2. Biotechnology Manufacturing
·Characteristics of Biopharmaceutical Plants:
i.High equipment costs, complex production processes, strict cleanliness and sterility requirements, and rigorous staff qualification standards.
ii.Potential biological hazards during production, including infection risks, toxicity/sensitization from dead bacteria/cells/metabolites, product-related biological reactions, and environmental impacts.
·Key Terms:
·Clean Zone: An area where airborne particles and microbial contamination are controlled, with architectural structures and equipment designed to prevent pollutant introduction, generation, and retention.
·Airlock: A sealed space with two or more doors between rooms (e.g., of different cleanliness classes), controlling airflow during personnel/material entry/exit. Types include personnel airlocks and material airlocks.
·Basic Features of Biopharmaceutical Cleanrooms:
·Must control both particles and microorganisms, with four cleanliness classes: Class 100 (or local Class 100 under Class 10,000 background), Class 1,000, Class 10,000, and Class 30,000.
·Temperature: 18–26°C (no special requirements); relative humidity: 45–65%.
·Pollution Control in Biopharmaceutical Cleanrooms:
·Source control, dispersion process control, and cross-contamination control.
·Key technology: Controlling dust and microorganisms, with microorganisms as the primary target.
·Common GMP Misconceptions:
·Equipment/pipeline contamination in cleanrooms can directly contaminate products without affecting cleanliness testing.
·Cleanliness classes do not characterize physical, chemical, radioactive, or biological properties of particles.
·Construction-Impact Factors on Product Quality:
·Poor HVAC duct cleaning, air leakage, inadequate partition sealing, dead corners in decoration, substandard sealant, flawed pipeline welding, and incorrect pressure difference settings.
3. Printing and Packaging Industry
·Integration with Cleanroom Technology:
·Large printing equipment in cleanrooms improves product quality and pass rates by controlling temperature, humidity, and particle count in coating environments.
·Packaging (food/drug) focuses on temperature, humidity, particle count, and water quality, alongside standardized operator procedures.
·Dust-Free Spraying Process:
·Enclosed production workshops with steel sandwich panels filter ambient pollution, reducing defect rates. Applications include TV/computer casings, mobile phones, DVDs, and toys.
·Workflow: Loading → manual dust removal → static dust removal → manual/auto spraying → drying → UV curing → cooling → silk screening → quality inspection → unloading.
·Food Packaging Cleanroom Standards:
i.Sufficient supply air to dilute/eliminate indoor contamination.
ii.Airflow from clean to less clean areas, with minimal contaminated air movement.
iii.Supply air does not significantly increase indoor pollution.
iv.Airflow patterns prevent high-concentration particle accumulation.
·Testing Methods:
·Supply/exhaust air volume (turbulent flow cleanrooms) or air velocity (unidirectional flow cleanrooms).
·Inter-zone pressure difference and airflow direction verification.
·HEPA filter leak testing, isolation leak testing, and airflow pattern validation.
·Particle/microbial concentration measurement (if required).
Suzhou Pharma Machinery Co.,Ltd.
2025/06/27
Gino
