Cleanroom Requirements for Medical Device Manufacturers Training Course

Course overview

Medical devices which will be aseptically manufactured, terminally sterilised or where their cleanliness is of importance in use need to be manufactured under controlled conditions. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state, including the environmental conditions under which manufacturing and primary packaging should take place. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving and maintaining sterility. Evidence of an appropriately controlled work environment is important and expected when demonstrating conformity with the regulations. 

These requirements are supported by a series of standards on designing, operating, testing and classifying clean environments.
This course provides an introduction to these regulatory requirements as they relate to the design and management of a controlled working environment for the manufacture of medical devices and how manufacturers may demonstrate compliance. 

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Benefits of attending

• Gain an overview of the types of controlled environments used for medical devices
• Understand the principles of cleanroom design, validation and ongoing monitoring
• Learn the regulatory requirements for controlled environments and how to comply
• Gain an awareness of the ISO 14644 and related series of standards.

Who should attend

• Quality Management System (QMS) specialists
• Maintenance and Validation Engineers
• Regulatory Compliance specialists
• Internal Auditors
• Regulatory and Quality professionals

Please note that delegates will require access to a copy of ISO 14644-1 and EN 17141 to gain the most from this training. If you do not already have access to these through your organisation, please see below the ways to acquire them:

• ISO 14644-1 - https://www.iso.org/standard/53394.html 
• EN 17141 - https://knowledge.bsigroup.com/products/cleanrooms-and-associated-controlled-environments-biocontamination-control

These standards are also available from national standards organisations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.

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