Microbiological Testing
Pharmacopoeial microbiological testing
The general testing methods of pharmacopeia are used for microbiological testing of pharmaceuticals.
The following three method are mainly used. These are internationally harmonized in Japan/US/ EU pharmacopeia.
- Endotoxin test <4.01>
- Microbial limit test（Total aerobic microbial count, Test for specified microorganisms) <4.05>
- Sterility test <4.06>
Samples of microbiological testing
We perform the following microbiological testing listed in the Japan pharmacopoeia supplement and we also offer services for US/EU pharmacopoeia.
| Disinfection method and decontamination method | Microbiological evaluations of disinfectants |
| Antimicrobial preservatives effectiveness testing |
- Antimicrobial preservatives effectiveness testing - Growth testing of microorganisms in liquid |
| Isolator for sterility test |
- Spore count analysis by Biological Indicator (BI) - Biological indicator resistance performance testing (BI for steam sterilization) by BIER（Biological Indicator Evaluation Resistometer) |
Method development / Method transfer
We offer services of method development and validation (Confirmation of method compatibility) under cGMP control.
We have established over 30 method development per year of raw materials, APIs, process liquid, as well as formulations.
In particular, the number of method development of microbiological limit testing (aerobic viable count) to monitor raw materials, APIs, and process is increasing.
We also offer extensive services of method transfer to manufacturing site.
We support your microbiological testing. Please feel free to contact us if you have any questions and requests.