Is pollution caused by poor quality of the culture medium?
1. The culture medium is not a sterile product, but there is control over the number of bacterial colonies.
2. The culture medium is sterilized by high pressure or filtration before use.
3. To prevent pollution, attention should be paid to the following matters:
A Starting from the source of pollution
Confirm whether the working cell bank is contaminated: Use bacterial, fungal, and mycoplasma sterility tests to confirm and exclude. At the same time, the sensitivity of the sterile test medium should be verified.
Confirm whether the seed batch of the virus seed work is contaminated: use bacterial, fungal, and mycoplasma sterility tests to confirm and exclude. At the same time, the sensitivity of the sterile test medium should be verified.
Confirm whether the culture medium and its added components (such as calf serum, NaHCO3, etc.) are contaminated: Use bacterial, fungal, and mycoplasma sterility tests to confirm and exclude. At the same time, the sensitivity of the sterile test medium should be verified. In actual production, the prepared liquid can be left at room temperature (≥ 18 ℃) for 7 days to observe for contamination and remove single bottles suspected of contamination.
Other: High pressure sterilization equipment and filtration sterilization equipment should be validated to ensure sterilization and sterilization effectiveness; The former should be validated before production and every 6 months thereafter, while the latter should be validated before and after each sterilization (at least once after sterilization).
B Strengthen efforts in GMP management and operation
Conduct GMP testing on sterile operating rooms and clean areas every two weeks
Enhanced training on GMP management and aseptic operation for personnel
C Some special circumstances
The size of bacteria ranges from 0.1-700 μ m. To prevent contamination by small bacteria, it is recommended to use a 0.1 μ m filter membrane or filter cartridge for filtration and sterilization.
When there is large-scale pollution, all facilities, tools, and operating environments should be thoroughly disinfected.
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