1 Scope
This standard specifies the test method for airborne particle pollution.
This standard is applicable to the verification for test and environment of airborne particles in clean room (zone), sterile room or localized air purification zone (including clean bench) of the pharmaceutical industry.
This standard cannot be used to characterize the physical, chemical, radiological, or viable nature of airborne particles.
Note: The actual distribution of particle concentrations within incremental size ranges normally is not predictable and typically is variable over time.
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.
YY 0033-2000 Good Manufacture Practice for Sterile Medical Devices
3 Terms and Definitions
For the purposes of this standard, the following terms and definitions apply.
3.1
clean room (zone)
room or zone in which the dust particles and microbiological pollution shall be subject to environment control, and which is constructed, equipped and used in a manner to minimize the introduction, generation, and retention of pollution source inside the room (zone), and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary
3.2
localized air purification
method used to make the concentration of airborne particles in the air in indoor working area or specific partial space reach the specified air cleanliness class
3.3
unidirectional airflow
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 Test Methods
5 Test Rules
6 Result Calculation
7 Result Evaluation
8 Test Report
Annex A (Normative) Arrangement of Sampling Points in Clean Room (Zone)
Annex B (Informative) Technical Requirements for Airborne Particles in Clean Room (Zone)
