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GB/T 16292-2010 (GB/T16292-2010)

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GB/T 16292-2010: PDF in English (GBT 16292-2010)
GB/T 16292-2010
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.30
C 30
Replacing GB/T 16292-1996
Test method for airborne particles in
cleanroom (zone) of the pharmaceutical industry
ISSUED ON. SEPTEMBER 02, 2010
IMPLEMENTED ON. FEBRUARY 01, 2011
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People's Republic of
China.
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 4 
4 Test methods ... 6 
5 Test rules ... 8 
6 Calculation of results ... 10 
7 Result evaluation ... 12 
8 Test report ... 12 
Annex A (normative) Sampling point layout in cleanroom (zone) ... 14 
Annex B (informative) Technical requirements for airborne particles in
cleanroom (zone) ... 16 
Test method for airborne particles in
cleanroom (zone) of the pharmaceutical industry
1 Scope
This Standard specifies the test method for airborne particle contamination.
This Standard is applicable to the verification of airborne particle testing and
environment in cleanroom and clean areas in the pharmaceutical industry,
sterile rooms or local air purification areas (including clean bench).
This Standard cannot be used to characterize physical, chemical, or reflective,
or reproducible properties of airborne particles.
NOTE. Within the sampling particle size range, the actual particle concentration is unpredictable and
significantly changes with time as the sampling amount increases.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
YY 0033-2000, Good manufacture practice for sterile medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 cleanroom (zone)
A room or area that requires environmental control for dust and microbial
contamination. Its building structure, equipment and its use have the function
of reducing the involvement, generation and retention of pollution sources in
the area. Other relevant parameters such as temperature, humidity, and
pressure are also necessary to control.
process equipment has been installed, and there are no production personnel
in the cleanroom (zone).
At-rest b. after the production operation is completed, the production operator
evacuates the site and after 20 minutes of self-purification of the cleanroom
(zone).
3.10 operational
The cleanroom (zone) is in normal production state, the equipment is carried
out in the specified mode, and the designated personnel are operating
according to the specifications.
3.11 clean bench
A workbench or a closed enclosure work area similar to it. It is characterized by
its ability to supply filtered air or gas, and is divided into a vertical one-way flow
table, a horizontal one-way flow table, etc. according to the air flow form.
4 Test methods
4.1 Method summary
The method adopts the counting concentration method, that is, the level of
airborne particles cleanness in the cleanroom (zone) is assessed by testing the
number of airborne particles that have a particle size greater than or equal to a
certain particle, in unit-volume in a clean environment.
4.2 Staff duties and training
Testers in cleanroom (zone) shall be trained in the profession and qualified to
perform their duties in cleanroom (zone) testing, including the health knowledge
and basic microbiological knowledge involved.
Testers in cleanroom (zone) shall choose the wear method that suits the air
cleanliness level requirements of the production operation. Outer clothes
cannot be brought into the area of level above 100000.
4.3 Instrument
The instrument shall use any of the following.
a) light scattering particle counter (for airborne particle counts with particle
sizes greater than or equal to 0.5μm);
b) laser particle counter (for airborne particle counts with a particle size
greater than or equal to 0.1μm).
5 Test rules
5.1 Test conditions
Pre-test the relevant parameters of the cleanroom (zone) before testing. Such
tests shall provide environmental conditions for testing airborne particles, such
as. such pre-tests may include.
a) Temperature and relative humidity testing. The temperature and relative
humidity of the cleanroom (zone) shall be compatible with its production
and process requirements (when no special requirements are required,
the temperature is between 18°C and 26°C, and the relative humidity is
between 45% and 65%), and the test equipment shall meet the use scope
of testing instrument.
b) Indoor air supply or wind speed test, or differential pressure test.
c) High efficiency filter leak test.
5.2 Test state
Three states of as-bulit, at-rest and operational-state can be tested.
In as-bulit or at-rest test, there must be no more than 2 testers in the room.
The test report shall indicate the state of the test and the number of testers in
the room.
5.3 Test time
5.3.1 In the case of as-bulit or at-rest a test, for a unidirectional flow cleanroom
(zone), the test shall begin after the normal operation time of the purified air
conditioning system is not less than 10min. For non-unidirectional flow
cleanroom (zone), the test shall start after the normal operation time of the
purified air conditioning system is not less than 30min. In the at-rest b test, for
the unidirectional airflow cleanroom (zone), the test shall be started after the
production operator evacuates the site and after 10min of self-cleaning. For
non-unidirectional flow cleanroom (zone), the test shall be started after the
production operator evacuates the site and after 20min of self-cleaning.
5.3.2 In operational-state testing, it must record the start of production and test
time.
5.4 Airborne particle count
5.4.1 Number of sampling points and their layouts
......
 
(Above excerpt was released on 2019-02-02, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/GBT16292-2010