As well as pharmaceutical production based on complex organic molecules, manufacturing of advanced biologic drugs and vaccines must ensure that in-process contamination risks are mitigated as effectively as possible. Tailored polymer-based single-use fluid management solutions offer a range of significant safety and efficiency benefits over conventional glass- or steel-based multi-use systems specifically to biopharma manufacturers.
In addition to safety aspects, biopharma manufacturers are particularly challenged to achieve cost efficiencies in a wider variety of laboratory settings and production scenarios, i.e. from very small to medium to larger scales, depending on the type of vaccine or drug and scope of therapeutic application. Another key challenge is the prevention of costly losses of these complex and typically high-value products due to in-process leakage or contamination. Last but not least, vaccine manufacturers may have to quickly and efficiently ramp up their production volumes in response to suddenly emerging increases in demand. Conversely, processes must allow for equally easy down-scaling when demand drops.
The utilization of customized, fully scalable polymer-based single-use fluid management systems yields major safety, cost efficiency, and flexibility/scalability benefits and thus are highly suitable for meeting all of the above challenges.
Drawing on many years of experience in the field of polymer materials and clean room production as well as extensive knowledge of biopharmaceutical processes and validation procedures, Parker Prädifa assists in identifying and maximizing the potential applications of single-use systems in laboratory and production environments.
The available solutions range from standardized TriClamp sanitary gaskets to highly customized solutions. They are based on a cost-effective open architecture and manufactured from approved TPE and LSR materials using state-of-the-art proprietary overmolding technology.
The support by a specialized team of industry experts starts with product design and culminates in a final, fully scalable, and ready-to-use solution ensuring that all regulatory and safety requirements are met. Every single-use solution is precisely tailored to the existing, validated production framework and provides significant overall system cost reduction potential.
Manufacturing, assembly, and packaging processes in certified cleanrooms are a basic prerequisite for serving pharmaceutical and biopharmaceutical customers. In Europe, Parker Prädifa operates two cleanroom production facilities: one in Sadska (Czech Republic) certified according to ISO 14464 Class 7 and one in Pleidelsheim (Germany) certified according to ISO 14464 Class 8.
Posted by Dr. Heinz-Christian Rost, market unit manager life sciences, Engineered Materials Group Europe, Prädifa Technology Division