®ZetaCarbonActivated Carbon Filter Cartridges

Featuring:

The smarter way for carbon use

Activated Carbon within a filter matrix

Encapsulated Formats

Scale up from discto sheet & cartridge

®

a 3M company

Innovation

ZetaCarbon® Medium: The efficient way todecolorize your process liquids

ZetaCarbon medium incorporates the latest technology to decolorize and removecontaminants from your process streams. ZetaCarbon cartridges and sheets eliminate theconcerns of using powdered carbon. In today's manufacturing processes, efficiency, yield,quality and consistency are critical as well as operating in a safe environment for operators.Bulk carbon can also be a limiting step in many operations preventing enhanced yields andincreased production batches. ZetaCarbon medium addresses all of these concerns.

Activated Carbon ProductionActivated carbon is a highly porous carbonaceous material that is characterized by a largeinternal surface area providing exceptional adsorptive properties. Pores within the structurecan be classified into different categories depending on their size: micropores (<10nmrange), mesopores (10-25 nm range) and macropores (larger than >25 nm).

Activated carbon can be produced from different sources such as peat, lignite, pine wood,coconut shell, etc. The raw material influences the pore structure of the activated carbon; as an example, activated carbon made from pinewood has a wide distribution of micro, mesoand macro pores, whereas activated carbon obtained from coconut shell is typicallymicroporous.

Two ways of activation used today to create the porosity and internal structure are steamand chemical activation. In practice steam activation leads to a greater degree ofmicro-porosity while chemical activation makes a more macroporous / mesoporousstructure.

The porous structure gives the activated carbon a very large internal surface area (largerthan 500 m2g-1) which allows the activated carbon to be efficient in adsorbing a wide rangeof molecules. Adsorption is caused by Van der Waals type forces. These short-rangeinteractions are influenced by the nature of the molecule being adsorbed, such as itsmolecular weight and the presence of functional groups (double bonds, halogen).

Figure 1 and Figure 2 show activated carbon and ZetaCarbon medium.

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Figure 1- Activated Carbon Figure 2 - ZetaCarbon Medium

ZetaCarbon principleThe activated carbon is made into ZetaCarbon filter media by the addition of cellulose fibers and a positively charged resin. This eliminates the use of bulk carbon that causes dust-related issuesespecially for operators.

CUNO incorporates five standard types of activated carbon to cover a broad range ofapplications. These have been specifically selected for their properties to meet industryrequirements. ZetaCarbon filter media are also available in different porosities so that solutionswith different viscosities can be processed.

All the CUNO ZetaCarbon filter media available meet the market requirements whether 21 CFRor USP Class VI plastics compliance is required, with the necessary traceability anddocumentation. Drug Master File (DMF) and further technical details are available in theRegulatory Support File for ZetaCarbon filter media.

Advantages of using ZetaCarbon medium versusbulk activated carbon

The concept of using activated carbon immobilized in a cellulose matrix provides many advantagescompared to bulk powder.

Some of the advantages of using ZetaCarbon media are summarized in the Table 1 below :

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Table 1 : Advantages of ZetaCarbon Compared To Bulk Activated Carbon

Bulk Activated carbon ZetaCarbon Advantage

Carbon dust Health issues: - Lung disease - Adsorbs oxygen

Safety:- Fire risk

Less fire risk and almost no carbon dust

Cleanliness Production environmentProduction process:

- Time consuming- Costly- Rarely 100% clean - Batch to batch contamination- Downstream carryover

Clean product. After initial flush of the cartridge, withminimal release of carbon fines in the filtered solution

Processtimes

Long due to contact time and preparationtime, and removal time

Decreased process time because of constant flow rate filtration and efficiency. Noproduct rework because of consistentperformance

Carbonpowder

Relies on diffusion of contaminants to reachactive siteAdditions of filter aid required to removecarbon

Activated carbon is fixed and the flow isforced through the matrix which increasesefficiency.

ProcessSteps

A filtration step is required to remove thecarbonCarry over to solvent recovery plants

A single step is used as decolorization iscombined with the filtration step. Reducedcosts in solvent recovery

Decolorization efficiency of ZetaCarbon MediaThe methylene blue value is widely used by activated carbon manufacturers as a referencefor decolorization efficiency. This molecule has a 8 nm diameter, which means that it hasthe ability to enter pores with a diameter larger than 8 nm. In the glucose syrup industry(where activated carbon is used to remove a color precursor called methyl-hydroxy-furfural) and in pharmaceutical and chemical synthesis (where many contaminants and by-productsare formed), activated carbon with a high methylene blue value is beneficial. ZetaCarbonmedia can also be characterized by their methylene blue value.

Methylene Blue test

Graph 1 shows the methylene blue adsorptioncapacity of several CUNO standardZetaCarbon grades. Although Methylene bluetests cannot be used to universally describe and compare ZetaCarbonmedia performance, it can be used as a starting point. In every product,the nature of the molecules to adsorb varies,and it is always recommended to perform abench scale test to identify the most efficientZetaCarbon grade rather than selecting it onlyon methylene blue value.

Flow rate influence

As discussed earlier, adsorption of molecules by activated carbon relies on Van der Waals'forces. As those interactions are of short range, contact time between the solution and the filter media is critical. Graph 2 shows the influenceof the flux on the adsorption capacity of thefilter media. It shows that when the fluxincreases the adsorption capacity ofZetaCarbon filter media decreases.

High decolorization efficiency

Because of its advanced technology and itsexperience in manufacturing ZetaCarbon media, CUNO incorporates into its filter media a highconcentration of activated carbon.

This technology used in combination with aselection of the most efficient types of activated carbon on the market, enables ZetaCarbonmedia to have high decolorization capacityoutperforming competitive media. Graph 3shows the methylene blue adsorption capacityof some competitor media and ZetaCarbonR53S and R55S.

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R51SStandard ZetaCarbon Grades

Challenged with 200 mg/liter methylene blue solution @ 10 liters per minute per square meter of media

R52S R53S R54S R55S

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Graph 1 : ZetaCarbon Adsorption Capacity by Grade

R53S Challenged with 200 mg/liter methylene blue solution @ various flow rates

220 L/min/m210 L/min/m25 L/min/m0

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200

300

400

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Graph 2 : ZetaCarbon R53S Adsorption Capacity atVarious flow Rates

0

100

200

300

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R53SChallenged with 200 ppm methylene blue solution @ 10 liters per minute per square meter of media

R55S Competitor Competitor Competitor

Graph 3 : Adsorption Capacity Comparison ZetaCarbonvs. Competitors

Evaluation and Scaling-upCUNO offers a range of ZetaCarbon products for laboratory-scale filtration, for process development scale-up work, and for small lot production runs all theway to full scale.

Biocap 30, 1000 and 2000 disposable devices have surface areas of 27cm2

through to 1700 cm2 enabling development to scale-up. In addition ZetaCarbondiscs (47 mm and 90 mm) are available. These are ideal for scale-up evaluation as working process volumes move from laboratory or bench-scale through pilotplant scale to full manufacturing scale operations. Numerous pharmaceutical andbiotechnology companies world-wide have scaled-up reliably and predictably tohigh area 12 inch and 16 inch diameter cartridge systems using small surface area ZetaCarbon discs in the CUNO filtration test kit, with the assistance ofApplication Scientists from CUNO Scientific Applications Support Services(SASS).

ZetaCarbon filtration is scaled up using a fixed value of filter flux (fluid flow rate per effectivefiltration area). ZetaCarbon media should be evaluated initially at a recommended flux of 3L/min/m2 (0.07gpm/ft2). However, there are some successful applications where flux is muchhigher than this recommended value, while maintaining high adsorption efficiency.

ApplicationsZetaCarbon media can be used in any application where bulk activated carbon is used. Thefollowing is a list of some common applications:Pharmaceutical :

• Decolorization in production of vitamins, antibodies, dextrose, gelatine enzymes, • Parenterals • Blood fractionation • Pesticide removal from plant extracts

Chemicals :• Catalyst removal• Bulk pharmaceutical actives and intermediates• Decolorization of solvents• Decolorization of fine chemicals and removal of organic contaminants

Cosmetics :• Alcohol deodorization• Decolorization of perfumes

Food and Beverage :• Removal of trace organic contaminants from gelatine, pectin, juices, oils• Decolorization of wine and cider• Decolorization of sugar• Spirit purification• Fatty haze removal

Specific applications are summarized in the following table 2 :

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Table 2 : Applications of ZetaCarbon Application Recommended gradeAntibiotic Decolorization: Capromycin, Penicillin V, Cefazolin R33S, R53S, R35S, R55SEndotoxin removal R53SRemoval of detergent R32S, R52SRemoval of precipitation agent R33S, R53SVaccine purification R33S, R53SCatalyst removal R53S, R54SSolvent decolorization ie acetone R31S, R51SRemoval of trace organic contaminants from active compounds R31S, R51S, R34S, R54SRemoval of trace organic contaminants from X-Ray contrast media R33S, R53SBlood fractionation: albumin decolorization, pKa reduction, biliverdine removal R33S, R53STrace contaminant removal from Vodka, Whisky and Gin R31S, R51SSilicon oil decolorization R11S, R14S

Grades of ZetaCarbon MediaZetaCarbon media are available in differentfiltration ratings in order to deal withproducts of different viscosity. The Graph 4can be used as a guide for optimum filterselection.

Different types of carbon can be specified as required. This can minimize validation forease of ZetaCarbon media implementationinto the process. Please contact CUNO formore information.

Cartridge constructionPre-tensioned cartridge construction, utilizing 316 stainless steel oroptional* Hastelloy® bands ensuresintegrity in severe environmentsincluding in-situ steam sterilization and hot water sanitation. The uniqueedge seal design provides durable cell construction that maintains itsintegrity even under the mostdemanding process conditions.

BioCap® CapsulesZetaCarbon media is also available in BioCap Capsules, a range of completely encapsulateddisposable depth filter assemblies for small volume biological, bioprocess, and pharmaceuticalapplications. BioCap units are available in three sizes (see ordering guide) to offer a high degreeof application flexibility.

Filter housingsCUNO offers a wide range of sanitary filter housings ideal for ZetaCarbon cartridges. To comply with the regulations in the pharmaceutical and bioprocessing industry, these filter housings are in 316L stainless steel or Hastelloy™ with mirror polished surfaces or electropolished surfacefinish. For more information, contact your local CUNO distributor.

Operating parametersTable 3 : ZetaCarbon operating parameters

Max operating temp 80°C (176°F)

Max differential pressure 2 bar (29 psid)

Recommended rinse volume 50 liters/m2 of medium (1.25 gal/ft2)

Recommended flow rate 3 liters/minute/m2 of medium (0.07 gpm/ft2)

Steam sterilization (BioCap Autoclave only) 1 cycle @ 121°C (205°F) for 30 minutes

* Available on request, contact CUNO for additional information. Hastelloy™ is a registered trademark ofHaynes Int.

5

10 4 0.5

R5X

R3X

R1XViscosity of60 to 80 cp

Viscosity of 20 to 60 cp

Viscosity of 1 to 20 cp

0.1µm2 1

Graph 4: Selection Guide

Extractables & PyrogenicityInorganic and organic extractable testing was performed on ZetaCarbon media with a variety offluids. The following table lists typical level of metal extractables (mg/g medium)

Table 4 : ZetaCarbon extractables of metal mg/g mediumZetaCarbon

Type Al Ca Fe Mg Fe Si Na

R51S 0.005 0.355 0.016 0.023 0.048 0.033 0.069R52S <0.005 0.470 0.005 0.070 0.083 0.160 0.510R53S <0.005 0.240 0.010 0.015 0.033 0.023 0.062R54S <0.005 0.190 0.009 0.035 0.053 0.029 1.218R55S 0.026 0.190 0.022 0.022 0.056 0.034 0.415

The SP and SLP versions of ZetaCarbon are tested for pyrogenicity by the LAL clot test.Acceptance criteria are:

ZetaCarbon SP < 0.50 EU/ml

ZetaCarbon SLP < 0.125 EU/ml

More information on extractables and pyrogenicity is provided in theRegulatory Support File (LITTDRSFZC).

Quality AssuranceCUNO manufacturing operates using a complete quality assurancesystem following ISO 9000 procedures to ensure total quality.

ZetaCarbon SP and SLP media are sample audited for flow, density,and pyrogenicity. On release, a quality control certificate is packagedwith the product. In addition, ZetaCarbon cartridge packaging islabeled with a batch identification to provide complete traceabilityfrom the raw materials to the finished product.

All 12" and 16" ZetaCarbon cartridges are supplied with the part andlot number engraved into the side of the gasket retainer. Thisindividual engraving helps cartridge traceability once the filter isremoved from the protective packaging and assists in regulatorycompliance.

Scientific Applications Support Services (SASS)CUNO's 80+ years of experience are synonymous withquality, performance and high-level technical support.The cornerstone of CUNO's philosophy is service to customers, not only in product quality andprompt delivery, but also in validationassistance, applications support and in the sharing of scientific information.CUNO's Scientific ApplicationsSupport Services group works closelywith customers to solve difficultseparations problems and torecommend the most economical andefficient filter system. SASS specialists are skilled in performing on-site testing andrelating test results to full-scale manufacturingoperations.

CUNO A World Leader in Fluid PurificationCUNO's manufacturing sites have ISO 9000 registered quality systems. Global manufacturingtogether with trained stocking distributors and state-of-the-art laboratory support bring qualitysolutions to existing and challenging new filtration applications.

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ZetaCarbon Cartridge Ordering GuideBioCap Series

CapsuleDesignation Nominal Filter Area Packaging** Grade Quality Grade

BC - BioCap 0030 - Capsule, 24 cm2 (3.7 in2)A = Single Filter R11, R31, R51 S - StandardB = 10 Filter Pack R12, R32, R52 SP - Pharmaceutical

R13, R33, R53 SLP - Low Pyrogenicity1000 - Capsule, 650 cm2 (0.7 ft2) A = Single Filter R14, R34, R542000 - Capsule, 1300 cm2 (1.4 ft2) B = 3 Filter Pack R15, R35, R55

Standard ZetaCarbon CartridgesBase Cartridge Number Gasket Material** Grade Quality Grade

45109 - 8" x 7 Cell DOE* - 0.26 m2

(2.8 ft2) media surface area11 - Nitrile R11, R31, R51 S - Standard13 - Fluorocarbon R12, R32, R52 SP - Pharmaceutical

14 - EPR R13, R33, R53 SLP - Low Pyrogenicity

22 - Silicone R14, R34, R5423 - Teflon® R15, R35, R55

45167 - 8" x 7 Cell Plug-in - 0.23 m2

(2.5 ft2) media surface area01 - Nitrile02 - EPR03 - Fluorocarbon04 - Silicone09 - Teflon Encapsulated Viton® (TEV)

45158 - 12" x 9 Cell DOE* - 1.0 m2

(10.76 ft2) media surface area01 - Nitrile03 - Fluorocarbon04 - EPR Teflon is a tradename of E.I du Pont de Nemours and Company

45159 - 12" x 13 Cell DOE* - 1.45m2

(15.6 ft2) media surface area06 - Silicone Viton is a tradename of of DuPont Dow Elastomers07 - Teflon

Base Configuration O-Ring Material Packaging Grade Quality Grade

Z8FA2 - 8" Plug-in with 2cells - 650 cm2 area (0.7 ft2) NP

A - Silicone2

R11, R31, R51 S - StandardB - Fluorocarbon R12, R32, R52 SP - Pharmaceutical

Z8FA4 (8" Plug-in with 4cells - 1300 cm2 area (1.4 ft2)

C - EPR R13, R33, R53 SLP - Low Pyrogenicity

D - Nitrile R14, R34, R54

K - TEV R15, R35, R55

Base Cartridge Design Gasket Material Grade Quality Grade

C16 M = 16", 13 cells DOE with 3.0 m2

surface area (32.2 ft2)A - Silicone R11, R31, R51 S - StandardB - Fluorocarbon R12, R32, R52 SP - Pharmaceutical

C - Ethylene Propylene (EPDM) R13, R33, R53 SLP - Low Pyrogenicity

D - Nitrile R14, R34, R54

E - Teflon R15, R35, R55

*Double Open End ** Other Gasket Materials are available. For sheets and discs contact your local CUNO distributor.

© CUNO Incorporated, 2002 - All Rights Reserved LITCZC1.0602

Cuno Incorporated400 Research Parkway

Meriden, CT 06450, U.S.A.Tel: (800) 243-6894

(203) 237-5541Fax: (203) 630-4530

www.cuno.com

CUNO Pacific Pty Ltd140 Sunnyholt Road

Blacktown, NSW 2148Australia

CUNO K.K.Hodogaya Station

Building 6F1-7 Iwai-cho, Hodogaya-ku

Yokohama 240 Japan

CUNO Latina LtdaRua Amf Do Brasil 251

18120 Mairinque-SpBrazil

CUNO Ltd21 Woking Business Park

Albert DriveWoking, Surrey GU215JY

United Kingdom

CUNO Filtration Asia Pte Ltdrd18 Tuas Link 1 (3 Floor)

Singapore 638599

Cuno Filtration Shanghai Co, Ltd No. 2 Xin Miao San Rd,

Xin Miao Town, Song Jiang District,

Shanghai. China. 201612

a 3M company

WARRANTY

Seller warrants its equipment against defects in workmanship and material for a period of 12 months from date of shipment from the factory under normal use and service and otherwisewhen such equipment is used in accordance with instructions furnished by Seller and for purposes disclosed in writing at the time of purchase, if any. Any unauthorized alteration ormodification of the equipment by Buyer will void this warranty. Seller's liability under this warranty shall be limited to the replacement or repair, F.O.B. point of manufacture, of anydefective equipment or part which, having been returned to the factory, transportation charges prepaid, has been inspected and determined by the Seller to be defective. THISWARRANTY IS IN LIEU OF ANY OTHER WARRANTY, EITHER EXPRESSED OR IMPLIED, AS TO DESCRIPTION, QUALITY, MERCHANTABILITY, FITNESS FOR ANYPARTICULAR PURPOSE OR USE, OR ANY OTHER MATTER. Under no circumstances shall Seller be liable to Buyer or any third party for any loss of profits or other direct or indirectcosts, expenses, losses or consequential damages arising out of or as a result of any defects in or failure of its products or any part or parts thereof or arising out of or as a result of parts orcomponents incorporated in Seller's equipment but not supplied by the Seller.