLEANROOM ENVIRONMENTAL MONITORING PROGRAM
ACCORDING TO EEC AND PIC GMPs
Pedro Pascual and Maria Luisa Dominguez......................................................................
VALIDATION OF SURFACE DISINFECTANTS
Gary B. Smith and Robbi A. Wyatt ........................................ ............................................
NEW METHODS FOR CLEANROOM -SURFACES .
Destin A. LeBlanc and James M. Smi............................................................................
INVESTIGATIONAL TRENDS: ENVIRONMENTAL MONITORING
Ronald F. Tetzlaff ......................................................................
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104
115
136
PROPOSED CHANGES TO FED-STD-209 AND ES-RP-CCOOG
Robert L. Mielke, Mgnager of Physical Metrology
EG&G Mound Applied Technologies, Miamisburg, Ohio
Robert L. Mielke is the manager of Physical Metrology
for EG&G Mound Applied Technologies in
Miamisburg, Ohio, a facility operated by the U.S.Department of Energy. He received his BS in applied
sciences in manufacturing engineering from Miami
University in Ohio. Involved in cleanroom applications work for more than 24 years, Mielke has been
active in IES’s standards and practices programs since
1982. He is a senior member of IES and is chairman of
the Standardsand Practices Committeeof theInstitute’s
Contamination Control division.
Numerous changes are being proposed by Working
Group 100-the IFS working group that is revising
FED-STD-209. The highlights are as follows:
The primary definition of quantitative measure
will be in metric units; English units will be used in
parallel. The metric (SDdesignator will be predicated
on the base 10 logarithm of the number of particles 0 5
pm and larger allowed for the class in a cubic meter of
air; for example, in SI, M 3.5 is equivalent to the current
class 100. See Table I.
Cleanliness classes will be extended both above
Class 100,000 and below Class 1.
Description of ultrafine particle concentration
through the use of CNCs will be provided for. Ultrafine
particles are defined as particles having diameters of
0.02 pm and larger and will be expressed by the U
descriptor, U(x), where x is the maximum allowable
concentration of ultrafine particles.
IN THE UNITED
STATES,two documents have been
considered basic to work with cleanrooms and controlled environments. They are Cleanroom and Work
Stah’on Requirements, Controlled Environrnenf-Federal
Standard 2090, published by the U.S.General Services
Administration, and Recommended Practice for Testing
Cleanrooms (IES-RP-CC006), published by the Institute
of Environmental Sciences (IES). FED-STD-209 is the
authoritative document on air cleanliness classification and cleanroom certification. Recommended Practice 006 is the recognized source for testing cleanroom
performance. This paper covers the purpose and proposed changes for both FED-STD-209D and IES-RP- *
CC006.
Verification measurement will be designated at
one or more particle sizes. The sta ted test particle sizes
0.2 p,
0.3 pm, 0.5 pm, and 5.0 p;
howare 0.1 p,
ever,alternativeparticlesizescanbeusedaslongas the
provisions in the document are followed.
A requirement that particle concentrations be reported as particles per unit volume of air, regardless of
sample size, will be included. (The overall sample size
would still be reported, and the standard would continue to allow different sample volumes at different
locations).
The upper confidence limit (UCL) for 10 or more
sample locations will be eliminated. The soIe criterion
for 10or more locations will be that the average of each
sample location be below the class limit.
FED-STD-209
The purpose of FED-STD-209 is to establish standard
classes of air cleanliness based on airborne particulate
levels in cleanrooms and clean zones and to prescribe
methodsfor class verificationand air-cleanlinessmonitoring. Revision E of FED-STD-209 will introduce a
method for determining anddescribingconcentrations
of ultrafine particles (Udescriptors) and provide for
sequential sampling for Some classes.
There will be asequential samplingplan for classes
M 2.5 and cleaner jclasses 10 and cleaner). Such a
technique could simplify and reduce the cost of samsituations.
, pling in-?ppropriate
The definitionssectionwill be expanded to include
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such topics as clean zone, isoaxial sampling, single
particle counter, U descriptor, ultrafine particles.
will be in metric units; English units will be used in
parallel.
There will be a modificationto the existing appendixes on counting and sizing particles using optical
microscopy; operation of a single particle counter;
rationale of the statistical rules used in FED-STD-209;
and sources of supplemental information.Three additional appendixes will be added on the subjects-of
isokinetic and anisokinetic sampling; methods for
measuring the concentrationof ultrafine particles; and
sequential sampling-n
optional me tfioa-ftr verifying the compliance of air to the limits of airborne
particulate cleanliness classes M 2.5 and cleaner.
Tests will be grouped according to the level of
certification. Categories will be: primary cleanroom
tests (level 1); user optional cleanroom tests (level 2);
and user-operational environmental tests (level 3).
IES-RP-CC006
Recommendationswillbeincluded for diagnosing
problem areas detected during air-cleanliness tests
according to FED-STD-209.
The section on HEPA-filter leak testing will be
extensivelyrevised. More completebackground information will be provided on filter-scan methods (to
avoid confusion concerning the applicability of photometer versus particle counte;scanning) and a procedure will be included for determining a suitable scanning rate.
The purpose of IES-RP-CC006 is to address testing
methods fordetermining the performanceofcleanroom
environmental variables. The environmental variables .
are:
The section on air supply volume and reserve
illbe deleted.
capacity tests w
Airflow velocity and uniformity
The section on temperature and humidity will be
revised to include
HEPA-filter leakage
a dewpoint test as an alternative to humidity
testing;
Airflow parallelism
Recovery interval
expanded coverage of procedures and equipment to provide a broader range of testing
protocols to match specificuserneeds and test
capabilities; and
Airborne particle count
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Particle fallout count
Enclosure induction leakage
3) an appendix that provides’ guidance on the
statisticaltreatment of temperature and moisture test data.
Room pressurization
Lighting level and uniformity
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PUBLICATION OF DOCUMENTS
Noise level
It is anticipated that both FED-STD-2O9E and IES-RPCC006 will be published during 1992. These publications are the products of many dedicated and talented
1% working group members whose expertiseand diligence ar? creating two extremely valuable reference
documents.
Temperature
Humidity
Vibration
IES-RP-CCOO6 provides test methods and procedures
for thirteen different test variables. Some of these procedures provide for alternative test methods based on
the needs of the process used in the cleanroom. The
document recommends types of equipment to be used
for each of the procedures. In general, the document
leaves thespecified requirements for each test up to the
customer;however,fiveof the tests do provide requirements.
Only fiveof theoriginal fourteen tests were extensively
revised. The highlightsof the changes to the document
are:
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The primary definition of quantitative measure
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REFERENCES
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ACKNOWLEDGEMENTS
1. Cfeunroom and Work Station Requiremenis, Cuntrolled
Environment-Federal Standard 2090. General Services
Administration, Fort Worth, Texas, 1988.
The author wishes to thank the following people for
their help in preparing this paper: Barbara A. Barnhart,
EG&G Mound Applied Technologies; Janet A. Ehmann, Executive Director of the IES; David C. Swinehart, Delco Electronics Corporation; and Vinette N.
Kopek, Associate Director-Publications, IES.
2. Recommended Practice for Testing Cleanrooms,LES-XPCC-006-84-T. institu te of Environmental Sciences,'
Mount Prospect, Ilinois, 1984.
3.Minutes of WG-100meetings held Setember 25,
1988; April 29-30,1989; November 6-7,1989; April 2122,1990;October1-2,1990,and May4-5,1991.Institute
of Environmental Sciences, Mount Prospect, Illinois.
Changes To FED-STD-209D
Airborne Particulate Cleanliness Classes, Per Table I
SI
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MI
M I .5
M2
M2.5
M3
M3.5
M4
M4.5
M5
M5.5
M6
M6.5
M7
0.5urn Particles
Customary
1
10
100
1000
10 000
100 000
rn
LCL.
10 .o
35.3
;
0.283
1 .oo
2.83
10 .o
28 .3
100
353
1000
3 530
10 000
35 300
100 000
353 '000
1 000000
3 530 000
10 000000
100
283
1000
2 830
10 000
28 300
100 000
283 000'
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Table 1. This table is a portion of Table 1 in the proposed FED-STDZiOBE. It demonstrates the relationship
between the metric (SI)units and the English (customary) units. It displays this relationship for only one of
the particle sizes, 0 5 p.(The complete table includes additional columns for 0.1,0.2,0.3,5.0
pm particles.)
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