Sterilization Validation

Medical device sterilization validation is one of the most important elements of medical device Validation & Verification plan, since compromised state of sterility of medical device could impact the patient’s health or, in severe cases, lead to patient death.
Sterilization describes the process that destroys or eliminates all forms of microbial life, rendering products sterile – free of viable microorganisms. Sterilization can be achieved through various means, both physical and chemical. Physical methods include steam under pressure (autoclave), dry heat and gamma irradiation, while common chemical methods include sterilization by Ethylene Oxide gas.

Key advantages of sterilization by Ethylene Oxide

• EO sterilization is the method of choice for medical devices that cannot withstand high temperatures and moisture;
• EO sterilization is particularly suitable for devices with long lumens (such as catheters and endoscopes);
• EO Sterilization is compatible with most materials used in medical device manufacture.
• EO sterilization is one of the most used sterilization methods worldwide with a long history of use, accepted globally by regulatory authorities.

EO sterilization effectiveness depends on the ability of Ethylene Oxide to penetrate through all packaging materials to the most difficult-to-sterilize location in your product. The EO sterilization process depends on control of four parameters: EO concentration, temperature, relative humidity, and EO exposure time.

The ISO 11135 standard outlines requirements for Ethylene oxide sterilization process development, validation and routine control of a sterilization process for medical devices.

Since 2007 Li-Med has been working with both domestic and international customers to formulate and execute successful regulatory activities and quality assurance, exclusively serving the medical device industry.

We can provide expert service to support your EO sterilization projects:

• Product/packaging design considerations with respect to EO sterilization
• Product families and procedure kits – establishment of representative device
• Load configuration to meet current and future goals of your company
• EO sterilization validation study design
• Process Challenge Device design and feasibility testing
• Single Batch Release
• Annual Requalification, risk assessment in case of Requalification failure
• Assessment of impact of a change on validated sterilization process
• Product adoption into validated EO sterilization process
• Laboratory testing strategy (microbiology/EO residuals).
• Audit of sterilization subcontractor’ facilities, IQ/OQ reports review
• Project Management

We will be happy to supply additional vital information in the field of sterilization and assist your efforts towards achieving a better product.