MICROBIOLOGICAL TESTING

Kymos has an EMA and FDA inspected microbiology lab for GMP compliant microbiological testing of sterile and non-sterile APIs and finished products, including injectables, tablets and topical products, both small and large molecules. Our microbiology lab is authorized to conduct microbiological testing in quality control of pharmaceutical products for human and veterinary use as well as investigational purposes in addition to medical devices, nutraceuticals, phytopharmaceuticals and cosmetics. Within our microbiology lab we own a cleanroom with airlock technology and HEPA filters for the most sensitive operations and a 4-glove isolator Isoflex-S® coupled with a Steritest® pump and H2O2 sterilizer. The microbiological testing service are often provided in combination with other quality control assessments. Our microbiology lab can support you in the following area:

List of GMP-certified microbiological testing services in our microbiology lab

Microbial limit test (TAMC, TYMC and pathogenic microorganisms)
Total viable spore count
Sterility test (Isolator Technology + Symbio® Pump Millipore)
Bacterial endotoxins (Chromogenic LAL and Gel Clot assays)
Particulate matter (visible and subvisible particles)
Water for pharmaceutical use (TOC and conductivity analysis)
Growth promotion testing of culture media
Antibiotics microbiological assays and method development and validation
Suitability and validation of microbial and sterility tests
Challenge tests
Run Media Fill (small batches)
Environmental monitoring (air and surfaces contamination)
Antimicrobial effectiveness testing
Biocides effectiveness

List of tests based on nutraceutical and cosmetic guidelines performed by our microbiology lab

ISO 11930:2012 – Evaluation of the antimicrobial protection of a cosmetic product
ISO 16212:2008 – Enumeration of yeast and mould
ISO 17516:2014 – Microbiological limits
ISO 18416:2015 – Detection of Candida albicans
ISO 21148:2005 – General instructions for microbiological examination
ISO 21149:2006 – Enumeration and detection of aerobic mesophilic bacteria
ISO 21150:2015 – Detection of Escherichia coli
ISO 22716:2007 – Guidelines on Good Manufacturing Practices
ISO 22717:2015 – Detection of Pseudomonas aeruginosa
ISO 22718:2015 – Detection of Staphylococcus aureus