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EO Sterilization Equipment, Software and Product Validation Per ISO 11135

November 18 | 1:00 PM EST| Duration: 60 Min

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ISO 11135:2014: “Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices”, defines the latest requirements for the validation of Ethylene Oxide sterilization of medical devices, the sterilization chamber, and sterilization controls.

This webinar will use ISO 11135 as a basis for a field-tested approach to sterilization validation and its documentation, including the chamber control software.

Medical device sterilization failures can have serious consequences to patient health and a company’s reputation with both regulatory agencies and the public. EO sterilization is one of the most common methods of device sterilization, and must be performed by a company on its products whether the company does in-house sterilization or contracts a third party to perform it.

A review of Internet forums shows confusion as to what is involved in V&V in general and EO sterilization in particular. And what must be addressed to ensure all requirements of sterilization validation are addressed per the ISO 11135 standard.

What are the "must have" elements? How are the many different required test cases constructed, formatted, and completed? How are all these unique elements integrated into the final EO sterilization validation documentation? How is the often neglected EO sterilization chamber control software / firmware V&V activities performed and documented with minimal extra activities.

This webinar will use ISO 11135’s requirements to address such point as: BI characterization, B&F testing, Bioburden, product characterization, PCDs, SAL, EO IQ, OQ, MPQ, and PPQ (terms / acronyms will be explained).

It will focus on the overkill approach, test case constructions, required software documentation, and re-qualification. The methods discussed provide a field-tested approach to EO sterilization validation and its documentation, including the chamber control software.

The models presented simplify product, process, equipment, software V&V, assuring key US FDA and ISO 11135 requirements are not overlooked. 21 CFR Part 11 is also briefly considered.

Areas Covered in the Webinar:

  • ISO 11135:2014 – current requirements
  • Overkill approach
  • BI, PCD, SAL, B&B, Bioburden terms explained
  • Product characterization considerations / documentation
  • How to use the IQ, OQ, MPQ, and PPQ as required under ISO 11135
  • Constructing the several different test case categories and populating them during validation
  • Required preliminary verification activities – choices under ISO 11135
  • The 11 Elements of the FDA’s software / firmware VT&V "Model".
  • Some Part 11 software V&V consideration.

Instructor Profile:

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation.