The 2020 release of the EU GMP Annex 1 includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity that is referenced multiple times. We discuss the changes here.
When Argonaut Manufacturing was setting up their new state-of-the-art fill line they wanted the best contamination monitoring solution in a tight timeframe. Watch how Argonaut and PMS worked together to complete the mission.
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.