You will learn how to apply qualification measurements in cleanrooms

– You will receive a concise overview of measurements in cleanrooms

Measurement technology, implementation according to Annex 1 and DIN ISO 14644

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

This seminar will thoroughly cover the essential regulatory frameworks such as the EU GMP Guide with Annex 1, 21 CFR Parts 210 and 211, as well as relevant standards. A focus will be on the various methods for qualifying cleanrooms, including measuring air velocities, determining cleanroom classes, and conducting leak tests.

Participants will also gain practical insights into the use of modern testing and measuring devices necessary for these tasks. The monitoring of cleanrooms, including the supervision of HVAC systems and GMP-compliant data collection, will be discussed in detail. Additionally, microbiological monitoring will be presented as an important component of cleanroom surveillance.

Additional modules

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