In our laboratory, microbial limit test analyses are performed using aa directions in accordance with EP 9.8 2.6.12 <2.6.12> / < 2.6.13> 2.6.13 and USP 43 NF 38 61 <61> / <62> 62 standards, unless another standard is reported.
- Pour Plate Method
- Spread plate method,
- smear plate method, Membrane fitration method.
- Bile Tolerant Gram Negative Bacteria Method (Quantitative and/or Qualitative)
It is done using methods.
Aerobic bacteria, anaerobic bacteria, yeast-mold, thermophilic bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, Bacillus subtilis, Salmonella sp., Escherichia coli, Aspergillus brasiliensis, Clostridium perfringens, Bile Tolerant Gram Negative Bacteria, Candida albicans analyses are performed on the samples.
Microbial Limit Test Method Validation
Method validation is performed to verify that the performance characteristics of the standards reported for microbial limit analyses to be applied to the samples perform as expected under laboratory test conditions.
With method validation, analyses are standardized by determining the working method and method-related details.