01Dissolution

Dissolution

Dissolution Apparatus Overview 6

Dissolution Instrumentation 7VK 7000 and VK 7010 Key Features 8VK 7010 Dissolution Testing Apparatus 10VK 7000 Dissolution Testing Apparatus 14VK 7000 Small Volume Apparatus 17

VanKel Total Solution 18VK 7000 / 7010 Single-bath Configurations 20VK 7000 / 7010 Dual-bath Configurations 22

Dissolution Compatible Systems 25Varian, Inc. 26Agilent Technologies 27Perkin Elmer Instruments 30Waters Corporation 30Carl Zeiss Jena GmbH 31C Technologies, Inc. 31Delphian Technology L.P. 31Zymark Corporation 32

Dissolution Vessel Washing Stations 34

Dissolution Accessories 36QAII Station 36VK 5010 CLH Measurement System 38Calibration Tools 39Vessels 41Paddles 47Baskets 50Capsule Weights 55Manual Sampling Cannula Assembly 56Cannula Filters 57Resident Cannula Kits 59Internal Dosage Delivery Module Retrofit 60Temperature Controller 61Motorized Sampling Manifold 62Manual Sampling Bracket 62Report Center II Retrofit Kit 62Vessel Conversion Kits 63Intrinsic Dissolution Apparatus 65USP Apparatus 6 Rotating Cylinder 65Suspension Cup 66Paddle Over Disk Assembly 66Transdermal Patch Holder System 66Products for Release Rate Studies 67

VanKel Technology Group • 13000 Weston Parkway • Cary, North Carolina 27513-2228 USA800.229.1108 • 919.677.1108 • fax 919.677.1138 • [email protected] • www.vankel.com

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USP APPARATUS 1Rotating Basket• Standard 40-mesh basket.• Other mesh size baskets are available.• Special baskets of various design and sizes are available.• Volume ranges from 100 mL to 4L.• A variety of vessel sizes are available.• See pages 50 - 54.

USP APPARATUS 2Paddle• Standard stainless steel paddle or Teflon-coated

stainless steel paddle.• Special Teflon and PEEK paddles are available.• Volume ranges from 100 mL to 4L.• A variety of vessel sizes are available.• See pages 47 - 49.

USP APPARATUS 3Reciprocating Cylinder• Sequential operation for pH profiling.• Volume ranges from 100 mL to 1L.• 300 mL outer tubes are standard.• See pages 70 - 71.

USP APPARATUS 5Paddle over Disk• Standard stainless steel with disposable stainless screens.• Used for transdermal patches in a standard round bottom vessel.• Volume 900 mL.• See page 66.

USP APPARATUS 6Rotating Cylinder• Two-piece assembly for testing transdermal patches using

Apparatus 1 and 2 dissolution testers.• Volume 900 mL.• See page 65.

USP APPARATUS 7Reciprocating Holder• Utilizes sequential operation and a variety of dosage

holders.• Volume ranges from 20 mL to 275 mL.• Useful for transdermal patches, osmotic pump delivery

systems as well as other non-disintegrating dosage forms.• See pages 74 - 75.

VanKel manufactures USP dissolution apparatus 1, 2, 3, 5, 6 and 7. Please let us know how we canbe of assistance with specialized requirements.

Dissolution Instrumentation 7


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VanKel is proud of our commitment to quality. Of the three standards after which companies can model theirquality system, VanKel complies with the most comprehensive, ISO 9001. This standard is a model for use byboth manufacturing and service organizations to certify their quality system from initial design anddevelopment of a desired product or service through production, installation and servicing.

VanKel Quality Policy

VanKel is committed to designing andmanufacturing reliable products that exceed theneeds and expectations of our customers and todeliver defect-free products and services on timeand at competitive prices. Every member of theVanKel team is committed to rapid and continuousimprovement through well-documented andcustomer-focused quality processes.

To achieve this policy the team shall:

• conduct design, product quality and program status reviews.

• implement procedures to ensure quality in marketing, design, procurement, product,inspection, test and service.

• operate an effective quality reporting and corrective action system.

• provide training programs relating to quality.

• maintain the Quality System Manual, so as to increase its usefulness as an aid in producingquality products.

• ensure the Quality Policy is understood, implemented and maintained at all levels in theorganization.

• Reliable and robust• Unique time-saving features including

automatic start• 1L, 2L and 4L Apparatus• Meets all current USP, JP and EP

requirements

The VK 7000 and VK 7010 models are designedwith automation and flexibility in mind. Thesemicroprocessor-controlled instruments allow for easymanual sampling and are designed to interfacedirectly with the VK 8000 Autosampling Station. TheEaseAlign system for centering vessels allows theuse of a variety of vessel sizes (with options of100 mL, 200 mL, 500 mL, 1L (standard), 2L and 4Lvessels with Benchsaver models). These units arepreconfigured so they can accept accessoryupgrades. VK 7000 series units can be fitted withAutoTemp and Dosage Delivery capabilities shouldyour testing needs change. As testing volumes grow,you can modify your equipment; these models areeasily adapted to interface directly to a variety of UVor LC systems or can be retrofitted into a ZymarkMultiDose system.

EaseAlign Centering RingsEliminate the need for tedious, time-consumingvessel centering after each run. EaseAlign centeringrings allow the vessel to simply slide into place.Once in place, your vessels do not float—even whileempty.

The EaseAlign rings center and align from the insideof each vessel. This provides a simple, accuratevessel-alignment process.

Display InformationThe 4-line, 40-character LCD operational monitorallows for a simple, easy-to-read display. Duringoperation the display includes time, date, elapsedtime, start time, set and actual RPM, set and actualbath temperature, and printer status.

Built-in AlarmsBoth the VK 7000 and the VK 7010 have a variety ofbuilt-in alarm features. You are warned of anytemperature deviations from the set parameters,power outages, as well as the upcoming calibrationdate.

VK 7000 AND VK 7010 KEY FEATURES

Parameter ProgrammingA simple menu allows you to easily program yourparameters including:• delayed start • RPM (8 - 250 RPM)• length of test• temperature• infinity spin

Timed Wake-upThis unique feature automatically turns on the testerand circulator at a predetermined time. This ensuresyour bath is at the proper temperature withoutoperating the circulator continuously.

Elapsed Time IndicatorThese testers offer an on-screen elapsed timeindicator. This indicator can be easily read fromacross the room.


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VK 7010

VK 7000 Options Display



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Spindle Motor MonitorThese testers report the number of spindle motorhours that the instrument has been in use. This on-screen record allows you to schedule preventativemaintenance on actual operating hours rather thanarbitrary time periods.

Motorized Tester Drive UnitVanKel pioneered the use of a motorized drive unit.With the touch of a button, the motorized drive uniton the VK 7000 / 7010 dissolution testerelectronically lowers to the proper position. Whenthe drive unit is down, you can automatically raisethe head. The motorized head ensures it returns toprecisely the same location.

Automated Sampling ManifoldOne of the unique features of the VK 7000 / 7010 isthe ability to incorporate an automated samplingmanifold. At programmed intervals or by manualcontrol, the motorized sampling manifold providesproperly timed and precisely positioned sampling.See the automated sampling manifold on page 10.

Chuck AssemblyOur unique chuck design assures the shaft is lockedin place. Once the height is set, there is no need toworry about a change in alignment.

In addition, this system offers the flexibility of usingsmaller diameter shafts and mini paddles for low-volume dissolution testing.

Our type 316 stainless steel chuck offers rust-resistant and wobble-free support for your shafts.

Should you prefer a differentdesign using O-rings with a lockingring—this design can beincorporated into either theVK 7000 or VK 7010. This designis preferred by some customerswho perform a number ofstaggered basket starts. Contactyour VanKel representative formore information.

Individual Spindle ControlOur easy-to-use clutch system makes droppingtablets into non-rotating media per USP guidelineseffortless. The system provides a simple way toperform manual staggered drops for Apparatus 2.Just raise the clutch handle and the spindle isdisengaged. Push down the clutch handle to engagethe spindle.

PrinterOur built-in dot matrix printersproduce documents that can bedirectly inserted into your laboratorynotebooks. Every VK 7000 / 7010includes a built-in Report Center IIprinter.

VK 750D Heater / CirculatorThe external circulator providesprecise temperature control. Itshigh throughput minimizes warmup time. The external VK 750DHeater / Circulator reducesvibration and fits easily behindthe dissolution tester in order toconserve valuable bench space.

Molded BathThis seamless bath was designed to warm allvessels evenly by stabilizing the temperaturegradient. This design assures uniform temperaturecontrol and makes cleaning easy.

The seamless water bath is molded from clearPETG, a high performance polymer with more heatand chemical stability than acrylic. The clear colorallows you to see the vessels through the waterbath.

To ensure the bath contains the appropriate amountof water, there is a fill line for baths without vesselsas well as for baths with vessels in place.

Easy DrainThe easy access water bath drain spout allows forquick and simple routine cleaning.

Complete Operating System, No Post-purchaseAdd-onsWhen you purchase a VanKel dissolution tester,VanKel provides you with an all-inclusive pricequote. This quote includes the price of theequipment necessary to appropriately operate theinstrument. You receive your choice of baskets orpaddles, glass or plastic vessels, as well asevaporation covers and all tubing and connectors.

For VK 7000 Dissolution Testers, see pages 14 - 17.For VK 7010 Dissolution Testers, see pages 10 - 12.

Locking Ring

VK 7000 / 7010Printout

VK 750D



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• Preconfigured for automated analysis• Measures and records temperature in each

vessel• Programmable Dosage Delivery Module

automatically delivers dosage form intovessel when used as Apparatus 2

• Incorporates all VK 7000 system features (seepage 14)

• Meets all current USP, JP and EPrequirements

ModularityThe VK 7010 allows for in-vessel temperaturemonitoring at programmed time points andautomated delivery of the dosage form. Theseautomation building blocks combine to create anextremely efficient stand-alone unit that can beutilized in an in-line sampling or analysis system asyour testing demands increase. For example,sampling can be easily added to the motorizedmanifold, a standard feature on the VK 7010.

In-vessel Temperature MeasurementThis motorized manifold automatically lowers,collects temperature readings from each vessel, andimmediately raises at programmable intervals. Eachsubsequent temperature reading repeats thissequence precisely.

Automatic Temperature MeasurementThe AutoTemp feature allows you to measure andrecord temperature. It can be used to automaticallystart a test after measuring the temperature in eachvessel to ensure they are stable and within limits.Because the manifold raises between time points, iteliminates the resident probe effect and maintainscorrect hydrodynamics.

Dosage Delivery ModuleThe Dosage DeliveryModule allows you to beelsewhere when the runstarts and drops occur withfar greater precision thanmanual techniques allow.This feature allows you toprogram simultaneous orsequential drops.

VK 7010 DISSOLUTION TESTING APPARATUS

Pathway to AutomationBecause the VK 7010 includes the internal hardwarenecessary for automation, it can easily connect to anautomated sample collector, UV spectrophotometer,LC instrument or Zymark's MultiDose systems. YourVanKel technical sales representative can explainthese options.

FlexibilityDue to the numerous options available, this versatilesystem can perform everything from simple manualsample collection to complete sample automation.

A standard VK 7010 accepts several vessel volumesincluding 100 mL, 200 mL, 500 mL and 1L vessels.If these volumes do not satisfy your sink conditions,an optional upgrade can be purchased whichaccommodates 1L and 2L vessel volumes. Seepage 12.

As with all VanKel products, we can tailor theVK 7010 to address most customer requests.

Resident Probe EffectThe USP recommends that when employingautomated systems which alter the agitationcharacteristics of the test, the equipment be

validated prior to use. The motorized samplingmanifold fully removes the cannula from the media

between time points in the same manner assomeone sampling manually. This reduces the

increased agitation associated with resident probes.

Didyou

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VK 7010 Automated Sampling Manifold

Part Number Description

10-0700 VK 7010, 4+4, 115 V, 60 Hz

10-0800 VK 7010, 4+4, 230 V, 50 Hz


10-0100 VK 7010, 3+3, 115 V, 60 Hz

10-0200 VK 7010, 3+3, 230 V, 50 Hz



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System Configurations

VK 7010 Benchsaver6-spindle, 6-vesselThe Benchsaver configuration saves laboratory benchspace. The vessel configuration consists of 2 rows of3 vessels. The Benchsaver comes with 15-inchpaddles. For increased flexibility when samplingmanually, we recommend use of the 19-inch paddlesand extended height spacer PN 12-0321 (see page39). This allows greater clearance to access themiddle position of the back row.


10-0300 VK 7010, 4+2, 115 V, 60 Hz

10-0400 VK 7010, 4+2, 230 V, 50 Hz

VK 7010 Easy Access6-spindle, 8-vessel locationsThis model provides "easy access" to the activevessels around the perimeter of the bath—facilitatingmanual sample collection. The 2 open positionsinclude covers to reduce bath water loss. Theseopen positions can be used with vessels (optional)for media replacement. Should your needs change,these 2 positions can be upgraded with spindles tohave an 8-spindle, 8-vessel configuration.

VK 7010 Easy Access8-spindle, 8-vesselThis configuration is ideal for customers interested inautomation. The VK 7010 Easy Access 8-spindle, 8-vessel tester includes 2 additional functioningpositions that can be used for any combination ofstandards, controls and blanks.

SpecificationsWidth: 54 cm Depth: 56 cm Height: 94 cm



Each of the following configurations includes yourchoice of glass or plastic vessels, paddles or basketsand basket shafts. EaseAlign Centering Rings andevaporation covers are included. The VK 750D isstandard.

6-spindle VK 7010 Benchsaver Vessel Plate

8-spindle VK 7010 Easy Access Vessel Plate

6-spindle VK 7010 Easy Access Vessel Plate


VK 7010 equipped with a 2L bath

10-1935 Easy Access 4+2, 115 V, 60 Hz

10-1940 Easy Access 4+4, 115 V, 60 Hz

10-1950 Easy Access 4+4, 230 V, 50 Hz

10-1955 Easy Access 4+2, 230 V, 50 Hz



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VK 7010 2LThe VK 7010 2L model is available in the EasyAccess (4+2 and 4+4) configuration. The 2L unitsare configured the same as the 1L units except theyhave a deeper water bath positioned under anelevated base plate. The VK 7010 2L system can beused with conventional 1L vessels or 2L vessels formaximum flexibility.

System price includes:6 2L vessels6 1L vessels6 19-inch paddles or rotating baskets and shafts

A 2L system is shown on page 16.

SpecificationsWidth: 66 cm (25.98 inches)Depth: 56 cm (22.05 inches)Height: 117 cm (46.06 inches)

FREE with any purchase—a Dissolution Calculation Diskette containing three Excel spreadsheets:

• The Single Point Dissolution Calculation Spreadsheet calculates milligrams dissolved andpercent dissolved per dose for dissolution tests with a single time point.

• The Replacement Media Dissolution Calculation Spreadsheet calculates milligramsdissolved and percent dissolved per dose and corrects for analyte removed for up to 12time points.

• The Non-Replacement Media Dissolution Calculation Spreadsheet calculates milligramsdissolved and percent dissolved per dose correcting for non-replacement media andanalyte removed at up to 12 time points.

Use these spreadsheets to quickly and easily make calculations and reduce mathematical errors in your analysis. Yours free with any purchase! Please request PN 77-2000. The calculation spreadsheets are also available for download at www.vankel.com.

Sink Conditions

Defined as maintaining a volume ofdissolution media that is 5 to 10 times greaterthan the volume at the saturation point of the

drug contained in the drug delivery system being tested.

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VanKel is always working to develop new technology. Visit the VanKel Web site at www.vankel.com for our latest

innovative new products.

VanKel strives to provide quality products and effective service to our customers. VanKel’s LaboratoryServices department provides technical support and assistance to clients throughout the pharmaceuticalindustry. We offer educational services, live training and conferencing through our interactive video system,timely and accurate answers to your questions through our hotline and much more. Call 800.229.1108 or visitour Web site at www.vankel.com to find out more about all the ways VanKel wants to meet your needs.




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Dissolution Instrumentation

VK 7000 DISSOLUTION TESTING APPARATUS• Microprocessor-controlled dissolution testing• Modular design for future upgradability• Meets all current USP, JP and EP

requirements• Same platform as the VK 7010• Preconfigured to accept system upgrades

These microprocessor-controlled units offertremendous flexibility. The EaseAlign system forcentering vessels allows the use of a variety ofvessel sizes (with options of 100 mL, 200 mL,500 mL, 1L (standard), 2L and 4L vessels withBenchsaver models).

The built-in Report Center II dot matrix printerprovides you with a permanent record of the time ofday, elapsed time, RPM and bath temperature.

To review the many other standard features of theVK 7000, see pages 8 and 9.

Cost-effective AlternativeThis cost-effective dissolution tester will not restrictfuture productivity enhancements. With theappropriate accessories it can be upgraded to anonline UV, LC or fully automated system.

System Upgrades The following upgrades can be added easily to theVK 7000 as your needs change:

Dosage Delivery Module (DDM)—The DDMcan be programmed to drop tablets into non-rotating media simultaneously or sequentially.See page 60.

AutoTemp—AutoTemp measures and recordsin-vessel temperature at designated time points.It can also be used to initiate a run when thevessel temperatures have stabilized. See page61.

Manual Sampling Bracketwith Luer Fittings

VanKel offers a manualsampling manifold which raises and lowers the

sampling cannulas and can be used withthe manual sampling bracket on the

VK 7000 or the VK 7010 (see page 62).

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Manual Sampling with Luer Lock-type Cannula

Motorized Sampling Manifold

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VK 7010

Motorized Sampling Manifold—There are twomethods for pulling samples using the motorizedVanKel Sampling Manifold. The manualsampling bracket in conjunction with themotorized manifold facilitates the raising andlowering of the sampling cannula to ensure thecorrect USP sampling location. The automaticsampling manifold used in conjunction with theVK 8000 allows the entire sampling process tobe performed automatically. See page 62.

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10-1600 VK 7000, 4+4, 115 V, 60 Hz

10-1700 VK 7000, 4+4, 230 V, 50 Hz


10-1200 VK 7000, 4+2, 115 V, 60 Hz

10-1300 VK 7000, 4+2, 230 V, 50 Hz


10-1000 VK 7000, 3+3, 115 V, 60 Hz

10-1100 VK 7000, 3+3, 230 V, 50 Hz



VK 7000 Benchsaver6-spindle, 6-vesselThe Benchsaver configuration saves laboratory benchspace. The vessel configuration consists of 2 rows of3 vessels. The Benchsaver comes with 15-inchpaddles. For increased flexibility when samplingmanually, we recommend use of the 19-inch paddlesand extended height spacer PN 12-0321 (see page39). This allows greater clearance to access themiddle position of the back row.

VK 7000 Easy Access6-spindle, 8-vessel locationsThis model provides "easy access" to the activevessels. All of the spindle locations are on the“outside” of the base plate around the perimeter—facilitating manual sample collection. The 2 openpositions come with covers to reduce evaporativeloss. These open positions can be used with vessels(optional) for media replacement. Should your needschange, these 2 positions can be upgraded withspindles to have an 8-spindle, 8-vessel configuration.

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VK 7000 Easy Access8-spindle, 8-vesselThis configuration is ideal for automation. TheVK 7000 Easy Access 8-spindle, 8-vessel tester has 2 additional functioning positions that can be used forany combination of standards, controls and blanks.

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Each of the following configurations includes your choiceof glass or plastic vessels, paddles or baskets and basketshafts. EaseAlign Centering Rings and evaporation coversare included. The VK 750D is standard.


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VK 7000 convertible

10-5300 4L / 1L, 115 V, 60 Hz

10-5400 4L / 1L, 230 V, 50 Hz

Part Number DescriptionVK 7000 equipped with a 2L bath

10-1810 Benchsaver 3+3, 115 V, 60 Hz

10-1910 Easy Access 3+3, 230 V, 50 Hz

10-1800 Easy Access 4+2, 115 V, 60 Hz

10-1900 Easy Access 4+2, 230 V, 50 Hz

10-1920 Easy Access 4+4, 115 V, 60 Hz

10-1930 Easy Access 4+4, 230 V, 50 Hz


VK 7000 2L unit with 1L vessels

VK 7000 2L unit with 2L vessels

VK 7000 4L unit

VK 7000 2LVK 7000 2L models are available in both Benchsaver(3+3) and Easy Access (4+2 and 4+4) configurations.The 2L units use the same configuration as the 1Lunits except they have a deeper water bathpositioned under an elevated base plate. TheVK 7000 2L system can be used with conventional 1Lvessels or 2L vessels for maximum flexibility.

System price includes:6 2L vessels6 1L vessels6 19-inch paddles or rotating baskets and shafts

VK 7000 4LMaximize the utility of your dissolution bath

VK 7000 4L units are available in theBenchsaver configuration only. When theBenchsaver model is configured for 4Lvessels, only three spindles can be used.The VK 7000 is offered in an easilyconvertible format allowing you to use 4L,2L and 1L vessels. By changing the vesselplate insert you can switch from three 4L vessels tosix 2L or six 1L vessels. This option offers you thegreatest flexibility when dealing with sink conditions.

System price includes:6 1L vessels3 4L vessels6 15-inch paddles or rotating baskets and shafts3 24-inch paddles or rotating baskets and shafts

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SpecificationsBenchsaverWidth: 54 cm Depth: 56 cm Height: 117 cmEasy AccessWidth: 66 cm Depth: 56 cm Height: 117 cm

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VK 7000 Small Volume Apparatus

10-5000 6+6, 115 V, 60 Hz

10-5100 6+6, 230 V, 50 Hz


• Use with mini paddles and minibaskets

• Use with the Enhancer Cell fortopicals, creams and ointments(see page 67)

• Requires few accessories tooperate

This specially configured VK 7000 will accept 12vessels (either 100 or 200 mL) along with VanKel’smini paddle or mini basket shafts. You get all thesame programming features of the VK 7000 (seepages 8 and 9 for details).

Although designed for use with Enhancer Cells, thissystem is also used when special, smaller volumesare required. Flat- or round-bottom vessels areavailable. Additionally, both mini paddles and minibaskets are designed for this system.

Drug Release Testing for Topical TreatmentsThe VK 7000 small volume system solves thedissolution testing dilemma associated with creams,ointments or other topical treatment. This systemuses the tested Paddle over Enhancer CellApparatus. See page 67 for the Enhancer Cell.

Perfect Enhancer Cell Centering Our specially designed 200 mL flat-bottom, self-aligning glass vessels perfectly align your EnhancerCell in the vessel. A consistent placement of theEnhancer Cell provides you with reliable andreproducible results. See page 67 for the EnhancerCell.

Run Multiple Lots SimultaneouslyThe 12-vessel, 12-paddle configuration allows you tooperate two 6-vessel runs simultaneously. Each runis conducted under the same method,instrumentation and physical environment.

Can Also be Used with NewMini Baskets!A newly designed mini basketfits on a special Dura-Fitbasket shaft. See page 54 fordetails.

VK 7000 SMALL VOLUME APPARATUS

SpecificationsWidth: 66 cm (25.95 inches)Depth: 56 cm (22.05 inches)Height: 94 cm (37 inches)

System Configuration

VK 7000 Small Volume Apparatus12-spindle, 12-vesselThis alternative requires few accessories to operateand produces reliable, reproducible results.

System price includes:12 Glass vessels (specify 100 or 200 mL, round-

bottom or flat-bottom)12 Teflon-coated mini paddles (standard)

Note the Enhancer Cells must be ordered separately(see page 67).

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Mini Basket and Dura-Fit Basket Shaft


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TOTAL SOLUTION• Complete UV automation package• IQ OQ PQ available for the system• Automatic start (including dosage drop)• Easy testing, validation and reporting • Meets all current USP, JP and EP

requirements

The VanKel and Varian TeamVanKel and Varian have combined forces to provideyou with one of the most innovative and flexibletablet dissolution systems on the market. Thissystem provides you with a simple automateddissolution testing system using UV-VIS analysis.When you order from VanKel, you have one vendorto handle your training as well as any questions thatmay arise.

Complete Dissolution SystemThe Total Solution system includes a computer,monitor, printer, Cary 50 Spectrophotometer andyour choice of VanKel dissolution tester. The TotalSolution is available in single- or dual-bathconfigurations.

Self-operating SystemThe software allows you to pre-program a start time.When used in conjunction with the VK 7010, paddlemethods can be started automatically.

Measures Samples with High BackgroundCorrectionYou can measure highly absorbing samples withoutdilution. The extended photometric range of the Caryinstrument allows you to measure samples requiringhigh background correction that would normallyrequire HPLC analysis.

Flow-through Sample CollectionThe Cary 50 utilizes an 18-position multicelltransport. The flow-through design maintains aconstant volume in the vessels throughout the entirerun by returning the solution back into the vessels,eliminating the need to calculate for volume lost.Cross-contamination between samples cannot occuras each vessel has a dedicated flow cell.

Variable Data Collection RateYou can specify multiple regions in the run, each ofwhich has a different data collection rate. This allowsyou to collect more data when the absorbance ischanging quickly and to have fewer data points inthe more stable parts of the dissolution profile.

Secure Data CollectionUnlike more conventional systems that store dataonly at the end of a run, the VanKel Total Solutionstores data as it is acquired. Because data is beingcontinually saved, even in the event of a poweroutage, your data to that point is secure.

Reporting SolutionA comprehensive report can be tailored for yourspecific reporting needs. Graphics showing timeversus percent dissolved, time versus milligramsdissolved, and time versus absorbance can beincluded in a report, with each vessel indicated by adifferent color trace. Your dissolution reports caninclude your company logo or any bitmap youchoose.

Audit trails are logged providing information abouthow the data was collected and calculated.

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GLP ComplianceGLP application is used to set up different privilegesfor the users in your laboratory and to comply withGood Laboratory Practice.

21 CFR Part 11 ComplianceVanKel and Varian are committed to providing asystem meeting this regulatory requirement. For anupdate on the current system, please check theVarian Web site at www.varianinc.com.

Cary 50 SpectrophotometerThe Cary 50 Xenon lamp allows 80data points per second.

The Xenon lamp flashes only whenacquiring a data point, unlike a diodearray which exposes the sample to thewhole wavelength range with eachreading, causing degradation ofphotosensitive samples.

The Cary 50 is unaffected by room light. It can beoperated with the sample compartment opened orclosed.

The 18-position multicell transport easily handleseither 1 or 2 dissolution baths. Because each vesselhas its own flow cell, there is no cross-contamination.

Software Components• Cary Win UV software version 2.02 is supported

by Windows 95, Windows 98 and Windows NT.• Version 2.10 (141) is supported by Windows 95,

Windows 98, Windows NT and Windows 2000.

Software applications allow you to:

• Create and store custom methods, which includeequipment parameters.

• Create multistandard calibration curves or importequations for your dissolution runs.

• Perform routine wavelength scanningmeasurements.

• Measure the photometric value of samples atfixed wavelengths.

• Export data as an ASCII file for further datamanipulation.

System QualificationVanKel offers a completequalification guide of theentire system(spectrophotometer,dissolution tester anddissolution protocols).This guide is available to you as is the qualificationservice by one of our laboratory chemists. VanKelcan perform the qualification of the complete systemfor you. Order PN 11-1130 for the qualification guideor call for details about our service capabilities.

Cary 50Spectrophotometer

VanKel Qualification Guide

http://www.varianinc.com



VK 7000 (4+4) Single-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing.

10-6920 VK 7000 with paddles, 115 V, 60 Hz

10-6930 VK 7000 with baskets, 115 V, 60 Hz




VK 7010 (4+4) Single-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing.





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VK 7000 / 7010 Single-bathConfigurationsThe Total Solution System can be set up with theVK 7000 as USP Apparatus 1 or 2 and can beconfigured with either 1 or 2 dissolution testers (seepage 22).

The automated sampling manifold automaticallyraises and lowers sampling cannulas unattended forultimate positioning control and perfecthydrodynamics. When the Total Solution is pairedwith the VK 7010, our Dosage Delivery Moduleallows you to preload and drop dosage units at aprescribed time or temperature for time-saving,automatic, unattended operation.

A complete system consists of 3 components: theUV package (PN 11-1100 or 11-1120), flow cellsmeeting your pathlength requirements and a VanKeldissolution tester (either the VK 7010 or VK 7000).

VK 7010 VK 7000

VanKel qualification documents are available for purchase (see page138). VanKel chemists areavailable to perform installation, operation and

performance qualifications onyour equipment.

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Total Solution Single-bath ConfigurationMedia Flow Diagram



VK 7000 (4+4) Dual-bath for use with Total Solution.Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing.

10-6925 2 VK 7000s with paddles, 115 V, 60 Hz

10-6935 2 VK 7000s with baskets, 115 V, 60 Hz




VK 7010 (4+4) Dual-bath for use with Total Solution.Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing.





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VK 7000In this configuration, 2 VK 7000s are linked to 1Cary 50 UV. Each bath is identical in their setup,method and start time. Dedicated lines and UV cellsensure no cross-contamination between vessels,standards or blanks.

VK 7000 / 7010 Dual-bathConfigurationsThe Total Solution System is also available in dual-bath configurations. This system allows you to runtwo baths with the same method at the same time.

A complete system consists of 3 components: theUV package (PN 11-1100 or 11-1120), flow cellsmeeting your pathlength requirements and 2 VanKeldissolution testers (either the VK 7010 or VK 7000).

VK 7010Two VK 7010 baths can be integrated into a single UV-VIS system. Both testers are configured in thesame manner including a built-in Dosage DeliveryModule and AutoTemp for in-vessel temperaturemonitoring.

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Total Solution Screen Display

Single-bath Total Solution

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Total Solution Dual-bath ConfigurationMedia Flow Diagram


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The Power of XenonThe Cary 50 uses a Xenon flash lamp which flashesonly when acquiring a data point, rather thanexposing the sample to the whole wavelength rangeat each reading. This minimizes degradation ofphotosensitive samples.

The Xenon lamp has a long life expectancy so youwon’t be changing bulbs very often—if at all.

The Xenon lamp allows the Cary 50 to use a beamsplitter for simultaneous reference beam correctionwithout the loss of energy, which causes excessivephotometric noise. In addition the peaks will not shiftas the scan speed changes.

Fast, Effective and FlexibleYou can scan the entire wavelength range from 190-1100 nm in less than 3 seconds.

The Cary 50 can measure samples up to 3.0 Abs.,decreasing the need for dilution.

The Cary 50 is unaffected by room light. Operatewith the sample compartment open or closed; thereis no difference.

Dual Cell Tubing KitThe Cary 50 makes it easyto interconnect two differentcells within the 18-positionmulticell transport. Thisallows you to switchbetween two sets of cells(typically with differentpathlengths) with nodisassembling or re-assembling of the tubing lines.Switching between methods requiring cells ofdifferent pathlengths is as easy as selecting the cellsto be read using the Total Solution software. Onlyone tester can be used when the dual cell tubing isin place.

Quartz Flow CellsFlow cells are specially designed for the VanKelTotal Solution System Cary 50. Smaller pathlengthsare available. Call VanKel for details.

The Cary 50 UV-VIS Spectrophotometer

System QualificationVanKel offers a complete qualification guide for theentire system (spectrophotometer, dissolution testerand dissolution protocols). This guide is available toyou as is the qualification service by one of ourlaboratory chemists.VanKel can perform thequalification of thecomplete system. OrderPN 70-4960 for thequalification guide or callfor details about ourservice capabilities.

For more information call your VanKelrepresentative.


11-1000 Cary 50 UV-VIS Spectrophotometer,115 V or 230 V (requires PC to operateand card and cable to connect PC andSpectrophotometer)

11-1030 Cary 50 Card and Cable

11-1050 Cary Win UV Dissolution Software

11-1010 Extended Sample Compartment

11-1015 Sample Compartment Tubing Coupler

11-1020 Eighteen-cell Multitransport

11-1035 Cable Kit—for connecting either one or two VanKel baths


11-1300 Flow Cell 1.0 cm for Cary 50 serialized




11-1320 Dual Cell Tubing Kit, dual pathlength

11-1325 Tubing Kit, replaces tubing between Peristaltic Pump and flow cells


11-1320 Dual Cell Tubing Kit, dual pathlength

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Cary 50 UV-VIS Spectrophotometer

VanKel Qualification Guide

Dual Cell Tubing Kit

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Total Solution Upgradefor Your Existing ApparatusIf you already have a VK 7000 or VK 7010 bath, you can integrate your existing equipment. Depending on theconfiguration of your existing equipment, you may need an automated sampling manifold with the internalmotor drive along with the appropriate Peristaltic Pump. Call for more details. To simplify the orderingprocedure, we have created the following packages (flow cells are not included—see page 24):

Package 11-11001 Cary 50 UV-VIS Spectrophotometer1 Extended cell compartment1 Sample compartment tubing coupler1 18-position cell holder1 Cary 50 accessory card and cable kit1 Cary Win UV dissolution software1 Dell Pentium-based PC with monitor1 HP color printer

Dosage Delivery Modules are available for the VK 7000 and are compatible with Cary 50 upgrades.See page 60 for details.

Package 11-11051 Cary 50 UV-VIS Spectrophotometer1 Extended cell compartment1 Sample compartment tubing coupler1 18-position cell holder1 Cary 50 accessory card and cable kit1 Cary Win UV dissolution software

Varian Fiber Optic Dip ProbeTo extend the utility of your Cary 50, we offer as anaccessory a fiber optic dip probe.

Varian’s fiber optic dip probe is a trouble-freealternative to a conventional sipper. Measurementscan be taken directly from a vessel. There is noneed to transfer samples to an instrument cuvette orto pump samples into flow cells. No more bubbles inthe flow cell blocking the light beam and destroyingyour measurement. The fiber optic dip probe doesnot use tubing or any metallic components—organicor corrosive solutions can be measured with ease.No more tubing leaks and degradation.


VanKel Total Solution Upgrade Cary 50 UV package

11-1100 Cary 50 UV Package 115 V, 60 Hz

11-1120 Cary 50 UV Package 230 V, 50 Hz


VanKel Total Solution Upgrade Cary 50 UV package without PC, monitor and printer

11-1105 Cary 50 UV Package 115 V / 230 V


11-1130 Varian Fiber Optic Probe Varian Fiber Optic Dip Probe

Dissolution Compatible Systems26D

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Varian, Inc.Varian incorporates VK 7000 and VK 7010 baths intotheir UV analysis systems. These systems incorporateeither the Cary 50 (see pages 18 - 25) or the Cary 100,300, 400 and 500 model spectrophotometer. No matterwhat your spectral demands are, VanKel has anautomated system that can work for you.

AUTOMATED COMPATIBLE SYSTEMSVanKel dissolution testers are ideal for use in automated systems. There are a number of analytical instrumentsystems designed for use with VanKel testers. The following list of companies is a representative sample ofcompanies whose products are compatible with VanKel’s products and is not intended to be an explicit orimplied endorsement, sponsorship or other association by these companies with VanKel or its affiliatedbusinesses. Among these are:

UV-VIS Spectroscopy• Varian, Inc.• Agilent Technologies (formerly Hewlett Packard)• Perkin Elmer Instruments

Liquid Chromatography• Varian, Inc.• Agilent Technologies • Waters Corporation• Shimadzu• Thermo Separations Products

VanKel testers can be integrated to almost any LCequipment using the VK 8020 Autosampler / Auto-Injector (see page 105).

Fiber Optic Spectroscopy• Carl Zeiss Jena GmbH• C Technologies, Inc.• Delphian Technology L.P.• Leap Technology• Varian, Inc.

Fully Automated• Zymark Corporation

To learn how to best integrate your analyticalinstruments with your VanKel dissolution tester, call800.229.1108 or contact your local VanKelrepresentative.

VK 7000 with External DDM connected to a Cary UV Spectrophotometer

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Dissolution Compatible Systems

Agilent’s ChemStation dissolution softwareinterfaces with the VK 7000 and VK 7010 baths.VanKel provides the drivers to communicate withthe HP 8453 Diode Array Spectrophotometer,ChemStation software (including the dissolutionmodule) and an 8-position cell changer. You caneasily incorporate an existing VanKel bath to theChemStation software utilizing VanKel UV interfacekits (see below). Both single- and multibathsystems are available. Contact us for drivers tocontrol your VanKel bath. For more information,contact your VanKel representative.

These devices control both the Agilent PeristalticPump as well as the VanKel bi-directional pump.Using the VanKel pump allows the back-flushing offilters.

The VanKel drivers allow for the maximum use ofthe VanKel baths. You can control the motorizedmanifold, in-vessel temperature measurement aswell as the dosage delivery mechanism (ideal forstaggered starts).

Agilent Technologies


11-0010 Software drivers for single-bath configuration. Includes driver qualificationguide and cables for use with HP 8453Spectrophotometer.

11-0011 Software drivers for multibath configuration.Includes driver qualification guide andcables for use with HP 8453Spectrophotometer.

Agilent HP 8453 Spectrophotometer with VK 7000-series Dissolution Tester

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Agilent Single-bath ConfigurationMedia Flow Diagram

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Agilent Multibath ConfigurationMedia Flow Diagram

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Perkin Elmer InstrumentsPerkin Elmer Dissolution Lab software works withVanKel testers in conjunction with their LambdaSeries Spectrometers. The software automates bothonline and offline tablet dissolution studies.Dissolution Lab software includes password securityand provides two levels of access: supervisor anduser. Additional security features include binarystorage of data files for manual verification of results,if needed. All report printouts include footnotes withdate, time and consecutive page numbers.

Waters CorporationThe VK 7000 and 7010 are fully compatible with theWaters Alliance System for automated samplingusing programming capabilities built into VanKeltesters. Unlike other testers, VanKel testers do notrequire the use of resident dwelling probes. Alloperating parameters can be initiated by the transferstation, including the dropping of tablets andrecording individual vessel temperaturemeasurements and sampling time points(dosage dropping and vessel temperaturemeasurement are standard features of theVK 7010). The Alliance System, withMillennium software, allows two testers tobe connected to one LC. To accommodatethe Waters sampling probes, we offercustomized sampling manifolds. These canbe fitted to any VK 7000 or VK 7010.

Using a VK 7010, you can automate thestart of the test (measuring and recordingthe temperature) as well as dropping thedosage form when used with paddles.

Note that• tubing and sampling cannulas are supplied by

Waters.• manifolds require the use of a motorized drive.

Your tester may or may not have this alreadyinstalled.

Please call your VanKel representative if you havequestions.


Customized Waters Manifold

17-3130 For Benchsaver testers (3+3 configuration)

17-3132 For Easy Access models (4+2, 4+3 or 4+4 configurations)

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Waters Alliance System with VK 7000-series Dissolution Testers

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Carl Zeiss Jena GmbHThe Zeiss Optical Dissolution In-situAnalysis and Control system, known as theZodiaC, is a new development which usesmultiple fiber optic probes for multichannelanalysis with the proven MCSspectrophotometer coupled to an 8-channelmultiplexer. Initially targeted for sustainedrelease products with dissolution profiles of24 - 48 hours, the system can also be usedfor fast-release products. The system can measuretime points down to a minimum of 1 minute due tothe use of a fast and precise multiplexer. The fiberoptic probes are mounted on a special manifold andpositioned for the correct height and distance fromthe vessel walls to comply with USP.

C Technologies, Inc.The Cassini multiplexer is an input-output multiplexerwhich allows multiple fiber optic probes to be usedwith a single Cary 50 spectrophotometer. Thisdevice allows software-controlled switching of thefibers coupled to the light source and detector of thespectrophotometer. These probes easily attach toVanKel’s manifold for fiber optic dissolution testing.

Delphian Technology L.P.The new Rainbow Dynamic Dissolution Monitorsystem can be used with one or more VanKeldissolution testers. This system gives you complete,calculated results in real-time—including GMP-compliant printouts for a fiber-optic methodology ofdissolution testing accepted by the FDA. It is idealfor analyzing both immediate- and extended-releaseoral forms. As your sample dissolves, fiber-opticprobes deliver a continuous stream of dissolutiondata—data displays every ten seconds. Set-up andsuitability testing are quick and easy, and there is nosampling, no transfer and no post-run calculations.

Zeiss ZodiaC with VK 7010

C Technologies Cassini Multiplexer and Cary 50 with VK 7010

Delphian Rainbow Dynamic Dissolution Monitor System

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ZYMARK CORPORATION

SpecificationsHeight: 101.6 cm (40 in.)Recommended bench space: 60.96 cm (23.99 in.)(not including space for PC controller, dissolution tester or sample output devices, such as fraction collector or UV-VIS spectrophotometer)

Zymark MultiDoseZymark has developed an advanced workstation forfully automated USP II dissolution testing. TheMultiDose Automated Dissolution Workstation runsup to 8 batches (48 samples) without intervention,using the same method or different methods. Thesystem can perform single-point dissolution tests ormultiple point dissolution profiles. All activities of thesystem are documented in an electronic audit trail.The system is fully USP compliant. The MultiDoseperforms a typical automated dissolution sequencein the following way:

• preheat and degas the media• dispense the requested volume of media into

each vessel with gravimetric confirmation • verify and record the temperature in all six

vessels• automatically introduce the dosage form to start

the test• remove and filter samples at prescribed time

interval(s)• replace the volume of media removed at user’s

option• perform online UV measurements or collect

fractions • empty vessels, then wash them in place• start again until all methods have been executed

The MultiDose is fully validated upon installation; IQ,OQ and PQ protocols executed and final reportgenerated. Also, the new MultiDose G3 softwarepackage now makes the unit fully 21 CFR Part 11compliant.


VK 7000s for use with the MultiDose

10-6000 VK 7000 Benchsaver 3+3, 115 V, 60 Hz

10-6200 VK 7000 Benchsaver 3+3, 230 V, 50 Hz

10-6400 VK 7000 Easy Access 4+2, 115 V, 60 Hz




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Zymark MultiDose with VK 7000-series Dissolution Tester

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SpecificationsHeight: 101.6 cm (40 inches)Recommended bench space

Linear array: 210.82 cm (83 inches)Non-linear arrangement: 144.78 cm (57 inches)(not including space for PC controller, dissolution tester or sample output devices, such as fraction collector or UV-VIS spectrophotometer)

Zymark MultiDose PlusThe MultiDose Plus, in conjunction with an"automation ready" VK 7000 dissolution tester, canrun up to eight batches of samples unattended. Thesystem preheats and conditions the dissolutionmedia, fills each vessel with the appropriate volumeof media, verifies temperature, starts the dissolutiontest, removes sample aliquots at the user-definedtime intervals, then empties and cleans each vesselbefore starting another run. When configured forApparatus 1, the system removes the spent basketand replaces it with a new basket containing thedosage form for the next analysis. When configuredfor Apparatus 2 with capsule sinkers, the system iscapable of retrieving the sinker at the end of the run.The system can also act as a standard MultiDoseSystem for ordinary Apparatus 2 dissolution tests.Dissolution samples are either stored for offlineanalysis or can be analyzed online with anappropriate multicell UV-VIS Spectrophotometer. Alloperations of the system are documented in anelectronic audit trail.

The new MultiDose Plus G3 software package nowmakes the unit fully 21 CFR Part 11 compliant.


VK 7000s for use with the MultiDose Plus



Zymark MultiDose Plus with VK 7000-series Dissolution Tester


Dissolution Vessel Washing StationsD

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Clean vessels in place!

• Designed to clean 1L vessels• Quickly and efficiently cleans vessels in place• Fits securely over any standard 1L vessel• Reduces risk of damage to vessels

Evacuate, Rinse, RepeatThe VK 900 Washing Station pressure washes thevessel with three washing cycles. The VK 900’swashing ball uses a revolving action and highpressure stream to wash the interior of your vessels.In less than five minutes your tester is ready for thenext test.

With one filling of the rinse tank you can clean up to32 1L vessels before a changeover is required.

Easy to Fill, Easy to EmptyThe quick-disconnect fitting on the top of thewashing station makes filling the rinse tank as easyas turning on a water faucet. The rinse tank isequipped with an inlet valve and float device toprevent overfilling. An LED illuminates to indicate thetank is full.

An antifoaming agent can be added to the wastetank to minimize foaming when evacuating mediacontaining surfactants.

The built-in vacuum pump easily evacuates thewaste tank. Neutralizing agents can be added to thewaste tank prior to disposal.

Saves TimeWhen you remove vessels for washing, you shouldalways reverify the centering and heightparameters. Cleaning the vessels in placepreserves set parameters and eliminates the time-consuming step of reverification from future tests.

One Station Fits AllThe VK 900 is compatible with most dissolutiontesters. The aspiration tube can be configured toremove spent media from any 1L vessel. Thecleaning head fits securely over any standardvessel.

MobileThe VK 900 is a cleaning, containment and disposalunit all in one mobile housing. The durable casterssmoothly roll the unit directly to your dissolutiontester.

VK 900 MOBILE WASHING STATIONS

Carry-over studies should be performed onautomated equipment to ensure proper cleaning

between collection and analysis of samples. Carry-over can affect the sample reading possibly

causing erroneous results.

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VK 900 Washing Station

VK 900 In Use


35Dissolution Vessel Washing Stations

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VK 900 Washing StationThe VK 900 is a fully mobile, self-contained washingstation that cleans your vessels quickly andefficiently.

SpecificationsLength: 81.28 cm (32 inches)Width: 45.72 cm (18 inches)Height: 121.92 cm (48 inches)

VK 900 Washing Station with HeaterOptionHeats cleaning fluid for better washing efficiency.The heater option keeps your cleaning fluids heatedup to 50 °C.

SpecificationsLength: 81.28 cm (32 inches)Width: 45.72 cm (18 inches)Height: 121.92 cm (48 inches)

When evacuating media where a surfactanthas been used, an antifoaming agent should

be added to the VK 900 to keep foamingto a minimum.

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Wash CompleteRinse StageEvacuation Stage


VK 900 with heater

11-5020 Mobile Washing Station, 115 V, 60 Hz



VK 900




VK 900 Replacement Parts

11-5200 2-inch VK 900 Cleaning Head Tubing

11-5210 6-inch VK 900 Cleaning Head Tubing

11-5215 VK 900 Rinse Tank Fill Hose

11-5220 VK 900 Rinse / Waste Tank Drain Hose

11-5225 500 mL VK 900 Rinse Tube

VK 900 Washing Station

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QAII STATIONPatent 6,155,113

Effective Measurement SystemThe QAII allows you to measure and recorddissolution physical parameters (as specified in USP,EP and JP). It easily measures and documentsindividual spindle speeds, shaft wobble, shaftperpendicularity, temperature and instrument level.In addition, the QAII measures vibration. Thevibration display shows vibration is a function of fourdifferent parameters (acceleration, velocity,frequency and displacement) in all three axes X, Yand Z.

The QAII can be used on almost all brands ofdissolution testers. An adapter ring for non-VanKeltesters is included.

NIST-traceable Results A calibration certificate is included.

Truly PortableThe QAII is battery operated as well as line-operable. The printer is only operated when theinstrument is plugged into a wall socket to conservebattery life.

Information StorageThe QAII stores information for up to 30 testers andretains the serial numbers by unit and eachindividual shaft ID.

The easy-to-use menu prompts you through thestep-by-step process. You have the option ofskipping various positions or measurements.

Station includes the following, as pictured above:• Digital wobble gauge, mounted to an EaseAlign

mounting bracket (A)• Magnetic tachometer sensor (B)• Black reflection clip with magnetic tag (C)• Electronic level sensor (also measures shaft

perpendicularity) (D)• Precision temperature probe (E)• Electronic vibration sensor (F)• Universal adapter for use with

non-VanKel units (G)• Calibrated shaft (not shown)

AB

C

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D

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G


12-0520 QAII Station 115 V, 60 Hz

12-0530 QAII Station 230 V, 50 Hz

12-0531 Carrying Case

Digital Wobble Gauge Vibration Sensor

QAII Printout

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Dissolution Accessories

QA and QAII Station Replacement PartsIf you have an earlier model QA Station, contactVanKel for part replacement information.

NIST-traceable Re-certification ofQAII StationVanKel will re-certify your QAII Station. Call ourTechnical Service Department for packinginstructions and Return Authorization Number (fortracking purposes) before returning your instrument.Equipment should be shipped in the originalpackaging to prevent damage during shipping.

NIST-traceable items include the wobble gauge,temperature probe and the tachometer sensor.

If you have an original QA Station, contact VanKelfor calibration information.

QAII UpgradeThe QA Station with optical reflective chips can beupgraded to use the new magnetic tachometersensor and chip. Call VanKel for details!

Return your QA Station toVanKel for re-calibration!

Call our Technical Service Department to have your QA Station re-calibrated. Your calibration will be

expedited and your instrument will be back inservice in a very short time.


12-9005 Universal Adapter for QAII Station (for non-VanKel instruments)

12-9006 Adapter, 4L vessels

12-9010 Calibration Shaft

12-9015 RPM Sensor Reflective Clip, black

12-9020 RPM Sensor Reflective Clip, white

12-9021 Magnetic RPM Sensor for 1/4-inch shaft

12-9025 Magnetic RPM Sensor for 3/8-inch shaft

12-9995 Plain Paper for Report Center II printerfor QAII, package of 10 rolls

12-9996 Plain Paper for Report Center II printerfor QAII, package of 100 rolls

12-9997 Ribbon Cartridge for Report Center IIprinter for QAII, package of 5

12-9999 Thermal Paper for Report Center Iprinter for QA, package of 10 rolls

12-9994 Thermal Paper for Report Center I printer for QA, package of 100 rolls

12-0531 Carrying Case for QAII—hardplastic case with foam support inside


75-7500 NIST Re-certification of QAII Station


12-7505 QAII Sensor Upgrade (magnetic)

Protect your investment by shipping your QAII in thishard plastic carrying case.

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• Provides absolute readings for shaftcentering and paddle or basket heightmeasuring

• Improves accuracy over manual gauges• Takes digital measurements

Reliable ResultsFor increased overall accuracy of your dissolutiontests, this system utilizes easily calibrated andtraceable gauges to measure the actual centerlineoffset for a shaft. It also measures the distancebetween the bottom of the paddle or basket and theinner apex of the bottom of the vessel.

Digital MeasurementsThe VK 5010 takes measurements digitally—eliminating visual interpretation and estimation andremoving the likelihood of human error.

Reproducible Results and Hard Copy PrintoutsConsistently reproducible results are viewable on theLCD display, and hard copy printouts are providedby the on-board printer.

Non-volatile MemoryThe VK 5010 is also capable of storing the followingdata in non-volatile memory:• Tester serial number• Shaft ID• Vessel ID• Vessel position

The VK 5010 can store information for up to30 testers at 8 vessels per tester.

VK 5010 CLH MEASUREMENT SYSTEMPatent Pending

Paddle ConfigurationHeight Measurement

Basket ConfigurationHeight Measurement

Centerline Offset Measurement


12-0540 VK 5010 CLH Measurement System—centerline offset and heightmeasurement, 115 V or 230 V, includesall necessary gauges

12-0531 Carrying Case—hard plastic case withcutouts for instrument and gauges

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12-7270 Height Gauge for Paddles—attaches to paddles toposition 25 mm above bottom of vessel (G)

12-7280 Height Gauge for Baskets—attaches tobasket to position 25 mm above bottom of vessel (H)


12-0321 Spacer, 3.25 inch, for use with 100 / 200 mL vessels.Can also be used with standard dissolution vesselswhen more space between the head and the vesselplate is desired. This application requires 19-inchpaddles. (A)

12-7210 Depth Spacer for basket (B)

12-7200 Depth Spacer for paddle (C)

12-0320 Height Gauge for use with 15 mm paddle and 100 / 200 mL round-bottom vessel (D)

12-7220 Depth Spacer for use with Peak Vessels (E)

12-7250 Spherical Height Gauge, 25 mm (F)

12-7260 Spherical Height Gauge, 38 mm forintrinsic dissolution (not shown)


CALIBRATION TOOLS

Tachometer, Hand-heldThe hand-held tachometer measures RPM with continuous update eachsecond. The measured value can be stored and read on the display byuse of a slide switch. Unit includes three tips: cone shape, conical anddisk. The range is 1 to 19,999 with accuracy of ± 1.0, ± 0.5% of meanvalue. The power supply is a 9V battery.

EaseAlign Shaft Wobble GaugeThese gauges indicate shaft wobble in 0.001 inch or 0.01 millimeter graduations and include a snap-in adapter for non-VanKel instruments.

Height Spacers for USP Apparatus 1 and 2The height spacers are easy to use and are designed for use withVanKel testers. Height spacers A through E snap on the leg of the tester.One spacer sets all paddle or basket heights at the same time.

A

E

BC

DF

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10-2429 Digital Wobble Gauge

12-7000 Analog Wobble Gauge, reads in 0.001 inch increments

12-7020 Analog Wobble Gauge, reads in 0.01 mm increments

12-7520 Calibration Certification for thickness and wobble gauge


12-7100 Tachometer

12-7110 Calibration Certificate for hand-held tachometer

12-7120 Calibration Certificate with Calibration Data Sheet forhand-held tachometer

H

Hand-held Tachometer

Analogue Wobble Gauge

Height Spacers

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Spacers and Centering ToolsHeight tools can be used with dissolution testersfrom any manufacturer.

C and D

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When using Peak Vessels, the height is setas if the indentation were not present. PN 12-7230 takes this into account,

making it easy to set the height.

Didyou

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12-7311 Centering tool for use with stainless steel centering rings. Stainless steelgauge for checking the centering of 3/8-inch diameter basket or paddle shaftwith dissolution vessels. (A)

12-7310 Centering Pass / Fail Gauge for use with EaseAlign centering rings. Aluminumgauge for checking the centering of 3/8-inch diameter basket or paddle shaftwith dissolution vessels. (B)

12-7300 Height tool, stainless steel, to accurately set the depth (2.5 cm) of the paddle orbasket for USP Apparatus 1 and 2dissolution tests. (C)

12-7301 Height tool, stainless steel, similar to item “C” designed for 2-liter vessels (2.5 cm)depth with longer handle for deepervessel. (D)

12-7330 Height tool, stainless steel, similar toitem “C” designed with (4.5 cm) depth asrequired in some instances for dissolutiontesting of antibiotics. (E)

12-7230 Height tool, special design, made ofstainless steel and delrin, to be used withPeak vessels. (F)

12-7320 Circular level for all directionalhorizontal leveling. Base of level is 3/4-inch diameter. (G)

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41Dissolution Accessories

VESSELS

VanKel Verified Vessels• Individual certificate• Critical dimensions measured• Results are traceable

If an apparatus is not set up correctly from the start,it is going to need attention in the future. TheVK Verified program is your assurance that youraccessories will conform to all regulatory standards,as well as to the more stringent internalspecifications of VanKel.

Almost all dissolution vessels are hand-made fromglass tubing. Due to hand-forming, no 2 vessels areexactly alike. This is particularly important for thebottom curvature. As of this publication, there are nopublished specifications as to the “hemisphericity” ofthe vessel. At VanKel, we’ve created our owntolerances based on those the USP hasrecommended for the ID. The diameter (1) has aUSP tolerance of ±4 mm. We have taken half of thisvalue and created a requirement for the hemisphere(3) to be ±2 mm. We inspect each vessel and recordthe actual dimension. The result—you get vesselsthat are neither too shallow nor too deep and acertificate to verify the actual dimensions.

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The benefit to you is greater consistency of testresults. Although not exactly alike, these VK verifiedvessels are held to very tight tolerances. Substitutinga VK verified vessel for a broken vessel should yieldno perceptive difference in results. A certificate isincluded to provide the actual measured values, thetype of measuring device used, and its traceability.

VanKel Technology Group • 13000 Weston Parkway • Cary, North Carolina 27513-2228 USA800.229.1108 (within the US) • 919.677.1108 • FAX 919.677.1138 • [email protected] • www.vankel.com


12-5005V Certified Glass Vessel, serialized 1000 mL for Apparatus 1 and 2

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VanKel Peak VesselFor more detailed informationregarding studies preformedwith the Peak Vessel, call theVanKel Hotline for a reprint of

the article: “Improvedhydrodynamics for USP

Apparatus 2”.

Peak VesselsPatent 5,700,087

The Peak vessel reduces the inherentinconsistencies in the hydrodynamics of standardhemispherical dissolution vessels. An inverted peakis designed into the bottom of the vessel, displacingthe unstirred zone, preventing cone formation.

Glass Dissolution Vessels• Serialized• Wide range of sizes• Custom versions available (amber-coated or

Teflon-lined)

1000 mL VesselsThe standard 1000 mL vessels are designed to meetor exceed current USP specifications. All areindividually serialized for documentation purposesand easy relocation.

Amber-tinted

4L 2L

100 mL, 200 mL, 500 mL, 2L and 4L Vessels

200 mL 200 mL 100 mLPN 12-5055

Teflon-lined

500 mL

Peak


Glass Dissolution Vessel

12-5040 100 mL, round-bottom

12-5041 100 mL, amber-tinted, round-bottom



12-5055 200 mL, flat-bottom, self-aligningindentation for use with Enhancer Cell



12-5070 USP 2L, round-bottom

12-5075 USP 2L, amber-tinted, round-bottom

12-5080 USP 4L, round-bottom

12-5090 USP 4L, amber-tinted, round-bottom


12-5500 Peak Vessel 1L

12-5025 Peak Vessel 1L, Teflon-coated bottom



42

1000 mL


12-5000 USP Vessel, 1000 mL standard

12-5010 USP Vessel, 1000 mL amber-tinted

12-5020 Vessel, 1000 mL Teflon-lined (interior lower hemispherical radius only)

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Volumetric FlasksThis volumetric dissolution flask meets class Aspecifications. A stopper is included and the flask isdesigned with a space-saving square bottom. Theflasks are marked to deliver and to contain.

Calibrated Volumetric FlasksThis volumetric dissolution flask meets class Aspecifications. Unlike other volumetric flasks, these arecalibrated to contain as well as deliver media at 37 ºC.Most conventional flasks are calibrated at 20 ºC.

��

Preheating media in volumetric flasks can save time. Be sure

to verify the volume when the media is at37 ºC. The volume will differ from that at

room temperature.

Didyou

know?

TruCenter VesselsPatent Pending

• Empty vessels will not float• Retrofit kits available

All dissolution vessels have inconsistencies in theglass thickness. Consequently it is difficult to centerfrom the outside of the vessel. Not any longer!

These dissolution vessels have a ground concentricring around the outside which holds a centeringcollar in place. The result is a vessel for which youcan establish the true center from the outside.

��

Plastic Dissolution VesselsThe standard 1000 mL plastic vessels are designedto meet or exceed current USP specifications. Theplastic dissolution vessel has 3 molded feet forsupport and is manufactured of polyethylene.

TruCenter Vessel must be used only withVanKel testers equipped with the

TruCenter collar.


12-5315 Calibrated Volumetric Flask, 900 mL

12-5320 Calibrated Volumetric Flask, 500 mL


12-5300 Volumetric Flask, 900 mL

12-5310 Volumetric Flask, 500 mL


12-5200 Plastic Dissolution Vessel, 1000 mL


12-5035 TruCenter Vessel, 1L, with ground centering groove, vessel only

12-5037 TruCenter Vessel, 500 mL, with groundcentering groove, vessel only

12-6105 TruCenter Centering Collar

Volumetric Flasks

Plastic Vessel

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Dissolution Accessories44

EaseAlign Centering Rings


12-6050 EaseAlign Centering Rings only

Stainless Steel Centering Rings


12-6100 TruCenter System Conversion Kit—includes vessel, centering collar andalignment plate

12-5035 TruCenter Vessel, 1L, with groundcentering groove

12-5037 TruCenter Vessel, 500 mL, with groundcentering groove

12-6115 TruCenter Alignment Plate

12-6105 TruCenter Centering Collar

12-6120 Pegs for Alignment Plate

12-6110 O-rings for TruCenter Centering Collar

12-6327 Evaporation Covers for TruCenterVessels


12-6000 Upper and Lower Ring Assembly,stainless steel

12-6004 Centering Ring, 4L, stainless steel

12-6005 Replacement Gasket

12-6010 Replacement Knobs (2)

12-6015 Upper Centering Ring, stainless steel

12-6020 Lower Centering Ring, stainless steel

12-6025 Adapter Plate for 200 mL conversion kit

TruCenter SystemPatent Pending

This system assures you of perfectly centeredvessels every time. We start by turning a dissolutionvessel and grinding a concentric ring around theoutside of the glass vessel. Next we fasten acentering collar around the ground ring and placethe system into the alignment plate. The result is avessel that can be perfectly centered. One lessvariable for you to worry about. Once your vesselsare in place, they will not float. This system can beretrofit to any existing VK 7000 or VK 7010 bath.

��

EaseAlign Centering RingsPatent 5,403,090

These centering rings position the vessels accuratelyusing the inside diameter of the vessel. Emptyvessels will not float. Locating pegs mounted on thevessel plates ensure centering each time a vessel isplaced in position. Does not include evaporationcover or pegs. For use with VK 700, VK 7000 andVK 7010.

Stainless Steel Centering RingsThese centering rings provide easy, one-timecentering. PN 12-6000 includes the upper and lowerrings with locating pins to position vessels andthumb screws to lock the vessel in place.

VESSEL CENTERING RINGS

TruCenter Centering Collar

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EaseAlign Centering Retrofit Kit

EaseAlign Centering Retrofit KitsUpgrade your VK 600, 6000, 6010 or Hansondissolution testers to accommodate VanKel’sEaseAlign Centering Rings. Also designed for usewith most dissolution baths. Easy to assemble.


12-6060 EaseAlign Centering Ring 6-position Kit

12-6062 EaseAlign Centering Ring 8-position Kit

12-6065 EaseAlign Locating Pegs, set of 12

12-6070 Complete Conversion Kit for Hanson, set of 6

VESSEL EVAPORATION COVERSEvaporation covers slow the loss of media duringdissolution testing.

DC

A B


Evaporation Cover for Stainless Steel Rings

12-6200 Standard

12-6205 Robotic Zymark type

12-6210 Amber-tinted

12-6306 For use with baskets

12-6325 For use with 4L vessels


Evaporation Cover for EaseAlign Centering Rings

12-6300 Standard, PETG construction (A)

12-6301 Standard, PVC construction

12-6305 For rotating basket - auto start (B)

12-6310 For Dosage Delivery Module type (C)

12-6330 Solid for use in 7th or 8th position with an EaseAlign ring when no vessel is inuse (D)

12-6315 200 mL

12-6320 Amber-tinted (same design as PN 12-6300)

12-0463 Evaporation Cover, basket, Agilentmolded

12-0464 Evaporation Cover only for auto start with baskets

Vessel Evaporation Covers for EaseAlign Centering Rings

Vessel Evaporation Covers for Stainless SteelCentering Rings

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Low Loss Evaporation CoverThe unique conical design of these low lossevaporation covers causes condensation to return tothe vessel and is ideal for extended testing. The lowloss evaporation cover dramatically reduces medialoss during long runs. Use with VanKel’s EaseAlignCentering Rings.

Hinged Low Loss Evaporation CoverVanKel’s new, two-piece, hinged evaporation coveris designed for all systems where the evaporationcover sits directly on the dissolution vessel (either 1Lor 500 mL). Its unique conical shape causescondensation to return to the vessel. Split hingedesign makes manual sampling easy.

Evaporation PlugsPress-fit plugs are used to close sampling holes inevaporation covers (PNs 12-6300, 12-6305 and 12-6310).

��


12-0469 Low Loss Evaporation Cover, conical shape for extended release analysis


12-6327 Hinged Low Loss Evaporation Cover


12-6350 Set of 36

Low Loss Evaporation Cover

Hinged Low Loss Evaporation Cover

Evaporation Plugs

47



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PADDLES

VanKel Verified Paddles• Individual certificate• Critical dimensions measured• Results are traceable

All VanKel accessories are lot inspected. Manycustomers request their accessories be individuallyinspected, measured and documented. We nowoffer this service for a number of accessories. Acertificate is included to provide the actual measuredvalues, the measuring device used, and itstraceability.


Teflon-coated Paddles

12-1000V 15-inch Shaft with individual inspection certificate



Uncoated Electropolished Paddles




PEEK Paddles



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Dura-Tef Replacement Blade and Shafts


USP Apparatus 2Dissolution Paddles

Teflon-coatedThese paddles are serialized and designed to meet orexceed current USP specifications for Apparatus 2.They are constructed of type 316 stainless steel andhave a 3/8-inch diameter shaft. The blade and lowerpart of the shaft are Teflon-coated.

These paddles are serialized and designed to meet orexceed current USP specifications for Apparatus 2.They are electropolished and constructed of type 316stainless steel. The shaft is 3/8-inch diameter.

Electropolished / Stainless Steel

PEEKThese paddles are serialized and of single-entityconstruction. The shaft is manufactured of type 316stainless steel with a 1/16-inch thick PEEK sleeveand solid PEEK blade. These paddles meet all thedimensional specifications of the USP, EP and JP forApparatus 2. PEEK paddles are impervious to mosttypes of media used in dissolution. They offergreater chemical resistance and have greater rigidity(thereby ensuring the proper shape is maintained).

��

PEEK

Electropolished / Stainless Steel

Teflon-coated

PEEK (polyetheretherketone) is biocompatible,chemically inert, and can be used to replace

stainless steel in most liquid analytical equipment systems.

Didyou

know?


12-1000 15-inch Shaft, Teflon-coated

12-1010 19-inch Shaft, Teflon-coated

12-1015 24-inch Shaft, Teflon-coatedPart Number Description

12-1201 15-inch Shaft, PEEK

12-1211 19-inch Shaft, PEEK


12-1030 15-inch Shaft, electropolished




Teflon Replacement Blade

12-1220 Blade with 1/4-inch diameter opening

12-1225 Blade with 3/8-inch diameter opening

12-1226 Blade fits 1/4-inch threaded shafts, meets USP dimensional specifications

Dura-Tef Shaft

12-1221 15-inch Shaft only, 3/8-inch



48

Paddles

Dura-Tef Replacement Blade and Shaft

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Paddle / Basket Support RackProtect your investment—avoid bends and nicks. Thesupport rack, with sturdy acrylic construction, holds 12dissolution paddles or basket shafts.

Mini Paddles for 100 and 200 mLDissolution VesselsThe mini paddle is made of type 316 stainless steel. Ithas a 1.174-inch (29.8 cm) paddle diameter and either a1/4-inch or 3/8-inch diameter shaft.

Replacement Collets for VanKel TestersInterchangeable collets allow the use of 3/8-inch or 1/4-inch shafts. Collets are ideal for use with minipaddles or baskets. Collets have 3-point shaft alignmentand support. They are for use with VanKel stainless steelspindles. A nose piece and ring secure the collet on theshaft.

Mega PaddleThis paddle can be used in 2L and 4L vessels whengreater fluid movement is required. The proposedmodification to USP dissolution Apparatus 2 may befound in Pharmacopeial Forum volume 24, number 3,page 6351.

Mini Paddle pictured in a 100 mL dissolution vessel. Vessel not included.

To use the mini paddles, you need the 1/4-inch collet(see below) with the VanKel type 316 stainless steelchuck assembly.


Mini Paddle

12-1300 Teflon-coated, 1/4-inch diameter shaft

12-1305 Teflon-coated, 3/8-inch diameter shaft

12-1310 Electropolished, 1/4-inch diameter shaft

12-1315 Electropolished, 3/8-inch diameter shaft


12-1318 Mega Paddle 24-inch, 3/8-inch diameter shaft


12-1350 Paddle / Basket Support Rack


12-1320 Collet for use with 3/8-inch diameter shaft

12-1330 Collet for use with 1/4-inch diameter shaft Collets

Support Rack

Mega Paddle

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BASKETS

VanKel Verified Baskets• Individual certificate• Critical dimensions measured• Results are traceable

VK Verified is your assurance the accessories youare using meet all the required specifications. Weprovide an individual certificate for each basketdetailing the USP specifications, the measuredvalue, the measuring device used, its serial numberand the date of its inspection.


Rotating Basket Assembly

12-2000V USP 15-inch Shaft, standard head with individual inspection certificate



Basket Drive Shafts

12-2070V 15-inch Shaft, USP standard head with individual inspection certificate



Baskets Only, Standard

12-2100V USP Basket, 40-mesh, type 316 SS basket standard with individualinspection certificate

12-2120V USP Basket, 20-mesh, 864-micron, type 316 stainless steel basket withindividual inspection certificate

50

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USP Apparatus 1Rotating Basket Assembly

Shaft with 40-mesh BasketThe rotating basket assembly is individuallyserialized with the serial number laser imprinted onthe shaft for record-keeping purposes. Theseassemblies meet USP specifications requiring 3retention spring clips for Apparatus 1. The shaft iselectropolished (except PN 12-2030 which is Teflon-coated) and constructed of type 316 stainless steel.It is 15 inches long with a 3/8-inch diameter. Eachbasket assembly comes with a Certificate ofCompliance.

Stationary Basket AssemblyThe stationary basket assembly is a stationarybasket attached to the evaporation cover which isheld in place above a rotating paddle by a 1/4-inchdiameter shaft. The 4-inch long shaft constructed oftype 316 stainless steel is threaded at one end forassembly to the flask cover. The assembly includes1 mesh basket, 1 basket shaft and fasteners.

Stationary Basket Assembly (paddle isshown for illustrative purposes only)

The current USP Apparatus 1 basket shaft requires three retention clips on 120 degree

centers to hold the basketin place.

Didyou

know?


USP Rotating Basket Assembly

12-2000 15-inch Shaft, standard




Rotating Basket Assembly

12-2010 15-inch Shaft, conical head, disperses bubbles

12-2030 15-inch Teflon-coated Shaft, (lower 6 inches Teflon-coated) and Teflon-coated40-mesh Baskets


12-2060 Basket Shaft and 20-mesh Basket



Shaft with Conical Head and Basket

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Basket Drive Shafts

Dura-Fit Basket ShaftsThe Dura-Fit basket shafts are individually serialized andare shipped with a Certificate of Lot Compliance. The 3/8-inch diameter shafts are manufactured of type 316stainless steel. The heads have O-rings for press fitattachment of the baskets.

Conical Head Shaft

Gold-plated shaft Teflon-coated Shaft

Basket Drive ShaftsThe electropolished basket shafts are individuallyserialized and are shipped with a Certificate of LotCompliance. The drive shafts are only for use with USPApparatus 1. The 3/8-inch diameter shafts aremanufactured of type 316 stainless steel. There is a clipassembly to attach baskets to the shafts.

Shaft Lock RingThis adjustable shaft lock ring with type 316 stainlesssteel collar is used to preset the basket shaft height.

Dura-Fit Conical Head Dura-Fit Standard Head


Dura-Fit Basket Shaft

12-2040 15-inch Shaft, standard head

12-2050 15-inch Shaft, conical head disperses air bubbles

12-2093 15-inch Shaft, lower 6 inches Teflon-coated

12-2055 19-inch Shaft, standard head



Basket Drive Shaft

12-2070 15-inch Shaft, USP standard head





12-2085 15-inch Shaft, lower 6 inches gold-plated

12-2086 19-inch Shaft, lower 6 inches gold-plated



12-2097 15-inch Shaft for Bolus Basket (shaft only)


12-2099 Shaft Lock Ring, set of 6

Shaft Locking Ring

52

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Standard BasketsThe standard baskets fit the standard USP rotatingand stationary basket shafts. USP standard 40-mesh baskets are serialized for traceability.

Stainless Steel Gold-plated

Teflon-coated 3-fin

Suppository Basket

You wrote the book!This compilation of the Dissolution Discussion Group’s first year of business iscertain to be one of your most valuable reference books on dissolution. This hardcover text, containing over 300 pages, includes:

• Meeting notes from the Dissolution Discussion Group (DDG) regional and annualmeetings.

• Transcripts of online discussions and comments submitted to the DDG Web site.

• An appendix of USP and EP Apparatus.

• A complete glossary of over 200 terms defined and cross-referenced.

See page 152 for more information on the DDG.

Order PN 70-1000 today!

See the following page for additional custombaskets.

All stainless steel baskets are vulnerable to wear over time. Openings increase as wire diameters decrease. Replace your

baskets as necessary.

Didyou

know?


12-2100 USP Basket, 40-mesh, type 316 stainless steel, standard

12-2105 USP Basket, 40-mesh, gold-platedNote: gold-plating may reduce micronopening

12-2110 Basket, 40-mesh, Teflon-coated, type 316 stainless steel Note: Teflon-coating may reduce micronopening

12-2115 Basket, 40-mesh, type 316 stainless steel, 3-fin assembly,

12-2120 Basket, 20-mesh, 864-micron, type 316 stainless steel

12-2125 Basket, 10-mesh, 1905-micron, type 316 stainless steel

12-2130 Suppository Basket, slotted, plastic

Baskets - mesh vs. micron

Fabricated with 316 stainless steel, basketshave a standard mesh screen of 40. Mesh isdefined as the number of openings per linearinch. Another term often associated with meshsize is micron, which is defined as the size of

the openings. The number of openings perlinear inch and the diameter of the wire will

affect micron size.

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Mini BasketsThis new size basket fits on a specially designed Dura-Fit basket shaft. Use with 100 and 200 mLvessels. Inquire about other mesh and micron sizes.

Custom BasketsVanKel can manufacture custom-made baskets toyour specifications. We have manufactured thefollowing basket configurations which fit standardUSP shafts in the past. Contact your VanKelrepresentative if you are interested in one of these,or one with different specifications.

Didyou

know?

SpecificationsInside diameter: 990.6 mm (0.39 inches)Height: 32 mm (1.26 inches)

Bolus Baskets


12-2057 Mini Basket, 40-mesh and Dura-Fit Shaft, 15-inch

12-2102 Mini Basket, 40-mesh (basket only)

12-2077 Dura-Fit Shaft, 15-inch for 1/4-inch drive (shaft only)


12-2140 450 x 2750 mesh, 1-micron

12-2145 400 x 2800 mesh, 2-micron

12-2146 325 x 2300 mesh, 5-micron

12-2148 200 x 1400 mesh, 10-micron

12-2149 165 x 800 mesh, 20-micron

12-2150 325 x 325 mesh, 43-micron

12-2151 270 x 270 mesh, 53-micron

12-2152 150 x 150 mesh, 104-micron

12-2154 100 x 100 mesh, 140-micron

12-2155 50 x 50 mesh, 280-micron

12-2160 30 x 30 mesh, 533-micron


12-2180 20 x 20 mesh, 864-micron

12-2185 40 x 40 mesh

Bolus BasketsThe following bolus baskets require a special shaft,PN 12-2097 (see page 52).

54

SpecificationsInside diameter: 30 mm (1.18 inches)Height: 94.97 mm (3.74 inches)

Mini Basket and Dura-Fit Shaft

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CAPSULE WEIGHTS

WireThis wire is flexible enough for weighting capsules. Itis type 316 stainless steel wire and meets currentUSP specifications.

VanKel Type Capsule WeightsThe three-prong assembly retains the capsule.Capsule weights fit capsules sizes three throughone. The part numbers listed below are for capsuleweights sold individually.

Sinker BasketsThe sinker baskets are designed to retain thedosage form at the bottom of the vessel. They aremade of type 316 stainless steel and use press-oncaps (with O-rings). They are currently manufacturedin 6 mesh sizes. Custom mesh sizes are available—call for details.

SpecificationsInside diameter: 20.2 mm (0.8 inches)Inside height: 11.7 mm (0.46 inches)

Japanese Sinker Baskets


Sinker Basket

12-3060 Enclosure 10-mesh, 1905-micron


12-3064 Enclosure 40-mesh




12-3070 Japanese Sinker Basket, JP 13 version


12-3050 Capsule Weight, three prong

12-3055 Capsule Weight, three prong robotic type with magnetic contact on end ofcapsule weight

12-3056 Capsule Weight, robotic, with steel embedded in each capsule leg. Assuresbetter contact during retrieval.


12-3000 Stainless Steel Wire, 50-foot roll

Stainless Steel Wire

VanKel Type Capsule Weights

Sinker Baskets

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Cannula - Luer Lock TypeThe cannula is bent for easier accessibility to USPsampling position. Type 316 stainless steel withstainless steel Luer fitting. Use with Full Flow filters(see page 57).

Glass SyringeThis 20 cc Luer-type syringe is graduated to 1 cc.

Sampling Syringe AssemblyThe sampling syringe assembly includes a 20 ccsyringe and a cannula.

MANUAL SAMPLING CANNULA ASSEMBLY

BA

Manual Sampling

To gain more working room when samplingmanually, use spacer PN 12-0321 (see page 39).When used with 19-inch paddles, this allows for

greater accessibility.

Didyou

know?


12-3240 Syringe with 4.75-inch cannula

12-3250 Syringe with 7.75-inch cannula (A & B)


12-3230 Glass Syringe only, 20 cc (B)


12-3200 Bent Cannula, 4.75-inch, for sampling 900 mL

12-3210 Bent Cannula, 7.75-inch, for sampling 500 mL (A)

12-3211 Bent Cannula with Luer fitting for sampling from 1L vessel—includesheight-adjustment gauge to ensure yousample at the correct height each time(C)

12-3215 Bent Cannula, 4.75-inch, with adjustable gauge for setting proper height

12-3216 Bent Cannula, 7.75-inch, with adjustable gauge for setting proper height

12-3220 Filter Holder, 25 mm

56

C

Manual Sampling Manifold

Manual Sampling

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CANNULA FILTERS

Full Flow FiltersDissolution continues until the sample is filtered. TheFull Flow filter, when attached to a manual orautomated sampling cannula, provides immediatefiltration which preserves the integrity of thedissolution sample.

Filters are made of ultrahigh molecular weight(UHMW) polyethylene. The increased surface areaof the Full Flow filter versus conventional filter tipsoptimizes filter life. Use with 1/8-inch cannulas. Soldin package and case quantity.

Full Flow filters are color coded to avoid using thewrong porosity.

Proper Sampling Position

When sampling, withdraw a sample from a zone midway between the surface of the dissolution medium and the top of

the rotating basket or blade, not less than one centimeter

from the vessel wall.

Didyou

know?


Full Flow Filters

17-4000 Blue, 10-micron, package of 100(available in cases of 1000)

17-4010 White, 35-micron, package of 100(available in cases of 1000)

17-4020 Red, 70-micron, package of 100 (available in cases of 1000)

Full Flow Filters

Full Flow Filter on Cannula

Full Flow Filter Filtration Diagram

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Conventional Filter TipsFilter tips are made of polyethylene and are for usewith 1/8-inch cannulas. Sold in package and casequantity.

Automation FiltersThese 25 mm disk filters are individually lot analyzedand designed to work with VanKel’s Automated FilterChanger (see page 94) as well as the ZymarkMultidose and Tablet Processing Workstation (TPW).The specially designed housing prevents themembrane from being compressed. VanKel offersnylon and PVDF filters as standard products. Filtersare packaged in boxes of 200 and prestacked intubes of 25 for easy loading. Other membrane typesare available—call VanKel for details.

Deaeration is the process of removing dissolvedgases from a liquid media. The USP method of

deaeration is to heat the media to 41 ºC with gentlestirring. Filter under vacuum using a filter having a

porosity of 0.45-micron or less with vigorousstirring and continue stirring under vacuum for

approximately 5 minutes. Other validateddeaeration methods can be used.

Didyou

know?


17-4200 Filter, 1.0 µm APFB glass fiber prefilter for processing and clarification ofaqueous and organic solutionscontaining high particle levels

17-4210 Filter, 0.45 µm low protein binding PVDF membrane for processing andclarification of aqueous and mild organicsolutions

17-4220 Filter, 0.45 µm nylon membrane for processing and clarification of aqueousand organic solutions


Filter Tips

17-4100 2-micron, package of 100 (available in cases of 1000)




17-4140 45-micron, package of 100 (available in cases of 1000) Conventional Filter Tips

Automation Filters

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RESIDENT CANNULA KITSWhere the addition and removal of a samplingcannula is not mechanically practical, the residentcannula kit allows you to interface with Agilent,Beckman, Perkin Elmer and many other UVinstruments for online analysis.

VanKel - Your Source for Practical Solutions

Practical Solutions is a quarterly publication. Our goal is to provide you with a timely communication

vehicle for new regulations, helpful hintsand product updates.

Call today for a free subscription or to receive pastissues including topics such as:

• Intrinsic Dissolution Testing: a valuablecharacterization tool

• Improving Workflow in Your Lab• Precalibration Routine for USP Suitability

Testing of Dissolution Apparatus 1 and 2


12-0450 Resident Cannula Kit for Stainless Steel Centering Rings (set of 6)

12-0455 Resident Cannula Kit for EaseAlignCentering Rings for use with paddles (set of 6)

12-0447 Cannula and Bushing only(sampling 4.5 in)

12-0460 Resident Cannula Kit for EaseAlignCentering Rings for use with baskets (set of 6)

12-0465 Resident Cannula Kit for EaseAlignCentering Rings (1 each)

12-0467 Cannula and Bushing (return 2.5)

12-0468 Evaporation Cover only with UV-VISadapter for use with EaseAlignCentering Rings

See page 45 for evaporation covers.

Resident Cannula Kit

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INTERNAL DOSAGE DELIVERYMODULE RETROFIT• Saves time• Easy and precise way to drop tablets for

automatic (simultaneous or sequential)delivery of dosage forms to vessels withinstant or delayed start through keypad orcomputer control

• Eliminates errors when manually droppingtablets or capsules

• For the VK 7000 Dissolution Tester

This option replaces the existing top cover of thedissolution tester with a new one containing motors,staging platforms and Dosage Delivery Moduletubes. This retrofit requires a service technician toinstall.

Replacement Delivery TubesThe dosage form drops into the vessel throughinternal delivery tubes. The replacement tubes aresold in sets of eight and have a threaded end foreasy replacement (except PN 12-0115).

Dissolution Discussion Groupwww.dissolution.com

See page 152 for more information on the DDG.

Join fellow analysts from around the world for an on-going open discussion on dissolution issues. Free to join; free to use. You can register online at www.dissolution.com.

Mission StatementOur mission is to provide an independent forum to freely discuss the practical issues which challenge the

industry and affect the day-to-day task of performing dissolution tests and chemical analysis.

Over 2000

members

worldwide


12-0101 Dosage Delivery Module for 6-vessel Benchsaver 3+3

12-0104 Dosage Delivery Module for 6-vessel Easy Access 4+2




12-0115 DDM Tubes (external) with O-rings (set of 8)

12-0120 DDM Tubes (internal) for use with VK 7010 (set of 8)

12-0121 DDM Tubes (bottom extension) for use with VK 7010 (set of 8)

Dosage Delivery Module

DDM Tubes

http://www.dissolution.com

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TEMPERATURE CONTROLLER

AutoTemp In-vessel TemperatureSensing System• Individual vessel temperatures measured and

recorded• Monitor media temperatures and

automatically start a test once all the vesselshave stabilized

The new AutoTemp System board plugs directly intothe RS232 serial port on your VK 7000 DissolutionTesting Station. AutoTemp measures individual in-vessel temperatures, transmitting them via theRS232 serial port and displaying them on the statusscreen of your VK 7000. Sensors are lowered intothe vessels by a motorized manifold and thenremoved as soon as temperatures have beenmeasured to eliminate disturbances associated withresident dwelling probes during the test. TheAutoTemp accessory is available factory installedwhen ordered with a new bath or can be retrofit toan existing unit. You can program the frequency atwhich you wish to monitor and record thetemperature.

Internal Connection Includes Internally MountedMotor Drive

Internal Connection without Motor Drive (for units already equipped with Automated SamplingManifold)

Sampling and Temperature Cannula Assemblies


12-0601 AutoTemp for 6 vessels, 3+3









The built-in dot matrix printer documentsthe temperature for individual vessels

before and after the test and atprogrammable intervals.

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REPORT CENTER II RETROFIT KITThis kit allows easy upgrading of older VK 700 andVK 7000 equipped with thermal printers to ReportCenter II dot matrix printer. Reports print on plainpaper which will not fade or discolor over time orupon exposure to light. The retrofit kit containseverything required, including a box of 10 plainpaper rolls.

MANUAL SAMPLING BRACKETThis bracket attaches to the spindle drive unit of aVK 7000 or VK 7010. Designed for manual sampling,a syringe can be attached to the bracket which isconnected to the automated sampling manifold. Thesampling manifold is lowered into place with thepush of a button. Simply pull the plunger of eachsyringe to sample. This system easily incorporatesan in-line 25 mm syringe filter. This system assuresthat you sample in the same location each time.Requires motorized sampling manifold.

MOTORIZED SAMPLING MANIFOLDWhen using the manual sampling bracket, you willlower the sampling manifold with the touch of abutton on the front panel of the VK 7000 or VK 7010.All of the sampling cannulas are lowered into thevessels simultaneously. Included is the manifold,internal drive motor, sampling bracket and all tubingand connections. Includes manual sampling bracket(PN 17-3150).



17-3350 3+3 configuration

17-3355 4+2 or 4+4 configuration


17-3150 Luer Fitting Bracket for manual sampling (requires sampling manifold)


12-0240 Report Center II for Easy Access models 4+2, 4+4

12-0245 Report Center II for Benchsaver 3+3

12-9997 Replacement Ribbons, package of 5ribbons

12-9995 Plain Paper, 2.25-inch wide, package of10 rolls

12-9996 Plain Paper, 2.25-inch wide, case of 100

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Manual Sampling Manifold

Report Center II Printer

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VESSEL CONVERSION KITSVessel conversion kits allow you to use your existingequipment for testing with varying volumes of media.

Saves Money, Less WasteUse the 100 or 200 mL conversion kits for testswhere a smaller volume is required. Save moneywhen preparing standards during automated analysisby only preparing the amount you need. Theconversion kits work with EaseAlign CenteringRings.

100 mL Conversion Kits

200 mL Conversion KitsPart Number Description

12-0300 200 mL Conversion Kit for use with stainless steel centering rings, set of 6

12-0305 200 mL Conversion Kit for use with EaseAlign Centering Rings, set of 6

12-0306 200 mL Conversion Kit for use with EaseAlign Centering Rings

12-0307 200 mL Conversion Kit for use with stainless steel centering rings, set of 8

12-0309 200 mL Conversion Kit for use with EaseAlign Centering Rings, set of 8

12-6025 200 mL Adapter Plate only for use with stainless steel centering rings

12-1305 Paddle, Teflon-coated, 100 and 200 mL (1/4-inch diameter shaft for 3/8-inchdrive)

12-1315 Paddle, electropolished, 100 and 200 mL (1/4-inch diameter shaft for 3/8-inch drive)


12-0310 100 mL Conversion Kit, single-vessel for use with EaseAlign Centering Rings(mini paddle not included)

12-0311 100 mL Conversion Kit, single-vessel for use with EaseAlign Centering Rings,includes mini paddle and collet

12-0320 15 mm Height Gauge for 100 / 200 mL round-bottom vessel

12-1305 Paddle, Teflon-coated, 100 and 200 mL(1/4-inch diameter shaft for 3/8-inchdrive)

12-1315 Paddle, electropolished, 100 and 200 mL (1/4-inch diameter shaft for 3/8-inch drive)

VanKel’s vessel conversion kits not only work with VanKel dissolution testers, but

also with most other manufacturer’sdissolution testers. See page 45

for PN 12-6070.

Didyou

know?

100 mL Conversion Kit

200 mL Conversion Kit

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2L Conversion Kits

4L Conversion Kits

The 2L and 4L conversion kits make your existingdissolution tester more flexible by providing legextenders and an extra-deep water bath for use witheither standard 1L vessels or the larger vesselsprovided with the kit you select.

The 2L conversion kit is available for the Benchsaveror Easy Access models of the VK 700, VK 7000 orthe VK 6000 series dissolution tester. VK 7010 2Lconversion kits are available for the Easy Accessmodels only.

The 4L conversion kit is available only on theBenchsaver model of the VK 7000 series or VK 6000series dissolution testers. The convertible base platesystem allows easy switching between 4L vesselswith one plate and either 2L, 1L or 500 mL vesselswith the standard base plate. This kit requires aVanKel field service technician or factory installation.

The 19- and 24-inch paddles and basket shafts aresold separately (see pages 48-52).

USP LARGE VOLUME CONVERSION KITS• Offers great flexibility in changing from one

vessel size to another


2L Conversion Kits

12-0400 VK 700 / 7000 Benchsaver, 3+3 units

12-0415 VK 600 / 6000 / 6010 Benchsaver, 3+3 units

12-0420 VK 700 / 7000 / 7010 Easy Access, 4+2 and 4+4 units

12-0425 VK 600 / 6000 / 6010 Easy Access, 4+2 and 4+4 units


4L Conversion Kit

12-0440 VK 600 / 6000 / 6010

12-0445 VK 700 / 7000

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2L Conversion Kit

4L Conversion Kit

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The VanKel Type Intrinsic Dissolution Apparatus is anupdated version of the original Wood Apparatus forintrinsic dissolution. The VanKel design includes ahardened punch, a controlled surface area and animproved die design for more reproducible results. It isdesigned to meet or exceed current USP specificationsas described in USP Physical Test <1087>. The groundand hardened surface plate (ordered separately)provides an ideal surface for compressing samples. Theintrinsic dissolution apparatus is designed for use withstandard USP Apparatus 1 and 2 dissolution testers.

Intrinsic dissolution is the dissolution of a puresubstance under conditions of constant

surface area expressed in terms of mg/time/cm².Intrinsic dissolution is useful in studying the

solubility characteristics of a puredrug substance.

Didyou

know?

INTRINSIC DISSOLUTION APPARATUS

USP APPARATUS 6 ROTATING CYLINDERUSP Apparatus 6 is used for testing transdermal patches.The rotating cylinder is manufactured of type 316 stainlesssteel with removable extension. The rotating cylinder isdesigned for use with standard USP Apparatus 1 and 2dissolution testers.


12-4100 Standard USP design consists of 0.5 cm² Holder, Punch and Die Cavity(one set—surface plate not included)

12-4110 0.125 cm² Holder, Punch and Die Cavity (one set—surface plate not included)

12-4120 Intrinsic Die only

12-4130 Surface Plate (only one is required)

12-4140 Punch only

12-4150 Shaft and Holder only


Rotating Cylinder, 2-piece assembly

12-1360 USP 4.45 cm outside diameter

12-1365 2.5 cm outside diameter

Intrinsic Dissolution Apparatus

Rotating Cylinder

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The paddle over disk assembly includes only the diskassembly. The VanKel Type comes with a removabledisposable screen and a Teflon locking ring. The type316 stainless steel ring keeps the screen in place.

TRANSDERMAL PATCH HOLDER SYSTEMPatent 5,108,710

This type 316 stainless steel 2-piece assembly providesan easy-to-use alternative to the USP Apparatus 5. TheO-ring assembly eliminates the need for adhesives. It isdesigned for patches with an inactive perimeter aroundthe release area. Custom holders (square, oblong) arealso available—call us!

PADDLE OVER DISK ASSEMBLY

SUSPENSION CUPThe suspension cup is a Teflon 2-piece assembly. Theweighted holder has a hemispheric bottom designed tosit in the bottom of a 1L dissolution vessel. Theremovable center cup, available in 2 sizes, allowscontents to be weighed, retains the suspension andprovides a controlled surface area.


12-4050 Weighted Holder only 5.72 cm outside diameter, 2.52 cm inside diameter forsuspensions

12-4055 Insert Cup only 17.5 x 8.2 mm, use with PN 12-4050 (exposed surface area2.405 cm², vol 1.972 cm³)

12-4060 Insert Cup only 20 x 8.2 mm, use with PN 12-4050 (exposed surface area 3.14 cm²,vol 2.576 cm³)


Paddle Over Disk

12-4200 Assembly 35 mm opening (40-mesh screen), meets USP Apparatus 5 specifications

12-4210 Replacement Screens for PN 12-4200, type 316 SS (40-mesh screens), pack of 100

12-4211 Disassembly Tool for PN 12-4200

12-4230 Assembly 56 mm opening (120-mesh screen)

12-4231 Replacement Screens for PN 12-4230, pack of 100

12-4232 Disassembly Tool for PN 12-4230


Transdermal Patch Holder12-4300 Release area 2.5 cm²12-4310 Release area 5.0 cm²12-4320 Release area 7.0 cm²12-4330 Release area 10.0 cm²

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Suspension Cup

Paddle Over Disk Assembly

Transdermal Patch Holder System

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Enhancer CellPatent 5,408,865

• Meets SUPAC SS guidelines• Ideal for use with topicals, such as ointments,

creams and suspensions• Can be used with traditional dissolution

apparatus• Available in surface areas of 4.0, 2.0 and

0.5 cm²• Alternative to the Franz Cell

Teflon cell with adjustable volume and screw cap toeliminate air pockets trapped against the skin orartificial membrane. The result is more consistentrelease rates. Designed for research, quality controland product development laboratories, the Paddleover Enhancer Cell method provides release ratescomparable to Franz Cell technology. It providesrelease rate data for quality control of topicals usingreadily available dissolution apparatus, including200 mL or standard 900 mL dissolution vessels,without the investment in fragile Franz Cells, pumpsand stirrers.

An alignment tool is used to hold the membrane inplace while using the adjustment tool to set thevolume adjustment plate. Only one alignment andadjustment tool are required per size. Whenpurchasing more than one Enhancer Cell, orderseparately.

The Enhancer Cell does not include the vessel,paddle or membrane / skin.

PRODUCTS FOR RELEASE RATE STUDIES

Adjustment Tool

Retaining Ring

Washer

Membrane or Skin

Adjustment Plate with O-ring

Alignment Tool

Cell Body

0.5 cm² 2 cm² 4 cm²

Adjustment Tool, Enhancer Cells (assembled) and corresponding Alignment Tools

Adjustment Tool, Enhancer Cell (disassembled)and Alignment Tool

ACE

G

FD B


12-4000 Enhancer Cell, 4 cm² only (A)

12-4010 Alignment Tool, 4 cm² only (B)

12-4001 Enhancer Cell, 2 cm² only (C)

12-4011 Alignment Tool, 2 cm² only (D)

12-4002 Enhancer Cell, 0.5 cm² only (E)

12-4012 Alignment Tool, 0.5 cm² only (F)

12-4015 Adjustment Tool only, for all sizes (G)

12-5055 200 mL, flat-bottom, self-aligningindentation for use with Enhancer Cell

Vessel, Mini Paddleand Enhancer Cell

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