Sterile Packaging Validation PRO - ISO 11607-1 and ISO 11607-2 in Practice

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Course description

A course in the Special Process Validation series dedicated to the complete development and validation life cycle of sterile barrier systems (SBS) for medical devices, based on ISO 11607-1 (requirements for materials and systems) and ISO 11607-2 (validation of forming, sealing and assembly processes). Covers system architecture and material qualification, seal design and process development, IQ/OQ/PQ, stability and shelf-life studies, simulated distribution (ASTM D4169) and packaging integrity, meeting ANVISA, FDA and European notified body expectations.

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Course objective

Equip participants to develop, validate and maintain robust sterile barrier systems, including material qualification, sealing process validation (IQ/OQ/PQ), accelerated and real-time ageing studies, distribution simulation and integrity testing, fully meeting global regulatory requirements.

03

Course programme

10h of in-depth learning
  1. 01

    Packaging System Architecture and Materials

    ISO 11607-1:2019: sterile barrier systems (SBS) versus protective packaging, preformed SBS (pouches, trays, header bags), material qualification (Tyvek, medical-grade paper, films), performance testing (ASTM F2638 microbial barrier, breathability), sterilisation compatibility and usability for aseptic presentation.

    2h
  2. 02

    Seal Design and Process Development

    Sealing technologies (heat, impulse, ultrasonic, adhesive), critical seal parameters (temperature, time, pressure), design principles (peel versus non-peel, chevron seals), process development using DOE, geometry and channel testing, forming processes (thermoforming) and labelling integration.

    2h
  3. 03

    Packaging Process Validation: IQ/OQ/PQ (ISO 11607-2)

    ISO 11607-2:2019 requirements, forming and sealing IQ/OQ/PQ, seal strength testing (ASTM F88 peel, ASTM F1140/F2054 burst), integrity testing (ASTM F1929 dye penetration, ASTM F2096 bubble emission, vacuum decay, HVLD), visual inspection and assembly validation. ISO/TS 16775:2021 guidance. Sealing OQ/PQ protocol workshop.

    3h
  4. 04

    Stability, Shelf Life and Distribution Validation

    Accelerated ageing (ASTM F1980, Q₁₀ factor), real-time studies, post-ageing performance testing, distribution simulation (ASTM D4169, ISTA 2A/3A), worst-case transport scenarios and shelf-life claim substantiation. A complete case study for a Tyvek pouch system.

    2h
  5. 05

    Packaging Integrity and Point-of-Use Considerations

    Non-destructive integrity testing (vacuum decay, HVLD, headspace), pre-use inspection (ISO 11607-1 Annex B), aseptic presentation assessment, double sterile barrier systems, event-related versus time-related shelf life and post-market packaging surveillance.

    1h

04

Who can attend?

  • Packaging engineers, Validation, Quality, R&D, Process Engineering and Regulatory Affairs professionals, and consultants working in sterile medical device development and manufacturing.

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.