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Ethylene Oxide Sterilization Validation

Life Sciences / Medical Device / EO Sterilization Validation

Ensure Compliance with EO Sterilization Validation

Evaluate the efficacy of your sterilization procedures using ethylene oxide by partnering with our team for testing support. We support EO sterilization validation using ISO 10993-7 guidance so your processes comply with regulatory requirements and ensure quality compliance. 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 (EO) and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG) are removed from the product and packaging.

We offer analytical ethylene oxide residual testing of terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods:

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Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.