ZJNF Custom GMP Design Modular Cleanroom for different product characteristics process requirements compliance standards

The key to determining the sensitivity of the production process to particles is to consider the tolerance of your product, process, and regulations towards particles. This requires a comprehensive evaluation from three dimensions: product characteristics, process requirements, and compliance standards.
1. Look at product features
Firstly, clarify the sensitivity of your product to particles. For example, in the pharmaceutical industry, injections, implantable medical devices, or sterile drugs have extremely low tolerance for particles, and any micron sized particles may directly affect the safety and effectiveness of the product. However, some ordinary raw materials or low-risk products have relatively relaxed requirements for particles.
2. Check the process requirements
Secondly, analyze whether your production process itself is prone to producing particles, and whether these particles will affect product quality. For example, in chip manufacturing or precision optical component production, submicron sized particles may cause product defects. You need to evaluate the equipment, materials, operations, and other aspects of the production process to determine which are potential sources of particulate pollution.
3. Check compliance standards
Finally, it is necessary to refer to relevant industry regulations and standards. For example, GMP has clear requirements for the concentration of suspended particles in clean areas, and the particle control standards in Class A areas (high-risk operations) are much higher than those in Class D areas (low-risk operations). You need to ensure that your production process and cleanroom level meet these regulatory requirements.
How to match? ‌
Based on the above analysis, you can match the product characteristics and process requirements with the cleanroom level. For example, sterile pharmaceutical production that is highly sensitive to particles typically requires Class A or Class B clean environments; For ordinary food packaging with relatively relaxed requirements for particles, a D-level environment may be sufficient. Meanwhile, choose a suitable particle detection method (such as photoresist or microscopic counting) to monitor and verify your cleanliness level.

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