1 Environmental control requirements:
(1) Provide the level of air purification required for production. Dust particle number and microorganism in packing workshop clean room. It should be tested and recorded regularly, between different grade of packaging workshop the static pressuredifference shall be kept within the specidified value.
(2) The temperature and relative humidity of packaging clean room should be adapted to the production process requirements.
(3) Penicillin, high sensitivity and anti-tumor drug production area should be equipped with and independent air conditioning system
(4) For the room that generate dust, effective dust catching device should be installed. Prevent cross contanination of dust.
(5) Ventilation installatin and temperature and humidity should correspond with drug produciton and packaging requirements.
2, Cleanliness partition and ventilation rate. Clena room should strictly control air cleanliness and temperature&himidity of the environment and fresh air quantity and pressure difference.
(1)Pharmaceutical productong packaging workshop cleanroom air cleanliness level divide into 100 class, 10 thousand class, 100 thousand class, 300 thousand class. Determine the number of clean room air chages, Each air volume needs to be compared. Take the maximun value. inpractice, the ventilation rate of class100 is 300~400 /h, class 10,000 is 25~35/h, and class 100,000 is 15~20/h
(2) Pharmaceutical packaging clean room workshop cleanliness partition according to national standard purification standard
(3) Determination of other environmental parameter in clean room of packaging workshop
(4) Packaging clean room temperature and humidity, should conform to the production technology of medicine. Temperature 20~23℃(Summer) for class 100 and class 10,000; The grades of 100 thousand and 300 thouthand are 24~26℃, The general area is 26~27℃. relative humidity: Moisture-absorbent drug 45~50%(summer). Tablets and other solid preparation 50%55%. Water needle and oral liquid 55%~65%
(5) Clean room pressure to maintain indoor cleanliness of the room must maintain positive pressure, for dust generation, hazzardours substance, production of penicillin and other strong sensitization drugs cleanroom, to prevent external contamination, between areas and maintain jpositie pressure, the static pressure difference between the clean room and the outdoor atmosphere is greater than 10Pa。