MEDICAL DEVICES TESTING

MEDICAL DEVICES TESTING

Medical Devices Testing

Product sterility testing of medical devices and associated packaging must avoid false positives that can waste significant time, money, and effort. At Boston Analytical, we perform medical device sterility testing through two independent programs.

In the first program, Boston Analytical performs VHP sterility testing in a Class 100 glove box isolator equipped with a state-of-the-art vaporized hydrogen peroxide (VHP) sterilization system. The isolator system is located in a class 8 cleanroom for added sterility assurance. In the second program, Boston Analytical performs traditional sterility testing of large bulky items and medical devices packaged in Tyvek configurations in a traditional ISO 5 cleanroom. The ISO 5 cleanroom is supported by ISO 7 support spaces.

Boston Analytical also performs both bioburden method validation and bioburden testing, in accordance with ISO 11737-2. Bioburden testing (also called bioburden enumeration), determines the population of microorganisms on a medical device, device component, or device packaging.

Sterilization process validation is required to ensure the bioburden test method recovers all microorganisms present on the medical device and that the test itself does not inhibit microbial growth. This bioburden level must remain consistent in a sterilized product from lot-to-lot and within a single lot. Boston Analytical can work with you to ensure your medical devices are free from any microorganisms that could compromise patient safety.

Medical Devices Testing Services

  • Bacteriostasis / Fungistasis Validations, meeting USP <71>, “Sterility Tests” and EP 2.6.1
  • Membrane Filtration Sterility Test with Millipore Sigma Steritest™ System
  • Direct Inoculation (Direct Immersion) Testing
  • Fluid Pathway Testing
  • VDMax and ISO Bioburden Method Validation and Bioburden Testing
  • ISO 11737-2, “Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose”
  • Bacterial Endotoxin Testing, USP <85>, “Bacterial Endotoxins Test”
ISO bioburden testing and validation