ISO14644-2 (International standard for clean rooms and related controlled environments)

For detailed requirements and specific procedures, you would need to consult the official ISO 14644-2 document, which can be purchased through the ISO website or other standards organizations.iso 14644-2 is a standard that outlines the requirements for the monitoring and control of cleanrooms and controlled environments. Here are some of the key points:

Foreword

ISO is a federation of national standardization bodies around the world. Its international standards work is generally carried out by ISO technical committees. Each member group has the right to become a representative of this technical committee if it is interested in a topic of the technical committee.

• Part 1: Classification of air cleanliness levels

• Part 2: Technical requirements for testing and monitoring for certification of ISO14644-1 compliance

• Part 3: Measurement and test methods

• Part 4: Design, construction and commissioning

• Part 5: Operation

• Part 6: Terms and definitions

• Part 7: Enhanced Cleanrooms

Introduction

This section of ISO 14644 details methods for continuous compliance with iso 14644-1, outlining minimum testing and monitoring requirements. Each test plan must assess specific usage conditions and hazard prevention during installation.

Cleanrooms control airborne particulate contamination, crucial for industries like aerospace, pharmaceuticals, and food, ensuring the integrity of sensitive activities.

Designing cleanrooms involves considering factors beyond particle cleanliness, and authorities may propose additional policies that allow for adjustments to standard test procedures.

1. Scope

This part of ISO14644 requires regular testing of clean rooms or clean areas to certify the continuous compliance of ISO14644-1 to determine the airborne particle cleanliness level. In ISO14644-1, according to the above requirements, clean room or clean area level tests are proposed, and additional tests are also specified, which should also be completed in accordance with the requirements of this part of ISO14644. Optional tests adopted according to the user's wishes should also be identified. 

2. Specified references

According to the references in this article, the clauses contained in the following specified documents may become the clauses of this part of ISO14644. Outdated references, as well as their subsequent changes, revisions, or any of their publications, shall not be applied. 

ISO14644-1:1999, Cleanrooms and related controlled environments - Part 1 Classification of air cleanliness ISO14644-3:, Cleanrooms and related controlled environments - Part 3: Star counting and test methods.

3. Terms and definitions

In order to apply this part of ISO14644, the terms and definitions are proposed in ISO14644-1 and applied below.

3.1 General terms

3.1.1 Requalification

The sequence of tests to certify the conformity of a facility to ISO 14644-1, including certification of selected pre-test conditions, according to the level of the facility.

3.1.2 Testing

The procedure to determine the performance of a facility or part thereof according to specified methods

3.1.3 Monitoring

Monitoring of a facility by testing using specified methods and plans to obtain performance data for the facility.

Note: This information can be used to seek trends in operating conditions and provide support for operational processes.

3.2 Terms related to frequency

3.2.1 Continuous updates that have occurred so far.

3.2.2 Frequency Changes that occur within a specified operating time interval of no more than 60 minutes

3.2.3 6 months

Changes that occur within an effective period of use with an average interval of no more than 183 days, but not including intervals exceeding 190 days

3.2.4 12 months

Changes that occur within an effective period of use with an average interval of no more than 366 days, but not including intervals exceeding 400 days

3.2.5 24 months

Changes that occur within an effective period of use with an average interval of no more than 731 days, but not including intervals exceeding 800 days.

4 Verification of continuous compliance

4.1 Principle

Continuous compliance with the air cleanliness level (ISO level) specified for the facility is certified after specific tests have been completed and documents have been prepared based on the test results. Monitoring data can be used to indicate the status of the facility and determine the frequency of completion of the test.

4.2 Testing for continuous compliance

4.2.1 In order to obtain results for continuous compliance with ISO specified levels, standard test methods and their maximum time intervals are listed in Table 1.

Table 1 List of tests for certification of compliance with particle concentration limits

4.2.2 If the user requests, the certification compliance may be carried out according to the items listed in Table 2, but the requirements for each such test shall be determined by agreement between the owner and the supplier.

Table 2 List of additional tests for all levels

4.2.3 In addition to the normal tests listed in Tables 1 and 2, other test items may be added by agreement between the owner and the supplier, such as some of the test items listed in Appendix A, considering the conditions suitable for the facility.

4.2.4 If the facility is equipped with continuous or frequent monitoring of airborne particle concentration, and air pressure monitoring for the needs of use, the maximum time interval listed in Table 1 may be extended, but the continuous or frequency monitoring results obtained shall not exceed the specified limits.

4.2.5 For those facilities that require additional testing, if the facility is equipped with continuous frequency monitoring instruments for the corresponding test parameters, the maximum time interval listed in Table 2 may be extended, but the continuous or frequency monitoring results obtained shall still be within the specified limits.

4.2.6 All instruments used in the test should be calibrated according to current industrial practices.

4.2.7 If the test results are within the specified limits, the facility meets the continuous compliance conditions. If a test result exceeds the specified limits, the device does not meet the compliance requirements and must be recertified after taking modification measures.

4.2.8 The facility must be re-evaluated after each of the following events:

• Take modification measures to correct non-compliant conditions.

• Serious deviation from current performance specifications such as changing the operating level. The so-called serious deviation should be determined in the agreement between the owner and the supplier,

• Major failure of the wind system affects the operation of the facility. The so-called major failure should be determined in the agreement between the owner and the supplier.

• Special maintenance that seriously affects the operation of the facility (i.e. changing the terminal filter). The so-called serious impact should be determined in the agreement between the owner and the supplier.

4.3 Monitoring

4.3.1 Routine monitoring of airborne particle concentration and other parameters should be completed according to a written plan. Note: Generally, dynamic facilities should be monitored.

4.3.2 A monitoring plan for airborne particles should be developed based on the risk assessment related to the application of the device (see Appendix B). The plan should include the predetermined minimum sampling points, the minimum air volume for each sampling, the duration of the measurement, the number of measurements at each sampling point (as required), the time interval between multiple measurements, the particle size or particle number, the particle number acceptance limit, and, if necessary, the critical, impact and tolerance limit range of the particle number.

Note 1: If the plan stipulates that both the number of airborne particles and the air pressure difference should be monitored continuously and frequently, the particle number test table is required to be modified to extend the test time limit (see 4.2.4 and 4.2.5).

Note 2: Testing of other characteristics (such as temperature and humidity) can also be completed in the same way as above.

4.3.3 If the monitoring results are outside the specified range, the facility is deemed to be non-compliant and appropriate correction measures should be taken. After taking appropriate correction measures, the corresponding tests (see 4.2 and Appendix A) should be completed again to determine whether the facility meets the compliance requirements. If the compliance requirements are met, monitoring can be resumed.

4.3.4 The various instruments used for monitoring should be calibrated in accordance with current industrial practices.

4.4 Preparation of documents

4.4.1 After completing the assessment and testing of each facility for continuous compliance, the identification and test results should be recorded and a comprehensive results report should be submitted, together with an explanation of whether compliance was achieved or not after each test.

The test report shall contain the following:

• Name and address of the measuring unit;

• Signature of the operator and date of completion of the test;

• References cited in this part of ISO14644, i.e. ISO14644-2:2000;

• Exact address of the facility tested (including references to adjacent areas, if necessary) and specific numbers and coordinates of all sampling points;

• Specific technical conditions of the facility, including SO levels and particle sizes considered, relevant occupancy status, air flow and air pressure difference, verification of the measuring instruments used and calibration;

• Test results, including particle test data at all sampling point coordinates;

• Data from the above continuous compliance test.

If the maximum time interval is to be extended in accordance with clauses 4.2.4 and 4.2.5, the results of continuous or frequency monitoring shall also form part of the documentation.

4.4.2 The preparation of monitoring documentation for each facility shall also comply with the provisions of the monitoring plan.

4.5 Records

Records should be kept in accordance with the quality control procedures of the location

Records should comply with relevant regulatory requirements.

Appendix A(Information)

Optional tests

In addition to the various specified tests listed in Tables 1 and 2, Table A1 lists various optional tests and can be included in the test plan. 

Table A1--List of optional tests

Appendix B(Information)

Guidelines for risk assessment affecting testing and monitoring of clean rooms or clean areas Risk assessments related to special clean room or clean area applications will affect the following:

• Monitoring plan;

• Interpretation of monitoring data;

• Actions taken after obtaining monitoring data:

• Selection of parameters to be tested in Table 2,

• Selection of parameters to be tested in Table A,1.