This standard specifies the test conditions and methods of airborne microbe in the clean room (zone) of the pharmaceutical industry.
This standard applies to the testing and validation of the environment of airborne microbe in clean room (area), sterile room or local air purification area (including the clean bench) of pharmaceutical industry.
Contents:
Preface
Scope
Normative references
Terms and definitions
Test method
Test rules
Appendix A Sampling point layout in clean room (zone)
Appendix B Medium sterilization and preparation
Appendix C Technical requirement for airborne microbe in the clean room (zone)
Original regulatory document
