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

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1 Lenntech Tel Fax Data Sheet Clarigard Filters High-performance filters for the clarification and prefiltration of process fluids Clarigard filters 99.99% retention characteristic makes them ideal for the protection of critical downstream process steps such as membrane filters or chromatography columns. The graded-density depth structure of Clarigard filter media provides maximum filtration capacity, and the polypropylene construction offers low extractable levels and broad chemical compatibility. Clarigard.2 µm and.3 µm filters will easily extend the capacity of sterilizinggrade filters. Clarigard high performance prefilters consistently produce a 1 2 log bioburden reduction. Benefits 99.99% retention rating High capacity media Low extractable levels Effectively protects expensive membrane filters from premature plugging Designed for rigorous process conditions and broad chemical compatibility Ideal for designing scalable solutions from bench top to full-scale manufacturing

2 Regulatory Compliance Clarigard filters 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 Certificate of Quality. Each Opticap XL capsule and cartridge filter is supported by a Validation Guide for compliance with regulatory requirements. Multiple Formats Available Clarigard filters are available in two formats, five pore sizes, and multiple configurations that vary by filtration area and the type of inlet/outlet connection. Media Types Clarigard Media (99.99% retention).2 µm.3 µm. µm 1. µm 3. µm Filter Formats Opticap XL disposable capsule filters Cartridgefi lters Applications Precipitate Removal Proteinp rocessing Plasmaf ractions Undissolved Constituent Removal Cell culture media Buffersa lts Ophthalmics LVP/SVP Carbon Fine Removal Carbon beds in water processing Powdered carbon in chemical synthesis Gases Dust, rust and other solids 2

3 Opticap XL Disposable Capsule Filters Opticap XL disposable capsule filters with Clarigard media are available in multiple filter sizes, providing an optimal choice for every application. The patented Opticap XL capsule design allows unparalleled thermal and hydraulic stress resistance in a disposable filter, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design with Clarigard media minimizes hold-up volume and reduces production losses. The Right Size A wide range of filter sizes is available to fit all of your application needs for easy scale-up of your small volume filtration steps to larger, full-scale filtration processes. The Right Connections Self-contained and disposable, Opticap XL capsule filters are supplied with a choice of inlet and outlet connections to optimize your filtration process, including sanitary flanges which provide a higher flow rate, fractional sanitary flanges, and hose barbs. Cartridge Filters Clarigard cartridge filters provide high throughput and minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles. Opticap XL Filters A full range of filter sizes are available to suit your application requirements. A variety of connection options are offered for easy adaptation to existing housings. Cartridge Filters 3

4 Specifications Nominal dimensions Maximum length Diameter Filter element length Materials of construction filter media Supports Structural components Vent o-rings O-rings Opticap XL 1 Opticap XL Opticap XL 1 Cartridge Filters 2-inch Per 1-inch 21.6 cm (8. in.) 1.7 cm (4.2 in.) 2. cm (1 in.) 21.6 cm (8. in.) 1.7 cm (4.2 in.) 12.7 cm ( in.) 33. cm (13.2 in.) 1.7 cm (4.2 in.) 2.4 cm (1 in.) 7. cm (2.8 in.) Silicone 7. cm (2.8 in.) Vent/drain 1/4 in. hose barb with double o-ring seal Maximum inlet pressure. bar (8 psi) at 23 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 ambient room temperature 4.8 bar (7 ) at 23 C NVR gravimetric extractables After autoclaving and a 24 hour soak in ASTM Type 1 reagent grade water at controlled room temperature: 1 mg 1 mg 1 mg 1 mg Bacterial endotoxin Aqueous extraction contains <.2 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. Oxidizable substances Meets the requirements of the USP Oxidizable Substances Test after a water flush of: 1 ml 2 ml 3 ml 3 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. Non-fiber releasing Clarigard media meets the criteria for a non-fiber releasing filter as defined in 21 CFR 21.3 (b) (6). Component material toxicity Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Clarigard filters 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 classified 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. 4

5 Typical Clean Water Flow Rates Opticap XL 1 Capsule with Clarigard Media.2 µm Nominal (K2) Opticap XL Capsule with Clarigard Media.2 µm Nominal (K2) Opticap XL 1 Capsule with Clarigard Media.2 µm Nominal (K2) Opticap XL 1 Capsule with Clarigard Media.3 and. µm Nominal (K3, K) Opticap XL Capsule with Clarigard Media.3 and. µm Nominal (K3, K) Opticap XL 1 Capsule with Clarigard Media.3 and. µm Nominal (K3, K) Opticap XL Legends Refer to Connection Type = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet = 14 mm (9/16 in.) Hose Barb Inlet and Outlet

6 Typical Clean Water Flow Rates Opticap XL 1 Capsule with Clarigard Media 1. µm Nominal (K1) Opticap XL Capsule with Clarigard Media 1. µm Nominal (K1) Opticap XL 1 Capsule with Clarigard Media 1. µm Nominal (K1) Opticap XL 1 Capsule with Clarigard Media 3. µm Nominal (K3) Opticap XL Capsule with Clarigard Media 3. µm Nominal (K3) Opticap XL 1 Capsule with Clarigard Media 3. µm Nominal (K3) Opticap XL Legends Refer to Connection Type = 38 mm (11/2 in.) Sanitary Flange Inlet and Outlet = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet = 14 mm (9/16 in.) Hose Barb Inlet and Outlet Cartridge Filter with Clarigard Media 1-inch Pressure Drop () D2 D3, D D1 D Flow Rate () Cartridge Legend Refers to Pore Size D2 =.2 µm D3 =.3 µm D =. µm D1 = 1. µm D3 = 3. µm 6

7 Ordering Information Opticap XL Capsule Filters K A 1 Opticap XL Capsule Filter Pore Size (nominal) 2 =.2 µm 3 =.3 µm =. µm 1 = 1. µm 3 = 3. µm May be Autoclaved Capsule Length 1 = Opticap XL 1* = Opticap XL 1 = Opticap XL 1 Connection Type = 38 mm (1 1 /2 in.) Sanitary Flange Inlet & Outlet = 19 mm ( 3 /4 in.) Sanitary Flange Inlet & Outlet Quantity per Package *1-inch filter element in a -inch capsule housing. Cartridge Filters D Cartridge Filter Pore Size (nominal) 2 =.2 µm 3 =.3 µm =. µm 1 = 1. µm 3 = 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 N = (2-226) O-ring (2 in. cartridge only) F = Double open end flat gasket P = Double open end silicone flat gasket Cartridge Length 1 = 1 inch 2 = 2 inch 3 = 3 inch 4 = 4 inch = 2 inch (Cartridge Code N only) O-ring Material S = Silicone (std) E = Ethylene propylene V = Fluoroelastomers T = PTFE encapsulated fluoroelastomers P = Polyethylene flat seal (Cartridge code F only) Quantity per Package 1 = 1/pk 3 = 3/pk (2 in. only) *Not all configurations are available. 7

8 Merck Millipore and the M mark are trademarks of Merck KGaA, Darmstadt, Germany. Clarigard, Polygard, Opticap and OptiScale are registered trademarks of Merck KGaA, Darmstadt, Germany. ASTM is a trademark of American Society for Testing and Materials. ISO is a registered trademark of the International Organization for Standardization. Lit No. DS2638EN Rev. A 1/212 Job No. DP SBU Printed in the USA. 212 EMD Millipore Corporation, Billerica, MA 1821 USA. All rights reserved. 8 Lenntech bv Rotterdamseweg 42m 2629 Delft The Netherlands info@lenntech.com Tel Fax

9 Optical XL CCartridge Fliter K2A11 D21S1 D31S1 D1S1 D11S1 D31S1 D2F2S1 D3F2S1 DF2S1 D1F2S1 D3F2S1 K2A11 D21E1 D31E1 D1E1 D11E1 D31E1 D2F2E1 D3F2E1 DF2E1 D1F2E1 D3F2E1 K2A1 D21V1 D31V1 D1V1 D11V1 D31V1 D2F2V1 D3F2V1 DF2V1 D1F2V1 D3F2V1 K2A1 D21T1 D31T1 D1T1 D11T1 D31T1 D2F2T1 D3F2T1 DF2T1 D1F2T1 D3F2T1 K2A11 D22S1 D32S1 D2S1 D12S1 D32S1 D2F3S1 D3F3S1 DF3S1 D1F3S1 D3F3S1 K2A11 D22E1 D32E1 D2E1 D12E1 D32E1 D2F3E1 D3F3E1 DF3E1 D1F3E1 D3F3E1 K3A11 D22V1 D32V1 D2V1 D12V1 D32V1 D2F3V1 D3F3V1 DF3V1 D1F3V1 D3F3V1 K3A11 D22T1 D32T1 D2T1 D12T1 D32T1 D2F3T1 D3F3T1 DF3T1 D1F3T1 D3F3T1 K3A1 D23S1 D33S1 D3S1 D13S1 D33S1 D2F4S1 D3F4S1 DF4S1 D1F4S1 D3F4S1 K3A1 D23E1 D33E1 D3E1 D13E1 D33E1 D2F4E1 D3F4E1 DF4E1 D1F4E1 D3F4E1 K3A11 D23V1 D33V1 D3V1 D13V1 D33V1 D2F4V1 D3F4V1 DF4V1 D1F4V1 D3F4V1 K3A11 D23T1 D33T1 D3T1 D13T1 D33T1 D2F4T1 D3F4T1 DF4T1 D1F4T1 D3F4T1 KA11 D24S1 D34S1 D4S1 D14S1 D34S1 D2F4P1 D3F4P1 DF4P1 D1F4P1 D3F4P1 KA11 D24E1 D34E1 D4E1 D14E1 D34E1 D2P1S1 D3P1S1 DP1S1 D1P1S1 D3P1S1 KA1 D24V1 D34V1 D4V1 D14V1 D34V1 D2P1E1 D3P1E1 DP1E1 D1P1E1 D3P1E1 KA1 D24T1 D34T1 D4T1 D14T1 D34T1 D2P1V1 D3P1V1 DP1V1 D1P1V1 D3P1V1 KA11 D21S1 D31S1 D1S1 D11S1 D31S1 D2P1T1 D3P1T1 DP1T1 D1P1T1 D3P1T1 KA11 D21E1 D31E1 D1E1 D11E1 D31E1 D2P2S1 D3P2S1 DP2S1 D1P2S1 D3P2S1 K1A11 D21V1 D31V1 D1V1 D11V1 D31V1 D2P2E1 D3P2E1 DP2E1 D1P2E1 D3P2E1 K1A11 D21T1 D31T1 D1T1 D11T1 D31T1 D2P2V1 D3P2V1 DP2V1 D1P2V1 D3P2V1 K1A1 D22S1 D32S1 D2S1 D12S1 D32S1 D2P2T1 D3P2T1 DP2T1 D1P2T1 D3P2T1 K1A1 D22E1 D32E1 D2E1 D12E1 D32E1 D2P3S1 D3P3S1 DP3S1 D1P3S1 D3P3S1 K1A11 D22V1 D32V1 D2V1 D12V1 D32V1 D2P3E1 D3P3E1 DP3E1 D1P3E1 D3P3E1 K1A11 D22T1 D32T1 D2T1 D12T1 D32T1 D2P3V1 D3P3V1 DP3V1 D1P3V1 D3P3V1 K3A11 D23S1 D33S1 D3S1 D13S1 D33S1 D2P3T1 D3P3T1 DP3T1 D1P3T1 D3P3T1 K3A11 D23E1 D33E1 D3E1 D13E1 D33E1 D2P4S1 D3P4S1 DP4S1 D1P4S1 D3P4S1 K3A1 D23V1 D33V1 D3V1 D13V1 D33V1 D2P4E1 D3P4E1 DP4E1 D1P4E1 D3P4E1 K3A1 D23T1 D33T1 D3T1 D13T1 D33T1 D2P4V1 D3P4V1 DP4V1 D1P4V1 D3P4V1 K3A11 D24S1 D34S1 D4S1 D14S1 D34S1 D2P4T1 D3P4T1 DP4T1 D1P4T1 D3P4T1 K3A11 D24E1 D34E1 D4E1 D14E1 D34E1 D273S1 D373S1 D73S1 D173S1 D373S1 D24V1 D34V1 D4V1 D14V1 D34V1 D273E1 D373E1 D73E1 D173E1 D373E1 D2NS3 D24T1 D34T1 D4T1 D14T1 D34T1 D273V1 D373V1 D73V1 D173V1 D373V1 D2NE3 D271S1 D371S1 D71S1 D171S1 D371S1 D273T1 D373T1 D73T1 D173T1 D373T1 D2NV3 D271E1 D371E1 D71E1 D171E1 D371E1 D274S1 D374S1 D74S1 D174S1 D374S1 D2NT3 D271V1 D371V1 D71V1 D171V1 D371V1 D274E1 D374E1 D74E1 D174E1 D374E1 D3NS3 D271T1 D371T1 D71T1 D171T1 D371T1 D274V1 D374V1 D74V1 D174V1 D374V1 D3NE3 D272S1 D372S1 D72S1 D172S1 D372S1 D274T1 D374T1 D74T1 D174T1 D374T1 D3NV3 D272E1 D372E1 D72E1 D172E1 D372E1 D2F1S1 D3F1S1 DF1S1 D1F1S1 D3F1S1 D3NT3 D272V1 D372V1 D72V1 D172V1 D372V1 D2F1E1 D3F1E1 DF1E1 D1F1E1 D3F1E1 DNS3 D272T1 D372T1 D72T1 D172T1 D372T1 D2F1V1 D3F1V1 DF1V1 D1F1V1 D3F1V1 DNE3 D2F1T1 D3F1T1 DF1T1 D1F1T1 D3F1T1 DNV3 DNT3 D1NS3 D1NE3 D1NV3 D1NT3 D3NS3 D3NE3 D3NV3 D3NT3 Lenntech B.V. T F info@lenntech.com

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