FROM PURE TO STERILE MAIN FEATURES & BENEFITS Exellent mteril resistne towrds ggressive medi Inherently hydrophoi PTFE memrne Sterile grde t 0.2 µm (HIMA/ASTM) High flow rtes Biologilly inert Approved for Food Contt Use. to CFR Title 21 & 1935/2004/EC PRODUCT DESCRIPTION The filter element is sterile grde, pleted high performne PTFE memrne filter. It provides the gretest ssurne of filtrtion performne, stility nd durility ginst hemils even under severe proess onditions. The PTFE filter medium is inherently hydrophoi with highly porous memrne struture. This ensures high flow rtes nd high sorption of prtiles during the entire servie life time. The end ps nd the PTFE memrne re thermlly welded without the use of inders. This results in n integrl filter rtridge whih provides mximum durility rnge ginst hemils with miniml extrtles. 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 1935/2004/EC. The filter element is mnuftured in ordne with the mnufturing requirements, hs no migrtion of filter medi, is non-fire relesing nd is thermlly welded. INDUSTRIES Food Diries Phrmeutil Chemil Donldson Filtrtion Deutshlnd GmH Büssingstrße 1 42781 Hn Germny Tel. +49 2129 569 0 Fx +49 2129 569 100 CAP-de@donldson.om www.donldson.om Tehnil ltertions reserved (5/2016) EN - 2016/1
APPLICATIONS The sterile grde memrne filter is designed nd developed for the 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 Purifition of hemils: Highly onentrted Aids Highly onentrted Bses Oxidizing regents Complexing gents Alohols, Aldehydes Ethnts Chlorinted nd fluorinted solvents Esters nd Ketones Photolithogrphi Liquids Filtrtion of ir nd gses: Compressed Air Fermenttion Air Tnk Ventiltion Tehnil Gses Filter Mterils CFR Title 21 Memrne PTFE 177.1550 Upstrem Support Polypropylene 177.1520 Downstrem Support Polypropylene 177.1520 Outer Gurd Polypropylene 177.1520 Core Polypropylene 177.1520 End Cps Polypropylene 177.1520 O-Rings EPDM 177.2600 Silione 177.2600 Seling Method Therml Bonding QUALITY TEST All produts hve een inspeted nd relesed y Qulity Assurne s hving met the following requirements: 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, PTFE) 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 simulnt fter flushing or in flow onditions. For speifi detils on the O-rings, plese ontt your Donldson Sles Engineer. All sterile filters re integrity tested to verify ompline with estlished qulity nd design speifitions nd to ssure onsistent nd relile performne. All 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. RETENTION RATES (Aording to HIMA Chllenge per ASTM) Filter Grde Miroorgnism LRV / m² 0.2 µm Serrti Mresens Pseudomons diminut > 7 > 7 2/5
PRODUCT SPECIFICATIONS Produt Speifitions Filter Grde 0.2 μm (Retention Rtes LRV >/= 7 m²) Filtrtion Surfe 0.85 m² per 250 mm element (10 ) Mximum Differentil Pressure Operting temperture Differentil pressure C F r psi 38 100 5.5 80 66 150 4.1 60 82 180 2.1 30 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. For the filtrtion of queous solutions the memrne filter hs to e pre-wetted with suitle liquid of low surfe tension (e.g. IPA). FLOW CHARACTERISTICS 10, ir, 25 C, 1 r solute INTEGRITY TESTING Wter Intrusion Test Filter Grde 0,2 µm Mximum Diffusion Vlue 0.60 ml/min per 10 element fter 10 min @ 2.0 r (29 psi) 3/5
Dimensions (CODE 2 onnetion) 10 253 10.0 274 10.8 56 2.2 20 495 19.5 516 20.3 56 2.2 30 737 29.0 758 29.8 56 2.2 40 979 38.5 1000 39.4 56 2.2 CODE 2: 2 x 226 o-rings, yonet 2 loking ts, flt end p, integrted Dimensions (CODE 3 onnetion) 10 256 10.1 271 10.7 44 1.7 20 498 19.6 513 20.2 44 1.7 30 740 29.1 755 29.7 44 1.7 40 982 38.7 997 39.3 44 1.7 CODE 3: 2 x 222 o-rings, plug onnetion, flt end p, integrted Dimensions (CODE 7 onnetion) 10 251 9.9 315 12.4 56 2.2 20 493 19.4 557 21.9 56 2.2 30 735 28.9 799 31.5 56 2.2 40 977 38.5 1041 41.0 56 2.2 CODE 7: 2 x 226 o-rings, yonet 2 loking ts, loting fin, integrted Dimensions (CODE 8 onnetion) 10 254 10.0 311 12.2 44 1.7 20 496 19.5 553 21.8 44 1.7 30 738 29.1 795 31.3 44 1.7 40 980 38.6 1037 40.8 44 1.7 CODE 8: 2 x 222 o-rings, plug onnetion, loting fin, integrted 4/5
Dimensions (CODE 9 onnetion) 10 250 9.8 320 12.6 44 1.7 20 492 19.4 562 22.1 44 1.7 30 734 28.9 804 31.7 44 1.7 40 976 38.4 1046 41.2 44 1.7 CODE 9: 2 x 222 o-rings, yonet 3 loking ts, loting fin, integrted Dimensions (UF onnetion) 10 252 9.9 268 10.6 61 2.4 20 494 19.4 510 20.1 61 2.4 30 736 29.0 752 29.6 61 2.4 CODE UF: 2 x 226 o-rings, plug onnetion, flt end p, integrted Dimensions (DOE onnetion) 10 244 9.6 250 9.8 50 2.0 20 500 19.7 506 19.9 50 2.0 30 754 29.7 760 29.9 50 2.0 40 1008 39.7 1014 39.9 50 2.0 DOE: Doule open end with EPDM gskets Other end p onfigurtions on request. Integrity test to e done y Wter Intrusion Test. For informtion on test equipment or test servies, plese ontt your Donldson Sles Engineer nd visit our wesite t www.donldson.om! 5/5