Sterilizing Grade Filters USD 2461

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Ilene Berry
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1 Pall Supor EKV Sterilizing Grade Filters USD 6

Supor EKV Sterilizing Grade Filters Pall Supor EKV filters are validated sterilizing grade membranes

low protein binding to ensure the maximum transmission of the active ingredients.

2 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.

Allegro Systems: The Disposable Solutions High flexibility, minimized cleaning, cleaning validation, enhanced sterility, and cost

The Allegro disposable systems, which incorporate Pall Kleenpak capsules, are the answer to these requirements as they completely

while enhancing the quality of aseptic processing.

5 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

6 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, SM The Pall UpScale Program Save Time, Get Results 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 Filter Cartridges Page 5 6

7 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. 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 Typical Hold Up Volume <.5 ml 5 Flow rate (ml/min), water at ºC 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 Dimensions Capsule Length mm (.8 in.) Capsule Diameter 9 mm (. in.) Nominal Effective Filter Area (EFA).8 cm (. in ) Ordering Information () Pall Part Number: KMEKV S Shipping Format () 5 filters per box Presterilized using gamma irradiation 7

8 Mini Kleenpak Capsules Materials of Construction Filter Membrane Housing, Vent Plug and Support Material Filling Bell Sealing Technology Operating Parameters () Hydrophilic PES Polycarbonate Thermal bonding without adhesives Maximum Operating. bar (6 psi) at C Temperature and Pressure. bar (5 psi) at 6 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Typical Hold up Volume <.5 ml Flow rate (ml/min), water at ºC 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 Nominal Dimensions Capsule Length Capsule Diameter Nominal Effective Filter Area (EFA) cm (. in. ) 8 mm (. in.) 67 mm (.7 in.) Ordering Information () Pall Part Number: KM5EKVP Connection Shipping Format () filters per box in. (6 mm) stepped hose barb with inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet G S Non-sterile Gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation (maximum 5 kgy) 8

9 Materials of Construction Filter Membrane Support/Drainage Capsule Shell Filling Bell Sealing Technology Mini Kleenpak Capsules Operating Parameters () Maximum Temperature C Hydrophilic PES Polycarbonate Thermal bonding without adhesives Maximum Operating Pressure. bar (6 psi) at C Maximum Differential Pressure. bar (6 psi) at C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of constructionn Flow rate (ml/min), water at ºC Sterilization () Autoclave x 6 minutes at 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 - Length - 8 Nominal Effective Filter Area (EFA) cm (. ft ) mm (.6 in.) 5 mm (. in.) 97 mm (.8 in.) 7 mm (.9 in.) Ordering Information () Pall Part Number: KAEKVP Connection Options Shipping Format 8 in. (6 mm) hosebarb in. NPT connection in. ( 9 mm) sanitary flange G S () Non-sterile Gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation (maximum 5 kgy) () filters per box () S grade with P connection is provided with filling bell on outlet. It is removable for in-line use 9

10 Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Capsule Shell Sealing Technology Sterilization () Autoclave Gamma Irradiation Kleenpak Capsules Operating Parameters () Maximum Temperature C Hydrophilic PES Thermal bonding without adhesives Maximum Operating Pressure 5. bar (75 psi) at C. bar ( psi) at C Maximum Differential Pressure. bar ( psi) at C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 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 Typical Extractables in Water at C KA / KA KA < 5 mg per capsule < mg per capsule KA Flow rate (L/min), water at ºC Nominal Dimensions KA KA KA Diameter incl. Valves 9 mm (.7 in.) 9 mm (.7 in.) 5 mm (. in.) Length - 7 mm (.6 in.) 57 mm (6. in.) 7 mm (6.8 in.) Length mm (6. in.) 97 mm (7.7 in.) mm (8. in.) Length mm (5. in.) 77 mm (7 in.) 9 mm (7.6 in.) KA Nominal Effective Filter Area (EFA) KA 75 cm (. ft ) KA 75 cm (.8 ft ) KA 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)

11 Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Capsule Bowl Sealing Technology Housing Head Novasip Capsule Operating Parameters () Maximum Temperature 6 C Hydrophilic PES Polyetherimide Polyetherimide Polyetherimide Thermal bonding without adhesives Polyetherimide with TiO Maximum Operating Pressure 6.5 bar (9 psi) at C. bar (9 psi) at 6 C Maximum Differential Pressure. bar (6 psi) at 6 C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Flow rate (L/min), water at ºC Sterilization () Autoclave 5 x 6 minutes at 5 C, slow exhaust In-Line x 6 minutes at 5 C Nominal Dimensions Diameter incl. Valves Overall Length mm (.8 in.) 57 mm (6. in.) () Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing 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. in. ( 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

12 Kleenpak Nova Capsules Materials of Construction Filter Membrane Support/Drainage Core/End Caps Cage Internal adapter support ring O-rings Sealing Technology Housing Bowl Housing Head* Hydrophilic PES with TiO (white colored) Stainless steel Silicone elastomer Thermal bonding without adhesives Nominal Dimensions In-line NP6 NP7 NP8 Maximum Diameter including 5 mm (6. in.) 5 mm (6. in.) 5 mm (6.in.) valves Length with hose barb 97 mm (5.6 in.) 6 mm (5. in.) 895 mm (5. in.) inlet/outlet Length with sanitary 5 mm (. in.) 58 mm (. in.) 8 mm (.8 in.) inlet/outlet T-style *Formulated with TiO whitener which does not contribute to organic extractables Operating Parameters () Maximum Temperature C Maximum Operating Pressure bar ( psi) at C Maximum Differential Pressure bar ( psi) at C () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction NT6 NT7 NT8 Maximum Diameter including mm (9.5 in.) mm (9.5 in.) mm (9.5 in.) valves Length 9 mm (.7 in.) 598 mm (.5 in.) 88 mm (. in.) Nominal Effective Filter Area (EFA).6 m per 5 mm module (6.5 ft per in. module) Sterilization () Autoclave: x 6 minutes at 5 C Typical Extractables in Water at C < 5 mg after hours extraction (per 5 mm module) Gamma irradiation: Maximum of 5 kgy *Tested on elements without pre-flushing () 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

13 Kleenpak Nova (NT) Kleenpak Nova (NP) P Capsules (sanitary flange) P9 Capsule ( in. hose barb) 6 5 P6 Capsules ( in. hose barb) P9 Capsule ( in. hose barb) P Capsules (sanitary flange) Flow rate (L/min), water at ºC 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 mm ( in.) 58 mm ( in.) G Non-sterile Gamma irradiatable/autoclavable Blank Stäubli* vent and stepped hose barb drain 8 76 mm ( in.) S Pre-sterilized using gamma irradiation (mimimum 5 kgy) A Stäubli* vent and drain Connection Options () 6 () H () H9 () () For P-style only () For T-style only 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

14 Junior Filter Cartridges Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Sealing Technology O-rings Operating Parameters () Hydrophilic PES Thermal bonding without adhesives Silicone Elastomer Maximum Differential 5. bar (75 psi) at ºC Pressure () In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction 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: MCYEKVP H O-ring material Silicone elastomer (Other material available on request)

15 Materials of Construction Filter Membrane Support/Drainage Core/End Caps Cage Internal adapter support ring O-rings Sealing Technology Filter Cartridges Hydrophilic PES with TiO (white colored) Stainless steel Silicone elastomer Thermal bonding without adhesives Operating Parameters () Maximum Differential Pressure 5.5 bar (8 psi) at C (Forward Direction). bar ( psi) at 8 C Maximum Differential Pressure. bar ( psi) at C (Reverse Direction) () In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction AB5 AB 5 5 AB AB Flow rate (L/min), water at ºC Sterilization () Autoclave x 6 minutes at 5 C, slow exhaust In Situ Steam x 6 minutes at 5 C 5 x 6 minutes at O C () Water wet Supor EKV capsules prior to steaming to retain full water wettability for integrity testing Typical Extractables in Water at C () < 5 mg after hours extraction (per 5 mm module) () Tested on elements without pre-flushing Integrity Test Values: Values for 5 mm ( inch) filter at C Max. allowable Forward Flow Water wet 7 ml/min (air test gas) at 76 mbar ( psi) Contact Pall for multi-element integrity test values and recommended test procedures Nominal Effective Filter Area (EFA) ().6 m per 5 mm module (6.5 ft per in. module).6 m per 5 mm module (.8 ft per 5 in. module) () 5 in. filters are standard pleated. Ordering Information Pall Part Number: AB EKV P H Nominal Length Adapter Style O-ring material 5 5 mm (5 in.) 5 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

16 AllegroSystems New York - USA phone fax biotech@pall.com Portsmouth - Europe + () 9 phone + () 9 56 fax BioPharmUK@europe.pall.com Visit us on the web at 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. 7, Pall Corporation. PELEH/MG/CS/8.7

Pall Supor EKV Sterilizing Grade Filters. USD 2461b

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