Medical Device Sterilization Procedure Bundle

Coordinate four distinct medical device sterilization and manufacturing-control activities with editable procedures for ethylene oxide (EO) validation, gamma irradiation validation, sterile-load preparation and release, and environmental controls. Each procedure addresses its own method or stage and must be adapted to your devices and facilities.

Supplied as four editable Microsoft Word documents in a digital download.

Medical Device Sterilization Procedure Bundle - Content

Ethylene Oxide (EO) Sterilization Validation Procedure-The Ethylene Oxide (EO) Sterilization Validation Procedure defines the planning and testing requirements for conducting the validation, re-validation, adoption and routine sterilization of medical devices by ethylene oxide (EO) gas.

Gamma Irradiation Sterilization Validation Procedure- The Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The gamma sterilization validation procedure applies to all medical devices sterilized by gamma radiation.

Sterile Load Preparation and Release Procedure-The Sterile Load Preparation and Release Procedure governs the preparation and organization of a sterile load, the inspection of post-sterilized product, and the final release of a sterile load for commercial distribution.

Environmental Controls Procedure- The Environmental Controls Procedure establishes the requirements for cleanrooms and controlled manufacturing environments where a cleanliness standard is intended to be met or where other requirements for the manufacture of medical devices are necessary.

• Ethylene-oxide validation and routine monitoring

• Gamma-irradiation validation and dose monitoring

• Product families and sterilization-related responsibilities

The included sterilization procedures reference ISO 11135:2014 for ethylene oxide and the ISO 11137 series for gamma irradiation.

Individual documents in this bundle

• Ethylene Oxide EO Sterilization Validation Procedure | ISO 13485 | FDA QMSR

• Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QMSR

• Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QMSR

• Environmental Controls Procedure

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read EO and Gamma Sterilization: Validation, Product Adoption and Load Release for workflow guidance, a checklist and common mistakes.