Sterility Testing (TAMC + TYMC)

The Sterility Testing service is designed to assess microbial contamination in suitable samples using Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) cultivation tests.

The analysis is intended primarily for unopened peptide vials, ampoules, and other liquid samples where microbial contamination may affect product quality and safety.

About TAMC and TYMC

TAMC determines the total number of viable aerobic microorganisms present in a sample, while TYMC evaluates the presence of viable yeasts and molds.

Together, these cultivation-based tests provide an assessment of the overall microbial burden of the sample. Results are reported as Pass or Fail according to the applied acceptance criteria.

Key Features

• Cultivation-based microbial testing
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Suitable for unopened peptide vials, ampoules, and selected liquid samples
• Recommended sample amount of two unopened peptide vials
• Alternative sample formats include two 1 ml ampoules or one 10 ml vial
• Results reported as Pass or Fail
• Average turnaround time of 14 days

Analysis Parameters

• Testing method: Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC)
• Amount required for the test: Two unopened peptide vials recommended, two 1 ml ampoules, or one 10 ml vial (e.g. oil-based samples)
• Result format: Pass or Fail
• Average turnaround time: 14 days

Important Notice

• Unopened vials or ampoules are required to minimise the risk of contamination during shipping and handling.
• Submitting less than the recommended sample amount is possible, but it may affect the reliability of the results.
• This test is not recommended for oral products, as oral dosage forms are not generally required to be sterile for safe use.

Optional Additional Analyses

The following optional laboratory services are available:

• Additional Laboratory Report