洁净室沉降菌测试标准操作规程（Standard Practice for test of settling bacteria in clean rooms）.docVIP

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洁净室沉降菌测试标准操作规程（Standard Practice for test of settling bacteria in clean rooms）.doc

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洁净室沉降菌测试标准操作规程（Standard Practice for test of settling bacteria in clean rooms）

洁净室沉降菌测试标准操作规程（Standard Practice for test of settling bacteria in clean rooms） 1 Objective: to establish standard test procedures for the removal of bacteria in clean rooms, and to ensure the production of drugs at specified cleanliness levels. 2 Scope: monitoring of bacteria in clean room. 3 basis: national standard GB/T 16294-1996. 4 responsibilities: QA cleanliness monitoring personnel and microbiological inspection personnel are responsible for the implementation of the system. 5 content 5.1 clean room: room or area where environmental control is required for dust particles and microbiological contamination. 5.2 clean work table: a work table or similar enclosed enclosure. Its characteristic is itself can provide filtered air or gas, such as vertical laminar flow clean cover, horizontal laminar flow cover, vertical laminar flow clean work table, horizontal laminar flow clean work table, self purification device and so on. 5.3 cleanliness: the allowable statistics of the unit volume of air containing more than or equal to a particle size in a clean environment. 5.4 colony: a bacterial colony formed by the propagation of one or more bacteria after bacterial culture, referred to as CFU. Usually expressed in numbers. Overview of 5.5.1 method 5.5 test method: the test method of using sedimentation method by natural sedimentation principle of collecting biological particles in the air in the medium, after more than 48 hours of training, under suitable conditions to propagate to the number of colonies visible, to assess the number of viable microorganisms in a clean environment, and thus to evaluate the cleanliness of clean room. 5.5.2 instruments and equipment used 5.5.2.1 autoclave: use, refer to document GZ-ZL-SOP-066-00 operation. 5.5.2.2 incubator: it is necessary to check the thermometer of incubator at regular intervals. 5.5.2.3 culture dishes: medium 90mm * 15mm borosilicate glass Petri dishes. Put the dish in 121 degrees before use and sterilize in hot and hum