1. Environmental conditions of microbiological laboratory
Microbial examination room is used to check the microbial contamination of non prescribed sterilization preparations and their raw materials and accessories. Microbiological examination means that the articles are allowed to contain living microorganisms within the specified qualified range. According to the appendix of Chinese Pharmacopoeia (2010 Edition), microbiological examination should be carried out in the unidirectional laminar air area with environmental cleanliness below 10000 and local cleanliness of 100.
Large scale equipment: refrigerator, super clean table, incubator, drying oven, constant temperature water bath pot, oven, pure water machine, centrifuge, etc
Small equipment: balance, microscope, spectrophotometer, acidity meter, conductivity meter, turbidity meter, refractometer, impurity filter, etc
Others: Glassware, reagents (nutrient agar, beef extract peptone, sodium chloride, sodium hydroxide), etc
Setting of microbiological examination room and aseptic room
2. Environmental conditions of aseptic examination room
Aseptic examination room is used to check injections, raw materials and excipients in sterile preparations. It was expressed as sterility assurance level (SAL). Therefore, the environment of aseptic room is very important, which greatly interferes with the accuracy of sample test results.
Equipment: ultra clean working table and bacteria collecting instrument
3. Environmental conditions of positive control room
The positive control room is a place to prepare positive control strains and transfer strains. The positive control room should be a unidirectional laminar air area with local cleanliness of 100 grade, and the background environment cleanliness of 10000 level. The indoor air is directly discharged to the outside after being treated by the filter device, and is generally operated in the biological safety cabinet.
Equipment: biosafety cabinet, mixer
4. Setting and management of aseptic room, microbial limit laboratory and positive control room
The layout design of laboratory should avoid cross contamination, which is conducive to cleaning and routine maintenance. People and things are the biggest pollution source in clean area. The laboratory should set up the channel of people flow and logistics respectively, and have clear identification. The three laboratories should set up changing channels to avoid cross contamination. The environmental clothing should be consistent with the drug production. 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. All instruments used for sterility test should be sent to the sterile examination room after sterilization treatment; The sterilization effect should be verified and confirmed. The transmission window must be equipped with ultraviolet lamp, and its 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 operator and the operating environment. It is recommended to use the biological safety cabinet for operation. Therefore, the sterile room and microbial limit laboratory should ensure that the test environment does not pollute the experimental samples, which will affect the accuracy of the test data. At the same time, the test environment should be tested at the same time, and the cleanliness still meets the requirements of cleanliness. Therefore, the intensity of site cleaning and cleaning of the three laboratories are different after testing, but the final acceptable standard is to meet the requirements of 10000 cleanliness and 100 grade cleanliness.