Services available for Biocides

Extractables & Leachables (E&L) Testing

Extractables & Leachables (E&L) Testing

We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.

  • 10-16 weeks typical lead time
  • ISO 10993-18
  • USP<1663>/<1664>, USP <665>/<1665>
  • Aligned with MDR and FDA guidance
  • Custom Extractables Study Design
Medical Device Reprocessing Validation

Medical Device Reprocessing Validation

We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.

  • 4-8 week typical lead time
  • Custom test rigs
  • Bespoke testing setups
  • Cleaning, Disinfection & Sterilisation cycles
  • AAMI TIR30  / ANSI/AAMI ST98:2022
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Medical Device Reprocessing Instructions Development

We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.

  • 2-4 week typical lead time
  • Cleaning, Disinfection & Sterilisation
  • IFU Development
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-5
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Residual Hydrogen Peroxide Determination

We assess hydrogen peroxide residues remaining on medical devices following H2O2 sterilisation processes to assess biocompatibility and patient safety.

  • 2-3 week typical lead time
  • BS EN ISO 22441:2022
  • BS EN ISO 109931-1:2020
  • BS EN ISO 10993-17:2023
  • BS EN ISO 10993-18:2020+A1:2023
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