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Medical Device Testing

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 microbiological 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.

We can offer expedited turnaround times for the below testing services. Expedited testing can significantly increase the speed in which you get your results and help you meet tight deadlines. Please contact us for more information and timeframes.

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

Water Testing:

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.

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