GB/T 25915.2-2021_English: PDF (GB/T25915.2-2021)
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 25915.2-2021 | English | 334 |
Add to Cart
|
4 days [Need to translate]
|
Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
| Valid |
GB/T 25915.2-2021
|
| GB/T 25915.2-2010 | English | 170 |
Add to Cart
|
0--9 seconds. Auto-delivery
|
Cleanrooms and associated controlled environments -- Part 2: Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1
| Obsolete |
GB/T 25915.2-2010
|
| Standard ID | GB/T 25915.2-2021 (GB/T25915.2-2021) | | Description (Translated English) | Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C70 | | Classification of International Standard | 13.040.35 | | Word Count Estimation | 18,119 | | Date of Issue | 2021-08-20 | | Date of Implementation | 2022-03-01 | | Older Standard (superseded by this standard) | GB/T 25915.2-2010 | | Drafting Organization | China Electronic System Engineering Second Construction Co., Ltd., Jiangsu Jiahe Construction Co., Ltd., Tianjin Teda Clean Material Co., Ltd., Shenzhen Lifeng Purification Engineering Co., Ltd., Suzhou Antai Air Technology Co., Ltd., China Electronic Engineering Design Institute Co., Ltd., Shaanxi Zhong Dianjingtai Electronic Engineering Co., Ltd., Pionier Environmental Purification Engineering (Beijing) Co., Ltd., Beijianrunhe (Beijing) Technical Service Co., Ltd., Tianjushi Engineering Technology Group Co., Ltd., Suzhou Sujing Instrument Automatic Control Equipment Co., Ltd. , Tianjin University, China Association for Standardization, China Academy of Building Research Co., Ltd., Shanghai Indoor Environmental Purification Industry Association, Guangdong Clean Technology Industry Association, Suzhou Huatai Air Filter Co., Ltd., Shenzhen Langao Clean Technology Co., Ltd., Shanghai Food and drug packaging materials | | Administrative Organization | National Standardization Technical Committee for Cleanrooms and Related Controlled Environments (SAC/TC 319) | | Proposing organization | National Standardization Technical Committee for Cleanrooms and Related Controlled Environments (SAC/TC 319) | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | | Standard ID | GB/T 25915.2-2010 (GB/T25915.2-2010) | | Description (Translated English) | Cleanrooms and associated controlled environments. Part 2: Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1 | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C70 | | Classification of International Standard | 13.040.35 | | Word Count Estimation | 11,179 | | Date of Issue | 2011/1/14 | | Date of Implementation | 2011/6/1 | | Quoted Standard | GB/T 25915.1-2010; GB/T 25915.3-2010 | | Adopted Standard | ISO 14644-2-2000, IDT | | Drafting Organization | China Electronic Systems Engineering Second Construction Co., Ltd. | | Administrative Organization | National cleanrooms and associated controlled environments Standardization Technical Committee | | Regulation (derived from) | Announcement of Newly Approved National Standards No. 2 of 2011 | | Proposing organization | National cleanroom and associated controlled environments Standardization Technical Committee (SAC/TC 319) | | Issuing agency(ies) | Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China | | Summary | This Standard specifies the cleanroom or clean zone to put regular testing requirements to demonstrate continued compliance with air particulates concentration level of GB/T 25915. 1 prescribed. These requirements include hierarchical detection GB/T 25915. 1 Description cleanroom or clean zone. In addition, the project also provides for other tests in accordance with this standard implementation. Users can request an optional sense of project implementation, this standard also made instructions. This standard also provides for the cleanroom or clean zone (hereinafter referred to as "facilities") monitoring requirements in order to provide evidence of airborne particle concentration levels of GB/T 25915. 1 stipulated in its ongoing compliance. |
GB/T 25915.2-2021.Cleanrooms and related controlled environments Part 2.Monitoring of cleanroom air particle concentration
National Standard of the People's Republic of China
Replaces GB/T 25915.2-2010
State Administration for Market Regulation
The National Standardization Administration issued
1 Scope
This document specifies the basic requirements for a monitoring program. This monitoring program is based on the measured concentration of suspended particles in the air or the factors that affect it.
Monitor the performance of the clean room or clean area in terms of air cleanliness divided by particle concentration, and other parameters that are affected.
This document is applicable to the monitoring of particle concentration with a particle size of 0.1μm~5μm.
This document is not applicable to monitoring of vibration or general maintenance of engineering systems. Monitoring of ultrafine particle concentration (particles smaller than 0.1 μm) will
Specified in another standard.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 25915.1-2021 Clean rooms and related controlled environments Part 1.Classification of air cleanliness levels according to particle concentration
(ISO 14644-1.2015,MOD)
Note. There is no technical difference between the referenced content of GB/T 25915.1-2021 and the referenced content of ISO 14644-1.2015.
3 Terms and definitions
The terms and definitions defined in GB/T 25915.1-2021 and the following apply to this document.
4.Development, implementation and continuous improvement of monitoring plans
4.1 Description
In order to ensure that the clean room or clean area performs well, the particle concentration meets the control requirements and has good air cleanliness, a
and continuously improve the monitoring program.
The monitoring plan should consider the required air cleanliness level, critical locations and factors that affect the performance of cleanroom and clean area facilities.
The following steps should be included in the development, implementation and continual improvement of the monitoring plan.
---Use appropriate risk assessment methods to understand, evaluate and record the risks of adverse pollution events;
--- Develop a written monitoring plan;
--- Review and approve the monitoring plan;
---Carry out monitoring to implement the plan;
---Analyze the data obtained from monitoring activities, perform trend analysis when necessary and report on the performance of clean rooms and clean areas;
--- Implement and record the actions or corrective actions taken;
---Regularly review the monitoring plan.
The concentration of particles in the air measured according to the monitoring plan may be higher than the concentration in the static test.
Due to the influence of factors such as instrument or machine operation, activities in adjacent spaces, etc., the measured values may fluctuate greatly.
For processes that generate particles themselves and these particles do not pose a threat to the process or product, it is not necessary to monitor the dynamic particle concentration.
Regular static classification tests or dynamic classification tests that simulate operating conditions can be performed. Other parameters that affect performance and cleanliness can still be monitored.
4.2 Risk Assessment
Risk assessment is a systematic process of identifying hazards and analyzing and evaluating the risks of exposure to those hazards.
Risk assessment should achieve the following objectives.
--- Determine the factors that may affect the ability of a clean room or clean area to maintain its air cleanliness (the cleanliness is divided into
), so as to develop a monitoring plan;
--- Determine the monitoring requirements to demonstrate performance.
Risk assessment considerations are provided in Appendix A.
4.3 Monitoring plan
4.3.1 The monitoring plan should take into account the results of the risk assessment.
When developing a monitoring plan, at least the elements described in 4.3.2 to 4.3.13 should be included.
4.3.2 List and justify all parameters to be monitored, including those that may affect the concentration of particles in the air.
4.3.3 Explain the measurement method and justify its rationale. For matters that need to be considered in developing a monitoring plan, see Appendix A.
4.3.4 Accuracy, maintenance and calibration of monitoring instruments.
4.3.5 Identify the selected monitoring locations and explain their rationale. The monitoring locations shall be described using three-dimensional coordinates.
4.3.6 Identification and rationality of qualified monitoring standards or limits, including setting a single alarm value, or setting both an early warning value and an intervention value.
Alarm values are not set, but at least intervention values must be set. Setting the warning value can provide an early warning of performance deviation. See the attached
Record B.
4.3.7 Technical requirements for response measures when data exceeds specified limits.
4.3.8 The need to regularly classify the air cleanliness (by particle concentration) of clean rooms or clean areas in accordance with the provisions of 5.1 of GB/T 25915.1-2021
Need and frequency.
4.3.9 Data recording format.
4.3.10 Methods used for data trend analysis or other analysis, including statistical methods.
4.3.11 Requirements for reporting.
4.3.12 Regulations for record retention and the media used.
4.3.13 Frequency of review of monitoring plan.
Note. The monitoring plan should be reviewed regularly and modified based on the clean room or clean area conditions obtained from it.
4.4 Calibration
The instruments used for monitoring should meet the requirements of monitoring work, should have valid calibration certificates, and the calibration frequency and method should meet the current standards.
Require.
The calibration frequency and method of the particle counter shall be as specified in ISO 21501-4.
NOTE. When particle counters cannot be fully calibrated as required by ISO 21501-4, the decision to use the counter for monitoring shall be recorded in the monitoring plan.
4.5 Review and Approval
The monitoring plan should be reviewed and approved.
4.6 Countermeasures for Deviations in Monitoring
If the monitoring results exceed the specified limits, an investigation should be conducted to find out the reasons and remedial measures should be taken when necessary.
If the remedial measures involve major changes to the facility and/or its operation, graded testing should be carried out in accordance with GB/T 25915.1-2021.
Plans should also be reviewed based on changes to the facility and/or its operations.
When the classification level meets the requirements, monitoring can be resumed.
5.Regular classification of air cleanliness by particle concentration
Grade testing should be carried out every year according to GB/T 25915.1-2021.However, this frequency can be adjusted according to risk analysis, monitoring conditions, and data.
The extension will be granted if the qualified limit or level specified in the monitoring plan is met.
Note. GB/T 25915.3 specifies the test requirements for other clean room performance parameters such as pressure difference and airflow.
......
GB/T 25915.2-2010
Cleanrooms and associated controlled environments - Part 2.Specifications for testing and monitoring to prove continued compliance with GB/T 25915.1
ICS 13.040.35
C70
National Standards of People's Republic of China
Clean room and related controlled environment
Part 2.Demonstrating continued compliance
GB/T 25915.1 technical conditions for testing and monitoring
continuedcompliancewithGB/T 25915.1
(ISO 14644-2..2000, Cleanroomsandassociatedcontroledenvironments-
continuedcompliancewithISO 14644-1, IDT)
Released on.2011-01-14 and implemented on.2011-06-01
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Issued by China National Standardization Administration
Preface
GB/T 25915 "Clean Room and Related Controlled Environment" is divided into eight parts.
---Part 1.Air cleanliness grade;
---Part 2.Prove continuous compliance with GB/T 25915.1 testing and monitoring technical conditions;
---Part 3.Detection method;
---Part 4.Design, construction, start-up;
---Part 5.Operation;
---Part 6.Vocabulary;
---Part 7.Isolation device (clean wind hood, glove box, isolator, microenvironment);
---Part 8.Classification of air molecular pollution.
This part is Part 2 of GB/T 25915.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
The translation method used in this part is equivalent to ISO 14644-2.2000 "Cleanrooms and related controlled environments Part 2.Proof of continuous compliance
Technical conditions for testing and monitoring in compliance with ISO 14644-1.
This part is proposed and managed by the National Standardization Technical Committee for Cleanrooms and Related Controlled Environments (SAC/TC319).
This part is composed of China Electronic System Engineering Second Construction Co., Ltd., China Power Investment Engineering Research and Evaluation Center, China Pharmaceutical Biological Products
The inspection institute is responsible for drafting, Suzhou Shangke Clean Technology Co., Ltd. Shanghai Kexin Testing Technology Co., Ltd., Beijing Shiyuan Xida Engineering Technology Co., Ltd.
Participate in drafting.
The main drafters of this section. Chen Siyuan, Lu Jun, Bai Dongting, Wang Kaiyuan, Shi Hongping, Sun Guozheng, Cui Xianming, Long Jun, Wu Junmin, Guo Liang,
Wang Yang, Yang Xinyu, Mu Ruihong, Hong Feng, Hao Zhongying.
introduction
This part of GB/T 25915 provides a method to prove that the clean room and related controlled environment continue to comply with GB/T 25915.1, and specifies
The minimum requirements for testing and monitoring have been established. In the inspection plan, the specific operational requirements, the risk assessment of the facility and the use of the facility must also be considered.
Clean rooms and related controlled environments control pollutants in the air at an appropriate level to complete pollution-sensitive operations. Products and
The areas where processes benefit from air pollutant control are. aerospace, microelectronics, pharmaceuticals, medical equipment, food, medical and health industries. apart from
In addition to the concentration of airborne particles, there are many other considerations in the design, technical conditions, operation and control of clean rooms and related controlled environments.
factor.
On some occasions, relevant regulatory agencies may stipulate supplementary policies or restrictions. In this case, it may be necessary to
Method to make appropriate adjustments.
Clean room and related controlled environment
Part 2.Demonstrating continued compliance
GB/T 25915.1 technical conditions for testing and monitoring
1 Scope
This part of GB/T 25915 specifies the requirements for regular inspections of clean rooms or clean areas to prove that they continue to meet
The concentration level of airborne particles specified in GB/T 25915.1.
These requirements include the classification test of clean room or clean area described in GB/T 25915.1.In addition, it also stipulates that according to the requirements of this part
Other testing items implemented. The optional testing items that can be implemented according to user requirements are also explained in this section.
This part also specifies the monitoring requirements for clean rooms or clean areas (hereinafter referred to as "facility") to provide continuous compliance
Evidence of the concentration level of airborne particles specified in GB/T 25915.1.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 25915.1-2010 Clean room and related controlled environment Part 1.Air cleanliness grade (ISO 14644-1.1999,
IDT)
GB/T 25915.3-2010 Clean room and related controlled environment Part 3.Testing method (ISO 14644-3.2005, IDT)
3 Terms and definitions
The following terms and definitions defined in GB/T 25915.1-2010 apply to this document.
3.1 General terms
3.1.1
Requalification
The facility is tested in accordance with the prescribed test sequence, including verification of the selected pre-test conditions to prove that the facility complies with
The cleanliness grade of GB/T 25915.1.
3.1.2
Test
To determine the performance of a facility or a part of it, a procedure implemented in accordance with a prescribed method.
3.1.3
Monitoring
Testing performed in accordance with prescribed methods and plans to verify the performance of the facility.
Note. This information can be used to find trends under dynamic conditions and provide support for the process.
3.2 Terminology of detection cycle
3.2.1
Continuous monitoring
Uninterrupted monitoring.
3.2.2
Frequent monitoring
The monitoring interval does not exceed 60min during operation.
3.2.3
6 months 6months
During the whole dynamic operation period, the average interval of periodic re-inspection does not exceed 183d, and the longest interval does not exceed a period of 190d.
3.2.4
12months12months
During the whole dynamic operation period, the average interval of periodic re-inspection does not exceed 366d, and the longest interval does not exceed 400d cycles.
3.2.5
24months 24months
During the entire dynamic operation period, the average interval of periodic re-inspection does not exceed 731d, and the longest interval does not exceed a period of 800d.
4 Proof of continuous compliance
4.1 Overview
Carry out required tests and record the test results in the form of documents to verify that the clean room continues to meet the required air cleanliness
(ISO grade) requirements. The monitoring data is used to indicate the condition of the facility and can be used to determine the frequency of detection.
4.2 Testing to prove continuous compliance
4.2.1 Table 1 shows the standard test methods and the longest test period used to prove that the required ISO level is continuously achieved.
Table 1 The detection period to confirm that the particle concentration limit is continuously met
Longest period detection method of grade
≤ISO Level 5 6 months GB/T 25915.1-2010 Appendix B
>ISO Level 5 12 months GB/T 25915.1-2010 Appendix B
Note. Generally, the particle counting detection is carried out in the dynamic state according to the specified ISO grade, but it can also be carried out in the static state.
4.2.2 Where required, the tests listed in Table 2 should be carried out to prove that the requirements continue to be met. The specific requirements of each test listed in Table 2
Negotiated by both parties.
Table 2 Other testing cycles applicable to all cleanliness levels
Detection method of the longest interval time of detection parameters
Air volume a or wind speed for 12 months GB/T 25915.3-2010 B.4
Pressure difference b 12 months GB/T 25915.3-2010 B.5
Note. Generally, the above tests can be carried out under dynamic or static conditions according to the specified ISO level.
a Wind speed or air volume measurement can be used to obtain air volume data.
b This test is not applicable to non-enclosed clean areas.
4.2.3 In addition to the standard test items listed in Table 1 and Table 2, the supplier and the demander can negotiate other test items suitable for the facility, such as attached
Record the items listed in A.
4.2.4 When the facility is equipped with instruments for continuous or frequent monitoring of the airborne particle concentration and pressure difference (if applicable), if continuous or frequent monitoring is
The measured result does not exceed the specified limit, the longest period in Table 1 can be extended.
4.2.5 The facility needs to test other items and is equipped with equipment for continuous or frequent monitoring of relevant parameters. If the continuous monitoring or frequent testing results
If the specified limit is not exceeded, the longest period in Table 2 can be extended.
4.2.6 The testing instruments should be calibrated in accordance with current industrial specifications.
4.2.7 If the test result is within the specified limit, the facility continues to meet the requirements. If any test result exceeds the specified limit, set
If the implementation fails to meet the requirements, appropriate remedial measures shall be taken. After the remedial measures are completed, the facility should be re-inspected.
4.2.8 In the event of any of the following situations, the facility shall be re-inspected.
a) Implemented remedial measures to rectify non-conformities.
b) The current technical performance indicators have undergone significant changes, such as changes in dynamic operation. The significant degree of change should be determined by both parties
Agreed.
c) The air flow is severely interrupted, which affects the operation of the facility. The severity of the interruption should be negotiated between the supplier and the buyer.
d) The specific maintenance work performed has a significant impact on the facility (for example, replacing the end filter). The significant degree of impact should be determined by supply and demand
Both parties agreed.
4.3 Monitoring
4.3.1 Routine monitoring of the concentration of airborne particles and other parameters shall be implemented according to a written plan.
Note. The monitoring of facilities is generally carried out under dynamic conditions.
4.3.2 The airborne particulate monitoring plan is based on the risk assessment of the facilities used (see Appendix B). The minimum items that should be included in the plan
Contains. pre-set sampling points, minimum amount of each air sample, measurement time, the number of measurements required by each sampling point, measurement interval time,
The particle size to be measured, counting acceptance limit. If applicable, it should also include early warning values, intervention values, and drift limits.
Note 1.If continuous monitoring or frequent monitoring is specified for both suspended particle count and pressure difference in the plan, the cycle of particle count detection can be extended (see 4.2.4
And 4.2.5).
Note 2.The monitoring of other characteristics (such as temperature and humidity) can also be implemented in accordance with the above methods.
4.3.3 If the monitoring result exceeds the specified intervention value, it is deemed that the facility does not meet the requirements and appropriate remedial measures should be taken. End of remedial measures
After completion, appropriate testing (see 4.2 and Appendix A) should be carried out to determine whether the facility meets the requirements. If the requirements have been met, the routine can be resumed
monitor.
4.3.4 The monitoring instruments should be calibrated in accordance with current industrial specifications.
4.4 File
4.4.1 The re-inspection or test results that prove whether each facility continues to meet the requirements shall be recorded and submitted in the form of a comprehensive report. Report
In the report, it is necessary to make it clear that the required testing indicates that the facility meets or does not meet the requirements.
The following content should be included in the test report.
a) The name and address of the testing unit;
b) Operator's name and date of inspection;
d) Clearly mark the specific location of the facility to be tested (use the neighboring area as a reference if necessary), and mark the specific coordinates of all sampling points;
e) The indicators specified for the facility, including the ISO grade and particle size of interest, the corresponding occupancy status, air volume or wind speed, and pressure difference;
f) Measuring instruments and calibration certificates used;
g) Test results, including the coordinates of each sampling point and particle concentration data;
h) The scheduled date for the next proof of continued compliance with the test.
The monitoring results obtained after the longest period of continuous or frequent monitoring is extended according to 4.2.4 and 4.2.5 should also be included in the document.
In the records.
4.4.2 The monitoring plan shall stipulate the preparation of monitoring documents for each facility.
4.5 Record
Records should be kept in accordance with the existing quality control procedures of the facility. Records should meet the requirements of various mandatory regulations.
Appendix A
(Informative appendix)
Optional test items
In addition to the standard test items specified in Table 1 and Table 2, other test items can also be included in the test plan, such as Table A.1
Optional items listed.
Table A.1 Optional detection cycle
The longest cycle recommended value detection method of the test item level
Installed filter leak detection for all grades 24 months in GB/T 25915.3-2010 B.6
Airflow can be visually inspected for all grades for 24 months in GB/T 25915.3-2010 B.7
Self-cleaning all grades for 24 months GB/T 25915.3-2010 B.13
Isolate leak detection for all levels for 24 months GB/T 25915.3-2010 B.14
Appendix B
(Informative appendix)
The impact of risk assessment on clean room or clean area detection and monitoring
The risk assessment of a specific clean room or clean area can affect.
a) Monitoring plan;
b) Analysis of monitoring data;
c) Actions taken based on the monitoring data obtained;
d) Select the parameters to be tested from Table 2;
e) Select the parameters to be tested from Table A.1.
......
|