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Introduction to Cleanroom Management | new date TBD

This training will help you gain in-depth knowledge on the classification, operation and management of these classified areas.

Target group

  • Candidates who want to get an introduction into cleanrooms and their operation/management.
  • Candidates who, professionally, will be directly working in a cleanroom environment.

About Cleanrooms

Companies that manufacture Medical Devices or Medicinal Products must ensure their product are safe for patients. Suitable controlled manufacturing suites reduce the chances of contamination of the product. A cleanroom facility is a complex construction in which a low concentration of airborne particulates is maintained. For medical development various standards & guidelines apply, including: US FED STD 209E, ISO14644-1, GMP.

Cleanroom management

To ensure the continued safe and effective use of cleanrooms it’s rudimental that these areas are designed, constructed, and maintained according to high specifications.

  • During the design phase for instance, the types of building materials and air handling units can have a big impact on the usability and lifetime of a cleanroom. Moreover, specific product categories, for instance biologics require abrasive cleaning agents which can damage materials.
  • A clear and enforced facility layout and flow of material and personnel is a important tool in preventing cross-contamination.
  • During operation it is paramount that all operators are aware of the impact they can have on the cleanroom environment by their behaviour. Strict gowning, behaviour, cleaning, monitoring and validation procedures need to be in place. And all personnel needs to be trained and qualified to be able to work in these environments safely and effectively.

Covered topics:


Cleanroom introduction

Incl. Cleanroom classification, ISO14644-1 and GMP cleanroom requirements, Medical Device cleanroom requirements

Cleanroom design & construction

Incl. Types of cleanroom, HVAC, Utilities, Access, Adjacent rooms, Personnel & Material Flows, Documentation

Cleanroom processes

Incl. Qualification and Validation (room and equipment), Environmental Monitoring (viable and non-viable), Cleaning, Gowning, Suppliers/supply management, HVAC, Documentation and Changes, Behavior

Hands-on introduction to environmental monitoring equipment & Cleanroom facility tour

449 -, excl. VAT

4 hours

Medace facilities, Maastricht

1:1 access to Operational and Facility Experts


Chris Duxbury – Manager Facilities and Technical Engineering at Medace BV

Chris Duxbury ensures that all the facilities and technical aspects in the Medace facilities run smoothly. Combining both his scientific expertise and project management skills, Chris has made a great effort in the design and development of the medical device and ATMP cleanroom facilities at Medace, in which he applied best practices from earlier developed facilities.

Do you have a question about this training?

About Medace

Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.

Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.

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