The pharmaceutical moisture-proof packaging microbial limit control bacteria inspection method is used to check whether a specific microorganism is present in the test sample under the specified experimental conditions.
The medium used in the test sample control method should be checked for suitability. The method for controlling the control bacteria of the test sample is tested for applicability to confirm that the method used is applicable to the control bacteria inspection of the moisture-proof container of the drug. If the inspection procedure or product changes may affect the inspection results, the control bacteria inspection method shall be re-tested for suitability.
When the method is used to check whether non-sterile preparations and their sterile preparations, their raw materials, excipients, etc. meet the corresponding microbiological limit standards, they shall be tested according to the following provisions, including sample sampling amount and result judgment.
When the test sample is detected as a control bacteria or other pathogenic bacteria, the result of the detection shall be taken as the standard, and the test will not be repeated.
The preparation of the test solution and the experimental environment requirements are the same as the "microbiological limit inspection of non-sterile products: microbial counting method (General Rule 1105)"
If the test article has antibacterial activity, it should be removed or neutralized as much as possible. When using the neutralizer or inactivating agent when testing the test, the effectiveness and toxicity to the microorganisms should be confirmed.
If a surfactant is used in the preparation of the test solution, it should be confirmed that it is not toxic to microorganisms and compatibility with the neutralizing agent or inactivating agent used.
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