Objectives:
Aim to ensure compliance with regulatory requirements, maintain product safety, and minimize contamination risks. The key objectives are:
- To provide an overview of sterilization methods used for medical devices, with a focus on Ethylene Oxide (ETO) sterilization.
- To develop participants’ understanding of sterilization validation and routine control monitoring in compliance with ISO 11135.
- To introduce the requirements of sterile barrier systems and packaging validation based on ISO 11607 Parts 1 and 2.
- To enhance knowledge on microbiological and chemical testing, including:
- Bioburden testing (ISO 11737-1), Product sterility testing (ISO 11737-2)
- EO residual testing (ISO 10993-7)
- Biocompatibility and endotoxin testing (ISO 10993 series)
- To ensure participants are equipped to implement and maintain effective sterilization practices and quality assurance systems.
- To support compliance with international standards and regulatory requirements for sterile medical devices.
Sterilization:
- Sterilization in Medical Device Industry [ETO, Gamma, EBeam, X Ray, Moist Heat/Steam (Autoclave)]
- Sterilisation Validation
- Sterilisation Standards, Guidelines & Regulations (Malaysia / International)
Sterile Barrier System:
- Sterile Barrier Validation
- Packaging and Labelling
Microbiological and chemical testing:
- Microbiological Testing – Bioburden & Sterility testing, EO residual testing
- Biocompatibility (including endotoxin)
Summary of training plan:
| No | Topic | Course outlines | No of days |
| 1 | Sterilization | Introduction to Sterilization for Medical Devices (ETO, Gamma, EBeam, X-Ray, Moist Heat Sterilization/Steam) | 1 |
| 2 | Sterilization | Sterilization Validation and routine control monitoring – Ethylene oxide (including workshop) | 2 |
| 3 | Sterile Packaging System and Sterile Barrier System | Sterile barrier systems and Sterile packaging – ISO 11607 Part 1 and Part 2 (including shelf-life determination) | 1 |
| 4 | Microbiological and chemical testing | Microbiological Testing – Bioburden & sterility testing, EO residual testing & Biocompatibility (including endotoxin) | 1 |
|
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Total Manday for the training | 5 |
Course Outline and Training Methodology:
Topic 1: Introduction to Sterilization for Medical Devices (ETO, Gamma, EBeam, X Ray, Moist Heat Sterilization/Steam)
Session 1: Importance of Sterilization
- Purpose
- Significance
- Definitions
Session 2: Sterilization Methods Overview
- Physical Methods:
– Heat (moist and dry)
– Radiation (gamma, electron beam)
- Chemical Methods:
– Ethylene oxide (EtO)
Session 3: Validation and Monitoring
- Biological Indicators
- Chemical Indicators
- Mechanical Indicator
Session 4: Regulatory Standards
- ISO 11135: Sterilization of health care products – Ethylene oxide.
- ISO 11137: Sterilization of health care products – Radiation.
- ISO 17665: Sterilization of health care products – Moist heat.
Duration: 1 day
Topic 2: Sterilization Validation and routine control monitoring – Ethylene Oxide Sterilization
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
Session 3: Operation and Maintenance of Steriliser
- Maintenance of equipment
- Requalification of equipment
- Assessment of change
Duration: 2 days
Topic 1: Sterile barrier systems and Sterile packaging – ISO 11607 Part 1 and Part 2
Session 1: Overview of Sterile Barrier Systems and Packaging Systems
- Introduction
- Representative’s types of sterile barrier systems and packaging systems
- Packaging verification
Session 2: Key Factor of Sterile Barrier Systems and Packaging Systems Process Development
- Packaging process validation
- Awareness of ISO 11607-1 and ISO 11607-2
Session 3: Packaging and Labelling requirements for medical devices
- Introduction to regulatory framework
- Labelling requirements
- Packaging requirements
- Shelf-life determination
Duration: 1 day
Topic 1: Introduction to Medical Device Biocompatibility & Microbiological/Chemical Testing
- Overview of biocompatibility and its importance
- Understanding microbiological & chemical risks in medical devices
- Key regulatory and Standard/Guidelines framework
Topic 2: Biocompatibility testing for medical devices
- Biological evaluation planning and risk-based approach
- Material characterization and extractable/leachable study
- Selection of appropriate biocompatibility testing
Topic 3: Microbiological/Chemical testing for medical devices
- Bioburden testing and microbial limits
- Sterility testing methods
- Endotoxin (LAL) testing for pyrogen detection
- Environmental monitoring in cleanroom production
- Validation of microbiological test methods
- EO/ECH Residual testing requirement
Duration: 1 day
Course Duration:
- Standard Course: 5 Full Days (35 Hours)
- Customizable: Based on company needs
Target Audience:
- Quality Assurance (QA) & Regulatory Affairs (RA) Teams
- Manufacturing & Production Personnel
- Process Engineers & Validation Teams
Training Methodology:
- Workshop / Hands-On Practical Session
- Participants develop group workshop
- Interactive session: Identify typical nonconformities in an audit case study
- Course Assessment & Certification (1 hour)
- Quiz / Knowledge Assessment (MCQs, Open-ended Questions)
- Practical exercise: Evaluate a sample training matrix for effectiveness
- Certificates issued for successful participants
Course Deliverables:
✔ Training Material (Slides & Handouts)
✔ Certificate of Completion
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