child proof bottle microbial limit detection and counting method

Take the number of child proof bottles, add the sodium chloride injection with the indicated capacity of 1/2, cover the lid tightly, and shake for 1 minute to obtain the test solution. After the test solution is subjected to membrane filtration, pharmaceutical packaging shall be inspected according to law (Chinese Pharmacopoeia 2015 General Rules 1105 Microbial Counting Method, 1106 Controlled Bacteria Inspection Method), the number of bacteria shall not exceed 1000 cfu per bottle cap, and the number of mold and yeast shall not exceed 100 cfu per cap. Escherichia coli should not be detected in each bottle.

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Microbiological counting is used for the counting of mesophilic bacteria and fungi that can grow under aerobic conditions. When this method is used to check whether non-sterile preparations, their raw materials, excipients, etc. meet the corresponding microbiological limit standards, they shall be tested according to the following provisions, including the sampling amount of the samples and the judgment of the results. This law does not apply to the examination of live bacterial preparations unless otherwise specified.

The microbiological enumeration test environment should meet the requirements for microbiological limit inspection. The whole process of inspection shall be strictly followed by aseptic operation to prevent re-contamination. Measures to prevent pollution shall not affect the detection of microorganisms in the test sample. The unidirectional air flow area, work surface and environment shall be monitored regularly.

If the test article has antibacterial activity, it should be removed or neutralized as much as possible. If a neutralizer or inactivating agent is used during the test, the effectiveness and microbe toxicity 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 compatible with the neutralizing agent or extinguishing agent used.