ISO 11137 – Radiation Sterilisation (Gamma, Electron Beam and X-Ray) Training

Our Training Content

The purpose of this training is to comprehensively convey the requirements of the ISO 11137 series of standards relating to the radiation sterilisation of healthcare products to participants in a practical manner. The training covers the fundamentals of gamma, electron beam (E-Beam) and X-ray sterilisation methods, process development, validation (IQ/OQ/PQ), routine monitoring and post-sterilisation product release processes.

Participants who successfully complete the training will acquire the knowledge and competence to evaluate radiation sterilisation processes using a risk-based approach and to plan and manage dose determination and dose monitoring activities in accordance with the standard.

Fundamental Principles and Objectives of the Standard

• Structure and Scope of the ISO 11137 Standard
• Fundamental Principles of Radiation Sterilisation
• Dose Determination and Process Validation
• Routine Monitoring and Process Continuity
• Risk and Compliance Management

Training Method

• Interactive Presentations: Systematic explanation based on ISO 11137 clauses
• Application-Focused Content: Dose determination scenarios, validation and product family examples
• Case Studies: Participants learn to apply the knowledge gained during the training
• Assessment: Measurement exercises supporting the correct understanding of standard requirements

Who is it suitable for?

• Technical personnel working in medical device and healthcare product manufacturers
• Sterilisation and validation specialists
• Quality Assurance/Quality Control personnel
• Internal and external auditors, technical experts
• Engineers and managers responsible for radiation sterilisation processes

Training Dates and Registration

Our training courses are conducted online. For registration and detailed information, please visit our website or contact us at support@pcatrainings.com.tr.

What Will You Gain from the Training?

• Full technical mastery of the ISO 11137 standard series
• Competence in correctly selecting and evaluating radiation sterilisation methods
• The ability to manage dose determination, dose verification, and sterilisation dose control processes
• The ability to plan and interpret IQ/OQ/PQ validation studies
• Creating sustainable and auditable sterilisation processes compliant with ISO 13485