Duration: 2 Days (≈ 14 hours total)
Target Participants: QA/RA personnel, sterilization engineers, validation specialists, auditors, and regulatory assessors
Training Format: Instructor-led presentations + group exercises + case studies + quiz
Reference: ISO 17665:2024 – Sterilization of health-care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices.
Day 1 – Foundation & Process Characterization
Session 1.1 – Opening & Pre-Test
Learning Objectives: Assess baseline knowledge; Introduce objectives & expectations
Key Contents: Course overview, Training rules, 10 MCQ pre-test
Session 1.2 – Introduction to Sterilization Principles
Learning Objectives: Explain purpose of sterilization; Differentiate moist heat from other methods
Key Contents: Definition of sterile product; Probability of survival; SAL 10⁻⁶; Role of ISO 14937
Session 1.3 – Overview of ISO 17665:2024
Learning Objectives: Understand scope & structure; Compare to 2006 edition
Key Contents: Clauses 1–3 overview; Merged parts; Key terminologies; EU Annex ZA/ZB links
Session 1.4 – General Requirements (Clause 4)
Learning Objectives: Recognize QMS link to ISO 13485; Documentation & responsibilities
Key Contents: Management responsibility; Resources & competency; Calibration & record control; Traceability
Session 1.5 – Sterilizing Agent Characterization (Clause 5)
Learning Objectives: Define moist heat; Evaluate microbicidal effectiveness; Assess material compatibility
Key Contents: Moist heat mechanism; Steam quality; Contaminant limits; Environmental & safety requirements
Session 1.6 – Process & Equipment Characterization (Clause 6)
Learning Objectives: Understand process types and equipment requirements
Key Contents: Saturated steam vs contained product; Key parameters (T, P, Fo, z); Chamber design; Bowie-Dick test
Day 2 – Validation, Routine Control & Sustaining Effectiveness
Session 2.1 – Recap of Day 1
Learning Objectives: Review main concepts before Day 2
Key Contents: Quick quiz and open discussion
Session 2.2 – Product & Process Definition (Clauses 7 & 8)
Learning Objectives: Define product families and load configuration; Develop documented process definition
Key Contents: Product compatibility assessment; Packaging (ISO 11607); Cycle parameters (T, P, Fo); Reference load & PCD concepts
Session 2.3 – Validation (Clause 9)
Learning Objectives: Describe IQ/OQ/PQ requirements; Differentiate physical vs microbiological validation approaches
Key Contents: IQ: equipment installation; OQ: control systems; PQ: microbial lethality; Overkill vs bioburden; Review & approval
Session 2.4 – Routine Monitoring & Control (Clause 10)
Learning Objectives: Establish ongoing process verification and data review systems
Key Contents: Monitoring of cycle parameters; Chemical & biological indicators; Record retention and trend analysis
Session 2.5 – Product Release (Clause 11)
Learning Objectives: Define release criteria and responsibilities; Understand deviation handling
Key Contents: Evaluation of cycle data; Conditional release; Reprocessing requirements
Session 2.6 – Maintaining Process Effectiveness (Clause 12)
Learning Objectives: Describe requalification, calibration, and change management processes
Key Contents: Preventive maintenance; Recalibration; Partial & full requalification; Change assessment and risk review
Session 2.7 – Summary, Post-Test & Evaluation
Learning Objectives: Consolidate understanding; Assess knowledge gain
Key Contents: 10 MCQ post-test; Participant feedback; Certificate distribution
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