Transcription of MidiCaps - Psfiltración
1 SpecificationsMaterialsCapsule Housing: PolypropyleneO-Ring Material:SiliconeFilling Bell:PolycarbonateAvailable Sizes|Filtration Area Size 7 m2| ft2 Size 8 m2|1 ft2 Size 9 m2|2 ft2 Size 0 m2|5 ft2 Available Connectors StylesSS, SO, OO, FF, FO, HH (only size 7)S:11 Tri-Clamp (Sanitary)O:Single stepped hose barbF:3 Tri-Clamp (Sanitary)H:Small, multiple stepped hose barb(with filling bell at the outlet)Operation ParametersMax. Allowable5 bar| psi Differential Pressure: at 20 C2 bar|29 psi at 80 CMax. Allowable Back 2 bar|29 psi at 20 CPressure:MidiCapsDisposable Filter Capsules for Use in the Biopharmaceutical IndustryDescriptionThe new MidiCaps feature an innovative capsule housing design for the existing filterunits of all Sartorius filter media.
2 MidiCapsfocus on design improvements of the filtercapsule housing to allow for use in asepticprocessing in the biopharmaceutical will be made available for all filtermaterials. MidiCaps can be used for a broadrange of applications in biopharmaceuticaldownstream processing and filling operationslike: Sterilising grade filtration Mycoplasma retentive filtration Bioburden reduction Prefiltration ClarificationLabelingThe unique, easy to read labeling of eachMidiCap includes filter type, order code, pore-size or retention rating, lot-no., piece-no,operating parameters and flow direction indication. Correct handling and easy identi-fication of each filter element is assured toenhance manufacturing IntegrationMidiCaps are available with a broad range ofdifferent connector styles and with variousfilter sizes to allow for an easy integrationinto any process.
3 Vent DesignA GMP-complaint drain- and vent valve design,with double-o-ring sealing and integral hosebarb for fluid containment during the ventingand draining process make MidiCaps the ideal choice for using disposables in asepticprocessing operations for all filter DesignReduced dead volumes, maximized flow rates and enhanced mechanical stability arekey features of IntegrationMidiCaps will be available as gamma irradiatable capsules for use with flexible bag container will become available for all filtermaterials of Sartorius AG including: Sartopore 2 Sartopore 2 Gamma Sartobran P Sartolon Sartofluor Sartoclean CA Sartoclean GF Sartopure PP2 Sartopure GF2 have been fully validated accordingto USP and FDA requirements.
4 The validationdata has been summarized in a comprehensive Comparability Study to demonstrate fullcomparability between the existing capsuledesign and the MidiCaps meet, or exceed the requirementsfor WFI quality standards set by the ComplianceIntegrity test correlated to HIMA/ASTM F 838-83 Bacteria Challenge TestNon pyrogenic according to USP BacterialEndotoxinsPass USP Plastic Class VI TestNon fiber releasing according to 21 CFR SterilisationAutoclaving:134 C, 2 bar, 30 minNo In-Line Steam SterilizationSterilization CyclesAutoclaving:Min. 25 Technical ReferencesComparability Study:SPK5750-e04121 Change Notification LetterSPK1507-e05011 Water Flow Rates of MidiCaps housings of Size 9 with different connector stylesDifferential Pressure [bar]0,50,40,30,20,100200040006000800010 000 12000 14000 Flow Rate [l/h]Sartorius AGWeender Landstrasse 94 10837075 Goettingen, GermanyPhone + + + + + + + + subject to change without notice.
5 Printed and copyrighted by Sartorius W/sart-000 GPublication No.: SPK2060-e05011 Order No.: [psi]RR OOSSFlow Rate [l/h]80006000400020000 Size 7 SSSize 8 SSSize 9 SSSize 0 SSSartopore 2 Capsules m ratedFlow Rate Comparison of existing capsule design and MidiCapsExisiting Capsule DesignMidiCaps Design
