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Frequently Asked Question - Cleanroom Section
 


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Pharmaceutical Glossary of Terms

Definition of Common Cleanroom Terms


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Classification of Cleanrooms


Federal Standard 209 ISO Standards 14644 ISO 14698
ISO 14644-1 EUGGMP Examples of Cleanroom Conditions
EUGGMP Recommended Cleanroom Microbial Limits Guideline on Sterile Drug Products Cleanroom Critical Areas
Cleanroom Controlled Areas    

ISO Contamination Control Standards

Why International Cleanroom Standards ? International standardisation - objectives and procedures
International cleanroom standards - First Step The working groups of ISO/TC 209P
Present status of international cleanroom standardisation The impact of the ISO standards on contamination control practice
ISO 14644-26 ISO 14644-37
ISO 14644-48 ISO 14644-59
ISO 14644-610 ISO 14644-711
ISO 14644-812 Bio contamination control standards reviewed

Cleanroom Disciplines

Peoples Allowed into Cleanrooms Personal Items Not Allowed into the Cleanroom
Air Transfer with in the Cleanrooms Personnel behaviour with in the Cleanrooms
Handling materials with in the Cleanrooms Maintenance and Service in the Cleanrooms

Cleanrooms Personnel Entry and Exit Rules

Need for Cleanroom Entry Exit Rules Prior to arriving at the Cleanrooms
Changing in to Cleanroom Garments Approaching the pre-change Zone
Pre-Change Zones Changing Zones
Cleanroom Entrance Zone Cleanroom Exit Changing Procedures

   Why should anyone use a laminar flow system ?   Why should anyone use a laminar flow system ?
   What actually a laminar air flow system ?   What actually a laminar air flow system ?
   How are the High-efficiency particulate air ( HEPA filters) tested ?   How are the High-efficiency particulate air ( HEPA filters) tested ?
   What specifications or standards apply to testing the filters in place ?   What specifications or standards apply to testing the filters in place ?
   Is this in-place filter test the same one as the filter manufacturer uses ?   Is this in-place filter test the same one as the filter manufacturer uses ?
   What is the procedure for in-place test?   What is the procedure for in-place test?
   What does percent of penetration mean ?   What does percent of penetration mean ?
   Why was 0.01% established as a significant ?   Why was 0.01% established as a significant ?
   Why can't the leak test be run with ambient air within a room ?   Why can't the leak test be run with ambient air within a room ?
   If plates to obtain bacterial counts are used, must the in-place test still be run ?   If plates to obtain bacterial counts are used, must the in-place test still be run ?
   Can leaks not be detected by agar plates ?   Can leaks not be detected by agar plates ?
   How about impingement devices ?    How about impingement devices ? 
   Is DOP aerosol harmful to the filters ?   Is DOP aerosol harmful to the filters ?
   What happens to the DOP once it is in the system ?   What happens to the DOP once it is in the system ?
   When DOP is used to test a system, does the room have to be wiped down ?   When DOP is used to test a system, does the room have to be wiped down ?
    Has DOP test been accepted by the pharmaceutical industry ?   Has DOP test been accepted by the pharmaceutical industry ?
   With reference to Fed. Std. 209b, What is the relationship of the various classes of     With reference to Fed. Std. 209b, What is the relationship of the various classes of clean rooms ( 100, 10 000, and 100 000 ) to the 0.01% figure ?
   Can a particle counter not be used to determine the class of the room ?   Can a particle counter not be used to determine the class of the room ?
   But isn't a particle count important data ?   But isn't a particle count important data ?
   But, why can't leak test be carried out with a particle counters ?   But, why can't leak test be carried out with a particle counters ?
   What are the advantages of the DOP in-place test over attempting a leak test  with a    What are the advantages of the DOP in-place test over attempting a leak test  with a particle counter ?
   How often should the DOP in-place test to be run ?   How often should the DOP in-place test to be run ?
   What qualifications are necessary for in-place test personnel ?   What qualifications are necessary for in-place test personnel ?
   When should the HEPA filters be replaced ?   When should the HEPA filters be replaced ?
   Do all filter material makers and filter manufacturers use the same mehtods for testing    Do all filter material makers and filter manufacturers use the same mehtods for testing their products ?
   Federal Standard 209D Class Limits    Federal Standard 209D Class Limits
   Federal Standard 209E Class Limits    Federal Standard 209E Class Limits
   ISO Standard 14644-1 Class Limits   ISO Standard 14644-1 Class Limits
   Comparison between selected equivalent classes of FS 209 and ISO 14644-1    Comparison between selected equivalent classes of FS 209 and ISO 14644-1
   Airborne classification in the EU GGMP   Airborne classification in the EU GGMP
   Cleanroom Contamination Classification by Nature of Substance   Cleanroom Contamination Classification by Nature of Substance
   Particles in Outdoor Air    Particles in Outdoor Air
   Schedule of Mandatory Testing    Schedule of Mandatory Testing
   Schedule of Optional Testing    Schedule of Optional Testing
   International Standards Comparison    International Standards Comparison
   Limits for Microbial contamination    Limits for Microbial contamination
   Air classification as per WHO 2002    Air classification as per WHO 2002
   Air classification as per Schedule M   Air classification as per Schedule M
   Operations for Aseptic Preparation   Operations for Aseptic Preparation
   Operations for Terminally Sterilised Products    Operations for Terminally Sterilised Products
   Environmental Monitoring for Cleanrooms    Environmental Monitoring for Cleanrooms
   Air Classifications   Air Classifications
   Special Requirements for ISO Class 3 Cleanroom   Special Requirements for ISO Class 3 Cleanroom
   Cleanroom Industry Thumb Rule    Cleanroom Industry Thumb Rule