I Joint Confere.nce on Cleanrooms and Microenvironments
RECEIVED JUL 0 1 1996
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Proceedings c
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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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TABLE OF CONTENTS
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Test ikfethods PROPOSED CHANGES TO FED-STD-209 AND IES-RP-CCOO6
Robert L. Mielke .._____.____....___.I__.L.____________._ -----------..--------- .... 1 NEW METHODS FOR CHALLENGING HEPA FILTERS
Charles E Rose. ........................................................ ..--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 ........................................................................................................... 21
Phil Naughton .................................................................................................................... 37 VALIDATION OF TKE W A C SYS’IEM-SEMICONDUCTOR VIEWPOINT
MODULAR ROBOTIC SYSTEMS
ISOLATION TECHNOLOGY Gary DelVecChio ........................................................................................................................................... 47
Patrick Oles .......................................................... : ................................... .. ........................................................ 52
Monitoring VALIDATION OF ELECTRONIC PARTICLE COUNTER COUNTING ACCURACY
Julius 2. Knapp and Lee R. Abnmson ............................................................ 1 ......................... 55
Wayne P. KeUy,James A. Blesener, David B. Blackford, and Georg Schiirmann .......................................... 72 A NEW METHOD FOR MONITORING THE LEVEL OF PARTICLE CONTAMINATION OF SURFACES *
Donald G. Lulz and Gene J. Sullivan .......................................................................................................................... 76 ENVIRONMENTAL MONITORING’ OF VIABLES: SURFACE TESTING
Pam& D. Deschenes ................................................................................................................................................ 79
. FACILITY MONITORING SYSTEMS
. Regulation
RESPONSE TO THE NEW USP PROPOSAL: MICROBIAL EVALUATION AND CLASSIFICATION OF CLEANROOMS
M c h I S. Korczynski. ....................................................................... ............................................... 92 ESTABLISHING A CLEANROOM ENVIRONMENTAL MONITORING PROGRAM ACCORDING TO EEC AND PIC GMPs
Pedro Pascual and Maria Luisa Dominguez ...................................................................... 97 VALIDATION OF SURFACE DISINFECTANTS
Gary B. Smith and Robbi A. Wyatt ........................................ ............................................ 104
Destin A. LeBlanc and James M. Smi ............................................................................ 115
Ronald F. Tetzlaff ...................................................................... ... ............................................. 136
NEW METHODS FOR CLEANROOM -SURFACES .
INVESTIGATIONAL TRENDS: ENVIRONMENTAL MONITORING
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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. De- partment of Energy. He received his BS in applied sciences in manufacturing engineering from Miami University in Ohio. Involved in cleanroom applica- tions 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 Standards and Practices Committee of theIns titute’s Contamination Control division.
IN THE UNITED STATES, two documents have been considered basic to work with cleanrooms and con- trolled 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 classifica- tion and cleanroom certification. Recommended Prac- tice 006 is the recognized source for testing cleanroom performance. This paper covers the purpose and pro- posed changes for both FED-STD-209D and IES-RP- *
CC006.
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-cleanliness moni- toring. Revision E of FED-STD-209 will introduce a method for determining anddescribingconcentrations of ultrafine particles (U descriptors) and provide for sequential sampling for Some classes.
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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 (SD designator will be predicated on the base 10 logarithm of the number of particles 05 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.
Verification measurement will be designated at one or more particle sizes. The sta ted test particle sizes are 0.1 p, 0.2 p, 0.3 pm, 0.5 pm, and 5.0 p; how- ever,alternativeparticlesizescanbeusedaslong as the provisions in the document are followed.
A requirement that particle concentrations be re- ported 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 con- tinue 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 10 or more locations will be that the average of each sample location be below the class limit.
There will be asequential sampling plan for classes M 2.5 and cleaner jclasses 10 and cleaner). Such a technique could simplify and reduce the cost of sam-
, pling in-?ppropriate situations. The definitions section will be expanded to include
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such topics as clean zone, isoaxial sampling, single particle counter, U descriptor, ultrafine particles.
There will be a modification to the existing appen- dixes 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 addi- tional appendixes will be added on the subjects-of isokinetic and anisokinetic sampling; methods for measuring the concentration of ultrafine particles; and sequential sampling-n optional me tfioa-ftr verify- ing the compliance of air to the limits of airborne particulate cleanliness classes M 2.5 and cleaner.
will be in metric units; English units will be used in parallel.
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).
The section on HEPA-filter leak testing will be extensively revised. More complete background infor- mation will be provided on filter-scan methods (to avoid confusion concerning the applicability of pho- tometer versus particle counte;scanning) and a proce- dure will be included for determining a suitable scan- ning rate.
Recommendationswill beincluded for diagnosing problem areas detected during air-cleanliness tests according to FED-STD-209.
The section on air supply volume and reserve capacity tests will be deleted.
IES-RP-CC006 The purpose of IES-RP-CC006 is to address testing methods fordetermining the performanceofcleanroom environmental variables. The environmen tal variables are:
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Airflow velocity and uniformity HEPA-filter leakage Airflow parallelism Recovery interval Airborne particle count Particle fallout count
.. Enclosure induction leakage Room pressurization Lighting level and uniformity Noise level
Temperature Humidity Vibration
IES-RP-CCOO6 provides test methods and procedures for thirteen different test variables. Some of these pro- cedures 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 require- ments. Only fiveof theoriginal fourteen tests were extensively revised. The highlights of the changes to the document are:
The primary definition of quantitative measure
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The section on temperature and humidity will be revised to include
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a dewpoint test as an alternative to humidity testing; expanded coverage of procedures and equip- ment to provide a broader range of testing protocols to match specificuser needs and test capabilities; and an appendix that provides’ guidance on the statistical treatment of temperature and mois- ture test data.
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PUBLICATION OF DOCUMENTS It is anticipated that both FED-STD-2O9E and IES-RP- CC006 will be published during 1992. These publica- tions are the products of many dedicated and talented 1% working group members whose expertise and dili- gence ar? creating two extremely valuable reference documents.
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REFERENCES 1. Cfeunroom and Work Station Requiremenis, Cuntrolled Environment-Federal Standard 2090. General Services Administration, Fort Worth, Texas, 1988. 2. Recommended Practice for Testing Cleanrooms, LES-XP- CC-006-84-T. ins ti tu te of Environmental Sciences,' Mount Prospect, Ilinois, 1984. 3.Minutes of WG-100 meetings held Setember 25, 1988; April 29-30,1989; November 6-7,1989; April 21- 22,1990;October1-2,1990,and May4-5,1991.Institute of Environmental Sciences, Mount Prospect, Illinois.
ACKNOWLEDGEMENTS 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. Eh- mann, Executive Director of the IES; David C. Swine- hart, Delco Electronics Corporation; and Vinette N. Kopek, Associate Director-Publications, IES.
Changes To FED-STD-209D Airborne Particulate Cleanliness Classes, Per Table I
0.5urn Particles SI
M I M I .5 M2 M2.5 M3 M3.5 M4 M4.5 M5 M5.5 M6 M6.5 M7
- Customary
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10
100
1000
10 000
100 000
LCL. 10 .o 35.3 100 353
1000 3 530
10 000 35 300 100 000
1 000000 3 530 000
10 000000
353 '000
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rn 0.283 1 .oo 2.83
10 .o 28 .3 100 283
1000 2 830 10 000 28 300
100 000 283 000'
. ..- 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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