1 Scope
This standard specifies the test condition and method for airborne microbe in clean room (zone) of the pharmaceutical industry.
This standard is applicable to the verification for test and environment of airborne microbe in clean room (zone), sterile room or localized air purification zone (including clean bench) of the pharmaceutical industry.
2 Normative References
The following normative documents contain provisions which, through reference in this standard, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest editions apply.
GB/T 16292-2010 Test Method for Airborne Particles in Clean Room (Zone) of the Pharmaceutical Industry
JGJ 71-1990 Specification for Construction and Acceptance of Hygienic Room
3 Terms and Definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
colony forming units
microbial colony formed from reproduction of one or several microorganisms after microbial culture, which is referred to as CFU, and is generally expressed in the count of microorganisms
3.2
airborne microbe
count of visible colony forming units reproducing under suitable culture condition in special culture medium through collecting living microbial particles in the air with the method referred in this standard
3.3
airborne microbe concentration
count of colony forming units of airborne microbes per unit volume of air, expressed in terms of count concentration, in unit of CFU/m3 or CFU/L
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Test Methods
5 Test Rules
Annex A (Normative) Arrangement of Sampling Points in Clean Room (Zone)
Annex B (Normative) Sterilization and Preparation of Culture Media
Annex C (Informative) Technical Requirements for Airborne Microbe in Clean Room (Zone)
