Midicaps: disposable filter capsules for use in the biopharmaceutical industry

Description The new MidiCaps feature an innovative capsule housing design for the existing filter units of all Sartorius filter media. MidiCaps focus on design improvements of the filter capsule housing to allow for use in aseptic processing in the biopharmaceutical industry. Applications MidiCaps will be made available for all filter materials. MidiCaps can be used for a broad range of applications in biopharmaceutical downstream processing and filling operations like: Sterilizing grade filtration Mycoplasma retentive filtration Bioburden reduction Prefiltration Clarification Labeling The unique, easy to read labeling of each MidiCap includes filter type, order code, poresize or retention rating, lot-no., piece-no, operating parameters and flow direction indication. Correct handling and easy identification of each filter element is assured to enhance manufacturing security. Flexible Integration MidiCaps are available with a broad range of different connector styles and with various filter sizes to allow for an easy integration into any process. Vent Design A GMP-complaint drain- and vent valve design, with double-o-ring sealing and integral hose barb for fluid containment during the venting and draining process make MidiCaps the ideal choice for using disposables in aseptic processing operations for all filter media. Optimized Design Reduced dead volumes, maximized flow rates and enhanced mechanical stability are key features of MidiCaps. Technology Integration MidiCaps will be available as gamma irradiatable capsules for use with flexible bag container technology. Availabilility MidiCaps will become available for all filter materials of Sartorius AG including: Sartopore 2 544... Sartopore 2 Gamma 544...G Sartobran P 523.. Sartolon 510... Sartofluor 518... Sartoclean CA 562... Sartoclean GF 560... Sartopure PP2 559... Sartopure GFPlus 557... Documentation MidiCaps have been fully validated according to USP and FDA requirements. The validation data has been summarized in a comprehensive "Comparability Study" to demonstrate full comparability between the existing capsule design and the MidiCaps design.