QC Services >> Microbiology >> Non-sterile Products Testing

Non-sterile Products Testing

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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.

Test Items

  • Total aerobic microbial count / total combined yeast and mold count (TAMC / TYMC)
     Pour plate method
     Membrane filtration method
  • Test for specified microorganisms

Characteristic Equipment

  • Membrane filtration apparatus (Milliflex plus pump)