Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex 1.

Globally supplying companies, which deliver sterile drugs to Europe, must comply with this new regulatory requirement. There is an impact for all stakeholders of manufacturing, across hierarchy levels and various functions at manufacturers. Also, suppliers have to consider Annex 1 when supplying new equipment or installing new production facilities.

This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.

Linked to the lecture on aseptic process and facilities design, attendees will tour the facility to observe the practical implementation of the EASE facility design and conduct exercises to ensure compliance. In terms of processes, the training will enable participants to perform manipulations for aseptic operations within biosafety cabinets (BSC), and comprehend upstream processes, preparation, and connections/disconnections.

Additionally, attendees will explore the Restricted Access Barrier Systems (RABS) and an aseptic filling line in the EASE facility's preparation room, observing equipment loading procedures and understanding their usage. Subsequently, participants will move to the room housing the filling machine, where machine setup operations will be discussed, and a smoke study demonstration will be conducted to allow attendees to observe the effects on actions within critical areas. This part of the training will focus on learning how to operate a RABS machine effectively.