Quality Control Testing
Our quality control testing laboratory undertakes microbial examination of non-sterile products on a routine basis, and we have expertise in many different pharmaceutical formulations and presentations. We have also built up a portfolio of neutralising agents and developed techniques for dealing with microbiologically active products. Combined with our long standing industry experience, this allows us to quickly validate and determine the most appropriate method for your pharmaceutical QC testing. Our standard range of QC tests are listed as follows, however, if your quality control testing requirement falls outside of these, please contact us to discuss your project further.
Microbial Limits Testing
The Microbial Limits Test provides an estimation of the number of viable aerobic microorganisms, and determines the presence or absence of specified pathogenic organisms in raw materials, excipients and finished products.
Total Aerobic Microbial Counts
Determines the number of microorganisms in a product quantity by –
- Total bacterial count (TAMC)
- Yeasts & mould count (TYMC)
Absence of Specified Pathogens
Determines the presence or absence of specified pathogens that can include combinations of the following microorganisms –
- Escherichia coli
- Salmonella spp
- Pseudomonas aeruginosa
- Staphylococcus aureus
- Bile tolerant gram-negative bacteria
- Burkholderia cepacia
- Candida spp
- Clostridia spp
We can conduct testing on water from manufacturing facilities either as part of routine Environmental Monitoring sampling at your site, or through client samples sent to our test facility. We are able to determine the levels of microorganism present and identify any microorganisms found. We can also provide expertise in water systems, and management of water contamination and biofilm management as required.
All of our microbiological testing is backed up by an in-house identification service or sub-contracted GMP compliant phenotypic identification services, using mass spectrometry technology.
For further information on bioburden determination and sterility testing, please visit the links in the sidebar.