Microbial enumeration tests
Not all pharmaceutical products are required to be sterile. For non-sterile products there is often a limit on the number of microorganisms permitted in the product. Helvic provide testing services to cover this. To determine the bioburden of a material Microbial Enumeration / Microbial Limit Tests are performed as per the harmonised Pharmacopoeia methods.
A microbial enumeration test consists of a Total Aerobic Microbial Count (TAMC) and a Total Yeast and Moulds Count (TYMC).
These tests determine the quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. These tests reveal whether a substance or preparation complies with an established specification for microbial quality, in basic terms a determination of its bioburden.
Methods employed include:
- Plate count methods
- Membrane filtration
- Surface-spread method
- Pour-plate method
- Most-probable-number (MPN) method
Tests for specified organisms
These are tests to determine the absence or limited occurrence of specified microorganisms that may be detected in a substance or preparation. Helvic performs these tests as per the harmonised Pharmacopoeial methods, using the selective media and organism strains prescribed.