Clean Room and Cleanliness Characteristics of Various Industries (Ⅴ) Drug Packaging Clean Workshop

1. Environmental control requirements:

(1) To provide the air purification level required for production, the number of air dust particles and live microorganisms in the purification project of the packaging workshop should be regularly tested and recorded, and 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 purification project of the packaging workshop should be adapted to the requirements of its production process.

(3) The production area of penicillin, highly allergenic and anti-tumor drugs should be equipped with an independent air conditioning system, and the exhaust gas should be purified.

(4) For the room that produces dust, an effective dust catcher should be set up to prevent the cross pollution of dust.

(5) For auxiliary production rooms such as storage, the ventilation facilities and temperature and humidity should be adapted to the requirements of drug production and packaging.

2. Cleanliness partition and ventilation times: clean room should strictly control the air cleanliness, and environmental temperature, humidity, fresh air and pressure difference and other parameters.

(1) Purification level and ventilation times of drug production and packaging workshop Air cleanliness of drug production and packaging workshop purification engineering is divided into four grades: 100, 10000, 100000 and 300000. To determine the number of air changes in the clean room, it is necessary to compare the air volumes. In practice, the number of air changes for class 100 is 300~400/h, for class 10000, 25-35 times/h, and for class 100000, 15-20 times/h.

(2) Drug packaging workshop purification project cleanliness division the specific partition of the cleanliness of the drug production and packaging environment according to the national standard purification standard

(3) Determination of other environmental parameters of packaging workshop purification engineering.

(4) Packaging workshop purification project temperature and humidity clean room temperature and relative humidity should conform to the drug production process.

Temperature: 100 grade and 10,000 grade 20~23℃ (summer), 100,000 grade and 300,000 grade 24~26℃, general area 26~27℃. Class 100 and Class 10,000 are aseptic rooms. Relative humidity: moisture absorption drugs 45~50% (summer), tablets and other solid preparations 50%~55%, water needle and oral liquid 55%~65%.

(5) Clean room pressure to maintain indoor cleanliness, indoor positive pressure should be maintained. For the production of dust, harmful substances, the production of penicillin and other strong sensitizing drugs, the clean room should prevent external pollution or maintain relative negative pressure between regions. The inflow of static pressure dye and the outflow of internal air in different rooms of cleanliness level. The indoor pressure should be maintained, and the difference between the room and the adjacent room is greater than 5P, and the static pressure difference between the clean room and the outdoor atmosphere is greater than 10Pa.