Medical Engineering Technologies
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Validation Services

Product & Process Validation Services

MET provide a variety of tools for product and process validation as part of our commitment to ensure that project engineers and scientists' needs are fully addressed. Our packaging and automation equipment is offered as a validated package, typically to GAMP4. 21 CFR part 11 is also available on bespoke systems as is six sigma analysis. Calibration and maintenance services are available for all equipment supplied.
 
Product and Process Validation Services
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Complementary Services
Further Information
Which of Your Validation Problems Can We Solve?

MANUFACTURING PROCESS VALIDATION


PACK VALIDATION TESTS

  • Ageing trials - accelerated ageing at controlled temperatures and humidities
  • Burst and creep - to ASTM F1140 / F 2054
  • Dye penetration - to ASTM F1929
  • Gurley porosity - to ISO 11607
  • Microbial penetration
  • Microbial ranking - to ASTM F1608
  • Moisture penetration - to ASTM
  • Seal / peel tensile tests to ASTM F88
  • Transit trials - simulated shipping, handling and storage
  • Vacuum leak test for impermeable packs

STERILISATION VALIDATION

  • Autoclave process validation service
  • Bioburden measurement
  • Biological indicators
  • Clean room validation and monitoring
  • Cleaning process validation for re-useable medical devices
  • D Value measurement
  • Ethylene Oxide process validation service
  • Sterilisation indicator spots and inks


For further information and advice, please call MET on +44 (0)8454 588924 or E-mail: