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The Cytiva™ drug product filtration system operates using configurable recipe-controlled phases to automatically perform terminal sterilization prior to filling with maximum product recovery using standard flow kits. It has been designed to support EU GMP Annex 1: Manufacture of sterile medicinal products requirements for contamination control strategies with automated in situ pre-use post-sterilisation integrity testing (PUPSIT) and post-use integrity testing of sterile filters.
A Palltronic Flowstar LGR integrity test instrument has been integrated to perform PUPSIT and post-use integrity testing of liquid filter capsules. Leak testing of the single-use flow paths is also carried out, ensuring the main flow kit is defect-free before committing product to the system. The testing is incorporated into the batch recipe for the process for full automation.
The design enables process flexibility with small Kleenpak™ filter capsules KA1 format spanning to Kleenpak™ Nova filter capsule 10-inch format enabling compatibility with different drug product formulations and batch volume sizes on the same system. The system is also filter independent, enabling other filter capsules to be incorporated as required into the flow kit.
The system can support flow kits including a single sterilising grade filter capsule configuration or a redundant filter configuration. The redundancy can further reduce the risk of repeating batch processing due to a failure of post-use integrity testing of the primary sterilizing grade filter. The system can automatically conduct PUPSIT and post-use integrity testing on both primary and redundant filters.
The drug product filtration system has a patented method for enhanced product recovery to ensure minimal product loss within the entire system flow path. This includes the addition of a pump to recover product from the filter inner core which increases the product recovery by up to 54% compared to pump draining and air blown down procedures alone.
The system has an adjustable integrated touchscreen HMI, which shows the process instrumentation diagram (PID) and batch processing overview screens with real time process pictures showing the current flow path, valve positions, and monitored value.
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