This standard specifies the test conditions and methods of settling microbe in clean room (zone) of pharmaceutical industry. It applies to the testing and validation of the environment of settling microbe in clean room (zone), sterile room or local air purification area (including clean bench) of pharmaceutical industry.
Contents:
Scope
Normative reference documents
Terms and definitions
Test methods
Test rules
Sampling point layout in clean room (zone)
Medium sterilization and preparation
Technical requirements for settling microbe in the clean room (zone)
Original regulatory document
