GB/T 16294-2010 Translated English of Chinese Standard. (GBT 16294-2010, GB/T16294-2010, GBT16294-2010): Test method for settling microbe in clean room (zone) of the pharmaceutical industry
This Standard specifies the test conditions and test method for setting microbe in clean room and clean zone of the pharmaceutical industry. This Standard is applicable to the test of setting microbe in clean room and clean zone of the pharmaceutical industry, and in sterile room or local air purification area (including the clean bench), and the verification of the environment.
0.2 after sterilization 15 g Purified 5.8 Daily monitoring agar medium TSA air purification average colony number casein agar medium Casein trypsin digest clean room zone Cleanliness grade constant temperature incubator contamination correcting limits Count the number culture medium plate dynamic state test Figure A.1 g Purified water incubator at 30 indoor testing personnel ingredients except agar limits and warning location of on-site microbe in clean microbe plate count microorganisms Minimum number number and location number of colonies number of indoor number of petri number of sampling number of setting petri dish prepared pharmaceutical industry prepared by sabouraud prepared by soybean production operators refer to GB/T relative humidity sabouraud medium SDA sampled and cultured sampling frequency sampling point layout setting microbe settling microbe plate soybean casein agar static state test sterile operation requirements Sterilization and preparation test instrument Test method test point unidirectional airflow pattern unidirectional-flow clean rooms warning limits