Fluorodyne II Filters

Transcription

1 USD 5 Fluorodyne II Filters Bioburden, Sterility and Mycoplasma Control

2 Fluorodyne II Filter Series Fluorodyne II filters feature a unique hydrophilic modified polyvinylidene fluoride (PVDF) membrane with low binding properties, broad chemical and temperature resistance, and high flow rates. Fluorodyne II Grade DBL Filters These.5 micron rated filters are predominantly used in pre-filtration applications or viscous fluid filtrations. Validated removal of Serratia marcescens (ATCC 75) with a typical titer reduction (TR) of > ensures they are also suitable for bioburden control. A dual layer (.5 /.5 micron) membrane construction allows for high throughputs and high flow rates compared with other.5 micron rated filters. Fluorodyne II Grade Filters These validated. micron rated filters retain Brevundimonas diminuta (ATCC 9) at 7 CFU/cm Effective Filter Area (EFA) and feature very low extractables and adsorption. With a dual layer (./. micron) construction they are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions. Fluorodyne II Grade DJL Filters These. micron rated filters with dual (./. micron) membrane construction assure high flow rates compared with other. micron (and even some. micron) rated filters. Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC ) with a typical TR > and retention of B. diminuta (ATCC 9) at 7 CFU/cm EFA.

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4 AllegroSystems The Single-Use Solution Allegro Systems: The Single-Use Solution Cross-contamination elimination, assured sterility, reduction of manufacturing time and cost, and an improvement in flexibility are clear objectives for the biopharmaceutical industry. These factors, coupled with increasing titer s in drug manufacturing, may demand a new approach. Allegro single-use systems featuring Kleepak filter capsules eliminate the need for cleaning and associated validation efforts, minimize major capital investments, increase flexibility and provide high assurance of product safety. We provide full support for our single-use systems including training and validation services, to facilitate their use from upstream bioreactor, to final formulation and filling. With a comprehensive range of scal able products in the Fluorodyne II filter series and Pall Allegro product platform, single-use systems incorporating Fluorodyne II filters can be used to process several milliliters up to large production-scale volumes.

5 The Pall UpScaleSM Program Save Time, Get Results Fluorodyne II filters are available in a wide range of scalable, encapsulated formats that allow for fast and easy scale-up, helping you rapidly deliver your products to the market. Same Materials* From laboratory-scale filters to production-scale assemblies, all Fluorodyne II filter products incorporate the same membrane and identical materials of construction, eliminating the need to requalify filter units as processes are scaled up. Mini Kleenpak Capsules Page Mini Kleenpak Capsules Page 7 Kleenpak Capsules Page - 9 Quality Every Fluorodyne II pleated filter is: u Integrity tested during manufacture u Identified by lot and serial number for total traceability u 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 after flushing Is non-fiber-releasing Is non-pyrogenic per USP endotoxins (<.5 EU/mL) Meets Total Organic Carbon (TOC) and water conductivity per USP purified water after flushing * Except Novasip capsules. See material of construction tables for each product for further details. Novasip Capsules Page Junior Filter Cartridges MCY and SBF Style Page Junior Filter Cartridges Sealkleen Style Page High Area Filter Cartridges Page 3 High Area Kleenpak Nova Capsules Page

6 Mini Kleenpak Capsules Materials of Construction Filter Membrane Housing, Vent Plug and Support Material Filling Bell Sealing Technology Hydrophilic modified PVDF Polycarbonate Thermal bonding without adhesives Operating Parameters Maximum Operating. bar ( psi) at C Temperature and Pressure In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Typical Liquid Flow vs. Differential Pressure Sterilization Pre-sterilized, subject to a minimum of 5 kgy of gamma irradiation Pre-sterilized Mini Kleenpak filters must not be re-sterilized. Mini Kleenpak filters must not be sterilized in-situ by passing steam under pressure Typical Hold up Volume <.5 ml 3 Flow rate (ml/min), water at C DJL Nominal Effective Filter Area (EFA) cm (3. in. ) Nominal Dimensions Capsule Length Capsule Diameter 3 mm (3.3 in.) 7 mm (.7 in.) Ordering Information 3 Pall Part Number: KM5 P S DJL Filter Media. micron. micron and mycoplasma control Inlet/Outet Connection - in. ( 3 mm) stepped hose barb with inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet Shipping Format Pre-sterilized using gamma irradiation 3 3 filters per box

7 Mini Kleenpak Capsules Materials of Construction Filter Membrane Support/Drainage Capsule Shell Filling Bell Sealing Technology Hydrophilic modified PVDF Polycarbonate Thermal bonding without adhesives Operating Parameters Maximum Temperature C Maximum Operating Pressure. bar ( psi) at C Maximum Differential Pressure. bar ( psi) a t C (forward direction) In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Sterilization Autoclave (G option only) 3 x minutes at 5 C Gamma Irradiation (G option only) 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 Typical Extractables in Water at C 3 G option only < mg S option only < 5 mg 3 Tested on capsules without pre-flushing Typical Liquid Flow vs. Differential Pressure 3 3 Flow rate (ml/min), water at C DJL Nominal Dimensions Maximum Diameter Including Valves Length - Length - Nominal Effective Filter Area (EFA) cm (. ft ) mm (. in.) 5 mm (. in.) 73 mm (.9 in.) 3 Ordering Information Pall Part Number: KA P DJL Filter Media. micron. micron and mycoplasma control Inlet/Outet Connections - in. ( 3 mm) stepped hose barb - 3 in. (3 9 mm) sanitary flange G S 5 Shipping Format Non-sterile gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation 3 filters per box 5 S option with connection is provided with filling bell on outlet. It is removable for in-line use 7

8 Kleenpak Capsules Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Capsule Shell Sealing Technology Hydrophilic modified PVDF Thermal bonding without adhesives Sterilization Autoclave (G and blank option only) 3 x minutes at 35 C x minutes at C Gamma Irradiation (G option only) 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 Operating Parameters Maximum Temperature C Maximum Operating Pressure 5. bar (75 psi) at C. bar (5 psi) at C Maximum Differential Pressure. bar (5 psi) at C (forward direction) In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Typical Extractables in Water at C 3 All Styles < 5 mg per capsule 3 Tested on capsules without pre-flushing Nominal Effective Filter Area (EFA) KA cm (. ft ) KA cm (.9 ft ) KA3 5 cm (. ft ) KA 33 cm (3. ft ) Nominal Dimensions KA KA KA3 KA Diameter incl. Valves 9 mm (3.7 in.) 9 mm (3.7 in.) 5 mm (. in.) 5 mm (. in.) Length - 7 mm (. in.) 57 mm (. in.) 7 mm (. in.) 7 mm (.3 in.) Length - 5 mm (. in.) 9 mm (7. in.) Length - 57 mm (. in.) 97 mm (7. in.) mm (.3 in.) 37 mm (. in.) Length - 37 mm (5. in.) 77 mm (7. in.) Length - 37 mm (5. in.) 77 mm (7. in.) 9 mm (7. in.) 35 mm (. in.) Ordering Information Pall Part Number: KA P 3 DBL DJL Filter Media.5 micron bioburden control. micron. micron and mycoplasma control Inlet/Outlet Connections in. (5-3 mm) sanitary flange - in. ( 3 mm) stepped hose barb in. (3 mm) single hose barb in. sanitary flange inlet and in. (3 mm) single hose barb outlet G S Blank Shipping Format Non-sterile gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation Non-sterile autoclavable Only available with DBL and filter media

9 Typical Liquid Flow vs. Differential Pressure (KA) Typical Liquid Flow vs. Differential Pressure (KA) Flow rate (L/min), water at C DJL DBL Flow rate (L/min), water at C DJL DBL Typical Liquid Flow vs. Differential Pressure (KA3) Typical Liquid Flow vs. Differential Pressure (KA) Flow rate (L/min), water at C DJL DBL Flow rate (L/min), water at C DJL DBL 9

10 Novasip Capsules Materials of Construction Filter Membrane Hydrophilic modified PVDF Support/Drainage End Cap, Core and Cage Capsule Bowl Polyetherimide Sealing Technology Thermal bonding without adhesives Housing Head Polyetherimide with TiO whitener TiO is an insoluble inorganic mineral filler that does not contribute to organic extractables Operating Parameters Maximum Temperature C Maximum Operating Pressure.5 bar (9 psi) at C. bar (9 psi) at C Maximum Differential Pressure 5.3 bar (77 psi) at C (forward direction). bar ( psi) at C In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Sterilization Autoclave or In Situ Steam 3 x min utes at 5 C x minutes at C Typical Liquid Flow vs. Differential Pressure Flow rate (L/min), water at C Nominal Dimensions Diameter Incl. Valves Overall Length C5DJL C3DJL C5 C C3 CLM5 3 mm (. in.) mm (3.3 in.) C5/C/C3 3 mm (. in.) 57 mm (. in.) 3 Typical Extractables in Water at C 3 < 5 mg per capsule 3 Tested on capsules without pre-flushing Nominal Effective Filter Area (EFA) C(LM)5 cm (. ft ) C(L) 7 cm (.7 ft ) C(L)3 5 cm (. ft ) Ordering Information Pall Part Number: C P DJL filter media is not available in Size L LM Blank Holder Volume Special insert for low hold up volume Small Bowl (Only for size 5) Standard Capsule Size 5 3 DJL Filter Media. micron. micron and mycoplasma control Connections in. (5-3 mm) sanitary flange Blank A B Vent/Drain Vent: Quick connect and disconnect coupling (compatible with Stäubli fitting) Drain: Hose barb for in. in. ( mm) i.d. tube, with valve Vent and drain: Quick connect and disconnect coupling (Stäubli compatible) with valve Vent and drain: in. (3 mm) sanitary flange, no valve sanitary clamp

11 Junior Filter Cartridges - MCY and SBF Style Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Sealing Technology O-rings Hydrophilic modified PVDF Thermal bonding without adhesives Silicone elastomer Operating Parameters Maximum Temperature ºC Maximum Differential Pressure 5.3 bar (77 psi) at ºC (forward direction) 3. bar (5 psi) at ºC In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction filter media may be used at 9 ºC. Contact Pall for further details Sterilization Autoclave and In Situ Steam 3 x minutes at 5 C x minutes at C MCY style only Typical Extractables in Water at C 3 < 5 mg per Junior cartridge 3 Tested on elements without pre-flushing Nominal Dimensions MCY MCY MCY SBF Length mm 57 mm mm mm (.9 in.) (. in.) (.7 in.) (. in.) Typical Liquid Flow vs. Differential Pressure Flow rate (L/min), water at C MCYDJL MCYDJL MCYDBL SBF MCY MCY MCY Nominal Effective Filter Area (EFA) MCY cm (. ft ) MCY 7 cm (.7 ft ) MCY 5 cm (. ft ) SBF cm (. ft ) 3 Ordering Information `Pall Part Number: P H MCY MCY MCY SBF Style Single open-ended with double external o-rings and locating lugs Single open-ended with double external o-rings and locating lugs Single open-ended with double external o-rings and locating lugs Single open-ended with double external o-rings DBL 5 DJL Filter Media.5 micron bioburden control. micron. micron sterilizing grade and mycoplasma control O-ring Material Silicone elastomer (standard) Only available with filter media 5 Only available in MCY style Only available in MCY and MCY styles

12 Junior Filter Cartridges - Sealkleen Style Materials of Construction Filter Membrane Support/Drainage End Cap, Core and Cage Sealing Technology Hydrophilic modified PVDF Thermal bonding without adhesives Operating Parameters Maximum Temperature ºC Maximum Differential Pressure 5.3 bar (77 psi) at 5 ºC (forward direction) 3. bar (5 psi) at ºC In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction filter media may be used at 9 ºC. Contact Pall for further details Sterilization Autoclave or In Situ Steam 3 x minutes at 5 C Typical Liquid Flow vs. Differential Pressure Flow rate (L/min), water at C SLK7 SLK7 SLK7DBL 3 Typical Extractables in Water at C < 5 mg (per Sealkleen cartridge) Tested on elements without pre-flushing Nominal Dimensions Overall Length SLK7 mm (. in.) SLK7 33 mm (5. in.) Nominal Effective Filter Area (EFA) SLK7 9 cm (. ft ) SLK7 9 cm (. ft ) Ordering Information Pall Part Number: SLK P 7 3 DBL Filter Media.5 micron bioburden control 3 Only available with filter media 7. micron

13 High Area Filter Cartridges Materials of Construction Filter Membrane Hydrophilic modified PVDF Support/Drainage Core/End Caps Cage ( and DJL filter media) with TiO whitener Cage (DBL filter media) O-rings Silicone elastomer Sealing Technology Thermal bonding without adhesives TiO is an insoluble inorganic mineral filler that does not contribute to organic extractables Operating Parameters Maximum Temperature ºC Maximum Differential Pressure 5.3 bar (77 psi) at 5 C (forward direction) 3. bar (9 psi) at C Maximum Differential Pressure.3 bar ( psi) (reverse direction) In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction filter media may be used at 9 ºC. Contact Pall for further details Sterilization Autoclave or In Situ Steam 3 x minutes at 5 C x minutes at C Typical Extractables in Water at C 3 < 5 mg per 5 mm ( in.) module 3 Tested on elements without pre-flushing Ordering Information Typical Liquid Flow vs. Differential Pressure Flow rate (L/min), water at C per 5 mm ( in.) Module DJL DBL Integrity Test Values (Air test gas, water wet) Max. allowable forward flow values for 5 mm ( in.) module at C DBL 3 ml/min at mbar ( psi) ml/min at 7 mbar ( psi) DJL 9 ml/min at 75 mbar (5 psi) Contact Pall for multi-element integrity test values and recommended test procedures Nominal Effective Filter Area (EFA) per 5 mm ( in.) Module DBL 55 cm (5.9 ft ) 55 cm (5.9 ft ) DJL 55 cm (5.9 ft ) Pall Part Number: AB P H 5 3 Nominal Length 5 mm (5 in.) 5 mm ( in.) 5 mm ( in.) 7 mm (3 in.) DBL DJL Filter Media.5 micron bioburden control. micron. micron sterilizing grade and mycoplasma control 7 Adapter Style Pall 7 double O-ring bayonet lock and fin Pall double O-ring bayonet lock, no fin ( 5 only) O-ring material Silicone elastomer (Other materials available on request) 3

14 High Area Kleenpak Nova Capsules Materials of Construction Filter Membrane Hydrophilic modified PVDF Support/Drainage Core/End Caps Cage ( and DJL filter media) with TiO whitener Cage (DBL filter media) O-rings Silicone elastomer Sealing Technology Thermal bonding without adhesives Housing Bowl Housing Head Po lypropylene TiO is an insoluble inorganic mineral filler that does not contribute to organic extractables Operating Parameters Maximum Temperature C Maximum Operating Pressure 3 bar ( psi) at C Maximum Differential Pressure 3 bar ( psi) at C (forward direction) In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction Sterilization 3 Autoclave (G option only) 3 x minutes at 5 C Gamma Irradiation (G option only) Maximum of 5 kgy 3 Pre-sterilized Kleenpak Nova capsules must not be re-sterilized Kleenpak Nova capsules must not be sterilized in-situ by passing steam under pressure Typical Extractables in Water at C G option < mg per 5 mm ( in.) module S option < mg per 5 mm ( in.) module Tested on capsules without pre-flushing Integrity Test Values (Air test gas, water wet) 5 Max. allowable forward flow values for 5 mm ( in.) filter at C DBL 3 ml/min at mbar ( psi) ml/min at 7 mbar ( psi) DJL 9 ml/min at 75 mbar (5 psi) 5 Contact Pall for multi-element integrity test values and recommended test procedures Nominal Effective Filter Area (EFA) per 5 mm ( in.) Module DBL 55 cm (5.9 ft ) 55 cm (5.9 ft ) DJL 55 cm (5.9 ft ) Nominal Dimensions In-line NP5 NP NP7 NP Maximum diameter 5 mm (. in.) 5 mm (. in.) 5 mm (. in.) 5 mm (.in.) including valves Length with hose barb 75 mm (. in.) 397 mm (5. in.) mm (5. in.) 95 mm (35. in.) inlet/outlet Length with sanitary 3 mm (. in.) 335 mm (3. in.) 5 mm (3. in.) 3 mm (3. in.) inlet/outlet T-style NT NT7 NT Maximum diameter mm (9.5 in.) mm (9.5 in.) mm (9.5 in.) Including valves Length 39 mm (3.7 in.) 59 mm (3.5 in.) mm (33. in.)

15 Kleenpak Nova In-line Capsules (NP) Typical Liquid Flow vs. Differential Pressure Kleenpak Nova T-style Capsules (NT) Typical Liquid Flow vs. Differential Pressure Flow rate (L/min), water at C per 5 mm ( in.) Module P/P9/P9 DJL Ordering Information P/P DJL P/P9/P9 DBL P/P9/P9 P/P DBL P/P 3 Flow rate (L/min), water at C per 5 mm ( in.) Module DJL DBL Pall Part Number: N P P T Style In-line T-style 5L 7 Filter Size 7 mm (5 in.) 5 mm ( in.) 5 mm ( in.) 7 mm (3 in.) DBL DJL Filter Media.5 micron bioburden control. micron. micron sterilizing grade and mycoplasma control G S Shipping Format Non-sterile gamma irradiatable/ autoclavable Pre-sterilized using gamma irradiation Only available in In-Line style and with DJL and filter media only For In-line ( P) only 3 For T-style ( T) only 9 9 H 3 H9 3 Connection Options in. (5-3 mm) sanitary flange inlet and outlet in. (5 mm) single barb hose barb inlet and outlet in. (5-3 mm) sanitary flange inlet and in. (5 mm) single barb hose barb outlet in. (3 mm) single barb hose barb inlet and outlet in. (5-3 mm) sanitary flange inlet and in. (3 mm) single barb hose barb outlet in. (5-3 mm) sanitary flange inlet and outlet, with in. sanitary port on inlet ½ in. sanitary flange inlet and in. (5 mm) single barb hose barb outlet with ½ in. sanitary port on inlet Blank A Vent/Drain Stäubli vent and stepped hose barb drain Stäubli vent and drain 5

16 AllegroSystems The Single-Use Solution United States toll free (USA).5..5 phone fax Europe + () phone + () fax LifeSciences.EU@pall.com Visit us on the Web at us at biopharm@pall.com International Offices Pall Corporation has offices and plants throughout the world in locations such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, the United Kingdom, the United States, and Venezuela. Distributors in all major industrial areas of the world. The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly., Pall Corporation. Pall,, Allegro, the Allegro Design, Fluorodyne, Kleenpak and Novasip are trademarks of Pall Corporation. indicates a trademark registered in the USA and TM indicates a common law trademark. Filtration. Separation. Solution.SM and UpScaleSM are service marks of Pall Corporation. ATCC is a registered trademark of American Type Culture Collection. Stäubli is a trademark of Stäubli AG. /,, UK GN.3 USD 5