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Dissolution Apparatus Overview Dissolution Instrumentation VK 7000 and VK 7010 Key Features VK 7010 Dissolution Testing Apparatus VK 7000 Dissolution Testing Apparatus VK 7000 Small Volume Apparatus VanKel Total Solution VK 7000 / 7010 Single-bath Configurations VK 7000 / 7010 Dual-bath Configurations Dissolution Compatible Systems Varian, Inc. Agilent Technologies Perkin Elmer Instruments Waters Corporation Carl Zeiss Jena GmbH C Technologies, Inc. Delphian Technology L.P. Zymark Corporation Dissolution Vessel Washing Stations Dissolution Accessories QAII Station VK 5010 CLH Measurement System Calibration Tools Vessels Paddles Baskets Capsule Weights Manual Sampling Cannula Assembly Cannula Filters Resident Cannula Kits Internal Dosage Delivery Module Retrofit Temperature Controller Motorized Sampling Manifold Manual Sampling Bracket Report Center II Retrofit Kit Vessel Conversion Kits Intrinsic Dissolution Apparatus USP Apparatus 6 Rotating Cylinder Suspension Cup Paddle Over Disk Assembly Transdermal Patch Holder System Products for Release Rate Studies 6 7 8 10 14 17 18 20 22 25 26 27 30 30 31 31 31 32 34 36 36 38 39 41 47 50 55 56 57 59 60 61 62 62 62 63 65 65 66 66 66 67
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
VanKel is proud of our commitment to quality. Of the three standards after which companies can model their quality system, VanKel complies with the most comprehensive, ISO 9001. This standard is a model for use by both manufacturing and service organizations to certify their quality system from initial design and development of a desired product or service through production, installation and servicing.
VanKel Quality Policy VanKel is committed to designing and manufacturing reliable products that exceed the needs and expectations of our customers and to deliver defect-free products and services on time and at competitive prices. Every member of the VanKel team is committed to rapid and continuous improvement through well-documented and customer-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 producing quality products. ensure the Quality Policy is understood, implemented and maintained at all levels in the organization.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
Dissolution Instrumentation
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 designed with automation and flexibility in mind. These microprocessor-controlled instruments allow for easy manual sampling and are designed to interface directly with the VK 8000 Autosampling Station. The EaseAlign system for centering vessels allows the use of a variety of vessel sizes (with options of 100 mL, 200 mL, 500 mL, 1L (standard), 2L and 4L vessels with Benchsaver models). These units are preconfigured so they can accept accessory upgrades. VK 7000 series units can be fitted with AutoTemp and Dosage Delivery capabilities should your testing needs change. As testing volumes grow, you can modify your equipment; these models are easily adapted to interface directly to a variety of UV or LC systems or can be retrofitted into a Zymark MultiDose system. EaseAlign Centering Rings Eliminate the need for tedious, time-consuming vessel centering after each run. EaseAlign centering rings allow the vessel to simply slide into place. Once in place, your vessels do not floateven while empty. The EaseAlign rings center and align from the inside of each vessel. This provides a simple, accurate vessel-alignment process. Display Information The 4-line, 40-character LCD operational monitor allows for a simple, easy-to-read display. During operation the display includes time, date, elapsed time, start time, set and actual RPM, set and actual bath temperature, and printer status.
VK 7010
Parameter Programming A simple menu allows you to easily program your parameters including: delayed start RPM (8 - 250 RPM) length of test temperature infinity spin Timed Wake-up This unique feature automatically turns on the tester and circulator at a predetermined time. This ensures your bath is at the proper temperature without operating the circulator continuously. Elapsed Time Indicator These testers offer an on-screen elapsed time indicator. This indicator can be easily read from across the room.
Built-in Alarms Both the VK 7000 and the VK 7010 have a variety of built-in alarm features. You are warned of any temperature deviations from the set parameters, power outages, as well as the upcoming calibration date.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
Motorized Tester Drive Unit VanKel pioneered the use of a motorized drive unit. With the touch of a button, the motorized drive unit on the VK 7000 / 7010 dissolution tester electronically lowers to the proper position. When the drive unit is down, you can automatically raise the head. The motorized head ensures it returns to precisely the same location. Automated Sampling Manifold One of the unique features of the VK 7000 / 7010 is the ability to incorporate an automated sampling manifold. At programmed intervals or by manual control, the motorized sampling manifold provides properly timed and precisely positioned sampling. See the automated sampling manifold on page 10. Chuck Assembly Our unique chuck design assures the shaft is locked in place. Once the height is set, there is no need to worry about a change in alignment. In addition, this system offers the flexibility of using smaller diameter shafts and mini paddles for lowvolume dissolution testing. Our type 316 stainless steel chuck offers rustresistant and wobble-free support for your shafts. Should you prefer a different design using O-rings with a locking ringthis design can be incorporated into either the VK 7000 or VK 7010. This design is preferred by some customers who perform a number of staggered basket starts. Contact your VanKel representative for more information.
VK 750D Heater / Circulator The external circulator provides precise temperature control. Its high throughput minimizes warm up time. The external VK 750D Heater / Circulator reduces vibration and fits easily behind the dissolution tester in order to conserve valuable bench space.
VK 750D
Molded Bath This seamless bath was designed to warm all vessels evenly by stabilizing the temperature gradient. This design assures uniform temperature control and makes cleaning easy. The seamless water bath is molded from clear PETG, a high performance polymer with more heat and chemical stability than acrylic. The clear color allows you to see the vessels through the water bath. To ensure the bath contains the appropriate amount of water, there is a fill line for baths without vessels as well as for baths with vessels in place. Easy Drain The easy access water bath drain spout allows for quick and simple routine cleaning. Complete Operating System, No Post-purchase Add-ons When you purchase a VanKel dissolution tester, VanKel provides you with an all-inclusive price quote. This quote includes the price of the equipment necessary to appropriately operate the instrument. You receive your choice of baskets or paddles, glass or plastic vessels, as well as evaporation 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
Individual Spindle Control Our easy-to-use clutch system makes dropping tablets into non-rotating media per USP guidelines effortless. The system provides a simple way to perform manual staggered drops for Apparatus 2. Just raise the clutch handle and the spindle is disengaged. Push down the clutch handle to engage the spindle.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
Spindle Motor Monitor These testers report the number of spindle motor hours that the instrument has been in use. This onscreen record allows you to schedule preventative maintenance on actual operating hours rather than arbitrary time periods.
Printer Our built-in dot matrix printers produce documents that can be directly inserted into your laboratory notebooks. Every VK 7000 / 7010 includes a built-in Report Center II printer.
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Dissolution Instrumentation
Preconfigured for automated analysis Measures and records temperature in each vessel Programmable Dosage Delivery Module automatically delivers dosage form into vessel when used as Apparatus 2 Incorporates all VK 7000 system features (see page 14) Meets all current USP, JP and EP requirements
Modularity The VK 7010 allows for in-vessel temperature monitoring at programmed time points and automated delivery of the dosage form. These automation building blocks combine to create an extremely efficient stand-alone unit that can be utilized in an in-line sampling or analysis system as your testing demands increase. For example, sampling can be easily added to the motorized manifold, a standard feature on the VK 7010. In-vessel Temperature Measurement This motorized manifold automatically lowers, collects temperature readings from each vessel, and immediately raises at programmable intervals. Each subsequent temperature reading repeats this sequence precisely. Automatic Temperature Measurement The AutoTemp feature allows you to measure and record temperature. It can be used to automatically start a test after measuring the temperature in each vessel to ensure they are stable and within limits. Because the manifold raises between time points, it eliminates the resident probe effect and maintains correct hydrodynamics. Dosage Delivery Module The Dosage Delivery Module allows you to be elsewhere when the run starts and drops occur with far greater precision than manual techniques allow. This feature allows you to program simultaneous or sequential drops.
Pathway to Automation Because the VK 7010 includes the internal hardware necessary for automation, it can easily connect to an automated sample collector, UV spectrophotometer, LC instrument or Zymark's MultiDose systems. Your VanKel technical sales representative can explain these options. Flexibility Due to the numerous options available, this versatile system can perform everything from simple manual sample collection to complete sample automation. A standard VK 7010 accepts several vessel volumes including 100 mL, 200 mL, 500 mL and 1L vessels. If these volumes do not satisfy your sink conditions, an optional upgrade can be purchased which accommodates 1L and 2L vessel volumes. See page 12. As with all VanKel products, we can tailor the VK 7010 to address most customer requests.
Resident Probe Effect The USP recommends that when employing automated systems which alter the agitation characteristics of the test, the equipment be validated prior to use. The motorized sampling manifold fully removes the cannula from the media between time points in the same manner as someone sampling manually. This reduces the increased agitation associated with resident probes.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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VK 7010 Benchsaver
6-spindle, 6-vessel
The Benchsaver configuration saves laboratory bench space. The vessel configuration consists of 2 rows of 3 vessels. The Benchsaver comes with 15-inch paddles. For increased flexibility when sampling manually, we recommend use of the 19-inch paddles and extended height spacer PN 12-0321 (see page 39). This allows greater clearance to access the middle position of the back row. Specifications Width: 54 cm Depth: 56 cm
10-0100 10-0200
Part Number
Height: 94 cm
Part Number
Height: 94 cm
10-0400
Part Number
Depth: 56 cm
Height: 94 cm
10-0800
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
Each of the following configurations includes your choice of glass or plastic vessels, paddles or baskets and basket shafts. EaseAlign Centering Rings and evaporation covers are included. The VK 750D is standard.
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Dissolution Instrumentation
VK 7010 2L
Dissolution Instrumentation
The VK 7010 2L model is available in the Easy Access (4+2 and 4+4) configuration. The 2L units are configured the same as the 1L units except they have a deeper water bath positioned under an elevated base plate. The VK 7010 2L system can be used with conventional 1L vessels or 2L vessels for maximum flexibility. System price includes: 6 2L vessels 6 1L vessels 6 19-inch paddles or rotating baskets and shafts A 2L system is shown on page 16. Specifications Width: 66 cm (25.98 inches) Depth: 56 cm (22.05 inches) Height: 117 cm (46.06 inches)
Part Number 10-1935 10-1940 10-1950 10-1955 Description Easy Access 4+2, 115 V, 60 Hz Easy Access 4+4, 115 V, 60 Hz Easy Access 4+4, 230 V, 50 Hz Easy Access 4+2, 230 V, 50 Hz
Sink Conditions
Defined as maintaining a volume of dissolution media that is 5 to 10 times greater than the volume at the saturation point of the drug contained in the drug delivery system being tested.
FREE with any purchasea Dissolution Calculation Diskette containing three Excel spreadsheets: The Single Point Dissolution Calculation Spreadsheet calculates milligrams dissolved and percent dissolved per dose for dissolution tests with a single time point. The Replacement Media Dissolution Calculation Spreadsheet calculates milligrams dissolved and percent dissolved per dose and corrects for analyte removed for up to 12 time points. The Non-Replacement Media Dissolution Calculation Spreadsheet calculates milligrams dissolved and percent dissolved per dose correcting for non-replacement media and analyte 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.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
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VanKel strives to provide quality products and effective service to our customers. VanKels Laboratory Services department provides technical support and assistance to clients throughout the pharmaceutical industry. 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 visit our Web site at www.vankel.com to find out more about all the ways VanKel wants to meet your needs.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
VanKel is always working to develop new technology. Visit the VanKel Web site at www.vankel.com for our latest innovative new products.
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Dissolution Instrumentation
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 offer tremendous flexibility. The EaseAlign system for centering vessels allows the use of a variety of vessel sizes (with options of 100 mL, 200 mL, 500 mL, 1L (standard), 2L and 4L vessels with Benchsaver models). The built-in Report Center II dot matrix printer provides you with a permanent record of the time of day, elapsed time, RPM and bath temperature. To review the many other standard features of the VK 7000, see pages 8 and 9. Cost-effective Alternative This cost-effective dissolution tester will not restrict future productivity enhancements. With the appropriate accessories it can be upgraded to an online UV, LC or fully automated system. System Upgrades The following upgrades can be added easily to the VK 7000 as your needs change: Dosage Delivery Module (DDM)The DDM can be programmed to drop tablets into nonrotating media simultaneously or sequentially. See page 60. AutoTempAutoTemp measures and records in-vessel temperature at designated time points. It can also be used to initiate a run when the vessel temperatures have stabilized. See page 61.
VK 7010
VanKel offers a manual sampling manifold which raises and lowers the sampling cannulas and can be used with the manual sampling bracket on the VK 7000 or the VK 7010 (see page 62).
Motorized Sampling ManifoldThere are two methods for pulling samples using the motorized VanKel Sampling Manifold. The manual sampling bracket in conjunction with the motorized manifold facilitates the raising and lowering of the sampling cannula to ensure the correct USP sampling location. The automatic sampling manifold used in conjunction with the VK 8000 allows the entire sampling process to be performed automatically. See page 62.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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VK 7000 Benchsaver
6-spindle, 6-vessel
The Benchsaver configuration saves laboratory bench space. The vessel configuration consists of 2 rows of 3 vessels. The Benchsaver comes with 15-inch paddles. For increased flexibility when sampling manually, we recommend use of the 19-inch paddles and extended height spacer PN 12-0321 (see page 39). This allows greater clearance to access the middle position of the back row. Specifications Width: 54 cm Depth: 56 cm
S S
S S
S S
Height: 94 cm
10-1100
S S S S
S S
Height: 94 cm
10-1300
Height: 94 cm
S S S S S S S S
Dissolution Instrumentation
Each of the following configurations includes your choice of glass or plastic vessels, paddles or baskets and basket shafts. EaseAlign Centering Rings and evaporation covers are included. The VK 750D is standard.
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Dissolution Instrumentation
VK 7000 2L
VK 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 1L units except they have a deeper water bath positioned under an elevated base plate. The VK 7000 2L system can be used with conventional 1L vessels or 2L vessels for maximum flexibility. System price includes: 6 2L vessels 6 1L vessels 6 19-inch paddles or rotating baskets and shafts Specifications Benchsaver Width: 54 cm Depth: 56 cm Easy Access Width: 66 cm Depth: 56 cm
Part Number Description VK 7000 equipped with a 2L bath 10-1810 10-1910 10-1800 10-1900 10-1920 10-1930 Benchsaver 3+3, 115 V, 60 Hz Easy Access 3+3, 230 V, 50 Hz Easy Access 4+2, 115 V, 60 Hz Easy Access 4+2, 230 V, 50 Hz Easy Access 4+4, 115 V, 60 Hz Easy Access 4+4, 230 V, 50 Hz
VK 7000 2L unit with 2L vessels
Dissolution Instrumentation
VK 7000 4L
Maximize the utility of your dissolution bath VK 7000 4L units are available in the Benchsaver configuration only. When the Benchsaver model is configured for 4L vessels, only three spindles can be used. The VK 7000 is offered in an easily S convertible format allowing you to use 4L, 2L and 1L vessels. By changing the vessel plate insert you can switch from three 4L vessels to six 2L or six 1L vessels. This option offers you the greatest flexibility when dealing with sink conditions. System price includes: 6 1L vessels 3 4L vessels 6 15-inch paddles or rotating baskets and shafts 3 24-inch paddles or rotating baskets and shafts Specifications Width: 54 cm Depth: 56 cm
S S
VK 7000 4L unit
VK 7000 convertible
Height: 117 cm
10-5400
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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This specially configured VK 7000 will accept 12 vessels (either 100 or 200 mL) along with VanKels mini paddle or mini basket shafts. You get all the same programming features of the VK 7000 (see pages 8 and 9 for details). Although designed for use with Enhancer Cells, this system is also used when special, smaller volumes are required. Flat- or round-bottom vessels are available. Additionally, both mini paddles and mini baskets are designed for this system. Drug Release Testing for Topical Treatments The VK 7000 small volume system solves the dissolution testing dilemma associated with creams, ointments or other topical treatment. This system uses the tested Paddle over Enhancer Cell Apparatus. See page 67 for the Enhancer Cell. Perfect Enhancer Cell Centering Our specially designed 200 mL flat-bottom, selfaligning glass vessels perfectly align your Enhancer Cell in the vessel. A consistent placement of the Enhancer Cell provides you with reliable and reproducible results. See page 67 for the Enhancer Cell. Run Multiple Lots Simultaneously The 12-vessel, 12-paddle configuration allows you to operate two 6-vessel runs simultaneously. Each run is conducted under the same method, instrumentation and physical environment. Can Also be Used with New Mini Baskets! A newly designed mini basket fits on a special Dura-Fit basket shaft. See page 54 for details.
Vessel, Mini Paddle and Enhancer Cell
System Configuration
VK 7000 Small Volume Apparatus
12-spindle, 12-vessel
This alternative requires few accessories to operate and produces reliable, reproducible results. System price includes: 12 Glass vessels (specify 100 or 200 mL, roundbottom or flat-bottom) 12 Teflon-coated mini paddles (standard) Note the Enhancer Cells must be ordered separately (see page 67). Specifications Width: 66 cm (25.95 inches) Depth: 56 cm (22.05 inches) Height: 94 cm (37 inches)
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Instrumentation
Use with mini paddles and mini baskets Use with the Enhancer Cell for topicals, creams and ointments (see page 67) Requires few accessories to operate
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Total Solution
Total Solution
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 Flow-through Sample Collection The Cary 50 utilizes an 18-position multicell transport. The flow-through design maintains a constant volume in the vessels throughout the entire run by returning the solution back into the vessels, eliminating the need to calculate for volume lost. Cross-contamination between samples cannot occur as each vessel has a dedicated flow cell. Variable Data Collection Rate You can specify multiple regions in the run, each of which has a different data collection rate. This allows you to collect more data when the absorbance is changing quickly and to have fewer data points in the more stable parts of the dissolution profile. Secure Data Collection Unlike more conventional systems that store data only at the end of a run, the VanKel Total Solution stores data as it is acquired. Because data is being continually saved, even in the event of a power outage, your data to that point is secure. Reporting Solution A comprehensive report can be tailored for your specific reporting needs. Graphics showing time versus percent dissolved, time versus milligrams dissolved, and time versus absorbance can be included in a report, with each vessel indicated by a different color trace. Your dissolution reports can include your company logo or any bitmap you choose. Audit trails are logged providing information about how the data was collected and calculated.
The VanKel and Varian Team VanKel and Varian have combined forces to provide you with one of the most innovative and flexible tablet dissolution systems on the market. This system provides you with a simple automated dissolution testing system using UV-VIS analysis. When you order from VanKel, you have one vendor to handle your training as well as any questions that may arise. Complete Dissolution System The Total Solution system includes a computer, monitor, printer, Cary 50 Spectrophotometer and your choice of VanKel dissolution tester. The Total Solution is available in single- or dual-bath configurations. Self-operating System The software allows you to pre-program a start time. When used in conjunction with the VK 7010, paddle methods can be started automatically. Measures Samples with High Background Correction You can measure highly absorbing samples without dilution. The extended photometric range of the Cary instrument allows you to measure samples requiring high background correction that would normally require HPLC analysis.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
GLP Compliance GLP application is used to set up different privileges for the users in your laboratory and to comply with Good Laboratory Practice. 21 CFR Part 11 Compliance VanKel and Varian are committed to providing a system meeting this regulatory requirement. For an update on the current system, please check the Varian Web site at www.varianinc.com. Cary 50 Spectrophotometer The Cary 50 Xenon lamp allows 80 data points per second. The Xenon lamp flashes only when acquiring a data point, unlike a diode array which exposes the sample to the whole wavelength range with each reading, causing degradation of photosensitive samples. System Qualification VanKel offers a complete qualification guide of the entire system (spectrophotometer, dissolution tester and dissolution protocols). This guide is available to you as is the qualification service by one of our laboratory chemists. VanKel can perform the qualification of the complete system for you. Order PN 11-1130 for the qualification guide or call for details about our service capabilities.
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Cary 50 Spectrophotometer
The Cary 50 is unaffected by room light. It can be operated with the sample compartment opened or closed. The 18-position multicell transport easily handles either 1 or 2 dissolution baths. Because each vessel has 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 include equipment parameters. Create multistandard calibration curves or import equations for your dissolution runs. Perform routine wavelength scanning measurements. Measure the photometric value of samples at fixed wavelengths. Export data as an ASCII file for further data manipulation.
VanKel Qualification Guide
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
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Total Solution
VK 7010
Part Number Description VK 7010 (4+4) Single-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing. 11-1200 11-1205 11-1210 11-1215 VK 7010 with paddles, 115 V, 60 Hz VK 7010 with baskets, 115 V, 60 Hz VK 7010 with paddles, 230 V, 50 Hz VK 7010 with baskets, 230 V, 50 Hz
VK 7000
Part Number Description VK 7000 (4+4) Single-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing. 10-6920 10-6930 10-7032 10-7022 VK 7000 with paddles, 115 V, 60 Hz VK 7000 with baskets, 115 V, 60 Hz VK 7000 with paddles, 230 V, 50 Hz VK 7000 with baskets, 230 V, 50 Hz
VanKel qualification documents are available for purchase (see page138). VanKel chemists are available to perform installation, operation and performance qualifications on your equipment.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
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Total Solution
VK 7010
Two VK 7010 baths can be integrated into a single UV-VIS system. Both testers are configured in the same manner including a built-in Dosage Delivery Module and AutoTemp for in-vessel temperature monitoring.
Part Number Description VK 7010 (4+4) Dual-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing. 11-1220 11-1225 11-1230 11-1235 2 VK 7010s with paddles, 115 V, 60 Hz 2 VK 7010s with baskets, 115 V, 60 Hz 2 VK 7010s with paddles, 230 V, 50 Hz 2 VK 7010s with baskets, 230 V, 50 Hz
VK 7000
In this configuration, 2 VK 7000s are linked to 1 Cary 50 UV. Each bath is identical in their setup, method and start time. Dedicated lines and UV cells ensure no cross-contamination between vessels, standards or blanks.
Part Number Description VK 7000 (4+4) Dual-bath for use with Total Solution. Includes custom manifold, 200 mL conversion kit, Peristaltic Pump and tubing. 10-6925 10-6935 10-7035 10-7025 2 VK 7000s with paddles, 115 V, 60 Hz 2 VK 7000s with baskets, 115 V, 60 Hz 2 VK 7000s with paddles, 230 V, 50 Hz 2 VK 7000s with baskets, 230 V, 50 Hz
Single-bath Total Solution VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
Total Solution Dual-bath Configuration Media Flow Diagram
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VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
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Total Solution
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Package 11-1100 1 Cary 50 UV-VIS Spectrophotometer 1 Extended cell compartment 1 Sample compartment tubing coupler 1 18-position cell holder 1 Cary 50 accessory card and cable kit 1 Cary Win UV dissolution software 1 Dell Pentium-based PC with monitor 1 HP color printer
Part Number Description
Package 11-1105 1 Cary 50 UV-VIS Spectrophotometer 1 Extended cell compartment 1 Sample compartment tubing coupler 1 18-position cell holder 1 Cary 50 accessory card and cable kit 1 Cary Win UV dissolution software
Part Number
Description
VanKel Total Solution Upgrade Cary 50 UV package 11-1100 11-1120 Cary 50 UV Package 115 V, 60 Hz 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
Dosage Delivery Modules are available for the VK 7000 and are compatible with Cary 50 upgrades. See page 60 for details.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Total Solution
If you already have a VK 7000 or VK 7010 bath, you can integrate your existing equipment. Depending on the configuration of your existing equipment, you may need an automated sampling manifold with the internal motor drive along with the appropriate Peristaltic Pump. Call for more details. To simplify the ordering procedure, we have created the following packages (flow cells are not includedsee page 24):
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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
Fully Automated
Zymark Corporation To learn how to best integrate your analytical instruments with your VanKel dissolution tester, call 800.229.1108 or contact your local VanKel representative.
VanKel testers can be integrated to almost any LC equipment using the VK 8020 Autosampler / Auto-Injector (see page 105).
Varian, Inc.
Varian incorporates VK 7000 and VK 7010 baths into their UV analysis systems. These systems incorporate either the Cary 50 (see pages 18 - 25) or the Cary 100, 300, 400 and 500 model spectrophotometer. No matter what your spectral demands are, VanKel has an automated system that can work for you.
VK 7000 with External DDM connected to a Cary UV Spectrophotometer VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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These devices control both the Agilent Peristaltic Pump as well as the VanKel bi-directional pump. Using the VanKel pump allows the back-flushing of filters. The VanKel drivers allow for the maximum use of the VanKel baths. You can control the motorized manifold, in-vessel temperature measurement as well as the dosage delivery mechanism (ideal for staggered starts).
Description Software drivers for single-bath configuration. Includes driver qualification guide and cables for use with HP 8453 Spectrophotometer. Software drivers for multibath configuration. Includes driver qualification guide and cables for use with HP 8453 Spectrophotometer.
11-0011
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Agilents ChemStation dissolution software interfaces with the VK 7000 and VK 7010 baths. VanKel provides the drivers to communicate with the HP 8453 Diode Array Spectrophotometer, ChemStation software (including the dissolution module) and an 8-position cell changer. You can easily incorporate an existing VanKel bath to the ChemStation software utilizing VanKel UV interface kits (see below). Both single- and multibath systems are available. Contact us for drivers to control your VanKel bath. For more information, contact your VanKel representative.
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VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Perkin Elmer Dissolution Lab software works with VanKel testers in conjunction with their Lambda Series Spectrometers. The software automates both online and offline tablet dissolution studies. Dissolution Lab software includes password security and provides two levels of access: supervisor and user. Additional security features include binary storage of data files for manual verification of results, if needed. All report printouts include footnotes with date, time and consecutive page numbers.
Waters Corporation
The VK 7000 and 7010 are fully compatible with the Waters Alliance System for automated sampling using programming capabilities built into VanKel testers. Unlike other testers, VanKel testers do not require the use of resident dwelling probes. All operating parameters can be initiated by the transfer station, including the dropping of tablets and recording individual vessel temperature measurements and sampling time points (dosage dropping and vessel temperature measurement are standard features of the VK 7010). The Alliance System, with Millennium software, allows two testers to be connected to one LC. To accommodate the Waters sampling probes, we offer customized sampling manifolds. These can be fitted to any VK 7000 or VK 7010. Using a VK 7010, you can automate the start of the test (measuring and recording the temperature) as well as dropping the dosage 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 already installed. Please call your VanKel representative if you have questions.
Part Number 17-3130 17-3132 Description For Benchsaver testers (3+3 configuration) For Easy Access models (4+2, 4+3 or 4+4 configurations)
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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C Technologies, Inc.
The Cassini multiplexer is an input-output multiplexer which allows multiple fiber optic probes to be used with a single Cary 50 spectrophotometer. This device allows software-controlled switching of the fibers coupled to the light source and detector of the spectrophotometer. These probes easily attach to VanKels manifold for fiber optic dissolution testing.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
The Zeiss Optical Dissolution In-situ Analysis and Control system, known as the ZodiaC, is a new development which uses multiple fiber optic probes for multichannel analysis with the proven MCS spectrophotometer coupled to an 8-channel multiplexer. Initially targeted for sustained release products with dissolution profiles of 24 - 48 hours, the system can also be used for fast-release products. The system can measure time points down to a minimum of 1 minute due to the use of a fast and precise multiplexer. The fiber optic probes are mounted on a special manifold and positioned for the correct height and distance from the vessel walls to comply with USP.
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Specifications Height: 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)
Part Number 10-6000 10-6200 10-6400 10-6600 10-6615 10-6620 Description VK 7000 Benchsaver 3+3, 115 V, 60 Hz VK 7000 Benchsaver 3+3, 230 V, 50 Hz VK 7000 Easy Access 4+2, 115 V, 60 Hz VK 7000 Easy Access 4+2, 230 V, 50 Hz VK 7000 Easy Access 4+4, 115 V, 60 Hz VK 7000 Easy Access 4+4, 230 V, 50 Hz
Zymark MultiDose with VK 7000-series Dissolution Tester VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Specifications Height: 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)
Part Number 10-6800 10-6810 Description VK 7000 Easy Access 4+2, 115 V, 60 Hz VK 7000 Easy Access 4+2, 230 V, 50 Hz
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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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, Repeat The VK 900 Washing Station pressure washes the vessel with three washing cycles. The VK 900s washing ball uses a revolving action and high pressure stream to wash the interior of your vessels. In less than five minutes your tester is ready for the next test. With one filling of the rinse tank you can clean up to 32 1L vessels before a changeover is required. Easy to Fill, Easy to Empty The quick-disconnect fitting on the top of the washing station makes filling the rinse tank as easy as turning on a water faucet. The rinse tank is equipped with an inlet valve and float device to prevent overfilling. An LED illuminates to indicate the tank is full. An antifoaming agent can be added to the waste tank to minimize foaming when evacuating media containing surfactants. The built-in vacuum pump easily evacuates the waste tank. Neutralizing agents can be added to the waste tank prior to disposal. Saves Time When you remove vessels for washing, you should always reverify the centering and height parameters. Cleaning the vessels in place preserves set parameters and eliminates the timeconsuming step of reverification from future tests. One Station Fits All The VK 900 is compatible with most dissolution testers. The aspiration tube can be configured to remove spent media from any 1L vessel. The cleaning head fits securely over any standard vessel. Mobile The VK 900 is a cleaning, containment and disposal unit all in one mobile housing. The durable casters smoothly roll the unit directly to your dissolution tester.
VK 900 In Use VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Carry-over studies should be performed on automated 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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Heats cleaning fluid for better washing efficiency. The heater option keeps your cleaning fluids heated up to 50 C. Specifications Length: 81.28 cm (32 inches) Width: 45.72 cm (18 inches) Height: 121.92 cm (48 inches)
When evacuating media where a surfactant has been used, an antifoaming agent should be added to the VK 900 to keep foaming to a minimum.
Evacuation Stage
Rinse Stage
Wash Complete
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Dissolution Accessories
Effective Measurement System The QAII allows you to measure and record dissolution physical parameters (as specified in USP, EP and JP). It easily measures and documents individual spindle speeds, shaft wobble, shaft perpendicularity, temperature and instrument level. In addition, the QAII measures vibration. The vibration display shows vibration is a function of four different parameters (acceleration, velocity, frequency and displacement) in all three axes X, Y and Z. The QAII can be used on almost all brands of dissolution testers. An adapter ring for non-VanKel testers is included. NIST-traceable Results A calibration certificate is included. Truly Portable The QAII is battery operated as well as line-operable. The printer is only operated when the instrument is plugged into a wall socket to conserve battery life. Information Storage The QAII stores information for up to 30 testers and retains the serial numbers by unit and each individual shaft ID. The easy-to-use menu prompts you through the step-by-step process. You have the option of skipping 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)
Part Number 12-0520 12-0530 12-0531 Description QAII Station 115 V, 60 Hz QAII Station 230 V, 50 Hz Carrying Case
E B A C G F
Vibration Sensor
QAII Printout
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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QAII Upgrade
The QA Station with optical reflective chips can be upgraded to use the new magnetic tachometer sensor and chip. Call VanKel for details!
Part Number 12-7505 Description QAII Sensor Upgrade (magnetic)
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
Part Number
Description
38
Dissolution Accessories
Provides absolute readings for shaft centering and paddle or basket height measuring Improves accuracy over manual gauges Takes digital measurements
Reliable Results For increased overall accuracy of your dissolution tests, this system utilizes easily calibrated and traceable gauges to measure the actual centerline offset for a shaft. It also measures the distance between the bottom of the paddle or basket and the inner apex of the bottom of the vessel. Digital Measurements The VK 5010 takes measurements digitally eliminating visual interpretation and estimation and removing the likelihood of human error. Reproducible Results and Hard Copy Printouts Consistently reproducible results are viewable on the LCD display, and hard copy printouts are provided by the on-board printer. Non-volatile Memory The VK 5010 is also capable of storing the following data in non-volatile memory: Tester serial number Shaft ID Vessel ID Vessel position The VK 5010 can store information for up to 30 testers at 8 vessels per tester.
Centerline Offset Measurement
VK 5010
Description VK 5010 CLH Measurement System centerline offset and height measurement, 115 V or 230 V, includes all necessary gauges Carrying Casehard plastic case with cutouts for instrument and gauges
12-0531
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Tachometer, Hand-held
The hand-held tachometer measures RPM with continuous update each second. The measured value can be stored and read on the display by use of a slide switch. Unit includes three tips: cone shape, conical and disk. The range is 1 to 19,999 with accuracy of 1.0, 0.5% of mean value. The power supply is a 9V battery. Part Number 12-7100 12-7110 12-7120 Description Tachometer Calibration Certificate for hand-held tachometer Calibration Certificate with Calibration Data Sheet for hand-held tachometer
Hand-held Tachometer
A B C D E F
NEW
Height Gauge for Basketsattaches to basket to position 25 mm above bottom of vessel (H)
NEW
Height Spacers
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
These gauges indicate shaft wobble in 0.001 inch or 0.01 millimeter graduations and include a snap-in adapter for non-VanKel instruments.
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Dissolution Accessories
Dissolution Accessories
E
an d D
F
B
Spacers and Centering Tools
Description Centering tool for use with stainless steel centering rings. Stainless steel gauge for checking the centering of 3/8-inch diameter basket or paddle shaft with dissolution vessels. (A) Centering Pass / Fail Gauge for use with EaseAlign centering rings. Aluminum gauge for checking the centering of 3/8-inch diameter basket or paddle shaft with dissolution vessels. (B) Height tool, stainless steel, to accurately set the depth (2.5 cm) of the paddle or basket for USP Apparatus 1 and 2 dissolution tests. (C) Height tool, stainless steel, similar to item C designed for 2-liter vessels (2.5 cm) depth with longer handle for deeper vessel. (D) Height tool, stainless steel, similar to item C designed with (4.5 cm) depth as required in some instances for dissolution testing of antibiotics. (E) Height tool, special design, made of stainless steel and delrin, to be used with Peak vessels. (F) Circular level for all directional horizontal leveling. Base of level is 3/4-inch diameter. (G)
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
12-7310
When using Peak Vessels, the height is set as if the indentation were not present. PN 12-7230 takes this into account, making it easy to set the height.
12-7300
12-7301
12-7330
12-7230
12-7320
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If an apparatus is not set up correctly from the start, it is going to need attention in the future. The VK Verified program is your assurance that your accessories will conform to all regulatory standards, as well as to the more stringent internal specifications of VanKel. Almost all dissolution vessels are hand-made from glass tubing. Due to hand-forming, no 2 vessels are exactly alike. This is particularly important for the bottom curvature. As of this publication, there are no published specifications as to the hemisphericity of the vessel. At VanKel, weve created our own tolerances based on those the USP has recommended for the ID. The diameter (1) has a USP tolerance of 4 mm. We have taken half of this value and created a requirement for the hemisphere (3) to be 2 mm. We inspect each vessel and record the actual dimension. The resultyou get vessels that are neither too shallow nor too deep and a certificate to verify the actual dimensions.
The benefit to you is greater consistency of test results. Although not exactly alike, these VK verified vessels are held to very tight tolerances. Substituting a VK verified vessel for a broken vessel should yield no perceptive difference in results. A certificate is included to provide the actual measured values, the type of measuring device used, and its traceability.
Part Number 12-5005V Description Certified Glass Vessel, serialized 1000 mL for Apparatus 1 and 2
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 (within the US) 919.677.1108 FAX 919.677.1138 Vankel.Info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
1000 mL Vessels
The standard 1000 mL vessels are designed to meet or exceed current USP specifications. All are individually serialized for documentation purposes and easy relocation.
Part Number 12-5000 12-5010 12-5020 Description USP Vessel, 1000 mL standard USP Vessel, 1000 mL amber-tinted Vessel, 1000 mL Teflon-lined (interior lower hemispherical radius only)
Amber-tinted 1000 mL
Peak Vessels
Patent 5,700,087
4L
2L
The Peak vessel reduces the inherent inconsistencies in the hydrodynamics of standard hemispherical dissolution vessels. An inverted peak is designed into the bottom of the vessel, displacing the unstirred zone, preventing cone formation.
Part Number 12-5500 12-5025 12-5510 12-5520 Description Peak Vessel 1L Peak Vessel 1L, Teflon-coated bottom Peak Vessel 2L Peak Vessel 4L
Peak
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
TruCenter Vessels
Patent Pending
43
NEW
All dissolution vessels have inconsistencies in the glass thickness. Consequently it is difficult to center from the outside of the vessel. Not any longer! These dissolution vessels have a ground concentric ring around the outside which holds a centering collar in place. The result is a vessel for which you can establish the true center from the outside.
Part Number 12-5035 12-5037 12-6105 Description TruCenter Vessel, 1L, with ground centering groove, vessel only TruCenter Vessel, 500 mL, with ground centering groove, vessel only TruCenter Centering Collar
TruCenter Vessel must be used only with VanKel testers equipped with the TruCenter collar.
Volumetric Flasks
This volumetric dissolution flask meets class A specifications. A stopper is included and the flask is designed with a space-saving square bottom. The flasks are marked to deliver and to contain.
Part Number 12-5300 12-5310 Description Volumetric Flask, 900 mL Volumetric Flask, 500 mL
NEW
Volumetric Flasks
This volumetric dissolution flask meets class A specifications. Unlike other volumetric flasks, these are calibrated to contain as well as deliver media at 37 C. Most conventional flasks are calibrated at 20 C.
Part Number 12-5315 12-5320 Description Calibrated Volumetric Flask, 900 mL Calibrated Volumetric Flask, 500 mL
Preheating media in volumetric flasks can save time. Be sure to verify the volume when the media is at 37 C. The volume will differ from that at room temperature.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
TruCenter System
Patent Pending
NEW
Description TruCenter System Conversion Kit includes vessel, centering collar and alignment plate TruCenter Vessel, 1L, with ground centering groove TruCenter Vessel, 500 mL, with ground centering groove TruCenter Alignment Plate TruCenter Centering Collar Pegs for Alignment Plate O-rings for TruCenter Centering Collar Evaporation Covers for TruCenter Vessels
This system assures you of perfectly centered vessels every time. We start by turning a dissolution vessel and grinding a concentric ring around the outside of the glass vessel. Next we fasten a centering collar around the ground ring and place the system into the alignment plate. The result is a vessel that can be perfectly centered. One less variable for you to worry about. Once your vessels are in place, they will not float. This system can be retrofit to any existing VK 7000 or VK 7010 bath.
These centering rings position the vessels accurately using the inside diameter of the vessel. Empty vessels will not float. Locating pegs mounted on the vessel plates ensure centering each time a vessel is placed in position. Does not include evaporation cover or pegs. For use with VK 700, VK 7000 and VK 7010.
Part Number 12-6050 Description EaseAlign Centering Rings only
EaseAlign Centering Rings
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Upgrade your VK 600, 6000, 6010 or Hanson dissolution testers to accommodate VanKels EaseAlign Centering Rings. Also designed for use with most dissolution baths. Easy to assemble.
Part Number 12-6060 12-6062 12-6065 12-6070 Description EaseAlign Centering Ring 6-position Kit EaseAlign Centering Ring 8-position Kit EaseAlign Locating Pegs, set of 12 Complete Conversion Kit for Hanson, set of 6
C
Vessel Evaporation Covers for EaseAlign Centering Rings
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
Dissolution Accessories
NEW
Evaporation Plugs
Press-fit plugs are used to close sampling holes in evaporation covers (PNs 12-6300, 12-6305 and 12-6310).
Part Number 12-6350 Description Set of 36
Evaporation Plugs
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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All VanKel accessories are lot inspected. Many customers request their accessories be individually inspected, measured and documented. We now offer this service for a number of accessories. A certificate is included to provide the actual measured values, the measuring device used, and its traceability.
Part Number 12-1000V 12-1010V 12-1015V Description 15-inch Shaft with individual inspection certificate 19-inch Shaft with individual inspection certificate 24-inch Shaft with individual inspection certificate
Teflon-coated Paddles
Uncoated Electropolished Paddles 12-1030V 12-1040V 12-1045V 15-inch Shaft with individual inspection certificate 19-inch Shaft with individual inspection certificate 24-inch Shaft with individual inspection certificate
PEEK Paddles 12-1201V 12-1211V 15-inch Shaft with individual inspection certificate 19-inch Shaft with individual inspection certificate
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
Teflon-coated
These paddles are serialized and designed to meet or exceed current USP specifications for Apparatus 2. They are constructed of type 316 stainless steel and have a 3/8-inch diameter shaft. The blade and lower part of the shaft are Teflon-coated.
Part Number 12-1000 12-1010 12-1015 Description 15-inch Shaft, Teflon-coated 19-inch Shaft, Teflon-coated 24-inch Shaft, Teflon-coated
PEEK
NEW
These paddles are serialized and of single-entity construction. The shaft is manufactured of type 316 stainless steel with a 1/16-inch thick PEEK sleeve and solid PEEK blade. These paddles meet all the dimensional specifications of the USP, EP and JP for Apparatus 2. PEEK paddles are impervious to most types of media used in dissolution. They offer greater chemical resistance and have greater rigidity (thereby ensuring the proper shape is maintained).
Part Number 12-1201 12-1211 Description 15-inch Shaft, PEEK 19-inch Shaft, PEEK
Tefl o
n-co
ated
hed
/ Sta
inle
ss S
teel
PEE
Paddles
Dura-Tef Shaft 12-1221 12-1222 12-1223 15-inch Shaft only, 3/8-inch 19-inch Shaft only, 3/8-inch 24-inch Shaft only, 3/8-inch
PEEK (polyetheretherketone) is biocompatible, chemically inert, and can be used to replace stainless steel in most liquid analytical equipment systems.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories Mini Paddles for 100 and 200 mL Dissolution Vessels
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Description Teflon-coated, 1/4-inch diameter shaft Teflon-coated, 3/8-inch diameter shaft Electropolished, 1/4-inch diameter shaft Electropolished, 3/8-inch diameter shaft
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 steel chuck assembly.
Mega Paddle
This paddle can be used in 2L and 4L vessels when greater fluid movement is required. The proposed modification to USP dissolution Apparatus 2 may be found in Pharmacopeial Forum volume 24, number 3, page 6351.
Part Number 12-1318 Description Mega Paddle 24-inch, 3/8-inch diameter shaft
Mega Paddle
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
The mini paddle is made of type 316 stainless steel. It has a 1.174-inch (29.8 cm) paddle diameter and either a 1/4-inch or 3/8-inch diameter shaft.
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Dissolution Accessories
VK Verified is your assurance the accessories you are using meet all the required specifications. We provide an individual certificate for each basket detailing the USP specifications, the measured value, the measuring device used, its serial number and the date of its inspection.
Part Number 12-2000V 12-2020V 12-2025V Description USP 15-inch Shaft, standard head with individual inspection certificate USP 19-inch Shaft, standard head with individual inspection certificate USP 24-inch Shaft, standard head with individual inspection certificate Rotating Basket Assembly
Basket Drive Shafts 12-2070V 12-2080V 12-2095V 15-inch Shaft, USP standard head with individual inspection certificate 19-inch Shaft, USP standard head with individual inspection certificate 24-inch Shaft, USP standard head with individual inspection certificate
Baskets Only, Standard 12-2100V USP Basket, 40-mesh, type 316 SS basket standard with individual inspection certificate USP Basket, 20-mesh, 864-micron, type 316 stainless steel basket with individual inspection certificate
12-2120V
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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The current USP Apparatus 1 basket shaft requires three retention clips on 120 degree centers to hold the basket in place.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
52
Dissolution Accessories
The Dura-Fit basket shafts are individually serialized and are shipped with a Certificate of Lot Compliance. The 3/8-inch diameter shafts are manufactured of type 316 stainless steel. The heads have O-rings for press fit attachment of the baskets.
Part Number 12-2040 12-2050 12-2093 12-2055 12-2056 Description 15-inch Shaft, standard head 15-inch Shaft, conical head disperses air bubbles 15-inch Shaft, lower 6 inches Teflon-coated 19-inch Shaft, standard head 19-inch Shaft, conical head disperses air bubbles
Dura-Fit Conical Head Dura-Fit Standard Head
Basket Drive Shaft 15-inch Shaft, USP standard head 19-inch Shaft, USP standard head 24-inch Shaft, USP standard head 15-inch Shaft, conical head disperses air bubbles 19-inch Shaft, conical head disperses air bubbles 15-inch Shaft, lower 6 inches gold-plated 19-inch Shaft, lower 6 inches gold-plated 15-inch Shaft, lower 6 inches Teflon-coated 19-inch Shaft, lower 6 inches Teflon-coated 15-inch Shaft for Bolus Basket (shaft only)
Gold-plated shaft
Teflon-coated Shaft
53
Stainless Steel
12-2110
Gold-plated
All stainless steel baskets are vulnerable to wear over time. Openings increase as wire diameters decrease. Replace your baskets as necessary.
Suppository Basket
Dissolution Accessories
54
Dissolution Accessories
Custom Baskets
VanKel can manufacture custom-made baskets to your specifications. We have manufactured the following basket configurations which fit standard USP shafts in the past. Contact your VanKel representative if you are interested in one of these, or one with different specifications.
Part Number 12-2140 12-2145 12-2146 12-2148 12-2149 12-2150 12-2151 12-2152 12-2154 12-2155 12-2160 Description 450 x 2750 mesh, 1-micron 400 x 2800 mesh, 2-micron 325 x 2300 mesh, 5-micron 200 x 1400 mesh, 10-micron 165 x 800 mesh, 20-micron 325 x 325 mesh, 43-micron 270 x 270 mesh, 53-micron 150 x 150 mesh, 104-micron 100 x 100 mesh, 140-micron 50 x 50 mesh, 280-micron 30 x 30 mesh, 533-micron
Fabricated with 316 stainless steel, baskets have a standard mesh screen of 40. Mesh is defined as the number of openings per linear inch. Another term often associated with mesh size is micron, which is defined as the size of the openings. The number of openings per linear inch and the diameter of the wire will affect micron size.
Bolus Baskets
The following bolus baskets require a special shaft, PN 12-2097 (see page 52). Specifications Inside diameter: 30 mm (1.18 inches) Height: 94.97 mm (3.74 inches)
Part Number 12-2180 12-2185 Description 20 x 20 mesh, 864-micron 40 x 40 mesh
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com Bolus Baskets
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This wire is flexible enough for weighting capsules. It is type 316 stainless steel wire and meets current USP specifications.
Part Number 12-3000 Description Stainless Steel Wire, 50-foot roll
Stainless Steel Wire
12-3056
Sinker Baskets
The sinker baskets are designed to retain the dosage form at the bottom of the vessel. They are made of type 316 stainless steel and use press-on caps (with O-rings). They are currently manufactured in 6 mesh sizes. Custom mesh sizes are available call for details. Specifications Inside diameter: 20.2 mm (0.8 inches) Inside height: 11.7 mm (0.46 inches)
Part Number Sinker Basket 12-3060 12-3062 12-3064 12-3066 12-3068 12-3072 12-3070 Enclosure 10-mesh, 1905-micron Enclosure 8-mesh, 2591-micron Enclosure 40-mesh Enclosure 60-mesh, 229-micron Enclosure 270-mesh, 53-micron Enclosure 325-mesh, 45-micron Japanese Sinker Basket, JP 13 version
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com Japanese Sinker Baskets
Sinker Baskets
Description
Dissolution Accessories
Wire
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Dissolution Accessories
Glass Syringe
This 20 cc Luer-type syringe is graduated to 1 cc.
Part Number 12-3230 Description Glass Syringe only, 20 cc (B)
Manual Sampling Manifold
Manual Sampling
Manual Sampling
To gain more working room when sampling manually, use spacer PN 12-0321 (see page 39). When used with 19-inch paddles, this allows for greater accessibility.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
Description
Automation Filters
These 25 mm disk filters are individually lot analyzed and designed to work with VanKels Automated Filter Changer (see page 94) as well as the Zymark Multidose and Tablet Processing Workstation (TPW). The specially designed housing prevents the membrane from being compressed. VanKel offers nylon and PVDF filters as standard products. Filters are packaged in boxes of 200 and prestacked in tubes of 25 for easy loading. Other membrane types are availablecall VanKel for details.
Part Number 17-4200 Description Filter, 1.0 m APFB glass fiber prefilter for processing and clarification of aqueous and organic solutions containing high particle levels Filter, 0.45 m low protein binding PVDF membrane for processing and clarification of aqueous and mild organic solutions Filter, 0.45 m nylon membrane for processing and clarification of aqueous and organic solutions
Automation Filters
17-4210
17-4220
Deaeration is the process of removing dissolved gases from a liquid media. The USP method of deaeration is to heat the media to 41 C with gentle stirring. Filter under vacuum using a filter having a porosity of 0.45-micron or less with vigorous stirring and continue stirring under vacuum for approximately 5 minutes. Other validated deaeration methods can be used.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Description Resident Cannula Kit for Stainless Steel Centering Rings (set of 6) Resident Cannula Kit for EaseAlign Centering Rings for use with paddles (set of 6) Cannula and Bushing only (sampling 4.5 in) Resident Cannula Kit for EaseAlign Centering Rings for use with baskets (set of 6) Resident Cannula Kit for EaseAlign Centering Rings (1 each) Cannula and Bushing (return 2.5) Evaporation Cover only with UV-VIS adapter for use with EaseAlign Centering Rings
Resident Cannula Kit
12-0447 12-0460
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
Where the addition and removal of a sampling cannula is not mechanically practical, the resident cannula kit allows you to interface with Agilent, Beckman, Perkin Elmer and many other UV instruments for online analysis.
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Dissolution Accessories
Saves time Easy and precise way to drop tablets for automatic (simultaneous or sequential) delivery of dosage forms to vessels with instant or delayed start through keypad or computer control Eliminates errors when manually dropping tablets or capsules For the VK 7000 Dissolution Tester
This option replaces the existing top cover of the dissolution tester with a new one containing motors, staging platforms and Dosage Delivery Module tubes. This retrofit requires a service technician to install.
Part Number 12-0101 12-0104 12-0106 12-0111 Description Dosage Delivery Module for 6-vessel Benchsaver 3+3 Dosage Delivery Module for 6-vessel Easy Access 4+2 Dosage Delivery Module for 8-vessel Easy Access 4+4 Dosage Delivery Module for 7-vessel Easy Access 4+3
Dosage Delivery Module
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 Statement Our 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.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Individual vessel temperatures measured and recorded Monitor media temperatures and automatically start a test once all the vessels have stabilized
The new AutoTemp System board plugs directly into the RS232 serial port on your VK 7000 Dissolution Testing Station. AutoTemp measures individual invessel temperatures, transmitting them via the RS232 serial port and displaying them on the status screen of your VK 7000. Sensors are lowered into the vessels by a motorized manifold and then removed as soon as temperatures have been measured to eliminate disturbances associated with resident dwelling probes during the test. The AutoTemp accessory is available factory installed when ordered with a new bath or can be retrofit to an existing unit. You can program the frequency at which you wish to monitor and record the temperature. Internal Connection Includes Internally Mounted Motor Drive
Part Number 12-0601 12-0606 12-0611 12-0616 Description AutoTemp for 6 vessels, 3+3 AutoTemp for 6 vessels, 4+2 AutoTemp for 7 vessels, 4+3 AutoTemp for 8 vessels, 4+4
Internal Connection without Motor Drive (for units already equipped with Automated Sampling Manifold)
Part Number 12-0651 12-0656 12-0661 12-0666 Description AutoTemp for 6 vessels, 3+3 AutoTemp for 6 vessels, 4+2 AutoTemp for 7 vessels, 4+3 AutoTemp for 8 vessels, 4+4
The built-in dot matrix printer documents the temperature for individual vessels before and after the test and at programmable intervals.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
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Dissolution Accessories
When using the manual sampling bracket, you will lower the sampling manifold with the touch of a button on the front panel of the VK 7000 or VK 7010. All of the sampling cannulas are lowered into the vessels simultaneously. Included is the manifold, internal drive motor, sampling bracket and all tubing and connections. Includes manual sampling bracket (PN 17-3150).
Part Number 17-3350 17-3355 Description 3+3 configuration 4+2 or 4+4 configuration
Motorized Sampling Manifold
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12-0311
12-0320 12-1305
12-1315
12-1315
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
VanKels vessel conversion kits not only work with VanKel dissolution testers, but also with most other manufacturers dissolution testers. See page 45 for PN 12-6070.
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Dissolution Accessories
The 2L and 4L conversion kits make your existing dissolution tester more flexible by providing leg extenders and an extra-deep water bath for use with either standard 1L vessels or the larger vessels provided with the kit you select. The 2L conversion kit is available for the Benchsaver or Easy Access models of the VK 700, VK 7000 or the VK 6000 series dissolution tester. VK 7010 2L conversion kits are available for the Easy Access models only.
2L Conversion Kits
Part Number 12-0400 12-0415 12-0420 12-0425 Description VK 700 / 7000 Benchsaver, 3+3 units VK 600 / 6000 / 6010 Benchsaver, 3+3 units VK 700 / 7000 / 7010 Easy Access, 4+2 and 4+4 units VK 600 / 6000 / 6010 Easy Access, 4+2 and 4+4 units 2L Conversion Kits
2L Conversion Kit
4L Conversion Kits
Part Number 12-0440 12-0445 Description VK 600 / 6000 / 6010 VK 700 / 7000 4L Conversion Kit
4L Conversion Kit VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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Description Standard USP design consists of 0.5 cm Holder, Punch and Die Cavity (one setsurface plate not included) 0.125 cm Holder, Punch and Die Cavity (one setsurface plate not included) Intrinsic Die only Surface Plate (only one is required) Punch only Shaft and Holder only
Intrinsic Dissolution Apparatus
Rotating Cylinder
Intrinsic dissolution is the dissolution of a pure substance under conditions of constant surface area expressed in terms of mg/time/cm. Intrinsic dissolution is useful in studying the solubility characteristics of a pure drug substance.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
The VanKel Type Intrinsic Dissolution Apparatus is an updated version of the original Wood Apparatus for intrinsic dissolution. The VanKel design includes a hardened punch, a controlled surface area and an improved die design for more reproducible results. It is designed to meet or exceed current USP specifications as described in USP Physical Test <1087>. The ground and hardened surface plate (ordered separately) provides an ideal surface for compressing samples. The intrinsic dissolution apparatus is designed for use with standard USP Apparatus 1 and 2 dissolution testers.
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Dissolution Accessories
The suspension cup is a Teflon 2-piece assembly. The weighted holder has a hemispheric bottom designed to sit in the bottom of a 1L dissolution vessel. The removable center cup, available in 2 sizes, allows contents to be weighed, retains the suspension and provides a controlled surface area.
Part Number 12-4050 Description Weighted Holder only 5.72 cm outside diameter, 2.52 cm inside diameter for suspensions Insert Cup only 17.5 x 8.2 mm, use with PN 12-4050 (exposed surface area 2.405 cm, vol 1.972 cm) Insert Cup only 20 x 8.2 mm, use with PN 12-4050 (exposed surface area 3.14 cm, vol 2.576 cm)
12-4055
Suspension Cup
12-4060
This type 316 stainless steel 2-piece assembly provides an easy-to-use alternative to the USP Apparatus 5. The O-ring assembly eliminates the need for adhesives. It is designed for patches with an inactive perimeter around the release area. Custom holders (square, oblong) are also availablecall us!
Part Number Description 2.5 cm 5.0 cm 7.0 cm 10.0 cm Transdermal Patch Holder 12-4300 Release area 12-4310 Release area 12-4320 Release area 12-4330 Release area
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
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G E C
Teflon cell with adjustable volume and screw cap to eliminate air pockets trapped against the skin or artificial membrane. The result is more consistent release rates. Designed for research, quality control and product development laboratories, the Paddle over Enhancer Cell method provides release rates comparable to Franz Cell technology. It provides release rate data for quality control of topicals using readily available dissolution apparatus, including 200 mL or standard 900 mL dissolution vessels, without the investment in fragile Franz Cells, pumps and stirrers. An alignment tool is used to hold the membrane in place while using the adjustment tool to set the volume adjustment plate. Only one alignment and adjustment tool are required per size. When purchasing more than one Enhancer Cell, order separately. The Enhancer Cell does not include the vessel, paddle or membrane / skin.
F 0.5 cm
D 2 cm
B 4 cm
Part Number 12-4000 12-4010 12-4001 12-4011 12-4002 12-4012 12-4015 12-5055
Description Enhancer Cell, 4 cm only (A) Alignment Tool, 4 cm only (B) Enhancer Cell, 2 cm only (C) Alignment Tool, 2 cm only (D) Enhancer Cell, 0.5 cm only (E) Alignment Tool, 0.5 cm only (F) Adjustment Tool only, for all sizes (G) 200 mL, flat-bottom, self-aligning indentation for use with Enhancer Cell
Adjustment Plate with O-ring Cell Body Membrane or Skin Washer Retaining Ring
Adjustment Tool, Enhancer Cell (disassembled) and Alignment Tool Vessel, Mini Paddle and Enhancer Cell
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com
Dissolution Accessories
Patent 5,408,865
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Dissolution Accessories
Dissolution Accessories
VanKels chemists and technicians are accessible via live video feeds, eliminating travel costs.
Our service technicians and chemists come to your facility to perform physical and chemical calibration as well as product maintenance, maximizing your labs productivity.
SERVICE
Our team of expert instructors will educate and train your chemists on all the various aspects of dissolution testing, ensuring efficient application of current methodologies.
EDUCATION
LAB SERVICES
Contact VanKel free of charge for help with any dissolution matter. Call 888.VANKEL1 (888.826.5351) or e-mail vankel_hotline@vankel.com.
HOTLINE
At VanKel, we want to make sure you are minimizing the total cost of ownership of your dissolution equipment. We go beyond supplying you with high performance products by providing the top-quality service and support you deserve. Utilize our value-added services. Minimize cost. Maximize ownership. Stop by and visit our dissolution demonstration lab in Cary, NC, or call your VanKel representative.
VanKel Technology Group 13000 Weston Parkway Cary, North Carolina 27513-2228 USA 800.229.1108 919.677.1108 fax 919.677.1138 vankel_info@vankel.com www.vankel.com