Microbial Quality Determination
Our purpose built pharmaceutical microbiology laboratories are fully equipped for testing and analysis of raw materials, finished products or medical devices for microbiology, Total Viable Counts (TVC) and Pathogens. Our laboratory is fully versed in all Pharmacopoeia methodologies or testing to customers methods and routinely undertake work for companies around the world.
ILS has a highly experienced team and can advise on regulatory issues, product development studies, scientific evaluation of safety and efficacy data.
We provide a full range of pharmaceutical microbiology contract testing and research services, these include:
ILS perform Microbial Limit Testing to the EP, BP, USP and the JP. The testing is used to estimate the total number of viable micro-organisms present and for the absence of specific pathogens in raw materials, exipients and finished products of all kinds.
The microbial limit (contamination) test is used to test the microbiological content of pharmaceutical products which are not designed to be sterile, or raw materials used in the production of other products.
The presence of micro-organisms within purified water can also be assessed at ILS by performing a Total Viable Count using membrane filtration.
Total Viable Counts is used to test for mandatory and non-mandatory guidelines on the quality of pharmaceutical preparations and medicinal products to ensure they comply with their microbiological specifications. ILS perform this testing to Pharmacopoeia standards or customers own methods.
Testing for the absence of specific pathogens is to ensure the organisms below are not present in any pharmaceutical product or ingredient.
Gram Negative Bacteria
Various pharmaceutical preparations, depending on their use, require testing of various combinations of the above organisms.
We pride ourselves on customer service and value all of our customers please contact us to see if we can help you with your pharmaceutical testing requirements.