1 Scope
This standard specifies the test condition and method for settling microbe in clean room (zone) of the pharmaceutical industry.
This standard is applicable to the verification for test and environment of settling microbe in clean room (zone), sterile room or local 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
3 Terms and Definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
settling microbe
visible colony count reproducing under suitable culture condition in special culture medium through collecting living bioparticles in air with the method referred in this standard
3.2
settling microbe plate count
the quantity of settling microbe collected from air in each plate, expressed in pcs/plate
4 Test Methods
Foreword i
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 Medium
Annex C (Informative) Technical Requirements for Settling Microbe in Clean Room (Zone)
1 Scope
This standard specifies the test condition and method for settling microbe in clean room (zone) of the pharmaceutical industry.
This standard is applicable to the verification for test and environment of settling microbe in clean room (zone), sterile room or local 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
3 Terms and Definitions
For the purpose of this standard, the following terms and definitions apply.
3.1
settling microbe
visible colony count reproducing under suitable culture condition in special culture medium through collecting living bioparticles in air with the method referred in this standard
3.2
settling microbe plate count
the quantity of settling microbe collected from air in each plate, expressed in pcs/plate
4 Test Methods
Contents of GB/T 16294-2010
Foreword i
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 Medium
Annex C (Informative) Technical Requirements for Settling Microbe in Clean Room (Zone)
