Non-sterile Products Testing
We develop and validate methods for microbial examination of nonsterile products in compliance with general tests in Pharmacopoeia (JP <4.05>, USP <61>, <62>, EP 2.6.12, 2.6.13).
The test samples include nonsterile APIs, excipients, and finished products. We also develop the bioburden test for process solution of sterile products or unprocessed bulk harvest (UPBH) of biologics products.
- Total aerobic microbial count / total combined yeast and mold count (TAMC / TYMC)
Pour plate method
Membrane filtration method
- Test for specified microorganisms
- Membrane filtration apparatus (Milliflex plus pump)