Medical Device Testing

Pace Analytical Life Sciences, LLC provides industry-standard methods and custom analytical chemistry and microbiology services for the testing of medical devices.  Our service offerings for the medical device industry are based on industry standards and follow the guidance of ISO, AAMI, ANSI, and ASTM documents and methods.  The material- and product-specific testing details are defined by custom protocols developed in collaboration with our clients.

ISO 10993 testing provides the Medical Device industry with guidance to the analytical testing of both the materials used to make medical devices and the finished devices.  The services that we offer, which are a core of our laboratory operation, are:

• ISO 10993 Part 18, Chemical Characterization of Materials (ISO Material Characterization)
  • Regulators are requiring companies to provide quantifiable data on the chemical composition of the materials going into their medical devices.  Pace Analytical Life Sciences offers industry-leading analytical testing using current and state-of-the-art analytical instrumentation to support this standard.
• ISO 10993 Part 7
  
  • Many medical devices require some form of terminal sterilization and often Ethylene Oxide is chosen because it is effective and does not adversely affect many of the materials used to make medical devices.  The use of Ethylene Oxide as a sterilant obligates companies to demonstrate that ethylene oxide (ETO), and it’s common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG), are removed from the product and packaging.  Pace Analytical Life Sciences offers analytical services for terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods and has also researched and developed new methods for industry using unique technology to offer better sensitivity and improve data turnaround times over conventional testing methods.

Our device testing services include chemical characterization, biocompatibility testing, testing to support cleaning validation and plastic analysis ISO 10993 testing.

Microbiology

Pace Analytical Life Sciences offers a full-service microbiology lab to support your medical device testing needs.  We offer Microbial Bioburden and Test of Sterility following ISO 11737 guidelines, Biological indicator testing (including preparation of inoculums, population counts and post-exposure viability) and Bacterial Endotoxins testing following USP <85>

Pace Analytical Life Sciences is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.