Cleanroom Validation PRO - ISO 14644, EN 17141 and EU GMP Annex 1

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Course description

A course in the Special Process Validation series on the design, qualification and validation of cleanrooms and sterile barrier environments in medical device manufacturing. Integrates the ISO 14644 series (classification, qualification and operation), EN 17141 (biocontamination control) and the principles of the revised EU GMP Annex 1, covering classification fundamentals, design and commissioning, IQ/OQ/PQ, environmental monitoring programmes and contamination control, aligned with ISO 13485 and RDC 751/2022.

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Course objective

Enable participants to design, qualify (IQ/OQ/PQ) and maintain cleanrooms and sterile barrier environments for medical devices, applying a contamination control strategy, particle classification, viable and non-viable particle monitoring, and risk-based requalification in accordance with global best practice.

03

Course programme

10h of in-depth learning
  1. 01

    Cleanroom Fundamentals and Classification

    The ISO 14644-1:2015 classification system (Classes 1 to 9), the historical FED-STD-209E context, distinctions between classification, monitoring and qualification, at-rest versus operational states, risk-based selection by device class and correlation with EU GMP Annex 1 (Grades A-D).

    2h
  2. 02

    Cleanroom Design, Construction and Commissioning

    ISO 14644-4: design principles, HVAC and zoning, airflow patterns (unidirectional versus non-unidirectional), pressure cascades, HEPA/ULPA filtration and integrity testing (DOP/PAO), facility layout, construction materials, and FAT/SAT and commissioning protocols.

    2h
  3. 03

    Cleanroom Qualification: IQ/OQ/PQ

    Installation Qualification, Operational Qualification tests under ISO 14644-3 (particle concentration, airflow velocity and uniformity, pressure difference, filter integrity, recovery time), Performance Qualification, sampling strategy (ISO 14644-1 Annex A), calculation of the 95% UCL and requalification. An OQ protocol workshop for an ISO 7 packaging area.

    3h
  4. 04

    Environmental Monitoring Programmes

    EN 17141:2020, viable versus non-viable particle monitoring, active and passive sampling, surface monitoring (contact plates, swabs, RODAC), alert and action limits, personnel monitoring, data management and integration with CAPA, and ISO 11737-1 bioburden testing. A multi-room programme case study.

    2h
  5. 05

    Cleanroom Operations and Contamination Control

    ISO 14644-5:2025 (Operations Control Programme), personnel gowning and re-gowning, cleaning and disinfection, material transfer protocols, process-generated contamination and change control in cleanroom environments.

    1h

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Who can attend?

  • Facilities and HVAC engineers, Validation, Quality, Microbiology, Production and Regulatory Affairs professionals, and consultants working with controlled environments in medical device 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.