1. Environmental conditions of microbiological examination room
Microbiological examination room is used to check the non specified sterilization preparation and its raw materials, accessories contaminated by microorganisms. Microbiological examination means that the articles are allowed to contain live microorganisms within the specified qualified range.
Large equipment: refrigerator, ultra clean worktable, incubator, drying oven, constant temperature water bath pot, oven, water purifier, centrifuge, etc
Small equipment: balance, microscope, spectrophotometer, acidity meter, conductivity meter, turbidity meter, refractometer, impurity filter, etc
Others: Glassware, reagents (nutrient agar, beef peptone, sodium chloride, sodium hydroxide), etc
Setting of microbiological examination room and aseptic room
2. Environmental conditions of sterile examination room
Aseptic examination room is used to check injections, raw materials and accessories used in aseptic preparations. Expressed as sterility assurance level (SAL). Therefore, the environment of aseptic room is very critical, which greatly interferes with the accuracy of the test results.
Equipment: super clean worktable, bacteria collector
3. Environmental conditions of positive control room
The positive control room is the place to prepare positive control strains and transfer strains. The positive control room should be a one-way laminar flow air area with cleanliness of local level 100, and the background environment should have cleanliness of level 10000. The indoor air is directly discharged outside after being treated by the filter device, and generally operated in the biosafety cabinet.
Equipment: biosafety cabinet, mixer
Setting and management of aseptic room, microbial limit laboratory and positive control room
The layout design of the laboratory should avoid cross contamination, which is conducive to cleaning and routine maintenance. People and things are the biggest pollution sources in the clean area. The laboratory should set up the channels of people flow and logistics respectively, and have clear identification. The three laboratories should set up dressing channels to avoid cross contamination, the dressing of the environment should be consistent with the drug production, and the clean clothes in the sterility test should be sterilized by high pressure. The incoming logistics should be separated from the flow of people. Each laboratory should have a separate transfer window to transfer test samples and instruments. All samples should be wiped and disinfected with 75% ethanol. The instruments used for sterility test should be sterilized and sent to the sterility examination room; The effect of sterilization should be verified and confirmed. Ultraviolet lamp must be installed in the transfer window. The disinfection effect should be confirmed and evaluated regularly, and the ultraviolet lamp should be replaced in time.
The operation in the positive control room is mostly bacterial operation, which is more likely to pollute the operators and the operating environment. It is recommended to use the biological safety cabinet. Therefore, the sterile room and microbial limit laboratory should ensure that the testing environment should not pollute the experimental samples and affect the accuracy of the test data. At the same time of sterility inspection, the inspection environment should be detected simultaneously, and the cleanliness still meets the requirements. Therefore, the cleaning and cleaning intensities of the three laboratories are different after the test, but the final acceptable standard is to meet the 10000 clean requirements and 100 clean requirements.
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