Cytostatic preparation line – ISPE FOYA Winner (2016)
High containment production of cytostatics
The entire process technology for a cytostatic approach was to be realised as a complete solution for a customer. Protecting the product from all kinds of influences and protecting the operators from the highly active pharmaceutical ingredients (API) is the top priority here. Therefore, not only should the production containers be able to be filled contamination-free with the aid of containment isolators, but the entire system should also be CIP/SIP-capable. A Siemens PCS7 control system was selected for the required flexible recipe design, and the interfaces of the system with the incoming media and the downstream consumers were configured accordingly.
Process System in skid design
This process plant - which was honoured with the ISPE FOYA Award in 2016 - enabled the customer to double its output - without interrupting operations. State-of-the-art isolator technology in combination with preparation tanks and the corresponding skid-mounted system technology now offers maximum flexibility for the production of liquid formulations (organic solvents, biologics, suspensions) and guarantees flawless product quality with economical production.
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