You will learn how to apply qualification measurements in cleanrooms

– You will receive a concise overview of cleanroom measurements

Measurement technology, implementation in accordance with Annex 1 and DIN ISO 14644

You will be able to derive the various requirements for measurement technology. You will apply the specifications set out in the new Annex 1 and DIN ISO 14644 to your own operational environment. You will receive answers to your practical questions.

This seminar provides an in-depth examination of the key regulations, such as the EU GMP Guidelines with Annex 1, 21 CFR Parts 210 and 211, and relevant standards. A particular focus is placed on the various methods for qualifying cleanrooms, including measuring air velocities, determining cleanroom classifications, and conducting leak tests.

Participants will also gain practical insights into the use of modern testing and measuring equipment required for these tasks. Cleanroom monitoring, including the monitoring of HVAC systems and the GMP-compliant recording of measurement data, will be covered in detail. In addition, microbiological monitoring will be presented as an important component of cleanroom monitoring.

Further modules

– Rooms, Air and Technology: Design and Qualification of Rooms
– Rooms, Air and Technology: Ventilation Systems