Microbial counting method for soda effervescent tablets

The microbial counting method for soda base effervescent tablets is used to count mesophilic bacteria and fungi that can grow under aerobic conditions. When this method is used to check whether non-sterile preparations and their original and auxiliary materials meet the prescribed microbial limit standards, the inspection shall be carried out in accordance with the following regulations, including the sampling amount of the sample and the judgment of the result. Unless otherwise specified, this law does not apply to the inspection of live bacterial preparations.

The microbial count test environment should meet the requirements of microbial limit inspection. The entire inspection process must strictly abide by aseptic operation to prevent re-contamination, and the measures to prevent contamination shall not affect the detection of microorganisms in the test product. Clean air areas, work surfaces and the environment should be monitored regularly. If the test product has antibacterial activity, it should be removed or neutralized as much as possible. When inspecting the test product, if a neutralizer or inactivator is used, its effectiveness and non-toxicity to microorganisms should be confirmed. If a surfactant is used when preparing the test solution, it should be confirmed that it is non-toxic to microorganisms and compatible with the neutralizer or inactivator used.

Counting method of soda base effervescent tablets

Counting methods include plate method, membrane filtration method and most probable number method (Most-Probable-Number Method, referred to as MPN method). The MPN method has poor accuracy when used for microbial counting, but for some test products with small microbial contamination, the MPN method may be a more suitable method. When inspecting the test product, the counting method should be selected according to factors such as the physical and chemical properties of the test product and the microbial limit standard. The amount of sample tested should be able to ensure that the obtained test results can determine whether the test product meets the requirements. The suitability of the selected method must be confirmed.　

Counting medium suitability check and test sample counting method suitability test

The medium used in the microbial count of the test sample shall be checked for suitability.

The microbial enumeration method of the test product shall be tested for method suitability to confirm that the method used is suitable for the microbial enumeration of the product.

If changes in the inspection procedures or products may affect the inspection results, the counting method should be re-applicability test.