1. Environmental Control Requirements:
(1) Provide the level of air purification required for production. The number of dust particles and microorganisms in the clean room of the packaging workshop should be tested and recorded regularly. The static pressure difference between different grades of packaging workshops should be maintained within the specified value.
(2) The temperature and relative humidity of the packaging clean room should be adjusted according to the production process requirements.
(3) Penicillin, high-sensitivity drugs, and anti-tumor drug production areas should be equipped with an independent air conditioning system.
(4) For rooms that generate dust, effective dust-catching devices should be installed to prevent cross-contamination.
(5) Ventilation installations, as well as temperature and humidity controls, should align with drug production and packaging requirements.
2. Cleanliness Partition and Ventilation Rate:
Clean rooms should strictly control air cleanliness, temperature, humidity, fresh air quantity, and pressure differences.
(1) The cleanliness levels in pharmaceutical production packaging workshops are classified into Class 100, Class 10,000, Class 100,000, and Class 300,000. The number of clean room air changes and the corresponding air volume should be determined by taking the maximum value. In practice, the ventilation rate is 300400 times per hour for Class 100, 2535 times per hour for Class 10,000, and 15~20 times per hour for Class 100,000.
(2) The cleanliness partitions in pharmaceutical packaging clean rooms should comply with national purification standards.
(3) Other environmental parameters in the clean rooms of packaging workshops should be determined according to standards.
(4) The temperature and humidity in packaging clean rooms should align with the production requirements of the medicine. The temperature should be 2023℃ in summer for Class 100 and Class 10,000; 2426℃ for Class 100,000 and Class 300,000; and 2627℃ for general areas. Relative humidity should be 4550% (summer) for moisture-absorbent drugs, 5055% for tablets and other solid preparations, and 5565% for water-based injections and oral liquids.
(5) To maintain indoor cleanliness, clean rooms must maintain positive pressure. For rooms generating dust, handling hazardous substances, or producing penicillin and other highly sensitizing drugs, positive pressure must be maintained between different areas to prevent external contamination. The static pressure difference between the clean room and the outdoor atmosphere should be greater than 10 Pa.
