GB/T 16292-2010 PDF English
US$225.00 · In stock · Download in 9 secondsGB/T 16292-2010: Test method for airborne particles in clean room (zone) of the pharmaceutical industry Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB/T 16292: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 16292-2010 | English | 225 |
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Test method for airborne particles in clean room (zone) of the pharmaceutical industry
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| GB/T 16292-1996 | English | 399 |
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Test method for airborne particles in clean room (area) of the pharmaceutical industry
| Obsolete |
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GB/T 16292-2010: Test method for airborne particles in clean room (zone) of the pharmaceutical industry
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16292-2010
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
Foreword
This Standard was formulated based on ISO 14644-1 “Cleanrooms and
associated controlled environments -- Part 1.Classification of air cleanliness by
particle concentration” and JGJ 71-90 “Code for Construction and Acceptance
of Cleanroom”.
This Standard replaces GB/T 16292-1996 “Test method for airborne particles in
cleanroom(area)the pharmaceutical industry”.
The main differences between this Standard and GB/T 16292-1996 are as
follows.
- adjusted the scope of the standard; this Standard only specifies the test
method, and does not assess the cleanliness level of the cleanroom
(zone);
- deleted the filter microscope test method, used laser particle counter
method;
- added the method of determining the minimum number of sampling points;
- added and provided the latest informative annex.
Annex A of this Standard is normative.
Annex B of this Standard is informative.
This Standard was proposed by and shall be under the jurisdiction of China
Food and Drug Administration.
The drafting organization of this Standard. Shanghai Food and Drug Packaging
Materials Testing Institute.
Main drafters of this Standard. Xu Minfeng, Ji Yi, Wei Jiaming, Cai Jun, Han
Han, Feng Xiaoming.
Version of standard substituted by this Standard is. GB/T 16292-1996.
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.
3.2 localized air purification
A method in which only the concentration of suspended particles in the air in an
indoor working area or a specific partial space reaches a prescribed air
cleanliness level.
3.3 unidirectional airflow
Airflow with uniform wind speed on a section parallel to the flow direction in a
single direction and perpendicular to the direction of the airflow. Vertical
unidirectional airflow is perpendicular to the horizontal plane, and horizontal
unidirectional airflow is parallel to the horizontal plane.
3.4 non-unidirectional airflow
Airflow with multiple path cycling characteristics or non-parallel airflow
directions.
3.5 airborne particle
Solid and liquid particles with airborne particle size ranging from 0.1μm to
1000μm for air cleanliness fractionation. For a suspended particle count meter,
the area or volume of a particle sphere produces a response value, and different
response values are equivalent to different particle diameters.
3.6 cleanliness
The cleanliness of a unit volume of air in a clean environment containing a
statistical amount greater than or equal to a certain particle size of suspended
particles.
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.
4.3 Instrument
The instrument shall use any of the following.
4.3.1 Principle of light scattering particle counter
The airborne particles in the air produce light scattering under the illumination
of light. The intensity of the scattered light is proportional to the surface area of
the airborne particles.
4.4 Test points
4.4.1 The test instrument must be periodically verified according to the test
cycle of the test instrument. It shall use the instrument that passes the test and
is within the validity period of use.
4.4.2 When the test instrument does not enter the tested area, if necessary,
clean the surface first, or prepare and store in the corresponding cleanroom
(protect the instrument with a protective cover or other appropriate cover).
4.4.3 When using paper in level 100 cleanroom, it shall be covered with a
transparent, dust-free cover. It cannot use pencil and eraser in level 100
cleanroom.
4.4.4 When using the test instrument, strictly follow the instructions of the
instrument.
4.4.4.3 The sampling tube must be clean, and no leakage is allowed.
4.4.4.4 The length of the sampling tube shall be based on the allowable length
of the instrument. Unless otherwise specified, the length shall not exceed 1.5m.
4.4.4.5 The particle counter sampling port and the working position of the
instrument shall be at the same pressure and temperature to avoid
measurement deviation.
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.
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.
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.
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
In as-bulit or at-rest test, the number of airborne particle sampling points and
their layout stresses shall be uniform and not less than the minimum number of
sampling points. See Annex A for sampling point layout rules. In operational-
state testing, the number of airborne particle sampling points and their layouts
shall be set according to the production and process key operation areas of the product.
5.4.2 Limit of sampling times
For any small cleanroom (zone) or local air purification area, the number of
sampling points shall not be less than 2, and the total number of sampling times
shall not be less than 5 times. Each sampling point can be sampled more than
once, and the sampling times of different sampling points can be different.
5.4.3 Sampling amount
The minimum sampling amount for each cleanliness level is shown in Table 2.
5.4.4 Sampling considerations
5.4.4.1 For a unidirectional flow cleanroom (zone), the sampling nozzle of the
particle counter shall face the direction of the airflow. For non-unidirectional flow
cleanroom (zone), the sampling nozzle of the particle counter shall be upwards.
5.4.4.2 When arranging sampling points, try to avoid the return air outlet.
5.4.4.3 When sampling, the tester shall be on the leeward side of the sampling
port and have as little activity as possible.
5.4.4.4 After sampling, it is advisable to self-clean the particle counter.
5.4.4.5 It shall take measures as many as possible to prevent contamination
during the sampling process.
6 Calculation of results
6.1 Average airborne particle concentration A at the sampling point
The average airborne particle concentration A of the sampling point is
calculated according to formula (2).
6.2 Mean value of the average M
The mean value of the mean M is calculated according to formula (3).
6.3 Standard error SE
Standard error SE is calculated according to formula (4).
6.4 95% upper confidence limit (UCL)
The 95% upper confidence limit (UCL) is calculated according to formula (5).
7 Result evaluation
The evaluation the cleanliness level of airborne particles shall meet the
following two conditions simultaneously.
8 Test report
Test results from each cleanroom (zone) shall be recorded, and reports with
consistent or inconsistent reports shall also be submitted.
The test report shall contain the following information.
a) name and address of tester, date of test;
b) test reference;
c) plane position of the cleanroom (zone) to be tested (marking the position
of the adjacent area if necessary);
d) particle size of airborne particles;
Annex A
(normative)
Sampling point layout in cleanroom (zone)
A.1 The sampling point of the cleanroom (zone) shall be evenly arranged to
avoid the sampling point being too sparse in the local area. The following
sampling point layout diagram for multi-point sampling can be used as a
reference (see Figure A.1).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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