Polygard -CN Filters. Lenntech Tel Fax

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Data Sheet Polygard -CN Filters Versatile pleated ilters for the clariication and preiltration of process luids Lenntech info@lenntech.com www.lenntech.com Tel. +31-1-261.9. Fax. +31-1-261.62.

The pleated structure of Polygard -CN ilter media minimizes pressure differentials during the iltration process, and the all-polypropylene construction of these ilters conveys low levels of

1 Data Sheet Polygard -CN Filters Versatile pleated ilters for the clariication and preiltration of process luids Lenntech Tel Fax Polygard -CN products are nominally rated ilters designed for particle removal applications in liquids and gases. The pleated structure of Polygard -CN ilter media minimizes pressure differentials during the iltration process, and the all-polypropylene construction of these ilters conveys low levels of extractables and broad chemical compatibility. Downstream ilter performance is enhanced due to eficient particle and microorganism reduction. Benefits Nominal particle retention rating Low pressure drop Low extractables levels Broad range of micron ratings to match an array of particle removal applications Designed for rigorous process conditions and broad chemical compatibility Ideal for designing scalable solutions from bench top to full-scale manufacturing

Regulatory Compliance Polygard -CN ilters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 9 Quality

2 Regulatory Compliance Polygard -CN ilters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 9 Quality Systems Standard and are shipped with a Certiicate of Quality. Each Opticap XL capsule and cartridge ilter is supported by a Validation Guide for compliance with regulatory requirements. For traceability and easy identiication, each ilter is marked with identifying characteristics. Multiple Formats Available Polygard -CN ilters are available in three formats, seven pore sizes, and multiple conigurations that vary by iltration area and the type of inlet/outlet connection. Media Types Polygard -CN (nominal).3 µm.6 µm 1.2 µm 2. µm. µm 1. µm 3. µm Filter Formats OptiScale small-scale disposable capsule ilters Opticap XL disposable capsule ilters Cartridge ilters

OptiScale Process Development Screening Tool OptiScale disposable capsule ilters with Polygard -CN media provide a convenient small-volume option for process screening and scaling.

The OptiScale disposable capsule is ideally suited for process development and screening. OptiScale capsules are faster and easier to set up than conventional 47 mm discs.

The patented Opticap XL capsule design allows unparalleled thermal and hydraulic stress resistance in a disposable ilter, resulting in reliability, high conidence in the sterility process and

3 OptiScale Process Development Screening Tool OptiScale disposable capsule ilters with Polygard -CN media provide a convenient small-volume option for process screening and scaling. These drop in ilters are ideal for evaluating biopharmaceuticals. OptiScale capsule ilters offer speed-to-market strategies for eficiently developing compounds and biotherapeutics. The OptiScale disposable capsule is ideally suited for process development and screening. OptiScale capsules are faster and easier to set up than conventional 47 mm discs. OptiScale Filters Opticap XL Disposable Capsule Filters Opticap XL disposable capsule ilters with Polygard -CN media are available in two ilter sizes. The patented Opticap XL capsule design allows unparalleled thermal and hydraulic stress resistance in a disposable ilter, resulting in reliability, high conidence in the sterility process and improved cleanliness. The unique capsule design with pleated Polygard -CN media minimizes hold-up volume and reduces production losses. Convenient and Easy to Use Opticap XL capsule ilters eliminate the time and the expense associated with assembling, cleaning, and validating stainless steel housings. Adjustable, easy-toturn, upstream vents and drain valves with o-ring seals and hose barb connections allow for easy process control. Other ease-of-use features include low directional arrows and ribbed edges for easy gripping even with gloved hands. The Right Size A range of ilter sizes is available to it all of your application needs, and to allow easy scale-up of your small volume iltration steps to larger, full-scale iltration processes. Opticap XL Filters The Right Connections Self-contained and disposable, Opticap XL capsule ilters are supplied with a choice of inlet and outlet connections to optimize your iltration process, including sanitary langes which enables a higher low rate, fractional sanitary langes, and hose barbs. Cartridge Filters Polygard -CN cartridge ilters provide high throughput and minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. A full range of ilter sizes is available to suit your application requirements. A variety of connection options are offered for easy adaptation to existing housings. Cartridge Filters

4 Speciications OptiScale Nominal Dimensions Inlet/outlet: Flange/hose barb Flange/lange Hose barb/hose barb Maximum length: 82 mm (3.24 in.) 74 mm (2.91 in.) 94 mm (3.7 in.) Diameter: 69 mm (2.7 in.) 69 mm (2.7 in.) 69 mm (2.7 in.) Weight: 2.3 oz (67 g) 2.3 oz (67 g) 2.3 oz (67 g) Filtration Area 13.8 cm 2 Materials of Construction Filter media: Polypropylene Structural components: Polycarbonate Vent cap: PVDF Internal seal rings: luoroelastomers Housing Vent Adjustable vent with male luer and female Luer-Lok connections on inlet side of device. Maximum Inlet Pressure. bar (8 psi) at 2 C Oxidizable Substances Capsules meet the requirements of the USP Oxidizable Substance for Sterile Water for Filtration Test after a water lush of 1 ml. Sterilization by Autoclave May be autoclaved for 3 cycles of 6 minutes at 126 C. Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Good Manfacturing Practices. Component Material Toxicity Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. This product is non-toxic per the USP <88> Safety Test. Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR

5 Speciications (continued) Opticap XL Opticap XL 1 Cartridge Filters 4-inch Per 1-inch Nominal Dimensions Maximum length: 21.6 cm (8. in.) 33. cm (13.2 in.) Diameter: 1.7 cm (4.2 in.) 1.7 cm (4.2 in.) 71 mm (2.7 in.) 7 mm (2.7 in.) Filtration Area.18 m 2 (1.9 ft 2 ).42 m 2 (4. ft 2 ).18 m 2 (1.9 ft 2 ).42 m 2 (4. ft 2 ) Materials of Construction Filter media: Polypropylene Polypropylene Supports: Polypropylene Polypropylene Structural components: Polypropylene Polypropylene Vent o-rings: Silicone O-rings: Ethylene Propylene (Std) Vent/Drain 1 4 in. hose barb with double o-ring seal Maximum Inlet Pressure. bar (8 psi) at 2 C 2.8 bar (4 psi) at 6 C 1. bar (1 psi) at 8 C Maximum Operating Temperature 8 C continuous Maximum Differential Pressure Forward: 4.8 bar (7 ) at 2 C NVR Gravimetric Extractables After autoclaving and a 24 hour soak in ASTM Type 1 reagent grade water at controlled room temperature: 2 mg mg mg Bacterial Endotoxin Aqueous extraction contains <. EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. Oxidizable Substances Capsules meet the requirements of the USP Oxidizable Substances Test after a water lush of: 2 ml ml ml Sterilization by Autoclave May be autoclaved for 3 cycles of 3 minutes at 126 C. (Cannot be steam sterilized in-line) May be autoclaved for 1 cycles of 3 minutes at 126 C or steam sterilized for 1 cycles for 3 minutes at 126 C or hot water sanitized at 8 C maximum for 3 minutes. Component Material Toxicity Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Polygard -CN ilters meet the requirements of the USP <88> Safety Test utilizing a.9% sodium chloride extraction. Indirect Food Additive All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR European Pressure Equipment Directive We certify that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May This product has been classiied under Article 3 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 3 of this Pressure Equipment Directive, this product does not bear the CE mark.

6 Typical Clean Water Flow Rates Opticap XL Capsule with Polygard -CN Media.3 µm Nominal (KN3) Opticap XL Capsule with Polygard -CN Media. µm Nominal (KN) TT FF HH TT FF HH Opticap XL 1 Capsule with Polygard -CN Media.3 µm Nominal (KN3) Opticap XL 1 Capsule with Polygard -CN Media. µm Nominal (KN) TT 1.4 TT FF 3 FF HH 1.2 HH Opticap XL Legends Refer to Connection Type Cartridge Legend Refers to Pore Size Cartridge Filter with Polygard -CN Media 1-inch TT = 38 mm (1 1 2 in.) Sanitary Flange Inlet and Outlet FF = 19 mm ( 3 4 in.) Sanitary Flange Inlet and Outlet HH = 14 mm ( 9 16 in.) Hose Barb Inlet and Outlet CN3 =.3 µm CN6 =.6 µm CN12 = 1.2 µm CN2 = 2. µm CN =. µm CN3 CN6 CN12 CN2 CN

7 Ordering Information OptiScale Capsule Filters S N A OptiScale Capsule Filter May be Autoclaved Quantity per Package 3 = 3/pk Media Type N = Polygard -CN Pore Size (nominal) 3 =.3 µm 6 =.6 µm 12 = 1.2 µm 2 = 2. µm =. µm 1H = 1. µm 3H = 3. µm Connection Type HH = 6 mm ( 1 4 in.) Hose Barb Inlet & Outlet FF = 19 mm ( 3 4 in.) Sanitary Flange Inlet & Outlet FH = 19 mm ( 3 4 in.) Sanitary Flange Inlet & 6 mm ( 1 4 in.) Hose Barb Outlet Opticap XL Capsule Filters K N A 1 Opticap XL Capsule Filter Media Type N = Polygard -CN Pore Size (nominal) 3 =.3 µm 6 =.6 µm 12 = 1.2 µm 2 = 2. µm =. µm 1H = 1. µm 3H = 3. µm May be Autoclaved Capsule Length = Opticap XL 1 = Opticap XL 1 Connection Type TT = 38 mm (1 1 2 in.) Sanitary Flange Inlet & Outlet FF = 19 mm ( 3 4 in.) Sanitary Flange Inlet & Outlet HH = 14 mm ( 9 16 in.) Hose Barb Inlet & Outlet Quantity per Package 1 = 1/pk 7

8 Ordering Information Cartridge Filters C N 6 Cartridge Filter Media Type N = Polygard -CN Pore Size (nominal) 3 =.3 µm 6 =.6 µm 12 = 1.2 µm 2 = 2. µm =. µm 1H = 1. µm 3H = 3. µm Cartridge Code O = (2-222) O-ring = (2-222) O-ring w/spear 7 = (2-226) O-ring w/locking tab and spear F = Double open end flat gasket M = (2-118) O-ring (4 in. cartridge only) O-ring Material E = EP gasket (Std) V = Fluoroelastomer S = Silicone T = PTFE encapsulated with fluoroelastomers Cartridge Length 1 = 1 inch 2 = 2 inch 3 = 3 inch 4 = 4 inch 4 = 4 inch (Cartridge Code M only) Quantity per Package 6 = 6 per package To Place an Order or Receive Technical Assistance Lenntech bv Rotterdamseweg 42m 2629HH Delft The Netherlands info@lenntech.com Tel Fax Merck Millipore and the M mark are trademarks of Merck KGaA, Darmstadt, Germany. Polygard, Opticap and OptiScale are registered trademarks of Merck KGaA, Darmstadt, Germany. ISO is a registered trademark of the International Organization for Standardization. ASTM is a trademark of American Society for Testing and Materials. Luer-Lok is a trademark of Becton Dickinson and Company. Lit. No. DS6434EN Rev. B 1/11 Printed in U.S.A. DP SBU EMD Millipore Corporation, Billerica, MA U.S.A All rights reserved.

9 Polygard CN Filters SN3A47HH3 CN31E6 CN121E6 CN1E6 CN3H1E6 SN3A47FF3 CN31V6 CN121V6 CN1V6 CN3H1V6 SN3A47FH3 CN31S6 CN121S6 CN1S6 CN3H1S6 SN6A47HH3 CN31T6 CN121T6 CN1T6 CN3H1T6 SN6A47FF3 CN32E6 CN122E6 CN2E6 CN3H2E6 SN6A47FH3 CN32V6 CN122V6 CN2V6 CN3H2V6 SN12A47HH3 CN32S6 CN122S6 CN2S6 CN3H2S6 SN12A47FF3 CN32T6 CN122T6 CN2T6 CN3H2T6 SN12A47FH3 CN33E6 CN123E6 CN3E6 CN3H3E6 SN2A47HH3 CN33V6 CN123V6 CN3V6 CN3H3V6 SN2A47FF3 CN33S6 CN123S6 CN3S6 CN3H3S6 SN2A47FH3 CN33T6 CN123T6 CN3T6 CN3H3T6 SNA47HH3 CN31E6 CN121E6 CN1E6 CN3H1E6 SNA47FF3 CN31V6 CN121V6 CN1V6 CN3H1V6 SNA47FH3 CN31S6 CN121S6 CN1S6 CN3H1S6 SN1HA47HH3 CN31T6 CN121T6 CN1T6 CN3H1T6 SN1HA47FF3 CN32E6 CN122E6 CN2E6 CN3H2E6 SN1HA47FH3 CN32V6 CN122V6 CN2V6 CN3H2V6 SN3HA47HH3 CN32S6 CN122S6 CN2S6 CN3H2S6 SN3HA47FF3 CN32T6 CN122T6 CN2T6 CN3H2T6 SN3HA47FH3 CN33E6 CN123E6 CN3E6 CN3H3E6 CN33V6 CN123V6 CN3V6 CN3H3V6 KN3ATT1 CN33S6 CN123S6 CN3S6 CN3H3S6 KN3AFF1 CN33T6 CN123T6 CN3T6 CN3H3T6 KN3AHH1 CN371E6 CN1271E6 CN71E6 CN3H71E6 KN3A1TT1 CN371V6 CN1271V6 CN71V6 CN3H71V6 KN3A1FF1 CN371S6 CN1271S6 CN71S6 CN3H71S6 KN3A1HH1 CN371T6 CN1271T6 CN71T6 CN3H71T6 KN6ATT1 CN372E6 CN1272E6 CN72E6 CN3H72E6 KN6AFF1 CN372V6 CN1272V6 CN72V6 CN3H72V6 KN6AHH1 CN372S6 CN1272S6 CN72S6 CN3H72S6 KN6A1TT1 CN372T6 CN1272T6 CN72T6 CN3H72T6 KN6A1FF1 CN373E6 CN1273E6 CN73E6 CN3H73E6 KN6A1HH1 CN373V6 CN1273V6 CN73V6 CN3H73V6 KN12ATT1 CN373S6 CN1273S6 CN73S6 CN3H73S6 KN12AFF1 CN373T6 CN1273T6 CN73T6 CN3H73T6 KN12AHH1 CN3F1E6 CN12F1E6 CNF1E6 CN3HF1E6 KN12A1TT1 CN3F1V6 CN12F1V6 CNF1V6 CN3HF1V6 KN12A1FF1 CN3F1S6 CN12F1S6 CNF1S6 CN3HF1S6 KN12A1HH1 CN3F1T6 CN12F1T6 CNF1T6 CN3HF1T6 KN2ATT1 CN3F2E6 CN12F2E6 CNF2E6 CN3HF2E6 KN2AFF1 CN3F2V6 CN12F2V6 CNF2V6 CN3HF2V6 KN2AHH1 CN3F2S6 CN12F2S6 CNF2S6 CN3HF2S6 KN2A1TT1 CN3F2T6 CN12F2T6 CNF2T6 CN3HF2T6 KN2A1FF1 CN3F3E6 CN12F3E6 CNF3E6 CN3HF3E6 KN2A1HH1 CN3F3V6 CN12F3V6 CNF3V6 CN3HF3V6 KNATT1 CN3F3S6 CN12F3S6 CNF3S6 CN3HF3S6 KNAFF1 CN3F3T6 CN12F3T6 CNF3T6 CN3HF3T6 KNAHH1 CN61E6 CN21E6 CN1H1E6 KNA1TT1 CN61V6 CN21V6 CN1H1V6 KNA1FF1 CN61S6 CN21S6 CN1H1S6 CN3M4E6 KNA1HH1 CN61T6 CN21T6 CN1H1T6 CN3M4V6 KN1HATT1 CN62E6 CN22E6 CN1H2E6 CN3M4S6 KN1HAFF1 CN62V6 CN22V6 CN1H2V6 CN3M4T6 KN1HAHH1 CN62S6 CN22S6 CN1H2S6 CN6M4E6 KN1HA1TT1 CN62T6 CN22T6 CN1H2T6 CN6M4V6 KN1HA1FF1 CN63E6 CN23E6 CN1H3E6 CN6M4S6 KN1HA1HH1 CN63V6 CN23V6 CN1H3V6 CN6M4T6 KN3HATT1 CN63S6 CN23S6 CN1H3S6 CN12M4E6 KN3HAFF1 CN63T6 CN23T6 CN1H3T6 CN12M4V6 KN3HAHH1 CN61E6 CN21E6 CN1H1E6 CN12M4S6 KN3HA1TT1 CN61V6 CN21V6 CN1H1V6 CN12M4T6 KN3HA1FF1 CN61S6 CN21S6 CN1H1S6 CN2M4E6 KN3HA1HH1 CN61T6 CN21T6 CN1H1T6 CN2M4V6 CN62E6 CN22E6 CN1H2E6 CN2M4S6 CN62V6 CN22V6 CN1H2V6 CN2M4T6 CN62S6 CN22S6 CN1H2S6 CNM4E6 CN62T6 CN22T6 CN1H2T6 CNM4V6 CN63E6 CN23E6 CN1H3E6 CNM4S6 CN63V6 CN23V6 CN1H3V6 CNM4T6 CN63S6 CN23S6 CN1H3S6 CN1HM4E6 CN63T6 CN23T6 CN1H3T6 CN1HM4V6 CN671E6 CN271E6 CN1H71E6 CN1HM4S6 CN671V6 CN271V6 CN1H71V6 CN1HM4T6 CN671S6 CN271S6 CN1H71S6 CN3HM4E6 CN671T6 CN271T6 CN1H71T6 CN3HM4V6 CN672E6 CN272E6 CN1H72E6 CN3HM4S6 CN672V6 CN272V6 CN1H72V6 CN3HM4T6 CN672S6 CN272S6 CN1H72S6 CN672T6 CN272T6 CN1H72T6 CN673E6 CN273E6 CN1H73E6 CN673V6 CN273V6 CN1H73V6 CN673S6 CN273S6 CN1H73S6 CN673T6 CN273T6 CN1H73T6 CN6F1E6 CN2F1E6 CN1HF1E6 CN6F1V6 CN2F1V6 CN1HF1V6 CN6F1S6 CN2F1S6 CN1HF1S6 CN6F1T6 CN2F1T6 CN1HF1T6 CN6F2E6 CN2F2E6 CN1HF2E6 CN6F2V6 CN2F2V6 CN1HF2V6 CN6F2S6 CN2F2S6 CN1HF2S6 CN6F2T6 CN2F2T6 CN1HF2T6 CN6F3E6 CN2F3E6 CN1HF3E6 CN6F3V6 CN2F3V6 CN1HF3V6 CN6F3S6 CN2F3S6 CN1HF3S6 CN6F3T6 CN2F3T6 CN1HF3T6 Lenntech B.V. T F info@lenntech.com

Clarigard Filters High-performance filters for the clarification and prefiltration of process fluids

Lenntech info@lenntech.com www.lenntech.com Tel. +31-1-261.9. Fax. +31-1-261.62.89 Data Sheet Clarigard Filters High-performance filters for the clarification and prefiltration of process fluids Clarigard