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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.

Anchor ISO 11135

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

•    Ice breaker- Recognizing and Identifying STERILE Product
•    Objectives of the workshop
•    Agenda
•    Administrative arrangement

Session 1: Overview of Sterilization

•    Introduction
•    Validation
•    Process control & releasing

Session 2: Key Factor of Sterilization Process Development

•    Contamination control
•    Microbiological testing
•    Maintaining sterilization effectiveness

Target Audience

This program is very useful to participants who handles and are actively involved in Quality especially those who are QA/QC Lab technician, and QA/QC Executive.


2 full-day courses running from 8.30 am to 5.30 pm. Physical Training (On-site).

Register Here

Thanks for registering to our training program. See you there!

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