ISO 11137-1:2025 Transition, Technical Application & Radiation Sterilization Practical Training and Workshop (2 Days)

1. Programme Overview

This 2-day practical programme equips participants with the knowledge and skills to plan, validate, review, and maintain radiation sterilization processes (Gamma, Electron Beam, and X-ray) and to implement a structured transition to ISO 11137-1:2025. The training includes guided group workshops using templates and realistic case scenarios to produce audit-ready outputs (process definition pack and transition action plan).

2. Programme Details (Quick Facts)

3. Target Participants

• Sterilization / Validation Engineers and Specialists
• QA / QC and Quality Management System personnel (ISO 13485 environment)
• Manufacturing / Process Engineers (sterile products and packaging)
• Regulatory Affairs / Technical Documentation team
• Internal auditors and supplier auditors involved in sterilization oversight
• Sterilization service provider / contract sterilization personnel

4. Learning Outcomes

By the end of the programme, participants will be able to:

1. Explain radiation sterilization principles and key differences between Gamma, Electron Beam, and X-ray processes.
2. Interpret ISO 11137 series requirements and map them to a compliant sterilization lifecycle and documentation.
3. Plan dose mapping and define acceptance criteria, including dosimeter placement rationale and data review.
4. Apply practical approaches for dose establishment and justification based on bioburden and risk concepts.
5. Construct a routine monitoring and control plan (dosimetry, dose audit, batch review and release pathway).
6. Evaluate nonconformities (dose excursions, missing data, bioburden shifts, load changes) and determine actions.
7. Perform a structured ISO 11137-1:2025 transition gap assessment and develop an implementation action plan.
8. Produce audit-ready deliverables using provided templates (process definition pack and transition dossier elements).

5. Training Methodology

• Interactive lecture and facilitated discussion
• Case studies and real-world scenarios (manufacturer and sterilization provider perspectives)
• Group workshops with templates to produce practical outputs
• Hands-on exercises for documentation, review checklists, and decision-making
• Knowledge checks (quiz) and group presentations

6. Detailed Course Content

Day 1 – Technical Application & Control Fundamentals

Module 1: Radiation Sterilization Overview (Gamma / Electron Beam / X-ray)

• Technology principles and process characteristics
• Typical applications and limitations
• Key risk areas: dose distribution, density effects, product geometry, packaging influence
• Roles and responsibilities: legal manufacturer vs sterilization service provider

Module 2: ISO 11137 Series Structure and Sterilization Lifecycle

• Purpose and interaction of ISO 11137-1, ISO 11137-2, and ISO 11137-3
• Lifecycle approach: process definition, validation, routine control, maintenance
• Documentation expectations: specifications, procedures, records, traceability of decisions

Module 3: Microbiological Fundamentals for Dose Setting (Practical Level)

• Bioburden basics: sources, variability, trends, and manufacturing controls
• Sampling and recovery considerations (conceptual)
• SAL concept and practical implications for sterilization dose selection
• Common pitfalls: mixing sources/facilities, unstable process, uncontrolled environment

Module 4: Process Definition and Dose Mapping Essentials

• Product/load characterization: density, max/min configuration, packaging and orientation
• Dose mapping objectives and planning
• Dosimetry system fundamentals: selection, calibration link, handling, and traceability
• Defining dose distribution ratio and control strategy for min/max dose
• Acceptance criteria and reporting structure

Group Workshop 1: Process Definition Pack (Team-Based)

• Define grouping approach (product family / processing category / load family) and justify worst case
• Draft a dose mapping plan with dosimeter placement strategy and acceptance criteria
• Identify key risks and propose controls (documentation, monitoring, and change control triggers)

Workshop Deliverable: Completed “Process Definition Pack” template + short team presentation.

Day 2 – Dose Establishment, Routine Control & ISO 11137-1:2025 Transition

Module 5: Dose Establishment and Validation Strategy

• Selection of dose establishment approach (conceptual pathways and decision criteria)
• Managing different bioburden conditions across sites/suppliers (high vs low; change impact)
• Worst case definition and validation rationale
• Revalidation and periodic review triggers

Module 6: Routine Monitoring, Dose Audit and Release Decisions

• Routine dosimetry: frequency, placement, and acceptance
• Dose audit intent, trending, review frequency, and escalation rules
• Batch review and release checklist: minimum evidence for release decision
• Handling deviations: underdose/overdose, missing dosimeters, abnormal mapping results

Module 7: Change Control and Maintaining Effectiveness

• Change impact assessment for materials, packaging, suppliers, facilities, load patterns, and process settings
• Maintaining effectiveness: trending, CAPA, effectiveness checks, internal audit readiness
• Typical audit questions and expected objective evidence pack

Module 8: Transition to ISO 11137-1:2025 (Implementation Workshop)

• Transition approach: clause mapping, evidence mapping, and document control upgrades
• Building a transition dossier: procedures, records, competency/training, and verification of effectiveness
• Implementation planning: owners, timelines, and audit readiness

Group Workshop 2: ISO 11137-1:2025 Transition Gap Assessment and Action Plan

• Perform structured gap assessment using a sample sterilization file set
• Risk-rank gaps (critical/major/minor) and propose corrective actions
• Create a transition action plan with timeline and evidence requirements

Workshop Deliverable: Completed “Transition Gap Assessment & Action Plan” template (audit-ready).

7. Training Materials and Templates Provided

• Participant manual (slides + notes)
• Workshop pack (case studies + templates): process definition worksheet, dose mapping plan, routine monitoring and release checklist, deviation investigation worksheet, transition gap assessment and action plan
• Quiz and answer key
• Sample evidence pack structure for audit readiness

8. Assessment and Evaluation

• Quiz (10 to 15 questions) to confirm knowledge uptake
• Workshop deliverables evaluated using a rubric (completeness, justification, and audit readiness)
• Participant feedback form (course evaluation)
• Optional: Pre and post knowledge check (upon request)

9. Trainer Profile (for HRD Corp Submission)

Lead Trainer: Sterilization Technical Expert / Lead Auditor with practical experience in radiation sterilization validation, dose mapping, dose establishment, routine monitoring, change control, and audit support (ISO 11137 and ISO 13485 environment).

To be completed in HRD Corp application with: academic background, relevant certifications, and experience summary.

10. References (Standards)

• ISO 11137-1:2025 – Sterilization of health care products – Radiation
• ISO 11137-2 – Establishing the sterilization dose
• ISO 11137-3 – Dose measurement and dosimetry
• ISO 13485:2016 – Quality management systems – Requirements for regulatory purposes (supporting QMS context)

Interested with this course? Send us enquiries below!

Enquiry Now!