After disinfection treatment, the number of bacterial colonies in the air should be checked before and during the sterility test, so as to judge whether the sterility room has reached the specified cleanliness. There are often methods for the determination of settling bacteria and floating bacteria.
(1) detection method and standard of settling bacteria:
Three nutrient agar plates were brought into the sterile operation room in a sterile way, one on the left, one on the middle and one on the right of the table top in the operation area; the plate cover was opened, exposed in the air for 30 minutes, then the plate was covered, cultured at 36 ℃ ± 1 ℃ for 48 hours, and taken out for inspection. The average number of colonies on the three plates was less than one.
(2) detection methods and standards of planktonic bacteria:
Special samplers should be used, and the samplers with impact mechanism should be used. Generally, slit or centrifugal samplers should be used, equipped with flow meters and timers. They should be operated strictly according to the requirements of the instrument manual and checked regularly. Before entering the tested room, the samplers and Petri dishes should be sterilized with disinfectants in the disinfection room. The culture medium used is nutrient agar culture medium or other culture approved by the Pharmacopoeia Foster base. When using, start the vacuum pump to pump air for at least 5min, and adjust the flow, rotary table and rotation speed. Close the vacuum pump, put it in the Petri dish, cover the cover of the sampler, and adjust the height of the gap. After setting the sampling point at the sampling port, turn on the sampler and vacuum pump in turn, turn the timer, and set the sampling time according to the sampling amount.
After the completion of all sampling, culture the dish at 36 ℃ ± 1 ℃ for 48h, take it out for inspection, and the average number of floating colonies shall not exceed 5 / m3. Three Petri dishes should be selected as control culture for each batch of medium.
The suspended particles of the sterile operation table or ultra clean working table shall also be tested regularly, reaching level 100 (generally with dust particle counter), and the filter shall be replaced if necessary according to the sterile condition.
Periodically re verify cleanliness:
Regularly (quarterly, half a year, one year) or when the facilities in the sterile room change significantly, the cleanliness shall be re verified according to the national standard GB / t16292-16294-1996 test methods for suspended particles, floating bacteria and settling bacteria in the sterile room (area) of the pharmaceutical industry, so as to ensure that the cleanliness meets the requirements, keep the original verification records, file and keep them regularly, and record the verification results in the sterile room for use On the register, as the original basis and trend analysis data of experimental environment. According to the assessment results, we can understand the stable situation and change trend of the environmental quality of sterile room facilities, and decide whether it is necessary to revise the corresponding warning and correction limit.
Replace the new UV lamp regularly, replace the primary effect, medium effect and head of the purification system:
Replace the UV lamp regularly (at least once a year) to ensure the continuous and effective sterilization of UV lamp. At the same time, make replacement records on the use register, and keep them on file regularly. At least once every two years, or according to the actual situation verified by the sterile room, replace the initial effect, medium effect and head regularly. To ensure the continuous and effective function of the purification system, and at the same time, make replacement records on the use register, and regularly file and save.
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