Sterilization by Irradiation

Sterilization by irradiation course

This course - Sterilization by Irradiation - is designed to provide participants with an understanding of the EN ISO 11137-1 and -2 requirements for sterile medical devices and compliance with MDR .

This 1 day training course provides an in depth knowledge of the EN ISO 1137-1 to -3 requirements as well as attendant study cases.  To enrol in the course, contact Medical Device Software & Sterilization Professionals in Lee-on-the-Solent, Hampshire.  The course is available worldwide.

Learning objectives / course outcomes

On completion of this training, participants will be able to :

  • Identify the links between MDR and EN ISO 11137-1, -2, -3
  • Define the requirements for the validation of sterilization
  • Define the type of dosimeters used and their compliance with ISO ASTM 52628
  • Define the requirements for the sterilization in routine and the release of batches
  • Identify the content of a validation report of sterilization

Intended audience

  • Regulatory, quality assurance managers and personnel
  • Design and development managers and personnel
  • Quality control personnel

Content of the course

  • I- Introduction
  • II- Characterisation of the device’s material and interaction with the irradiation
  • III- What type of dosimeter to use
  • IV- Validation- IQ
  • V- Validation- OQ
  • VI- Validation- PQ
  • VII- Requalification- maintenance
  • VIII- Controls in routine
  • IX- Impact of the medical device’s modification on sterilization process and extension of range
  • X- Bioburden and sterility testing

Prerequisites

Participants should have basic knowledge of microbiology and packaging requirements.

How will I learn?

MDSSPRO use interactive learning techniques in order to keep the course varied.  We also incorporate applications and study cases. Our tutors are some of the best available and will make sure your learning needs are met. Choose between online or in-company courses - either can be tailored to your business needs.

Price

The online training course is available at £450 per person. We also offer this training at a special price for students, for more details contact us at admin@mdsspro.com. 

On site training can be tailored to your needs. For more details contact admin@mdsspro.com.
If you have any queries about our Sterilization by Irradiation course, please email
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