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Due to the long-lead time and high-cost of disrupting a commercial operation for an R&D or clinical activity, fill and finish machineability or compatibility testing is often performed after critical decisions like the finalization of the formulation and container closure.
Technology Excellence Centers offer small-scale replicas of industrial fill and finish setups, installed inside ISO-5 laminar air flow hoods in a laboratory environment, that can be used to prepare various containers (e.g., vials, syringes, cartridges) with various target media (e.g. viscous placebos, drug product).
Demonstrate the machineability of your container, closure, and drug as early as the container selection phase.
Improve the quality of your tests by using containers finished with representative vacuum or vent tube stoppering.
Start process development before your commercial line even arrives.
Factors like plunger location, plungering method, air bubble size, and fill volume variation can all affect your product performance and may change the values measured in downstream tests like extrusion force testing, dose accuracy and injection time. Our two TECs offer you multiple options to study and improve this critical process to deliver robust and phase appropriate results.
Our Colanar fill and finish machine offers immediate versatility for vacuum stoppered containers. Our existing change parts span multiple syringe, cartridge and vial formats to allow us to start filling your components as soon as possible. Both TEC’s have peristaltic and rotary piston pumps to dispense both water-like and high-viscosity drugs, from under 0.5ml to over 20 ml.
Our Groninger fill and finish machine offers both vent tube and vacuum assisted stoppering techniques while also being our fastest machine thanks to its dual dispensing and stoppering capability. With the capability to process syringes, cartridges and vials within an ISO Class 7 clean room under laminar air flow, our EMEA TEC location offers our highest quality environment to produce filled and stoppered containers.
