Dust-free workshop for pharmaceutical packaging
Release time:2019-09-27 source:
1. Environmental control requirements:
(1) Provide the level of air purification required for production, the number of air dust particles and living microorganisms in the purification project of packaging workshop should be regularly detected and recorded, and the static pressure difference between packaging workshop of different grades should be kept within the prescribed value.
(2) The temperature and relative humidity of the purification project in the packaging workshop should be in accordance with the requirements of its production process.
(3) Independent air-conditioning systems should be installed in the production areas of penicillins, high sensitivity and anti-cancer drugs, and the exhaust gas should be purified.
(4) Effective dust traps should be set up in the rooms where dust is produced to prevent cross-contamination of dust. (5) For auxiliary production rooms such as warehousing, the ventilation facilities, temperature and humidity should be in line with the requirements of drug production and packaging.
2. Cleanliness zoning and ventilation times: Cleanliness of air should be strictly controlled in clean rooms, and environmental parameters such as temperature, humidity, fresh air volume and pressure difference.
(1) The air cleanliness of pharmaceutical production and packaging workshop is divided into four grades: 100, 10,000, 100,000 and 300,000. To determine the number of ventilation in the clean room, it is necessary to compare the various air volumes to get the maximum. In practice, the ventilation times of 100 grades are 300-400 times/h, 25-35 times/h for 10,000 grades and 15-20 times/h for 100,000 grades.
(2) The cleanliness zoning of purification engineering in pharmaceutical packaging workshop The specific zoning of cleanliness in drug production and packaging environment shall be in accordance with the national standards for cleanliness.
(3) The determination of other environmental parameters in the purification project of packaging workshop.
(4) The temperature and humidity of the cleaning room in the packaging workshop should conform to the pharmaceutical production process.
Temperature: 20-23-C for 100 and 10,000 grades (summer), 24-26-C for 100,000 and 300,000 grades, and 26-27-C for general area. Class 100 and Class 10,000 belong to aseptic room. Relative humidity: 45-50% of hygroscopic drugs (summer), 50-55% of tablets and other solid preparations, 55-65% of water injection and oral liquid.
(5) Clean room pressure to maintain indoor cleanliness need to maintain positive indoor pressure. For the clean rooms that produce dust, harmful substances, penicillins and other highly sensitizing drugs, it is necessary to prevent external pollution or maintain relative negative pressure between regions. The inflow of static pressure dyeing and the outflow of internal air in different rooms with different cleanliness grades. The difference between indoor and adjacent rooms is more than 5 Pa, and the difference between clean room and outdoor atmosphere is more than 10 Pa.