ISO 11135 Training
Our training program centers on Ethylene Oxide sterilization with a specific emphasis on ISO 11135:2014, which offers comprehensive guidelines for the application of ethylene oxide gas sterilization within the healthcare industry. The standard encompasses the necessary criteria for the development, validation, and routine control of a sterilization process for medical devices. Adhering to this standard ensures the efficacy of sterilization while upholding device integrity, a critical factor for both patient safety and compliance with regulatory requirements.
Course Objectives
At the end of the program participants should be able to do the following:
-
Knowledgeable in Ethylene Oxide sterilization in terms of meeting the requirements of
international standard i.e., ISO 11135:2014 -
Highly competent and qualified company personnel in Ethylene Oxide
sterilization process.
Course Outline
Overview:
• Ice breaker- Recognizing and Identifying STERILE Product
• Objectives of the workshop
• Agenda
• Administrative arrangement
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Session 1: Overview of Sterilization
• Introduction
• Validation
• Process control & releasing
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Session 2: Key Factor of Sterilization Process Development
• Contamination control
• Microbiological testing
• Maintaining sterilization effectiveness