Lenntech Tel Fax

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1 Lenntech el Fax ROOR HC Filter Cartridges liquid filters polyethersulphone ROOR HC sterilizing grade filters have been specifically designed for the effective and economical processing of difficult to filter solutions. he optimised ROOR HC E membrane configuration features a highly asymmetric membrane prefilter layer, which significantly extends throughput and prevents the problems associated with premature filter blockage with complex solutions. ROOR HC filters are high capacity and fast flowing. he E membrane is inherently low binding, which minimizes product loss due to protein or preservative adsorption. he filters have low extractable levels and broad chemical compatibility. Features and Benefits Optimized membrane configuration allows up to ten times the throughput compared to single layer membrane products Integral prefilter layer can condense filter trains for greater processing economy Incorporates a fully validated and integrity testable. micron membrane for assurance of sterility Low binding for minimal product loss ote: ROOR and DEMICA are registered trademarks of arker domnick hunter erformance Characteristics Flow (gpm (U)) B ize Flow (gpm (U)) Flow (gpm (U)) Differential ressure (mbar) A ize K ize (5 mm) Differential ressure (psi) Differential ressure (mbar) Differential ressure (psi) Differential ressure (mbar) 5 E ize B ize A ize Differential ressure (psi) 6 8 Flow (L / min) for C and cp Flow (L / min) for C and cp 6 8 Flow (L / min) for C and cp Cartridge flow rates MURU flow rates ( ize (5 mm)) DEMICA flow rates

2 ROOR HC Filter Cartridges pecifications Materials of Construction Filtration Membrane: olyethersulphone refilter Membrane: olyethersulphone Upstream upport: olyester Downstream upport: olyester Filter Cartridges Inner upport Core: Outer rotection Cage: End Caps: End Caps Insert: ylon 6L tainless teel MURU Disposable Filter Capsules Core: leeve: End Caps Insert: 6L tainless teel tandard orings/gaskets: ilicone Capsule Body: Capsules Vent eals: ilicone DEMICA Filter Capsules Core: leeve: End Caps: Capsule Body: Capsules Vent eals: Filling Bell: yringe Filters Body: ylon ylon ilicone olycarbonate Recommended Operating Conditions Filter Cartridges Up to 7 C (58 F) continuous operating temperature and higher shortterm temperatures during CI to the following limits: emperature Max. Forward d C F (bar) (psi) Effective Filtration Area (EFA) (5 mm):.55 m (5.9 ft ) K ize:.6 m (.79 ft ) A ize:. m (.5 ft ) B ize:. m (.7 ft ) E ize:.5 m (.5 ft ) yringe ø5 mm:.5 cm (.5 in ) terilization Autoclave teaminlace Cycles emp Cycles emp ( min.) Cartridges C (66 F) C (66 F) MURU 5 C (66 F) DEMICA C (66 F) yringe C (66 F) ROOR HC filter cartridges can be sanitized with hot water at up to 9 C (9 F) and are compatible with a wide range of chemicals. For detailed operational procedures and advice on cleaning and sterilization, please contact the echnical upport roup through your usual arker domnick hunter contact. Food and Biological afety Materials conform to the relevant requirements of CFR art 77 and current U lastics Class VI C and IO99 equivalents. Quality tandards grade products are manufactured in accordance with cm, % flushed with pharmaceutical grade purified water and integrity tested prior to despatch. A sample of each lot is tested to demonstrate conformity to validated claims. ammairradiation ROOR HC MURU & DEMICA disposable filters can be gammairradiated up to a maximum dosage of ky. MURU Disposable Filter Capsules Up to 5 C ( barg (79.7 psig) Up to 6 C ( barg (.6 psig) arker Hannifin certify that this product complies with the European Council ressure Equipment Directive (ED) 97// EC Article, aragraph ound Engineering ractice (E). his product is intended for use with roup & Dangerous and Harmless Liquids and roup Harmless ases at the operating conditions stated in this document : In compliance with ED Article, aragraph, E, this product does not bear the CE mark. DEMICA Filter Capsules Up to C ( F) at line pressures up to 5. barg (7 psig).

3 ROOR HC Filter Cartridges erformance Characteristics OC / Conductivity he filtrate quality from a (5 mm) ROOR HC conforms to the requirements of current U <6> (OC) and U <65> (conductivity) within the first ml flush of purified water. Endotoxins Aqueous extracts from the (5 mm) ROOR HC contain <.5 EU / ml when tested in accordance with the Limulus Amoebocyte Lysate test. onvolatile Extractables (VE) otal VEs extracted in the first 5 litre flush of purified water for a (5 mm) cartridge are < mg. otal VEs extracted in the first 5 litre flush of purified water for an A size 7.9 ( mm) DEMICA capsule are <5 mg. Validation A full validation guide is available upon request from Laboratory ervices roup (L). Oxidizable ubstances ROOR HC filter cartridges meet current U and E quality standards for sterile purified water for oxidizable substances following a < litre water flush. Integrity est Data All filters are integrity testable to the following limits when wet with water and using air as the test gas. Micron Rating. Filter Cartridges / MURU / DEMICA / yringe Filters Min. Bubble oint (barg). (psig) 9. Filter Cartridges / MURU / DEMICA / yringe Filters Diffusional Flow (barg).8 est ressure (psig).6 Filter Cartridges / MURU / DEMICA / yringe Filters Max. Diffusional Flow ( ) 8. (ml / min) (K) 8. (A) 6.7 (B). (E). Retention Characteristics ROOR HC filter cartridges are validated by bacterial challenge testing with Brevundimonas diminuta to current AM F885 methodology ( 7 organisms / cm EFA minimum) with typical inhouse challenge levels being organisms per (5 mm) filter cartridge. rotein Adsorption (mg / cm ) 8 6 HA gglobulin Insulin ylon olysulphone VDF dh E Membrane Material rotein binding on membrane materials 6 Dual layer ROOR HC E. µm VDF. µm Volume hroughput (g) ime (s) otal volume throughput (g) vs time (s) for an insulin intermediate solution

4 ROOR HC Filter Cartridges Ordering Information Cartridges ZCHC Code ǀ Length (ominal) Code ǀ Endcap ( ) Code ǀ Orings B*.5 (65 mm) A* 5 (5 mm) K 5 (5 mm) (5 mm) (5 mm) (75 mm) ( mm) 6. µm C BF / 6 Bayonet D Fin / E Flat op / Recess / R BF / Bayonet Code ǀ Endcap (Demi) E V EDM ilicone Viton * upplied in packs of. Y Z RUEEAL Demi tub Demi A & B td MURU Capsules ZLHC Code ǀ Length (ominal) Code ǀ rade Code ǀ Design Code ǀ Orings K 5 (5 mm) (5 mm) (5 mm) (75 mm) 6. µm A B D / riclamp / riclamp Hosebarb riclamp A B D / riclamp / riclamp Hosebarb riclamp onsterile resterilized γ (>5 ky) L InLine * ort * Only available with a riclamp E EDM * ilicone V Viton * ilicone oring supplied as standard without having to specify the code. DEMICA Capsules ZEHC Code ǀ Length (ominal) Code ǀ rade Code ǀ ack Code ǀ Accessory E. ( mm) B 5.5 ( mm) A 7.9 ( mm) 6. µm H M Q R riclamp / Male / Hosebarb / Male Walther QC rommel / QC H M Q R riclamp / Male / Hosebarb / Male Walther QC rommel / QC onsterile resterilized γ (>5 ky) ack of FB Filling Bell & H connections only yringe Filters ZHC Code ǀ Diameter Code ǀ rade Code ǀ Options Code ǀ ack 5 5 mm 6. µm F Female Luer Lock F Female Luer Lock onsterile tandard 5 5 per box arker domnick hunter has a continuous policy of product development and although the Company reserves the right to change specifications, it attempts to keep customers informed of any alterations. his publication is for general information only and customers are requested to contact our rocess Filtration ales Department for detailed information and advice on a products suitability for specific applications. All products are sold subject to the company s tandard conditions of sale. D 5_/ Rev. A

5 he below arker ROOR series cartridge filters are all the models that are potentially possible in all variations. lease note that not all models are actually produced or on stock and some model numbers and names have become obsolete. evertheless this should help as cross reference table chart for Cuno filters nomenclature. ROOR ZCHCB 6C ZCHCA 6C ZCHCK 6C ZCHC 6C ZCHC 6C ZCHC 6C ZCHC 6C ZCHCB 6D ZCHCA 6D ZCHCK 6D ZCHC 6D ZCHC 6D ZCHC 6D ZCHC 6D ZCHCB 6E ZCHCA 6E ZCHCK 6E ZCHC 6E ZCHC 6E ZCHC 6E ZCHC 6E ZCHCB 6 ZCHCA 6 ZCHCK 6 ZCHC 6 ZCHC 6 ZCHC 6 ZCHC 6 ZCHCB 6R ZCHCA 6R ZCHCK 6R ZCHC 6R ZCHC 6R ZCHC 6R ZCHC 6R ZCHCB 6 ZCHCA 6 ZCHCK 6 ZCHC 6 ZCHC 6 ZCHC 6 ZCHC 6 ZCHCB 6Y ZCHCA 6Y ZCHCK 6Y ZCHC 6Y ZCHC 6Y ZCHC 6Y ZCHC 6Y ZCHCB 6Z ZCHCA 6Z ZCHCK 6Z ZCHC 6Z ZCHC 6Z ZCHC 6Z ZCHC 6Z ZLHCK 6A ZLHC 6A ZLHC 6A ZLHC 6A ZLHCK 6B ZLHC 6B ZLHC 6B ZLHC 6B ZLHCK 6D ZLHC 6D ZLHC 6D ZLHC 6D ZLHCK 6 ZLHC 6 ZLHC 6 ZLHC 6 ZEHCE 6 ZEHCB 6 ZEHCA 6 ZHC5 6Q ZEHCE 6 ZEHCB 6 ZEHCA 6 ZHC5 6R ZEHCE 6H ZEHCB 6H ZEHCA 6H ZEHCE 6 ZEHCB 6 ZEHCA 6 ZEHCE 6M ZEHCB 6M ZEHCA 6M ZEHCE 6Q ZEHCB 6Q ZEHCA 6Q ZEHCE 6R ZEHCB 6R ZEHCA 6R