Seminar: Cleanroom qualification and monitoring according to ISO 14644
Date: 17 September 2019
Particle Measuring Systems | CAS Clean-Air-Service AG
In the seminar you will learn…
The ISO norm 14644 is the bible for qualification and monitoring of cleanrooms. In part 3 test procedures e.g. it specifies how to scan the air filters. The part 3 exists in the version from 2005. We will give you a forecast of what will change in the new version of 2019. The part 1 qualification and part 2 monitoring of ISO norm have already been released 2015, but the changes of the previous version from 1999 are significant. For instance the 5µm particle is no longer mandatory. The hose length and the number of particles were relevant for this decision. The upcoming EU GMP Annex 1 specifies the 5µm particles for the production of sterile pharmaceuticals. So what about these two requirements? What should you observe? Until when do you have to update your SOPs? What about the intervals of control and monitoring? You will get answers to all these questions in the seminar. In the practical part in a cleanroom you will learn how to proceed a cleanroom qualification, measure properly and a lot more. Long-time practice-oriented referents point out where you can make mistakes, what you have to consider and how you will achieve your goal efficiently.
The event is aimed at all employees of the sectors
- Production in pharmaceutical companies
- Production in lab operation
- Pharmaceutical service provider
- engineering companies and plant constructors
- Quality assurance
- Hospital pharmacies that run cleanrooms, or plan and configure cleanrooms.