FREE WEBINAR – SARTORIUS: ROAD TO #PMC2021
The EU GMP Annex 1 Revision 2020 and its impact on Microbial Air Monitoring
The EU GMP Annex 1 revision on the manufacture of sterile medicinal products specifies that in Grade A areas, any growth detected in one cubic metre of sampled air should result in an investigation. It is therefore recommended that any risk caused by interventions of the monitoring operations be avoided. Most environmental monitoring programs are not restricted to the collection of only one cubic meter of air but rather involves the monitoring of the entire duration of the manufacturing shift. This can prove challenging for traditional monitoring methods. In this webcast, we present our solutions for continuous, intervention-free active air monitoring for a tested period of 8 hours – the period of a typical manufacturing shift.