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Lancaster Laboratories offers a comprehensive range of analyses and support functions to the Medical Device industry. Our microbiological laboratory facilities include class A/B and C clean rooms and a microbial identification laboratory.

We have experience in the validation of analytical methods and provide analysis of a wide range of medical devices. This includes prosthetic implants, ophthalmic implants, cutaneous adhesives and cardiac implants. We also provide contract facilities for the determination of API's associated with medical devices.

We have broad experience using internationally recognised methods such as ISO, Ph. Eur, BP or USP. Alternatively, we can work with our clients to develop validation and test protocols for a range of devices.

Microbiology Department

  • Bioburden analysis
  • Validation of bioburden methods
  • Sterility testing
  • Bacteriostasis and Fungistasis analysis
  • Sterility testing on biological indicator strips
  • Population verification of biological indicators
  • Bacterial endotoxins on waters and devices
  • Water analysis
  • Validation of water purification systems
  • Environmental analysis
  • Clean room monitoring
  • Bacterial identification (VITEK and API)
  • Spore testing of alcohol
  • Disinfectant use dilution testing

Chemistry Department

  • Analytical support for process validations
  • FTIR Analysis
  • Glutaraldehyde residue analysis
  • Trace metals
  • Total Organic Carbon
  • Organic Volatile Impurities
  • Purified water analysis
  • Method development for drug delivery devices
  • Ethylene oxide residue testing