Agilent Technologies Varian VK 7025 Operator's Manual
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Agilent Technologies Varian VK 7025 Operator's Manual

Agilent Technologies Varian VK 7025 Operator's Manual

Dissolution apparatus
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VK 7025 Dissolution
Apparatus Operator's
Manual
P/N 70-9033
November 2010
Revision H

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Summary of Contents for Agilent Technologies Varian VK 7025

  • Page 1 VK 7025 Dissolution Apparatus Operator’s Manual P/N 70-9033 November 2010 Revision H...
  • Page 2 Limitation of Liability The information in this document is subject to change without notice. Varian, Inc. makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Varian, Inc. shall not be liable for errors contained herein or for incidental consequential damages in connection with the furnishing, performance, or use of this material.

  • Page 3: Table Of Contents

    Table of Contents Safety Practices and Hazards 9 Chapter 1 Electrical Hazards 10 Other 10 General 13 WEEE Directive 13 Introduction 15 Chapter 2 Conventions Used in this Manual 17 Quick Key Guide 18 Screen Saver 18 Setup 19 Chapter 3 Unpacking Your VK 7025 19 Setting Up the VK 7025 22 Raising and Lowering the Drive Unit...
  • Page 4 Table of Contents Sliding Back the Drive Unit 24 Setting Up the Water Bath and Heater / Circulator 25 Filling the Water Bath 27 Installing and Centering the Vessels 28 Installing Paddle / Basket Shafts 28 Installing Paddles 29 Installing Basket Shafts 30 Installing Rotating Cylinders 31 Installing the Intrinsic Dissolution Apparatus 32 Removing the Dissolution Apparatus 33...
  • Page 5 Table of Contents Operation 59 Chapter 5 Main Menu 59 Manual Operation 60 Starting a Test 64 Paddles 65 Baskets 67 Paddle Over Disk 69 Rotating Cylinder Setting Delayed Heating 72 Start Method 73 Method Editor 84 Fiber Optics 93 Chapter 6 Installing Fiber Optics 93 Maintenance and Troubleshooting 97...
  • Page 6 Table of Contents Printer Configuration Fuse Replacement 113 Troubleshooting 114 Service and Warranty 117 Chapter 8 Exclusions and Limitations 118 Obtaining Warranty Service 118 Warranty Limitations 118 Exclusive Remedies 119 Index 121 Tell Us How We Are Doing 125 Varian, Inc.
  • Page 7 List of Figures FIGURE 1. Lifting Straps FIGURE 2. VK 7025 Lifting Guide FIGURE 3. VK 7025 Foot 23 FIGURE 4. Drive Unit Guide Rods 24 FIGURE 5. Drive Unit Release Lever 24 FIGURE 6. Centering Verification Gauge 34 FIGURE 7. EaseAlign Centering Ring 34 FIGURE 8.
  • Page 8 List of Figures FIGURE 10. Manual Sampling through the Top Cover 39 FIGURE 11. Vessel Plate Layout 43 FIGURE 12. Spindle Housing 50 FIGURE 13. Standard Evaporation Cover, Dropping Dosage Unit and Sampling 65 FIGURE 14. Basket / Low-loss Evaporation Cover, Positioning and Sampling 68 FIGURE 15.

  • Page 9: Safety Practices And Hazards

    Safety Practices Chapter 1 and Hazards The VK 7025 has been carefully designed so that when used properly you have an accurate, fast, flexible, and safe instrument. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.

  • Page 10: Electrical Hazards

    Page 10 VK 7025 Dissolution Apparatus Revision H, 11/10 Safety Practices and Hazards Operator’s Manual P/N 70-9033 Electrical Hazards The dissolution apparatus contains electrical circuits, devices, and components operating at dangerous voltages. Contact with these circuits, devices, and components can cause death, serious injury, or painful electric shock. Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian-trained, Varian-qualified, or Varian-authorized service engineers.
  • Page 11 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 11 P/N 70-9033 Operator’s Manual Safety Practices and Hazards These symbols are also used on warning labels attached to the instrument. When you see one of these symbols, you must refer to the relevant operation or service manual for the correct procedure referred to by that warning label.
  • Page 12 Page 12 VK 7025 Dissolution Apparatus Revision H, 11/10 Safety Practices and Hazards Operator’s Manual P/N 70-9033 Caution A ‘Caution’ message appears in the manual when failure to observe instructions could result in damage to equipment (Varian supplied and / or other associated equipment). A ‘Note’...

  • Page 13: General

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 13 P/N 70-9033 Operator’s Manual Safety Practices and Hazards General CE Compliant Products The VK 7025 has been designed to comply with the requirements of the Electro-magnetic Compatibility (EMC) Directive and the Low Voltage Directive (LVD) of the EU. Varian, Inc.
  • Page 14 Page 14 VK 7025 Dissolution Apparatus Revision H, 11/10 Safety Practices and Hazards Operator’s Manual P/N 70-9033 This page was intentionally left blank, except for this message. Varian, Inc.

  • Page 15: Introduction

    Introduction Chapter 2 The VK 7025 is designed for dissolution testing of a variety of pharmaceutical products, including tablets, capsules, transdermal patches, and membranes. It can be configured as USP Apparatus 1, 2, 5, or 6. The unique design of the VK 7025 has a lower profile than existing dissolution apparatus. The drive unit moves up and down with the touch of a key to move paddles or basket shafts into and out of the vessels.
  • Page 16 Page 16 VK 7025 Dissolution Apparatus Revision H, 11/10 Introduction Operator’s Manual P/N 70-9033 The VK 7025 Dissolution Apparatus comes with all accessories needed for proper function: • PETG water bath • Heater / circulator • USP dissolution paddles or rotating basket assemblies (14.5-inch shaft length) •...

  • Page 17: Conventions Used In This Manual

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 17 P/N 70-9033 Operator’s Manual Introduction The following illustration shows a VK 7025. Conventions Used in this Manual • Quick keys you are asked to press are in bold. For example, “press MENU”. •...

  • Page 18: Quick Key Guide

    Page 18 VK 7025 Dissolution Apparatus Revision H, 11/10 Introduction Operator’s Manual P/N 70-9033 Quick Key Guide Press ESC to return to the previous screen. MENU From any point after the Main Menu, press MENU to return to the Main Menu. ENTER After entering any input, press ENTER to complete the process.

  • Page 19: Setup

    Setup Chapter 3 Unpacking Your VK 7025 The VK 7025 is shipped in one carton containing the following: • VK 7025 drive unit assembly, PETG water bath, power supply box, glassware, and accessories • heater / circulator Follow these steps to safely unpack your tester and accessories: Step 1.

  • Page 20: Figure 1. Lifting Straps

    Page 20 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 2. Remove all packing from the dissolution apparatus. Warning The VK 7025 weighs approximately 200 pounds and therefore requires special handling. Step 3. There are four lifting straps included with the dissolution apparatus. One is positioned around each of the four legs.

  • Page 21: Figure 2. Vk 7025 Lifting Guide

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 21 P/N 70-9033 Operator’s Manual Setup Step 6. Once clear of the packaging materials, use the hand holds grooved into the base plate to lift the dissolution apparatus onto a sturdy benchtop (see Figure 2, “VK 7025 Lifting Guide,”...

  • Page 22: Setting Up The Vk 7025

    Page 22 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Setting Up the VK 7025 Complete the following steps to safely set up your VK 7025: Warning Ensure the tester is configured at the factory for the voltage supplied.

  • Page 23: Raising And Lowering The Drive Unit

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 23 P/N 70-9033 Operator’s Manual Setup FIGURE 3. VK 7025 Foot Raising and Lowering the Drive Unit Warning Ensure your hands are not in the path of the drive unit as it rises and lowers.

  • Page 24: Sliding Back The Drive Unit

    Page 24 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 The guide rods also serve to guarantee the drive unit is positioned with the apparatus in the correct centering location for operation. See Figure 4, “Drive Unit Guide Rods,” below. FIGURE 4.

  • Page 25: Setting Up The Water Bath And Heater / Circulator

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 25 P/N 70-9033 Operator’s Manual Setup Step 5. When in the forward position, ensure the drive unit latches into place. This guarantees it is positioned in the correct centering location for operation. Setting Up the Water Bath and Heater / Circulator The removable water bath connects directly to the inlet and outlet of the heater / circulator.
  • Page 26 Page 26 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 6. Slip a tubing clamp over one end of the longer length of tubing that is connected to the back of the water bath. Carefully place this end of the tubing over the outlet port on the heater / circulator.

  • Page 27: Filling The Water Bath

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 27 P/N 70-9033 Operator’s Manual Setup Filling the Water Bath Step 1. Raise the drive unit to its home position and slide it back to allow full access to the vessels. Step 2. If applicable, remove one of the vessels and set it aside.

  • Page 28: Installing And Centering The Vessels

    Page 28 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Installing and Centering the Vessels The tester is supplied with specially designed vessels and magnetic ring flanges. The magnetic ring flanges will keep the vessels centered at all times, without the use of tools, and prevent the vessels from “floating”...

  • Page 29: Installing Paddles

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 29 P/N 70-9033 Operator’s Manual Setup Installing Paddles Note If using paddles, it is easier to install the evaporation covers prior to installing the paddles. See “Installing Standard Evaporation Covers” on page 36 or “Installing Basket / Low-loss Evaporation Covers”...

  • Page 30: Installing Basket Shafts

    Page 30 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 7. Rotate each shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another, locking the shaft in place.

  • Page 31: Installing Rotating Cylinders

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 31 P/N 70-9033 Operator’s Manual Setup Step 6. Place a shaft locking ring on the top of the shaft and slide it down until it rests on the shaft collar. Step 7. Rotate the shaft locking ring so the drive positioning teeth on both the shaft locking ring and the shaft collar rest against one another, locking the shaft in place.

  • Page 32: Installing The Intrinsic Dissolution Apparatus

    Page 32 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 3. Press and hold DRIVE DOWN until the drive unit is at its lowest position. Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly.

  • Page 33: Removing The Dissolution Apparatus

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 33 P/N 70-9033 Operator’s Manual Setup Step 3. Press and hold DRIVE DOWN until the drive unit is at its lowest position. Note There is a safety mechanism in the bottom of the left side guide rod which keeps the drive unit from lowering improperly.

  • Page 34: Centering Verification

    Page 34 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Centering Verification To verify the centering of the paddle / basket shafts, complete the following steps: Step 1. Locate the centering verification gauge and the EaseAlign centering ring. FIGURE 6.

  • Page 35: Installing Cannula Assemblies

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 35 P/N 70-9033 Operator’s Manual Setup Step 4. Slide the centering verification gauge down the shaft until the tapered ends rest in two opposing slots of the EaseAlign centering ring. Step 5. Rotate the centering verification gauge 90 degrees and slide the gauge down the shaft until the tapered ends rest in the other two opposing slots of the EaseAlign centering ring.

  • Page 36: Installing Standard Evaporation Covers

    Page 36 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Installing Standard Evaporation Covers To place the evaporation covers onto the spindles, complete the following steps: Step 1. For vessel position 1, place the knobbed evaporation plug in the left manual sampling hole and the evaporation plug in the right manual sampling hole (see Figure 8, “Standard Evaporation Cover,”...

  • Page 37: Installing Basket / Low-Loss Evaporation Covers

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 37 P/N 70-9033 Operator’s Manual Setup Installing Basket / Low-loss Evaporation Covers The evaporation cover for low loss or baskets comes with two DDM alignment attachments. Both attachments aid the alignment of the evaporation cover on the vessel. The open alignment attachment allows use of the DDM.

  • Page 38: Setting The Manual Sampling Cannula

    Page 38 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 3. When lowering the drive unit to run the method, stop the downward movement two inches above the vessel plate. Align the evaporation cover with the cannula assembly and the DDM tube at each vessel position.

  • Page 39: Figure 10. Manual Sampling Through The Top Cover

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 39 P/N 70-9033 Operator’s Manual Setup FIGURE 10. Manual Sampling through the Top Cover cannula bushing Step 8. Loosen the hex screw on the cannula bushing and slide the bushing up or down the cannula until it is positioned for the correct USP-specified sampling location.

  • Page 40: Programming Administrative Control

    Page 40 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Programming Administrative Control Note For initial setup, the preprogrammed user identification is 9 and the preprogrammed password is 9. It is recommended that you immediately change the user identification and password for Administrative control of the VK 7020 / 7020 S / 7025 Dissolution Apparatus once your unit is operational.

  • Page 41: Setting Up The User List

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 41 P/N 70-9033 Operator’s Manual Setup Setting Up the User List For initial set up of user identifications and passwords, the preprogrammed user identification is 9 and the preprogrammed password is 9. It is recommended that you immediately change the user identification and password for Administrative control of the VK 7025 Dissolution Apparatus once your unit is installed.

  • Page 42: Deleting Preset User Definitions

    Page 42 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 Step 10. Determine the security level for the new user by selecting ADMINISTRATOR, SUPERVISOR, or OPERATE ONLY. The Administration screen displays. Step 11. Repeat steps 6 - 10 until all users’ identifications, passwords, and security levels have been entered.

  • Page 43: Vessel Plate Layout

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 43 P/N 70-9033 Operator’s Manual Setup Vessel Plate Layout The vessels on the VK 7025 are numbered counterclockwise beginning with the back left corner. FIGURE 11. Vessel Plate Layout Varian, Inc.
  • Page 44 Page 44 VK 7025 Dissolution Apparatus Revision H, 11/10 Setup Operator’s Manual P/N 70-9033 This page was intentionally left blank, except for this message. Varian, Inc.

  • Page 45: Administrator Operation

    Administrator Chapter 4 Operation If your security level is “supervisor” or “operate only,” continue to Chapter 5, “Operation,” on page 59. User Settings To add, list, or delete users, see “Programming Administrative Control” on page 40. After adding the user identifications, passwords, and security, press ESC to return to the System Setup Menu 1 screen.
  • Page 46 Page 46 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Following is a description of the System Setup Menu 1 screen options: Option Response Main Menu All operation functions begin at the Main Menu. See “Main Menu” on page 59.

  • Page 47: Administration

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 47 P/N 70-9033 Operator’s Manual Administrator Operation Administration From the System Setup Menu 1 screen, select ADMINISTRATION. The Administration screen displays. Following is a description of the Administration screen options: Option Response Add User Select ADD USER to enter user identifications and passwords.

  • Page 48: Calibration

    Page 48 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Calibration From the System Setup Menu 1 screen, select CALIBRATION. Spindle hours are displayed under the screen title. The Calibration Menu screen displays. Following is a description of the Calibration Menu screen options: Option Response Bath Vessel Diff.

  • Page 49: Setting An Alternate Drive Unit Position

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 49 P/N 70-9033 Operator’s Manual Administrator Operation Step 3. Enter the observed difference in the temperature between the water bath temperature and the vessel temperature. The acceptable range is 0.0 to 10.0 °C. Press CLEAR to delete the entry or press ENTER to continue. The Calibration Menu screen displays with the new bath vessel difference value.

  • Page 50: Cannula Height Calibration

    Page 50 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 FIGURE 12. Spindle Housing spindle housing Step 5. Ensure the optional basket evaporation covers are in place. Step 6. Lower the drive unit to position the baskets just above the evaporation covers.
  • Page 51 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 51 P/N 70-9033 Operator’s Manual Administrator Operation Step 2. From the Calibration Menu screen, select CANNULA HEIGHT CALIBRATION. The Set Sampling Depth screen displays with factory-set values for each apparatus. SET SAMPLING DEPTH BASKET 900 mL MOVE BASKET 500 mL...

  • Page 52: Alarms

    Page 52 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Step 6. When the cannulas are in the correct position, select the appropriate apparatus and volume. The number of steps the cannula motor moved to reach that position displays under the selected apparatus and volume. Note For volumes between 500 mL and 900 mL, the appropriate cannula height is interpolated from the 500 mL and 900 mL settings.

  • Page 53: Calibration Calendar

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 53 P/N 70-9033 Operator’s Manual Administrator Operation Calibration Calendar From the Setup Alarms screen, select USP CAL MENU. The Calibration Calendar screen displays. Following is a description of the Calibration Calendar screen options: Option Response Basket Calibration Date...

  • Page 54: Diagnostics

    Page 54 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Diagnostics To check the operation of applicable options for your instrument, select DIAGNOSTICS from the System Setup Menu 1 screen. The Diagnostic Menu screen displays. Following is a description of the Diagnostic Menu screen options: Option Response...

  • Page 55: Menu 2

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 55 P/N 70-9033 Operator’s Manual Administrator Operation Menu 2 From the System Setup Menu 1 screen, select MENU 2. The System Setup Menu 2 screen displays. Following is a description of the System Setup Menu 2 screen options: Option Response Clock...

  • Page 56: Setting The Clock

    Page 56 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Setting the Clock From the System Setup Menu 2 screen, select CLOCK. The Clock Functions screen displays. Following is a description of the Clock Functions screen options: Option Response Set Date...

  • Page 57: Setting Serial Numbers

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 57 P/N 70-9033 Operator’s Manual Administrator Operation Option Response Baud Rate Select BAUD RATE to toggle between 2400, 4800, 9600, 19200, 28800, and 38400. The baud rate must be set to 9600 when connected to a VK 8000 or Total Solution system.
  • Page 58 Page 58 VK 7025 Dissolution Apparatus Revision H, 11/10 Administrator Operation Operator’s Manual P/N 70-9033 Step 3. Enter the serial numbers for the vessel, paddle, basket and shaft, or rotating cylinder for each of the corresponding spindle locations. See “Vessel Plate Layout” on page 43. Note To display a letter, hold down the number key until the appropriate letter displays, then release the key.

  • Page 59: Operation

    Operation Chapter 5 Main Menu From the System Setup Menu 1 screen, select Main Menu. The Main Menu displays. MAIN MENU MANUAL START OPERATION METHOD BATH TEMPERATURE METHOD SET POINT: 37.5 EDITOR DELAYED PRINT HEATING REPORTS RPM 000.0 BATH 37.2 1:UP 2:UP 3:UP...

  • Page 60: Manual Operation

    Page 60 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Following is a description of the Main Menu options: Option Response Manual Operation Select MANUAL OPERATION to set parameters for manual operation. See “Manual Operation” below. Bath Temperature Select BATH TEMPERATURE SET POINT.
  • Page 61 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 61 P/N 70-9033 Operator’s Manual Operation Following is a description of the Manual Operation screen options: Note For the following options, if you enter a value outside the acceptable range, an error message displays indicating appropriate values.
  • Page 62 Page 62 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Option Response Sample Point Alarm The sample point alarm allows the user to set an alarm to sound at some time interval prior to the sample point. By default, the sample point alarm is disabled.
  • Page 63 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 63 P/N 70-9033 Operator’s Manual Operation Step 6. After all sample timepoints have been entered, press ESC to return to the Manual Operation screen. Note Press CLEAR to silence the alarm. Manual Sampling of Temperature From the Manual Operation screen, select MANUAL SAMPLE.

  • Page 64: Starting A Test

    Page 64 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Starting a Test Before starting the test, complete the following steps to set the DDM manual override adapters in place at vessel positions 7 and 8: Step 1.

  • Page 65: Paddles

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 65 P/N 70-9033 Operator’s Manual Operation Paddles Note If performing a staggered drop, remove the cannula assemblies, if applicable, to prevent the raised paddles from damaging them. Before starting the test, ensure the paddle spin is enabled or disabled depending on your configuration (see “Paddle Spin”...
  • Page 66 Page 66 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Step 5. Push down the paddle shaft at vessel position 1. Step 6. Press RUN. The Method Status screen displays and the paddles rotate. Note To quit the test from the Method Status screen, press ESC and select EXIT.

  • Page 67: Baskets

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 67 P/N 70-9033 Operator’s Manual Operation Baskets Note On the Manual Operation screen, USE STANDARD START HEIGHT displays. To use this setting, continue with the directions indicated below. To switch to the alternate height setting, select USE STANDARD START HEIGHT.

  • Page 68: Figure 14. Basket / Low-Loss Evaporation Cover, Positioning And Sampling

    Page 68 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 FIGURE 14. Basket / Low-loss Evaporation Cover, Positioning and Sampling Step 5. The Method Status screen displays and the baskets rotate. Note To quit the test from the Method Status screen, press ESC and select EXIT.

  • Page 69: Paddle Over Disk

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 69 P/N 70-9033 Operator’s Manual Operation Paddle Over Disk Note If performing a staggered drop, remove the cannula assemblies, if applicable, to prevent the raised paddles from damaging them. Before starting the test, ensure the paddle spin is enabled or disabled depending on your configuration (see “Paddle Spin”...

  • Page 70: Rotating Cylinder

    Page 70 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Step 6. At the desired time intervals, lift each evaporation cover, manually drop the disk assembly into each vessel and push down the corresponding paddle shaft. Step 7.
  • Page 71 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 71 P/N 70-9033 Operator’s Manual Operation Step 4. Press RUN. displays and the drive unit lowers to the LOWERING DRIVE operating position. The Method Status screen displays and the cylinders rotate. Note To quit the test from the Method Status screen, press ESC and select EXIT.

  • Page 72: Setting Delayed Heating

    Page 72 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Setting Delayed Heating Note For this option, if you enter a value outside of the acceptable range, an error message displays indicating appropriate values. By default, the delayed heating option is disabled. To enable delayed heating, complete the following steps: Step 1.

  • Page 73: Start Method

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 73 P/N 70-9033 Operator’s Manual Operation Start Method Note Methods are not write-protected. Check with other users before proceeding. From the Main Menu, select START METHOD. The Start Method screen displays. Following is a description of the Start Method screen options: Option Response Select Method...
  • Page 74 Page 74 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Option Response Print Method Use this option to print the method parameters. To print the information stored under the method number displayed on the Start Method screen, select PRINT METHOD. The printer must be turned on and enabled.
  • Page 75 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 75 P/N 70-9033 Operator’s Manual Operation Option Response Vessel Temp This option displays only when using paddles with a VK 7025. Start (VK 7025 You can program the test to begin automatically when the dissolution with Paddles) medium reaches a programmed temperature.
  • Page 76 Page 76 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Paddles Note Before starting the test, ensure DDM is enabled or disabled (see “Controlling Dosage Delivery Module (VK 7025 with Paddles only)” on page 87), paddle spin is enabled or disabled (see “Paddle Spin”...
  • Page 77 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 77 P/N 70-9033 Operator’s Manual Operation Step 2. If DDM is disabled and paddle spin or initial temp is enabled, press STOP to drop the dosage unit into non-rotating media. Manually drop a dosage unit into each vessel.
  • Page 78 Page 78 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Baskets Note If using baskets, ensure final temp is enabled or disabled. See “Sample Vessel Temp” on page 88. Step 1. From the Start Method screen, select INSTANT START. RAISE DRIVE TO INSTALL BASKETS PRESS RUN TO MOVE...
  • Page 79 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 79 P/N 70-9033 Operator’s Manual Operation Step 6. Continue the dissolution test according to the prescribed method. Two minutes after either the cannulas return to the home position or the final keystroke, the Test in Progress screen displays. Note To quit the test from the Test in Progress screen, press ESC once to return to the Method Status screen and a second time to quit...
  • Page 80 Page 80 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Step 3. Lift each vessel evaporation cover and manually drop the disk assembly into each vessel. Note If using the low-loss evaporation covers, press DRIVE UP to raise the drive unit slightly, lift each vessel evaporation cover, drop the disk assembly into each vessel, and press DRIVE DOWN until the drive unit is completely lowered.
  • Page 81 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 81 P/N 70-9033 Operator’s Manual Operation Step 4. Press RUN. displays and the drive unit lowers to the LOWERING DRIVE operating position. The Method Status screen displays and the cylinders rotate. Note To quit the test from the Method Status screen, press ESC and select EXIT.
  • Page 82 Page 82 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 If you press STOP / PAUSE, the Method Paused screen displays. The time paused and the current elapsed time display. Select EXIT to stop the current method. ABORTING displays and the screen returns to the Start Method screen.
  • Page 83 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 83 P/N 70-9033 Operator’s Manual Operation Vessel Temp Start Note For this option, if you enter a value outside of the acceptable range, an error message displays indicating appropriate values. If you are using paddles, DDMs, and an autosampler, you can program the instrument to start based on the dissolution medium reaching a specific temperature.

  • Page 84: Method Editor

    Page 84 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Method Editor From the Main Menu, select METHOD EDITOR. The Method Menu screen displays. You can view the method, but only those with appropriate security levels can change information in this section.
  • Page 85 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 85 P/N 70-9033 Operator’s Manual Operation Option Response Sampling Setup Use this option to enable or disable autosampling and set cannula down time, AutoTemp, volume, sample points, and sample point alarms. See “Sampling Setup” below. DDM Disabled (if This option indicates the status of the dosage delivery module.
  • Page 86 Page 86 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Option Response Volume Select VOLUME to enter the media volume. The cursor flashes. Enter a volume and press ENTER. The acceptable range is 500 to 1050 mL. Sample Points Select SAMPLE POINTS to toggle between .
  • Page 87 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 87 P/N 70-9033 Operator’s Manual Operation Step 4. Enter the desired timepoints and press ESC to return to the Sampling Setup screen. When all appropriate parameters have been entered on the Sampling Setup screen, press ESC to return to the Method Menu 1 screen.
  • Page 88 Page 88 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Step 5. Enter a delivery increment time in mm:ss format and press ENTER. The maximum acceptable value is 59:59. Step 6. Press ESC to return to the Method Menu 1 screen. When all the appropriate parameters have been entered on the Method Menu 1 screen, select MENU 2.
  • Page 89 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 89 P/N 70-9033 Operator’s Manual Operation select STORE METHOD and press ESC to go back further in the system, the following screen displays: USER: xxxxx CHANGES HAVE NOT BEEN STORED PRESS CONTINUE TO CONTINUE WITHOUT SAVING OR RETURN TO RETURN TO EDITOR...
  • Page 90 Page 90 VK 7025 Dissolution Apparatus Revision H, 11/10 Operation Operator’s Manual P/N 70-9033 Step 7. Press ESC again to return to the Main Menu. Storing Methods To save a new or modified method, complete the following steps: Step 1. From the Method Menu screen, select STORE METHOD to save the information.
  • Page 91 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 91 P/N 70-9033 Operator’s Manual Operation Following is a description of the Print Reports screen options: Note In order to operate any of the printer functions listed, the printer must be enabled. See “Report Printer On / Off” below. Option Response Print Method...
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  • Page 93: Fiber Optics

    Fiber Optics Chapter 6 Installing Fiber Optics To install and set the height for the fiber optic assemblies, complete the following steps: Step 1. Log into the VK 7025 as an administrator. Step 2. Clip the ferrule onto the fiber optic probe (see Figure 15, “Fiber Optic Assembly,”...

  • Page 94: Figure 16. Fiber Optic Assembly Setting

    Page 94 VK 7025 Dissolution Apparatus Revision H, 11/10 Fiber Optics Operator’s Manual P/N 70-9033 Step 3. Insert the fiber optic probe into the PEEK assembly housing. Step 4. Ensure the ferrule is positioned so once inside the assembly housing, the window is oriented away from the set screws.
  • Page 95 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 95 P/N 70-9033 Operator’s Manual Fiber Optics Step 7. Tighten the two set screws to lock the fiber optic probe in place (see Figure 16, “Fiber Optic Assembly Setting,” on page 94). Step 8.

  • Page 96: Figure 17. Fiber Optic Probe In Vessel

    Page 96 VK 7025 Dissolution Apparatus Revision H, 11/10 Fiber Optics Operator’s Manual P/N 70-9033 Step 14. To ensure the fiber optic probes are in their home position, select MOVE DOWN to move the fiber optic probes to their lowest position, then select MOVE UP to move the fiber optic probes to their highest position.

  • Page 97: Maintenance And Troubleshooting

    Maintenance and Chapter 7 Troubleshooting Maintenance Warning The dissolution apparatus contains electrical circuits, devices, and components operating at dangerous voltages. Contact with these circuits, devices, and components can cause death, serious injury, or painful electric shock. Periodic maintenance needs may vary depending on frequency of instrument usage. Daily Maintenance See “Paddle / Basket Shaft Care”...
  • Page 98 Page 98 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 thoroughly after use. If any stainless steel parts show signs of surface discoloration, lightly wipe the surface with a soft cloth or nonabrasive pad to remove it.

  • Page 99: Paddle / Basket Shaft Care

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 99 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting • It is recommended that the water bath temperature probe jack is checked for surface corrosion and wiped clean with a soft cloth or nonabrasive pad every one to three months.

  • Page 100: Basket Care

    Page 100 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 bump against each other. Place them back into the original styrofoam shipping container or other appropriate container between uses. This will prevent them from coming into contact with each other or anything else in the storage area.

  • Page 101: Water Bath / Acrylic Care

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 101 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Water Bath / Acrylic Care Note The following information pertains to any items, in addition to the water bath, made of acrylic. Caution Do not use cleaning compounds containing ammonia or abrasive cleaners on your water bath.

  • Page 102: Repairing Leaking Fittings

    Page 102 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 • Isopropyl alcohol: maximum 25% Repairing Leaking Fittings Complete these steps if any of your water bath fittings are leaking: Step 1. Turn off the heater / circulator and drain the water bath completely. Step 2.

  • Page 103: Removing The Top Cover

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 103 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Removing the Top Cover Caution Panels or covers that are retained by fasteners which require the use of a tool for removal may be opened only by Varian-trained, Varian-qualified, or Varian-authorized service engineers.

  • Page 104: Cleaning The Cannulas Using The Vk 8000 Clean System Function

    Page 104 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 Step 2. Remove the cannulas from the dissolution apparatus by pulling up the entire cannula assembly housing which contains the cannulas and, if applicable, the thermistor. Step 3.

  • Page 105: Figure 18. Cannula Cleaning Tray

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 105 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Step 4. Position the cannula cleaning tray on the vessel plate so the cannulas are centered above the containers. FIGURE 18. Cannula Cleaning Tray Step 5.

  • Page 106: Replacing The Flanges

    Page 106 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 Replacing the Flanges The tester is supplied with specially designed vessels and magnetic ring flanges. The magnetic ring flanges will keep the vessels centered at all times, without the use of tools, and prevent the vessels from “floating”...

  • Page 107: Report Center Impact Printer

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 107 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Step 2. To slide the upper and lower ring flanges off the old vessel, gently pull out and up until they clear the groove in the vessel. Step 3.

  • Page 108: Replacing The Paper Roll

    Page 108 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 Step 2. Four small grooves are embossed on the printer cover. Gently push on these grooves to tilt the cover. When the printer cover is tilted up, you can lift it off completely.
  • Page 109 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 109 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Step 4. Using scissors, cut the paper feeding to the printer and remove the paper roll. Step 5. Pull the remaining paper through the printer mechanism. Pull the paper from the front (paper cutter side).

  • Page 110: Toggling Your Printer Online

    Page 110 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 Toggling Your Printer Online Complete these steps to toggle your printer online: Step 1. Toggle the printer online by pressing the printer toggle switch to the OnLine / Off Line position.

  • Page 111: Printer Configuration

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 111 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Printer Configuration Note The printer configuration is set by the factory. This procedure should be performed only if the printer displays erroneous characters. Contact the Dissolution Systems Service Department for assistance, if necessary.
  • Page 112 Page 112 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 *** SETUP MENU*** CONFIGURE [NEXT/OK] Press NEXT to avoid configuration CUSTOM [NEXT/OK] Press OK to enter custom mode ***CUSTOM MENU*** PRINT CUSTOM SETUP [NEXT/OK] Press NEXT AUTO SEQ = NO [NEXT/OK]...

  • Page 113: Fuse Replacement

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 113 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting Fuse Replacement Warning The dissolution apparatus contains electrical circuits, devices, and components operating at dangerous voltages. Contact with these circuits, devices, and components can cause death, serious injury, or painful electric shock.

  • Page 114: Troubleshooting

    Page 114 VK 7025 Dissolution Apparatus Revision H, 11/10 Maintenance and Troubleshooting Operator’s Manual P/N 70-9033 Troubleshooting The Dissolution Systems Service Department can assist you if you experience problems or have questions concerning your dissolution apparatus. Many problems can be traced to simple sources and are easily solved.
  • Page 115 Revision H, 11/10 VK 7025 Dissolution Apparatus Page 115 P/N 70-9033 Operator’s Manual Maintenance and Troubleshooting If any of the listed problems persist, contact the Dissolution Systems Service Department. The Dissolution Systems Service Department can be reached at 800.229.1108 (inside the US) or 919.677.1108 (outside the US).
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  • Page 117: Service And Warranty

    Service and Chapter 8 Warranty The warranty is provided by Varian, Inc. or one of its authorized representatives. Service and Warranty Information Varian dissolution products carry a one-year warranty on parts and labor. The Dissolution Systems Service Department (or one of its representatives) will, at its option, either repair or replace any mechanical and electrical components in your instrument which prove to be defective.

  • Page 118: Exclusions And Limitations

    Page 118 VK 7025 Dissolution Apparatus Revision H, 11/10 Service and Warranty Operator’s Manual P/N 70-9033 Exclusions and Limitations Excluded from this warranty are expendable or consumable items such as, but not limited to, paddles, baskets, vessels, and acrylic water baths. Also excluded are defects from improper or inadequate maintenance by the customer, user-induced chemical action or contamination, unauthorized modification or misuse, and improper site preparation and maintenance.

  • Page 119: Exclusive Remedies

    Revision H, 11/10 VK 7025 Dissolution Apparatus Page 119 P/N 70-9033 Operator’s Manual Service and Warranty Exclusive Remedies The remedies provided herein are the customer’s sole and exclusive remedies. In no event shall Varian, Inc. or its representatives be liable for any direct, indirect, special, incidental, or consequential damages, whether based on contract, tort, or any other legal theory.
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  • Page 121: Index

    Index comm. port functions 56 conventions 17 acrylic care 101 copying methods 89 administration screen 47 administrative control 40 administrator operation 45 apparatus, selecting 61 delay start 74, 82 delayed heating, setting 72 deleting user ids 42 diagnostic menu 54 basket care 100 drive down key 18 basket height, setting 30...
  • Page 122 Index final sample vessel temp 88 final spin rpm 88 paddle care 99 fuse replacement 113 paddle height, setting 29 paddle installation 29 print method 74 print reports 90 hazards 9 printer configuration 111 self test 110 toggling online 110 initial sample vessel temp 88 installing fiber optics 93 installing paddle / basket shafts 28...
  • Page 123 Index temp set 61 temperature start 75, 83 top cover 103 unpacking your vk 7025 19 user list 41 user settings 45 using the vk 8000 clean system function 104 vessel installation 28, 106 vessel plate layout 43 vessel temperature start 83 volume, setting 61, 86 warranty 117 warranty limitations 118...
  • Page 124 Index This page was intentionally left blank, except for this message. Varian, Inc.

  • Page 125: Tell Us How We Are Doing

    Tell Us How We Are Doing We listen to our customers. We work hard to make our technical documentation user friendly, and to make the information in our manuals easy to retrieve and use. We’d like you to tell us the kinds of additional information you’d find helpful in our documentation.

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