GB/T 16293-2010 Translated English of Chinese Standard. (GBT 16293-2010, GB/T16293-2010, GBT16293-2010): Test method for airborne microbe in cleanroom (zone) of the pharmaceutical industry
https://www.chinesestandard.net, 2 févr. 2019 - 17 pages
This Standard specifies the test conditions, test methods for airborne microbe in cleanroom (zone) of the pharmaceutical industry. This Standard is applicable to the verifications of test and environment for airborne microbe in cleanroom and clean zone in the pharmaceutical industry, sterile room or partial air purification area (including clean bench).
0.2 after sterilization 15g Purified water 5.8 Daily monitoring Acceptance of Cleanroom action levels agar medium TSA air purification air supply airborne microbe concentration airborne microbe sampler airflow alert levels Annex aseptic attached live microbial average concentration clean concentration of airborne constant temperature incubator contamination culture dish prepared culture medium dextrose agar medium disinfectant Figure A.1 flow cleanroom zone incubator at 20°C least 5d level 100 cleanroom live microbial particles measuring point medium SDA method for airborne microbe in cleanroom microbial concentration microorganisms Minimum sampling amount minimum sampling points non-unidirectional flow cleanroom number and location number of colonies number of minimum Number of sampling particles are cultured petri dish pharmaceutical industry port production operator evacuates purified air conditioning relative humidity Sabouraud dextrose agar sampled and cultured sampling flow sampling frequency sampling point layout sampling tube Standard Sterilization and preparation surface test instrument Test method Trypticase soy agar turntable unidirectional flow cleanroom