GMP for cleanliness grade standard dust particle count, number of floating bacteria, sedimentation number test

In the context of Good Manufacturing Practices (GMP), maintaining air cleanliness is crucial for ensuring product quality and safety, particularly in aseptic production environments. To achieve this, GMP outlines specific standards for monitoring airborne particles, floating bacteria, and sedimentation bacteria. These tests are essential to evaluate the microbial status of cleanrooms and ensure that they meet required cleanliness levels. According to GMP Appendix Aseptic Drugs, Chapter III, Article 11, it's necessary to conduct dynamic microbial monitoring to assess the microbial load during active operations. This includes methods such as sedimentation, bacteriostatic sampling, and surface sampling. Monitoring should be performed continuously to ensure that the environment remains under control throughout the production process. Environmental monitoring data must also be included in batch records, and surface and operator monitoring should occur after critical steps have been completed. Additional microbiological testing may be conducted following system validation, cleaning, or disinfection to confirm the effectiveness of these procedures. The standards for airborne particles vary depending on the cleanliness class: | Cleanliness Level | Maximum Allowable Number of Suspended Particles (per m³) | |-------------------|----------------------------------------------------------| | | ≥0.5 μm | ≥5.0 μm | | **Class A** | 3,520 | 20 | | **Class B** | 3,520 | 29 | | **Class C** | 352,000 | 2,900 | | **Class D** | 3,520,000 | 29,000 | Note: Class A requires a minimum sampling volume of 1 cubic meter per point. For dynamic testing, it’s important to use appropriate equipment like portable particle counters with short sampling tubes to avoid particle settling. In unidirectional airflow systems, an isokinetic sampling head should be used to ensure accurate results. For microbial monitoring, the criteria for floating and sedimentation bacteria are as follows: | Cleanliness Level | Floating Bacteria (CFU/m³) | Sedimentation Bacteria (CFU/4 hours) | Surface Microorganisms (CFU/dish) | |-------------------|----------------------------|--------------------------------------|----------------------------------| | **Class A** | <1 | <1 | <1 | | **Class B** | 10 | 5 | 5 | | **Class C** | 100 | 50 | 25 | | **Class D** | 200 | 100 | 50 | Floating bacteria can be monitored using active sampling methods, such as the airborne bacterial sampler, which collects microorganisms by impacting them onto a culture medium. This method is more accurate than passive sedimentation, which only provides qualitative or semi-quantitative results. The sedimentation method involves exposing culture dishes in the air for up to 4 hours, but multiple dishes can be used for continuous monitoring. Surface sampling can be done using contact plates or swabbing techniques. Contact plates are preferred for flat surfaces, while swabs are suitable for irregular areas. The sampling area should be around 25 cm², and the medium should include a neutralizer or protective agent to enhance recovery of microorganisms. Personnel monitoring is also essential, especially after handling abnormal situations or before leaving the cleanroom. It's important to avoid sampling immediately after disinfection, as this could affect the accuracy of the results. Suzhou Changliu Purification Technology Co., Ltd. specializes in manufacturing high-quality environmental testing instruments, including laser dust particle counters, floating bacteria samplers, and microbial limiters. Their products comply with GMP, ISO, and other international standards. Whether you need a portable device, a large flow sampler, or a handheld unit, their range of solutions ensures accurate and reliable environmental monitoring. With advanced technology and excellent customer support, they provide comprehensive solutions for pharmaceutical, food, and cleanroom industries.

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