Supporting Programme 2023
Safe and flexible - a future oriented approach of filling small batches
Showing the attendees a new industry standard for fill/finish for small and micro batches. The core is a gloveless isolator allowing to fully exclude the operator out of the core filling process and with that ensuring high pharmaceutical quality.
To be prepared for batch sizes ˂ 3,000 units, the pharmaceutical industry must invent new processes and technologies. For example for very small batches, orphan drugs, cell and gene therapy, clinical trials...
Using a development partnership between Syntegon and Vetter, a new industry standard for fill/finish has been created. The innovative system is based on a gloveless isolator cell with a versatile robot, which is responsible for filling as well as for line set-up and environmental monitoring.
With the focus on flexibility, a broad range of pre-sterilized packaging components (mature as well as very new ones) including pre-filled syringes either made of glass or plastic can be handled. A new sorting system has been established to accomplish that. A comprehensive monitoring system and 100% fill weigh checks allow a continuous process control.
No operator is required for the aseptic set-up and monitoring. These activities are all carried out by the robot.
The small number of equipment parts, required for adapt to the different formats, can be exchanged in a fast process prior to H2O2 decontamination. These parts are all steam sterilized. This allows a fully automatic set-up of the machine by the robot completely in compliance with the new Annex 1 EU guideline Manufacture of Sterile Medicinal Products.
--- Date: 27.09.2023 Time: 10:30 - 11:00 Location: Expert Forum II in Hall 4, Booth 4-325