top of page

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

Overview:
•    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.

Duration

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

Training Fees

RM10,000 per session. Max of 15 pax per session. Additional RM700 for the subsequent participant (logistics and refreshments are excluded).

Register Here

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

bottom of page