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Pharmaceutical Glossary of Terms Definition of Common Cleanroom Terms Click Here for Information about Biological Safety Classification of Cleanrooms
ISO Contamination Control Standards
Cleanroom Disciplines
Why should anyone use a laminar flow system ? What actually a laminar air flow system ? How are the High-efficiency particulate air ( HEPA filters) tested ? 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 ? What is the procedure for in-place test? What does percent of penetration mean ? Why was 0.01% established as a significant ? 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 ? Can leaks not be detected by agar plates ? How about impingement devices ? Is DOP aerosol harmful to the filters ? 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 ? Has DOP test been accepted by the pharmaceutical industry ? 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 ? But isn't a particle count important data ? 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 particle counter ? How often should the DOP in-place test to be run ? What qualifications are necessary for in-place test personnel ? When should the HEPA filters be replaced ? Do all filter material makers and filter manufacturers use the same mehtods for testing their products ? Federal Standard 209D Class Limits Federal Standard 209E Class Limits ISO Standard 14644-1 Class Limits Comparison between selected equivalent classes of FS 209 and ISO 14644-1 Airborne classification in the EU GGMP Cleanroom Contamination Classification by Nature of Substance Particles in Outdoor Air Schedule of Mandatory Testing Schedule of Optional Testing International Standards Comparison Limits for Microbial contamination Air classification as per WHO 2002 Air classification as per Schedule M Operations for Aseptic Preparation Operations for Terminally Sterilised Products Environmental Monitoring for Cleanrooms Air Classifications Special Requirements for ISO Class 3 Cleanroom Cleanroom Industry Thumb Rule