Sterilisation Validation PRO - EtO, Radiation and Steam (ISO 11135, ISO 11137 and ISO 17665)

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Course description

A course in the Special Process Validation series dedicated to validating medical device sterilisation processes. Covers microbiology fundamentals (D-value, z-value, SAL 10⁻⁶), method selection and an in-depth examination of the three most widely used methods (ethylene oxide under ISO 11135, radiation under the ISO 11137 series, and moist heat/steam under ISO 17665), as well as emerging methods (VHP, NO₂, dry heat) and cross-cutting topics, with requirements aligned with ISO 13485, FDA QMSR, MDR and RDC 751/2022.

02

Course objective

Prepare participants to conduct and defend complete medical device sterilisation process validation, from defining SAL and bioburden to periodic revalidation, mastering IQ/OQ/PQ for each method, parametric release and contract steriliser management, producing robust dossiers for ANVISA, FDA and European notified bodies.

03

Course programme

14h of in-depth learning
  1. 01

    Sterilisation Fundamentals and Method Selection

    Applied microbiology (D-value, z-value, SAL), microbial inactivation kinetics and the SAL 10⁻⁶ requirement. Comparative analysis of methods (EtO, radiation, steam, VHP, dry heat), a method selection decision framework, bioburden-based versus overkill approaches, and the ISO 14937 framework for non-traditional sterilising agents.

    2h
  2. 02

    Ethylene Oxide (EtO) Sterilisation, ISO 11135

    Process fundamentals (preconditioning, exposure, aeration), cycle development and critical parameters, IQ/OQ/PQ, biological indicators and fractional cycles, parametric release, EtO residuals (ISO 10993-7 limits, GC-FID/GC-MS methods), and environmental and occupational safety. A polymer surgical kit case study.

    4h
  3. 03

    Radiation Sterilisation, ISO 11137 Series

    Gamma, electron beam and X-ray. Dose establishment methods (VDmax, Method 1, ISO/TS 13004), dose mapping, product qualification, dose auditing and SIP, material compatibility and transfer between facilities. A VDmax dose establishment case study for a Class IIa orthopaedic implant.

    3h
  4. 04

    Moist Heat (Steam) Sterilisation, ISO 17665

    Saturated steam principles, cycle types, thermocouple mapping and cold spot identification, biological and chemical indicators (ISO 11138, ISO 11140), Bowie-Dick and leak tests, cleaning validation for reusable devices (ISO 15883 interface), and liquid loads (F₀ calculation). A reusable instrument tray case study.

    3h
  5. 05

    Emerging Methods and Cross-Cutting Topics

    Vaporised hydrogen peroxide (VHP, ISO 22441), nitrogen dioxide (NO₂), dry heat (ISO 20857), sterility testing (ISO 11737-2), process equivalence and product family grouping, contract steriliser management and regulatory trends (FDA, EU MDR, MDSAP Health Canada).

    2h

04

Who can attend?

  • Validation, Quality, Process Engineering, Production and Regulatory Affairs professionals, microbiologists and consultants working in medical device manufacturing and outsourced sterilisation.

Instructor

Leda Longhi

Exemplar Global-certified ISO 13485:2016 and MDSAP Lead Auditor, specialising in special process validation (EtO, radiation and steam sterilisation under ISO 11135, ISO 11137 and ISO 17665), with experience in ANVISA and LATAM regulatory dossiers, Quality Management and Medical Device Vigilance.