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LifeTec PES-WN PROCESS FILTRATION FROM PURE TO STERILE MAIN FEATURES & BENEFITS PRODUCT DESCRIPTION INDUSTRIES

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FROM PURE TO STERILE MAIN FEATURES & BENEFITS Sterile grde memrne filters with rtings of 0.2 µm, 0.45 µm & 0.6 µm Exellent flow rte Highly resistnt mterils Extremely low dsorption of proteins High therml
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FROM PURE TO STERILE MAIN FEATURES & BENEFITS Sterile grde memrne filters with rtings of 0.2 µm, 0.45 µm & 0.6 µm Exellent flow rte Highly resistnt mterils Extremely low dsorption of proteins High therml stility, permnently hydrophili Approved for Food Contt Use. to CFR Title 21 & EC/1935/2004 PRODUCT DESCRIPTION The filter element is sterile grde, pleted high performne Polyethersulfone memrne filter. It provides the gretest ssurne of filtrtion performne, stility nd servie life for sterile filtrtion nd miroil stiliztion. The filter element is mnuftured in ordne with the GMP requirements s defined in EC/2023/2006, hs no migrtion of filter medi, is non-fire relesing nd is thermlly welded. All mterils used do not ontin ny Sustnes of very high onern (SVHC) s defined in EC/1907/2006 nd EC/65/2011. The outstnding performne of the filter element is sed on its stte-of-the-rt filtrtion medi. The Polyethersulfone memrne is inherently hydrophili nd distinguishes itself y hving n symmetrilly designed pore struture. The pore size stedily dereses towrds the entre of the medium resulting in highly porous struture. This extremely durle design mintins onsistent porosity nd impurity retention throughout its servie life without shedding or unloding ontmintions. All omponents meet the EU nd USA requirements for Food Contt Use in ordne with CFR (Code of Federl Regultions) Title 21 nd EC/1935/2004 nd susequent mendments. INDUSTRIES Bottled Wter Soft Drinks Diries Chemil Donldson Filtrtion Deutshlnd GmH Büssingstrße Hn Germny Tel Fx Tehnil ltertions reserved (5/2016) EN /1 APPLICATIONS The sterile grde memrne filter is designed nd developed for following pplitions: MATERIAL COMPLIANCE USA All omponents of the filter element re FDA listed for food ontt use in the Code of Federl Regultions (CFR), Title 21: Clrifition nd steriliztion of ll types of wter: Bottled Wter Minerl Wter Spring Wter Tle Wter Potle Wter High qulity filtrtion for vriety of ultrpure wter requirements: Deionized Wter Chemilly treted Wter High temperture Wter Proess Wter Ingredient Wter Sterile filtrtion of everges: Soft Drinks QUALITY TEST All produts hve een inspeted nd relesed y Qulity Assurne s hving met the following requirements: All 10 sterile filter modules re integrity tested to verify ompline with estlished qulity nd design speifitions nd to ssure onsistent nd relile performne. The treility of eh filter element ording to EC/1935/2004 is provided y Seril numer. All LifeTe PES WN filter elements re ompletely stged, ssemled, tested nd pkged in Clss 7 len room fility, whose Qulity Mngement System is pproved y n redited registering ody to the pproprite ISO 9001 Qulity Systems Stndrd. Filter Mterils CFR Title 21 Memrne Polyethersulfone Upstrem Support Polypropylene Downstrem Support Polypropylene Outer Gurd Polypropylene Core Polypropylene End Cps Polypropylene O-Rings EPDM Silione Seling Method Therml Bonding MATERIAL COMPLIANCE EU The Donldson filter element meets the guideline for Food Contt Use s given in Europen Regultion (EC) Numer 1935/2004. All polymeri omponents (Polypropylene, Polyethersulfone, EPDM) meet the requirements of EU Diretive EC/10/2011 relting to plsti mterils nd rtiles intended to ome into ontt with foodstuffs. Migrtion tests hve een rried out in simulnts (B, D1) fter flushing or in flow onditions. All mterils used do not ontin ny Sustnes of very high onern (SVHC) s defined in EC/1907/2006 (REACH Guideline) nd EC/65/2011 (RoHS Guideline) nd re free of ny Ltex-sed omponents. Furthermore the mterils do not ontin ny Animl derived ingredient (ADI-free) nd thus er no risk of trnsmitting TSE nd BSE. RETENTION RATES (Aording to HIMA Chllenge per ASTM) Filter Grde Miroorgnism LRV / m² 0.6 µm Shromyes erevisie Shromyes erevisie 0.45 µm Serrti Mresens Shromyes erevisie 0.2 µm Serrti Mresens Brevundimons diminut 2/5 PRODUCT SPECIFICATIONS Produt Speifitions Filter Grde 0.2 μm, 0.45 μm, 0.6 μm (Retention Rtes LRV /= 7 m²) Filtrtion Surfe 0.77 m² per 250 mm element (10 ) Mximum Differentil Pressure Operting temperture Differentil pressure C F r psi Cumultive Steming Time* 121 C 125 C (30 minutes) Sturted Stem (Forwrd Flow) up to 100 yles * Figures re sed on l tests to evlute steming resistne. Filter elements need to e heked in tul use. Contt Donldson for reommended Autolving/Steming proedures. FLOW CHARACTERISTICS 10, Deionised wter, 20 C INTEGRITY TESTING Bule-Point-Test Filter Grde Minimum Bule Point r psi Diffusion Test / Forwrd Flow Test Filter Grde Mximum Diffusion Vlues 0.6 µm µm r (10 psi) 0.45 µm µm r (25 psi) 0.2 µm µm r (35 psi) 3/5 Dimensions (CODE 2 onnetion) Size CODE 2: 2 x 226 o-rings, yonet 2 loking ts, flt end p, integrted Dimensions (CODE 3 onnetion) Size CODE 3: 2 x 222 o-rings, plug onnetion, flt end p, integrted Dimensions (CODE 7 onnetion) Size CODE 7: 2 x 226 o-rings, yonet 2 loking ts, loting fin, integrted Dimensions (CODE 8 onnetion) Size CODE 8: 2 x 222 o-rings, plug onnetion, loting fin, integrted 4/5 Dimensions (CODE 9 onnetion) Size CODE 9: 2 x 222 o-rings, yonet 3 loking ts, loting fin, integrted Dimensions (UF onnetion) Size CODE UF: 2 x 226 o-rings, plug onnetion, flt end p, integrted Dimensions (DOE onnetion) Size DOE: Doule open end with EPDM gskets Other end p onfigurtions on request. Integrity test to e done y Bule Point or Forwrd Flow Test For informtion on test equipment or test servies, plese ontt your Donldson Sles Engineer nd visit our wesite t 5/5
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