The functional areas of the cleanroom
I. Clean Core Area (High Cleanliness, Class 10,000/Class 1,000/Class 100/Class 100) The core area for direct production, operation, and product exposure, with the strictest dust and microbial control.
Production Operation Area: Main workshop for product processing, assembly, filling, packaging, ingredient mixing, reaction, and encapsulation.
Aseptic Operation Area: Aseptic filling, aseptic testing, cell culture, and formulation preparation; highest level.
Inner Packaging Room: Inner packaging, sealing, and dispensing of products.
Testing Laboratory (Clean Laboratory): Microbial limit testing, sterility testing, precise physicochemical testing, and sample retention testing.
II. Semi-Clean Area (Transition Buffer Zone, Class 100,000/Class 300,000) A buffer zone between the clean area and the outside world, providing changing facilities and air showers to prevent external contamination from entering the core area; an essential area for the workshop.
First Changing Room (Regular Changing Room): Remove everyday outer clothing and change into clean underwear and slippers.
Second Changing Room (Clean Changing Room): Put on clean work clothes, masks, caps, and gloves.
Air Shower Room: High-pressure clean airflow removes surface dust from personnel and clothing; essential passageway into the clean area.
Buffer Room: Pressure differential between rooms prevents cross-contamination; front and rear doors of the clean area are not opened simultaneously.
Disinfection Room: Cleaning, disinfection, and drying of work clothes, cleanroom equipment, and containers.
III. General Production Auxiliary Area (Non-clean/Low-cleanliness, no strict outdoor pressure differential requirements):** Serving production, no direct contact with products; low cleanliness requirements.
Outer Packaging Room: Packing, labeling, boxing, and palletizing of finished products.
Tool and Equipment Cleaning Room: Cleaning and drying of production molds, pallets, pipes, and containers.
Sanitary Ware Room: Storage and disinfection of cleanroom-specific mops, cloths, and cleaning tools.
Personnel and Material Flow Channels: Dedicated channels for separating personnel and materials to prevent cross-contamination.
Temporary Storage Room: Temporary storage for semi-finished products and materials awaiting processing.
IV. Warehouse Zoning (Dedicated Areas for Raw Materials, Finished Products, and Packaging Materials):**
Raw Material Warehouse: Storage and handling of raw and auxiliary materials.
Packaging Material Warehouse: Storage of inner and outer packaging materials.
Finished Product Warehouse: Storage of completed products awaiting shipment.
Non-conforming Product/Scrap Material Temporary Storage Room: Separate storage of scrapped products, waste materials, and non-conforming products.
Clean Storage Room: For some high-end industries, packaging materials and raw materials require clean storage.
V. Utilities and Equipment Area (Machine Room, Power Area): Ensures air conditioning, purification, water and electricity supply, and exhaust gas and wastewater for the workshop. Generally, these are independently separated and do not enter the clean area.
Air Conditioning and Purification Machine Room: Air conditioning units, FFUs, primary/medium/high-efficiency filters, and fresh air units.
Power Distribution Room: Electrical power distribution and control cabinets.
Pure Water Machine Room: Preparation room for purified and ultrapure water.
Compressed Air Machine Room: Air compressors, air tanks, and precision filters.
Exhaust Gas/Wastewater Treatment Room: Treatment of production exhaust gas and clean wastewater.
VI. Office and Management Support Area:
Offices: Workshop management, scheduling, and internal administration offices.
Sample Retention Room: Long-term product sample retention for traceability.
Document and Archive Room: Archives production records, validation documents, and GMP documentation.
Restrooms and Rest Area: Supporting living areas for employees (strictly prohibited from approaching the clean area).