EO Sterilization Control and Validation – Necessity and Requirements

  • Date: March 18, 2010
  • Source: Admin
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Sterilization validation is a topic of immense relevance as it pulls many audit observations from the FDA and international regulatory bodies. For medical device sterilization, comparing to other modes such as steam sterilization and etc, EO works in relatively low pressure temperature and therefore, has been regarded as one of the most excellent and useful method of medical device sterilization.

What is EO?

EO or Ethylene Oxide was originally used for sterilizing spices but now it has extensively been used for sterilization of medical devices. Arrival of plastics and disposables to the device field prompted the use of EO sterilization. 

Validating EO Sterilization

In comparison to other available methods of sterilization, EO is a lengthy and at the same time, a complicated process. Though EO sterilization has been used for sterilizing medical devices for last 50 years but its involvement with too many variables makes the process complicated. Hence, validating the process of EO sterilization becomes important for ensuring the quality and functionality of the medical device. 

Important Standards for Validating and Controlling EO Sterilization

Standards that have been developed to validate and control the sterilization process are mostly driven by AAMI and ISO. A few of the important standards

  • ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
  • AAMI/ISO 11137 Sterilization of healthcare products —Requirements for validation and routine control — Radiation sterilization
  • EN550 (European standard) Sterilization of medical devices Validation and routine control of ethylene oxide sterilization

To know more about how EO sterilization works, the equipment involved in the process, major issues with product sterilization via EO, and the validation requirements, and about how to control and monitoring routine process to maintain the process effectiveness, join the webinar Requirements of validation and control of EO Sterilization organized by Compliance Online.

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