It all started in 2013 with Boehringer Ingelheim (BI) requesting a flexible filling line for high value parenteral biopharmaceuticals. BI contacted Bausch+Stroebel and SKAN and asked for us to team up and to meet the following requirement: Design and build the first of its kind highly flexible portable filling skid to fill various containers in a pre-sterilized configuration (syringes, cartridges and vials) with the filling operation taking place in an isolator, different from the traditional way of thinking with individual filling and closing machines installed permanently in an isolator for each type of container. Further, BI requested for the line to be cost effective with a small footprint to keep facility costs to a minimum. A challenge, to be sure!
To render the project cost effective, we utilized a standard isolator from SKAN to allow for a modular and expandable line, as needed. The internal footprint of the isolator defined the size for the portable filling skids to enable filling the different containers.
To fit the design on to the portable filling skids Bausch+Stroebel took their existing vial and syringe technologies and made minimal changes. The skids are portable and once in location plug-and-play technology for the utilities is used to power the line. After numerous mock-up activities between Boehringer Ingelheim, SKAN and Bausch+Stroebel we were able to finalize the design and meet the ergonomics, making the line a success. Three isolators, a de-bagging station for the containers, a rapid transfer airlock and three portable skids for the filling and sealing operations make up the line. The isolator modularity enables the customer to start with one chamber and one filling skid and over time more isolators and other skids can be added. A new brand for flexible portable filling skids was born called:
In 2015, with several projects worldwide we continued to add flexibility and new technologies – such as different ways to handle the containers (with a washer and dry heat tunnel to increase efficiency), adding a larger GEA freeze dryer with ALUS, powder or three different liquid filling systems, IPC for weight checks (on the portable skid!), aseptic compounding, ampoule filling, cartridges with bulk or in-nest processing. The line is suitable for development through commercial filling.
The flexibility revolution and VarioSys® evolution continues today with more technology coming in the future!
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