Understanding the Interrelationships: Facilities, Production, Personnel, Microbiology in Aseptic Processing

– Training for employees, department heads or supervisors assigned tasks in aseptic production
– New Annex 1 of the EU GMP Guide

Sterility of the product must be achieved and maintained during manufacture!

Aseptic filling is one of the most demanding activities and is therefore considered a supreme discipline in pharmaceutical manufacturing. Aseptic filling can only be successful when the right balance of proven practical technology, microbiological expertise and qualified personnel comes together.

Annex 1 with the highest requirements for the production environment, personnel and processes to ensure product safety

As the title suggests, the new Annex 1 focuses on the manufacture of sterile medicinal products and, in particular, on aseptic production. But what is required for this?

You will learn which prerequisites should be in place and which regulatory requirements from the new Annex 1 must be observed.

Additional Modules

– Aseptic filling: Requirements for personnel
– Aseptic filling: Aseptic process simulation – Media Fill