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Standard Interpretation | The new version of GB/T 16292 "Test Method for Suspended Particles in Cleanrooms (Areas) of the Pharmaceutical Industry" has arrived
Date: 2024-08-09Read: 9
The recommended national standard GB/T 16292 covers the main indicators of clean room testing (suspended particles) and is one of the main pillars of clean room testing standards. This standard is applicable to industries such as pharmaceuticals, medical devices, pharmaceutical packaging materials, cosmetics, etc.
GB/T 16292 was first published in 1996, revised for the first time in 2010, and has been in use ever since. This is the second revision.
01 Detailed Interpretation of Changes
1. Changed the "Normative References" (see Chapter 2, 2010 edition);
2. Changed the "terms and definitions" (see Chapter 3, 2010 edition of Chapter 3);
3. Added the working principle and schematic diagram of the instrument, and refined the description of the working principle of the instrument (see 4.3 in the 2010 version of 4.1);
4. The testing method has been changed (see Chapter 4 of the 2010 version), and the determination of the minimum number of sampling points (see 5.4.1.1 of the 2010 version in 6.1.2), sampling point positions (see 5.4.1.2 of the 2010 version in 6.1.3), single sampling amount (see 5.4.3 of the 2010 version in 6.1.4), sampling time and number of sampling times for each point (see 5.4.2 of the 2010 version in 6.1.4) have been modified；
5. Added "monitoring" (see 6.2);
6. The calculation methods for standard deviation and 95% confidence upper limit have been removed (see 6.3 and 6.4 in the 2010 version), the calculation method for unit cubic meter particle concentration has been added (see 7.3), and the result evaluation has been deleted (see Chapter 7 in the 2010 version);
7. Added "Method Validation" (see Chapter 8);
8. Changed the "Test Report" (see Chapter 9, Chapter 8 of the 2010 edition);
9. Deleted "Layout of sampling points in clean rooms (areas)" (see Appendix A of the 2010 edition);
10. Added "Developing Environmental Monitoring Plan" (see Appendix A);
11. Deleted the technical requirements for suspended particles in clean rooms (areas) (see Appendix B of the 2010 edition)
02 Original draft for soliciting opinions
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