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Common technical questions of injection in process research and verification (2)

- 分类：知识中心
- 作者：
- 来源：
- 发布时间：2021-02-08 09:09
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【概要描述】

#
Common technical questions of injection in process research and verification (2)

【概要描述】

- 分类：知识中心
- 作者：
- 来源：
- 发布时间：2021-02-08 09:09
- 访问量：

21:May I ask test method for level of contamination and heat resistance (D value) of microorganism before sterilization?

Answer: the level of microbial contamination is usually intercepted by membrane filtration, and then transferred to the surface of solid medium, cultured and counted. The volume of filtration and the interception number of microorganisms should be paid to ensure sufficient detection rate (sufficient filtration yeild) and countability (too many intercepted microorganisms to be counted).

22:How to calculate the amount of inoculation according to D value?

25:Is it necessary to verify sterilization process for over-sterilization method? What is the difference between product research and development process and verification in the actual production of residual probability method ?

Answer: of course, verification is required. Article 83 of EU CGMP Appendix: all sterilization processes should be verified. Residual probability method is the design of sterilization process, which itself needs to be verified and confirmed.

26:Is over-killing method certain that there is no need for microbial challenge tests?

Answer: The connotation of over-killing method is that the number of microorganisms in product is reduced by 12 logarithms, and microbial challenge test is to prove that the residual probability of microorganisms is not more than 10-6, so over-killing method can not carry out microbial challenge tests.

27:Is the final sterilized product subject to separate equipment verification for each variety applied for registration? Is it possible to verify equipment only once and other varieties can be in common use? Can equipment verification data not be attached to variety verification data, but only for archival reference?

Answer: The final sterilization product does not need to be verified separately for each variety applied for registration. If the registered variety adopts the same or lower sterilization conditions, the equipment verification under the condition of higher temperature sterilization can only be carried out; the equipment verification data for sterilization conditions of the variety should also be attached to verification data of the variety.

28:Can the sterilization process of non-solution dosage form, semi-solid or powder injection calculate a value similar to F0? Can you calculate SAL? What is the specific stipulation?

Answer: Cannot, but can calculate SAL. Refer to the decision-making tree of EU sterilization process selection.

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