by Andrea Wagner, PhD, SVP, Business Development
Berkshire Sterile Manufacturing
This week I had the pleasure of attending Pharma Kongress in Dusseldorf where there were a wide variety of talks given on pharmaceutical packaging, filling, and dispensing. Berkshire Sterile Manufacturing co-presented a talk on “The Development of an Isolator Based Flexible Filling system for all Containers” with Alessandro Massignani from OMPI. The presentation focused on the flexible filling system that BSM has invested in for filling of vials/syringes and cartridges in isolated environments. The complexity that is required to install multiple lines is eliminated and it also offers much greater sterility assurance as the entire process is enclosed in an isolator. This line connects from the depyrogenation oven to the lyophilizers and offers filling of all types of containers.
Colanar, a German company, has produced the BSM flex filler that can withstand VHP sterilization – taking out the need to have three separate fillers for syringes, vials and cartridges. You remove change part needs as you don’t have fly wheels that are typically specific to the container. The isolator line is fully integrated with the lyophilizer and the depyrogenation oven as well.
Also available at BSM is a RABS system that introduces the pre-sterilized or ready to fill (RTU) containers that OMPI makes. They have been a world leader offering innovative solutions to containers to fill drug and device products into. OMPI has syringes, vials and cartridges in a pre-nested format that can fit into a flex filling line. They are in the process of doing this as an option to ETO sterilized materials. Innovation in the sterilization of these products continues.
The exciting part of this is not the fact that this system is available for clinical production or that OMPI provides excellent products that can be used in this environment but the combination of these elements. You can now get filling of all these on one line, add in flexibility of bulk glass with lyo and you have it all.
Check out their talk at www.pharma-kongress.de.