GMP(Good Manufacturing Practice) 
It stipulates the management standards required for all processes from the procurement of raw materials to manufacturing and shipment, aimed at producing high-quality pharmaceutical products. These standards set forth the minimum requirements that must be observed to ensure a consistent quality level in manufacturing products in accordance with their intended purpose.
| Grade | Class | Classification | Air Change Rate | Management Criteria |
|---|---|---|---|---|
| A | 100 | Workbench for aseptic operations | ≥ 600 times/hr | - Maximum viable particle count - Settling bacteria: <1/hr (φ9cm) - Airborne bacteria: <1/m³ - Sterility |
| Workbench for filling/dispensing sterile products | ||||
| B | 10,000 | Area required for clean room and clean operation of sterile products | ≥ 20 times/hr | - Maximum viable particle count - Settling bacteria: <5/hr - Airborne bacteria: <20/m³ - Sterility |
| Preparation room for aseptic operations | ||||
| C | 100,000 | Vessel washing room for sterile products | ≥ 10 times/hr | - Maximum viable particle count - Settling bacteria: <20/hr - Airborne bacteria: <200/m³ - Dedicated sterility |
| Washing room/storage after cleaning of final sterile products (incl. user sterile products) | ||||
| Work area for final sterile product processes (charging, cooking, packaging, etc.) | ||||
| Workroom for products supplied in non-sterile state but used for important purposes such as transplantation | ||||
| D | - | Area connected to C-grade zone with equivalent cleanliness | Ventilation | |
| Unclassified preparation room |
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