Description
This animation depicts the steps involved and flow path when using the manual drug product filtration system. Note that this is a visual representation; no voice-over. Using decades of experience in PUPSIT design, this ready-to-order PUPSIT solution includes both standardized hardware for consistent installation and standardized consumables for greater flexibility. By reducing the risk of incorrect installation and minimizing the time to implementation, our manual drug product filtration system allows you to meet EU GMP Annex 1 requirements with ease and confidence. Manual leak and integrity testing Integrity and leak testing ensure a defect-free single-use flow kit prior to committing the drug product. Using manually operated valves, the manual drug product filtration system can perform an integrity test, before and after sterile filtration. The Palltronic Flowstar V integrity test instrument can perform either a bubble point or forward flow integrity test. A leak test can be performed with the Palltronic Flowstar LGR integrity test instrument. Palltronic Flowstar integrity test instruments are provided separately from the system. Other integrity testers can also be used if desired. Minimized risk of incorrect installation The shadow board graphic guides the operator to correctly install the single-use flow kit to minimize the risk of operator error. The filter holders and valves enable the flow kit to quickly be attached and secured to the shadow board. The flow kit can be installed onto the system in less than 20 min and uninstalled in less than 10 min. Flexibility with movable valves and single-use flow kits The manual drug product filtration system can fit a wide variety of single-use flow kits. The patented movable valves can be moved along the shadow board graphic to accommodate single-use flow kits with either small or large capsules. This filtration system also fits flow kits with single and redundant filter configurations. The single-use filtration flow kits are available in a variety of sterilizing-grade membranes including Fluorodyne™ II DFL, Fluorodyne™ EX EDF, Supor™ EKV, Supor™ ECV, and Supor™ Prime membranes. Other membranes can be included upon request. Flow kits are offered with both Kleenpak™ Presto sterile connectors and AseptiQuik connectors. In addition to the single-use filtration flow kits, inlet, flush, and sampling flow kits are also available. Pressure monitoring An integrated pressure transmitter and pressure sensors monitor pressure during sterilizing-grade filtration. Pressure monitoring can be used to detect overpressurization of the single-use flow kit and possible sterility breach. Up to three pressure sensors are included in the flow kit design. When the pressure in the flow kit reaches a specified limit, the pump automatically shuts off, if the pump is plugged into the skid. The e-stop can also deactivate the pump and integrity tester immediately if this equipment is plugged into the skid. An RS232 data logger connection is available to log pressure data from the pressure transmitter. Connect to filling machine It is easy to connect the manual drug product filtration system to a final filling machine. Simply connect the outlet of the sterile filtration flow kit to the surge bag of the filling needle assembly . * All system product codes include a shadow board, trolley on casters, pressure transmitter, valves on valve plates, filter holders, sampling bracket, and 1× Allegro tray for biocontainers" up to 20 L. Click here for the automated version of the drug product filtration system
