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GMP for cleanliness grade standard dust particle count, number of floating bacteria, sedimentation number test
In compliance with GMP standards, air cleanliness is determined by monitoring dust particles, floating bacteria, and sedimentation bacteria. According to GMP Appendix Aseptic Drugs, Chapter III, Article 11, dynamic microbial monitoring is essential to assess the microbial status in aseptic production environments. This includes methods such as sedimentation, airborne bacterial sampling, and surface sampling (e.g., swabbing or contact plates). Monitoring should be conducted dynamically to ensure that the clean area remains within acceptable limits, and it should not interfere with normal operations.
Environmental monitoring results must be reviewed as part of batch records. Surface and operator monitoring should occur after critical steps have been completed. In addition to regular monitoring, microbiological checks can be added after system validation, cleaning, or disinfection processes.
The regulations for dust particles and airborne particles are outlined below:
| Cleanliness Level | Maximum Allowable Number of Suspended Particles (per m³) | |
|------------------|--------------------------------------------------------|---|
| | ≥0.5μm | ≥5.0μm |
| **Class A** | 3520 | 20 |
| **Class B** | 3520 | 29 |
| **Class C** | 352000 | 2900 |
| **Class D** | 3520000 | 29000 |
Note: For Class A, each sampling point must collect at least 1 cubic meter of air. The ISO standard for Class A is 4.8, while Class B corresponds to ISO 5. Dynamic testing should be performed under normal operation and during medium fill simulations, especially under worst-case conditions.
Dust particle counters are essential tools used to measure the concentration of particles in cleanrooms, ensuring that cleanliness standards are met. Suzhou Changliu Purification Technology Co., Ltd. specializes in manufacturing high-quality laser dust particle counters, including models like CLJ-E, CLJ-E301, CLJ-S3016, and others. These devices are widely used in pharmaceutical and food industries to meet GMP requirements.
For microbial monitoring, the following criteria apply:
| Cleanliness Level | Floating Bacteria (CFU/m³) | Settling Bacteria (f90mm, 4 hours) | Surface Microorganisms (f55mm) | Glove Test (CFU/glove) |
|------------------|----------------------------|------------------------------------|---------------------------------|------------------------|
| **Class A** | <1 | <1 | <1 | <1 |
| **Class B** | 10 | 5 | 5 | 5 |
| **Class C** | 100 | 50 | 25 | - |
| **Class D** | 200 | 100 | 50 | - |
Microbial monitoring includes both active and passive methods. Active methods involve using an airborne bacterial sampler, which draws a known volume of air and impacts microorganisms onto a culture medium. Passive methods, such as the settling plate technique, rely on natural deposition over a set time. Both approaches provide valuable data, though the active method is more quantitative.
Surface sampling can be done using contact plates or swabs, with contact plates being preferred for flat surfaces due to their ease of use and accuracy. Personnel monitoring also involves surface sampling, typically after key tasks or when handling anomalies.
Suzhou Changliu Purification Technology Co., Ltd. offers a wide range of GMP-compliant environmental testing instruments, including dust particle counters, floating bacteria samplers, microbial limiters, airflow meters, and more. Their products are designed to meet international standards and support cleanroom quality control effectively. Whether you're working in pharmaceuticals, food processing, or biotechnology, their solutions help maintain the highest level of cleanliness and safety.