Microbiological Testing

GMP compliant microbiological testing of sterile and non-sterile API and finished products.

Kymos Group 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 have two clean rooms: one dedicated to sterile products testing and the other for non-sterile products testing. Our two 4-glove isolators, coupled with a Steritest® pump and an H2O2 sterilizer, ensure the sterility and accuracy of our tests. The microbiological testing service are often provided in combination with other quality control assessments.

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Services

  • List of our GMP-certified microbiological testing services:

    • Microbial limit test (TAMC, TYMC and pathogenic microorganisms)
    • Bioburden test
    • Sterility test (Isolator Technology + Symbio® Pump Millipore)
    • Bacterial endotoxins (Kinetic Chromogenic LAL, Kinetic Turbidimetric LAL, Recombinant Cascade Reagent (rCR) and Gel Clot assays)
    • Particulate matter (visible and subvisible particles: by light obscuration and microscopy)
    • Water for pharmaceutical use (microbial total count and TOC)
    • Growth promotion testing of culture media
    • Suitability and validation of microbial and sterility tests
    • Run Media Fill (small batches)
    • Environmental monitoring (air and surfaces contamination)
    • Antimicrobial effectiveness testing (Challenge tests)
    • Disinfectant effectiveness

Services

Related services to Microbiological Testing

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Sample preparation MS

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Climatic chambers for stabilty studies

Stability Studies

Full ICH studies and on-going stability programmes at different storage conditions.

Analytisches CRO HPLCs

Batch Testing and Batch Release

Our laboratories are GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

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