Microbiology Testing

GMP & GLP Microbiology Testing

Microbiology testing for medical devices and pharmaceuticals is a crucial component of ensuring product safety and effectiveness.This testing utilises specialised techniques to identify and assess the presence of microorganisms. 

At Cormica, we prioritise quality assurance in pharmaceutical and medical device testing. Our GMP and GLP compliant laboratories boast decades of experience in microbiology and environmental monitoring, specialising in medical devices, combination products, and pharmaceuticals.

We are consistently audited by the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), ensuring our ongoing compliance with GMP and GLP standards.

Microbiology laboratory at Cormica
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Our Microbiology Testing Services

Sterilisation and Safety

  • Sterility Testing: Ensures medical devices meet rigorous standards for patient safety by verifying the effectiveness of sterilisation processes.
  • Bacterial Endotoxin Testing: A test to detect endotoxin from Gram negative bacteria using amoebocyte lysate from the horseshoe crab.
  • Biological Indicator Testing – BI Testing: Verifies sterilisation efficacy using highly resistant biological indicators for the utmost assurance.
  • Reprocessing Validation: Guarantees reusable medical devices can be safely cleaned and sterilized for multiple uses.
  • Cytotoxicity Testing: Incubation of mammalian cells in contact with a medical device and/or extracts of a device to determine the biological response

Contamination Control

  • Bioburden Testing: Quantifies microorganisms present on medical devices or pharmaceutical products prior to sterilisation.
  • Microbial Identification: Identifies specific types of bacteria, fungi, or other microorganisms to understand contamination sources and tailor control strategies.
  • Microbiological Environmental Monitoring: Assesses the cleanliness of manufacturing areas to prevent product contamination within pharmaceutical and medical device facilities.

Quality Assurance and Regulatory Compliance

  • Quality Control Release Testing: Ensures medical devices and pharmaceuticals meet quality specifications before release to global markets.
  • Method Validation: Verifies that laboratory testing methods are accurate, reliable, and suitable for their intended purpose, ensuring data integrity.
  • Stability Storage and Testing: Evaluates the shelf-life and stability of medical devices and pharmaceuticals under various storage conditions to assure ongoing safety and efficacy.

Specialised Microbiology Testing

  • Microbial Ingress Testing: Assesses the ability of medical device packaging to maintain sterility by preventing microbial entry.
  • Antimicrobial Efficacy Testing: Determines the effectiveness of antimicrobial agents within medical devices or formulations.
  • Disinfectant Efficacy Testing: Evaluates the ability of disinfectants to kill microorganisms for maintaining aseptic conditions in healthcare and manufacturing settings.
  • Autoclave Qualification: Verifies the performance and calibration of autoclaves (sterilisation chambers) to ensure they meet specific standards.
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