Pall Supor EKV Sterilizing Grade Filters USD 46b
Supor EKV Sterilizing Grade Filters Pall Supor EKV filters are validated sterilizing grade membranes for the most cost effective filtration of a wide range of liquids such as buffers tissue, culture media, and others. The incorporated PES membrane demonstrates very high compatibility over the whole ph range plus very low protein binding to ensure the maximum transmission of the active ingredients. The patented Ultipleat filter technology, combined with the optimized, built-in asymmetric prefilter for higher flow rates and throughput, allows very compact sizing for easy integration in disposable systems.
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Allegro Systems: The Disposable Solutions High flexibility, minimized cleaning, cleaning validation, enhanced sterility, and cost control, through the whole drug development cycle and during full manufacturing are clear industry targets. The Allegro disposable systems, which incorporate Pall Kleenpak capsules, are the answer to these requirements as they completely eliminate the need for cleaning and related validation, minimizing major capital investment, and offering very high flexibility while enhancing the quality of aseptic processing. For liquids from several milliliters up to full production scale volumes, a wide range of Supor EKV filter products are available in disposable format and can thus be integrated into Allegro disposable systems. AllegroSystems The Single-Use Solution 5 5
Mini Kleenpak Syringe Filters Page 7 Mini Kleenpak Capsules Page 8 Mini Kleenpak Capsules Page 9 Kleenpak Capsules Page Novasip Capsules Page Kleenpak Nova Capsules Page, Save Time, Get Results SM The Pall UpScale Program Supor EKV filters are available in a wide range of scalable, encapsulated formats which allow fast and easy scale-up, to bring your product to the market faster. Same materials* From syringe filters to production scale, all products incorporate the same membrane and the identical materials of construction. * Except Novasip Capsules. See material of construction tables for each product for further details. Quality Every Supor EKV pleated filter is: Integrity tested during manufacture Identified by lot and serial number for total traceability Supplied with a certificate of test confirming each filter: Meets USP Biological Reactivity test in vivo, for class VI- C plastics Meets cleanliness per USP Particulates in Injectables Is Non-Fiber-Releasing Is Non-Pyrogenic per USP Endotoxins (<.5 EU/mL) Meets Total Organic Carbon and Water Conductivity per USP Purified Water. Junior Filter Cartridges Page 4 Filter Cartridges Page 5 6
Mini Kleenpak Syringe Filters Materials of Construction Filter Membrane Housing, Vent Plug and Support Material Sealing Technology Operating Parameters () Hydrophilic PES Insert molding Maximum Operating 5.4 bar (8 psi) at C Temperature and Pressure. bar ( psi) at 6 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 8 6 4 4 5 Flow rate (ml/min), water at ºC 6 4 8 6 4 Typical Hold Up Volume <.5 ml Nominal Dimensions Capsule Length Capsule Diameter mm (.8 in.) 9 mm (. in.) Sterilization () Pre-sterilized, subject to a minimum of 5 kgy of Gamma-irradiation () Pre-sterilized Mini Kleenpak syringe filters must not be re-sterilized Mini Kleenpak syringe filters must not be sterilized in-situ by passing steam under pressure Nominal Effective Filter Area (EFA).8 cm (.4 in ) Ordering Information () Pall Part Number: KMEKVP S Shipping Format Presterilized using gamma irradiation () 5 filters per box 7
Mini Kleenpak Capsules Materials of Construction Filter Membrane Housing, Vent Plug and Support Material Filling Bell Sealing Technology Operating Parameters () Maximum Operating Temperature and Pressure Hydrophilic PES Polycarbonate Thermal bonding without adhesives.4 bard at C ( psid) 6 4 8 6 4 () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 4 5 6 Flow rate (ml/min), water at ºC Typical Hold up Volume <.5 ml Nominal Dimensions Capsule Length Capsule Diameter 8 mm (. in.) 67 mm (.7 in.) Sterilization () Autoclave x 6 minutes at 5 C () Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Pre-sterilized Mini Kleenpak capsules should not be re-irradiated Nominal Effective Filter Area (EFA) cm (. in. ) Ordering Information Pall Part Number: KM5EKVP () filters per box (4) filters per box Connection Shipping Format 4 in. (6 mm) stepped hose barb with inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet G (4) S () Non-sterile Gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation (maximum 5 kgy) 8
Materials of Construction Filter Membrane Support/Drainage Capsule Shell Filling Bell Sealing Technology Operating Parameters () Mini Kleenpak Capsules Maximum Temperature 4 C Hydrophilic PES Polycarbonate Thermal bonding without adhesives Maximum Operating Pressure 4. bar (6 psi) at 4 C Maximum Differential Pressure 4. bar (6 psi) a t 4 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 4 5 6 7 8 9 Flow rate (ml/min), water at ºC 4 Sterilization () Autoclave x 6 minutes at 4 C Gamma Irradiation Maximum of 5 kgy () Pre-sterilized Mini Kleenpak capsules must not be re-sterilized. Mini Kleenpak capsules must not be sterilized in-situ by passing steam under pressure Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Typical Extractables in Water at C < 5. mg per capsule Nominal Dimensions Maximum diameter including valves Length - Length - 8 Nominal Effective Filter Area (EFA) cm (.4 ft ) 5 mm (. in.) 5 mm (4. in.) 7 mm (.9 in.) Ordering Information () Pall Part Number: KAEKVP Connection Options Shipping Format 8 4 in. (6 mm) hosebarb 4 in. ( 9 mm) sanitary flange G S (4) Non-sterile Gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation (maximum 5 kgy) () filters per box (4) S grade with P connection is provided with filling bell on outlet. It is removable for in-line use 9
Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Capsule Shell Sealing Technology Operating Parameters () Kleenpak Capsules Hydrophilic PES Thermal bonding without adhesives Maximum Temperature 4 C Maximum Operating Pressure 5. bar (75 psi) at C 4. bar (58 psi) at 4 C Maximum Differential Pressure 4. bar (58 psi) at 4 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction KA 4 5 6 7 8 KA KA Flow rate (L/min), water at ºC 4 Sterilization () Autoclave Gamma Irradiation 5 x 6 minutes at 5 C, slow exhaust Maximum of 5 kgy () Pre-sterilized Kleenpak capsules must not be re-sterilized Kleenpak capsules must not be sterilized in-situ by passing steam under pressure Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Nominal Dimensions KA KA KA Diameter incl. Valves 94 mm (.7 in.) 94 mm (.7 in.) 5 mm (4. in.) Length - 7 mm (4.6 in.) 57 mm (6. in.) 74 mm (6.8 in.) Length - 6 57 mm (6. in.) 97 mm (7.7 in.) mm (8. in.) Length - 6 7 mm (5.4 in.) 77 mm (7. in.) 9 mm (7.6 in.) Typical Extractables in Water at C KA / KA KA < 5 mg per capsule < mg per capsule Nominal Effective Filter Area (EFA) KA 75 cm (.4 ft ) KA 75 cm (.8 ft ) KA 5 cm (.6 ft ) Ordering Information Pall Part Number: KA EKVP Inlet/Outlet Connections Shipping Format 6 6 in. sanitary flange in. ( mm) single hose barb in. sanitary flange inlet and in. ( mm) single hose barb outlet G S Non-sterile Gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation (maximum 5 kgy)
Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Capsule Bowl Sealing Technology Housing Head Operating Parameters () Novasip Capsule Hydrophilic PES Polyetherimide Thermal bonding without adhesives Polyetherimide with TiO Maximum Temperature 6 C Maximum Operating Pressure 6.5 bar (94 psi) at 4 C. bar (9 psi) at 6 C Maximum Differential Pressure 4. bar (6 psi) at 6 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 4 5 6 7 8 Flow rate (L/min), water at ºC 4 Sterilization () Autoclave 5 x 6 minutes at 5 C, slow exhaust In-Line 5 x 6 minutes at 5 C () Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Nominal Dimensions Diameter incl. Valves Overall Length mm (4.8 in.) 57 mm (6. in.) Typical Extractables in Water at C < mg per capsule Nominal Effective Filter Area (EFA) 5 cm (.6 ft ) Ordering Information Pall Part Number: CEKVP Inlet/Outlet Connections in. sanitary flange Blank A B Vent/Drain Connections Vent: Quick connect and disconnect coupling (compatible with Stäubli* fitting) Valve drain: Hose barb for 8 in. 4 in. (4 6 mm) i.d. tube, with valve Vent and drain: Quick connect and disconnect coupling (Stäubli* compatible) with valve Vent and drain: in. ( mm) sanitary flange, no valve sanitary clamp
Kleenpak Nova Capsules Materials of Construction Filter Membrane Support/Drainage Core/End Caps Cage O-rings Sealing Technology Housing Bowl Housing Head* Hydrophilic PES with TiO (white colored) Silicone elastomer Thermal bonding without adhesives Po lypropylene *Formulated with TiO whitener which does not contribute to organic extractables Typical Extractables in Water at C < 5 mg after 4 hours extraction (per 54 mm module) *Tested on elements without pre-flushing Nominal Dimensions In-line NP6 NP7 NP8 Maximum Diameter including valves 54 mm (6. in.) 54 mm (6. in.) 54 mm (6.in.) Length with hose barb inlet/outlet 97 mm (5.6 in.) 644 mm (5.4 in.) 895 mm (5. in.) Length with sanitary inlet/outlet 5 mm (. in.) 584 mm (. in.) 84 mm (.8 in.) Operating Parameters () Maximum Temperature 4 C Maximum Operating Pressure bar (44 psi) at 4 C Maximum Differential Pressure bar (44 psi) at 4 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction T-style NT6 NT7 NT8 Maximum Diameter including valves 4 mm (9.5 in.) 4 mm (9.5 in.) 4 mm (9.5 in.) Length 49 mm (.7 in.) 598 mm (.5 in.) 848 mm (.4 in.) Sterilization () Autoclave: x 6 minutes at 5 C Gamma irradiation: Maximum of 5 kgy Nominal Effective Filter Area (EFA).6 m per 54 mm module (6.5 ft per in. module) () Pre-sterilized Kleenpak Nova capsules must not be re-sterilized Kleenpak Nova capsules must not be sterilized in-situ by passing steam under pressure Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing
Kleenpak Nova (NP) Kleenpak Nova (NT) 6 8 6 8 5 7 5 7 4 P Capsules (sanitary flange) P9 Capsules ( in. hose barb) 6 5 4 4 P6 Capsules ( in. hose barb) P9 Capsules ( in. hose barb) P Capsules (sanitary flange) 6 5 4 4 6 8 Flow rate (L/min), water at ºC 4 6 8 Flow rate (L/min), water at ºC Ordering Information Pall Part Number: N EKVP Style Filter Size Shipping Format Vent/Drain P T In-line T-style 6 7 8 54 mm ( in.) 58 mm ( in.) 76 mm ( in.) G S Non-sterile Gamma irradiatable/autoclavable Pre-sterilized using gamma irradiation (mimimum 5 kgy) Blank A Stäubli* vent and stepped hose barb drain Stäubli* vent and drain Connection Options 9 9 6 () 6 () H () H9 () in. sanitary flange inlet and outlet in. (5 mm) single barb hose barb inlet and outlet in. sanitary flange inlet and in. (5 mm) single barb hose barb outlet in. ( mm) single barb hose barb inlet and outlet in. sanitary flange inlet and in. ( mm) single barb hose barb outlet in. sanitary flange inlet and outlet, with in. sanitary port on inlet in. sanitary flange inlet and in. (5 mm) single barb hose barb outlet, with in. sanitary port on inlet () For P-style only () For T-style only
Junior Filter Cartridges Materials of Construction Filter Membrane Hydrophilic PES 4 Support/Drainage End Cap, Core and Cage Sealing Technology O-rings Operating Parameters () Thermal bonding without adhesives Silicone Elastomer Maximum Differential Pressure 5. bar (75 psi) at 4 ºC () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 4 5 6 7 8 Flow rate (L/min), water at ºC Sterilization () Autoclave 5 x 6 minutes at 5 C, slow exhaust In Situ Steam x 6 minutes at 5 C () Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Typical Extractables in Water at C < mg per filter Nominal Effective Filter Area (EFA) 5 cm (.6 ft ) Ordering Information Pall Part Number: MCY444EKVP H4 O-ring material Silicone elastomer (Other material available on request) 4
Materials of Construction Filter Membrane Support/Drainage Core/End Caps Cage O-rings Sealing Technology Operating Parameters () Sterilization () Filter Cartridges Hydrophilic PES with TiO (white colored) Silicone elastomer Thermal bonding without adhesives Maximum Differential Pressure 5.5 bar (8 psi) at 4 C (Forward Direction) 4. bar (58 psi) at 8 C Maximum Differential Pressure. bar ( psi) at 4 C (Reverse Direction) () In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction Autoclave x 6 minutes at 5 C, slow exhaust In Situ Steam x 6 minutes at 5 C 5 x 6 minutes at 4 C () Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing AB5 4 AB 5 5 AB AB 5 5 5 5 Flow rate (L/min), water at ºC Integrity Test Values: Values for 54 mm ( inch) filter at C Max. allowable Forward Flow Water wet 7 ml/min (air test gas) at 76 mbar (4 psi) Contact Pall for multi-element integrity test values and recommended test procedures Typical Extractables in Water at C () < 5 mg after 4 hours extraction (per 54 mm module) () Tested on elements without pre-flushing Nominal Effective Filter Area (EFA) (4).6 m per 54 mm module (6.5 ft per in. module).6 m per 5 mm module (.8 ft per 5 in. module) (4) 5 in. filters are standard pleated. Ordering Information Pall Part Number: AB EKV P H4 Nominal Length Adapter Style O-ring material 5 5 mm (5 in.) 54 mm ( in.) 58 mm ( in.) 76 mm ( in.) 7 Pall code 7 double O-ring bayonet lock and fin Pall code double O-ring bayonet lock, no fin ( 5 only) Silicone elastomer (Other materials available on request) 5
New York - USA + 56 484 54 phone + 56 8 9548 fax biotech@pall.com e-mail Portsmouth - Europe +44 () 9 phone +44 () 9 56 fax BioPharmUK@europe.pall.com e-mail Visit us on the web at www.pall.com/biopharmaceutical Pall Corporation has offices and plants throughout the world in locations including: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, the United States and Venezuela. Distributors are located in all major industrial areas of the world. Because of developments in technology these data or procedures may be subject to change., Pall, Allegro, Kleenpak, Novasip and the Allegro design are trademarks of Pall Corporation. Filtration. Separation. Solution. and the UpScale logo are service marks of Pall Corporation. Staübli is a trademark of Staübli. Part Numbers quoted above are protected by the Copyright of Pall Corporation. indicates a trademark registered in the USA. 8, Pall Corporation. PELWR/MG/5.8/GN8.79/PDF