1. Scope 2. Normative reference documents 3. Terms and definitions 4. Quality management system 5. Method principle 6. Challenge container 7. Selection of challenge microorganisms, media and culture conditions 8. Sample preparation 9. Sampling principles 10. Challenge Suspension preparation 11. Exposure test conditions 12. Overview of test procedures 13. Acceptance criteria and result determination Appendix A (informative) Method sensitivity verification test Appendix B (informative) Sample test and method sensitivity test process example
T/ZJPA 002-2023 history
2024T/ZJPA 002-2023 Injectable packaging seal inspection Microbiological challenges: immersion exposure test requirements
2023T/ZJPA 002-2022 Technical Guidelines for Energy Saving and Carbon Reduction and Emission Reduction Engineering for Pharmaceutical and Chemical Enterprises