Agilent Technologies Varian VK 7025 User manual

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

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.
All rights are reserved. Reproduction, adaptation, or translation without
prior written permission is prohibited, except as allowed under copyright
laws.
First Edition (November 2010)
VK 7025 Dissolution Apparatus Operator’s Manual
Part Number 70-9033 Revision H
Printed in the United States of America
The following terms are trademarks of Varian, Inc.:
Varian, Inc.
13000 Weston Parkway
Cary, North Carolina 27513-2250
800.229.1108
919.677.1108
Fax: [phone]
www.varianinc.com
Copyright (c) 2002 - 2010 by Varian, Inc.
• BenchsaverTM
• BIO-DIS III®
• Enhancer Cell®
• Full Flow FiltersTM
• Peak VesselTM
• Practical Solutions®
• QA and QAIITM
• TruCenterTM
• VanKel®
• VK®

Varian, Inc.
Table of Contents
Chapter 1 Safety Practices and Hazards 9
Electrical Hazards 10
Other 10
General 13
WEEE Directive 13
Chapter 2 Introduction 15
Conventions Used in this Manual 17
Quick Key Guide 18
Screen Saver 18
Chapter 3 Setup 19
Unpacking Your VK 7025 19
Setting Up the VK 7025 22
Raising and Lowering the Drive Unit 23

Table of Contents
Varian, Inc.
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
Centering Verification 34
Installing Cannula Assemblies 35
Installing Standard Evaporation Covers 36
Installing Basket / Low-loss Evaporation Covers 37
Setting the Manual Sampling Cannula 38
Programming Administrative Control 40
Security Levels 40
Setting Up the User List 41
Deleting Preset User Definitions 42
Vessel Plate Layout 43
Chapter 4 Administrator Operation 45
User Settings 45
Administration 47
Calibration 48
Bath Vessel Difference 48
Setting an Alternate Drive Unit Position 49
Cannula Height Calibration 50
Alarms 52
Calibration Calendar 53
Diagnostics 54
Menu 2 55
Setting the Clock 56
Setting Communication Port Functions 56
Setting Serial Numbers 57

Varian, Inc.
Table of Contents
Chapter 5 Operation 59
Main Menu 59
Manual Operation 60
Starting a Test 64
Paddles 65
Baskets 67
Paddle Over Disk 69
Rotating Cylinder 70
Setting Delayed Heating 72
Start Method 73
Method Editor 84
Chapter 6 Fiber Optics 93
Installing Fiber Optics 93
Chapter 7 Maintenance and Troubleshooting 97
Maintenance 97
Daily Maintenance 97
Paddle / Basket Shaft Care 99
Basket Care 100
Water Bath / Acrylic Care 101
Repairing Leaking Fittings 102
Removing the Top Cover 103
Replacing the Top Cover 103
Cleaning the Cannulas 103
Cleaning the Cannulas Using the VK 8000 Clean System
Function 104
Replacing the Flanges 106
Report Center Impact Printer 107
Installing the Cartridge Ribbon 107
Replacing the Paper Roll 108
Toggling Your Printer Online 110
Printer Self Test 110

Table of Contents
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Printer Configuration 111
Fuse Replacement 113
Troubleshooting 114
Chapter 8 Service and Warranty 117
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.
List of Figures
FIGURE 1. Lifting Straps 20
FIGURE 2. VK 7025 Lifting Guide 21
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. Standard Evaporation Cover 36
FIGURE 9. Evaporation Cover for Low Loss or Baskets 37

List of Figures
Varian, Inc.
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. Fiber Optic Assembly 93
FIGURE 16. Fiber Optic Assembly Setting 94
FIGURE 17. Fiber Optic Probe in Vessel 96
FIGURE 18. Cannula Cleaning Tray 105
FIGURE 19. TruCenter Vessel—exploded view 106

Varian, Inc.
Chapter 1 Safety Practices
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.
Operation of a VK 7025 involves the use of aqueous liquids and various pharmaceutical
dosage forms. Unskilled, improper, or careless use of this instrument can create shock
hazards, fire hazards, or other hazards which can cause death, serious injury to
personnel, or severe damage to equipment and property.
Information on safety practices is provided with your instrument and operation manuals.
Before using your instrument or accessories, you must thoroughly read these safety
practices.
Observe all relevant safety practices at all times.

Varian, Inc.
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. Consult the manuals or product labels supplied with the dissolution
apparatus to determine which parts are operator-accessible.
Application of the wrong supply voltage, connection of the instrument to an incorrectly
wired supply outlet, or lack of proper electrical grounding can create a fire hazard or a
potentially serious shock hazard and could seriously damage the instrument and any
attached ancillary equipment.
Always use a three-wire outlet with ground connection which is adequately rated for
the load. The installation must comply with local, state, and federal safety regulations.
Do not connect the instrument to the main power supply until you have made sure
that the operating voltage is correctly set for the main power supply in the specific
outlet in your laboratory to which the equipment will be connected.
Other
Other specific warnings and cautions appear in the manuals where appropriate and
detail the specific hazard, describe how to avoid it, and specify the possible
consequences of not heeding the warning or caution.
Warning
A ‘Warning’ message appears in the manual when failure to observe instructions or
precautions could result in death or injury. Symbols depicting the nature of the specific
hazard are also placed alongside warnings.

Varian, Inc.
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.
The meaning of the symbols that appear alongside warnings in this manual are as
follows:
Read all warnings and cautions carefully and observe them at all times.
Electrical shock
Pinch point
Caution
Refer to accompanying documents

Varian, Inc.
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’ appears in the manual to give advice or information.
Information Symbols
I
Switches main power on
0
Switches main power off
Indicates single-phase alternating current
Indicates the product complies with the requirements of one
or more European Union (EU) directives
Indicates that this product must not be disposed of as
unsorted municipal waste (see “WEEE Directive” on
page 13)

Varian, Inc.
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. has confirmed that each product complies with the relevant directives by
testing a prototype against the prescribed European Norm (EN) standards.
Proof that a product complies with the directives is indicated by:
• the CE marking appearing on the rear of the product.
• the documentation package that accompanies the product containing a copy of
the declaration of conformity. This declaration is the legal declaration by Varian,
Inc. that the product complies with the directives and also shows the EN standards
to which the product was tested to demonstrate compliance. The declaration of
conformity is signed by the representative of the manufacturing plant.
WEEE Directive
All Varian products that are subject to the WEEE directive shipped after August 13, 2005
are compliant with the WEEE marking requirements. Such products are marked with the
“crossed out wheelie bin” WEEE symbol shown on page 12 in accordance with European
Standard EN 50419.
This symbol on the product or on its packaging indicates that this product must not be
disposed of as unsorted municipal waste. The separate collection and recycling of your
waste equipment at the time of disposal will help to conserve natural resources and
ensure that it is recycled in a manner that protects human health and the environment.
For more information on collection, reuse, and recycling systems, please contact your
local/regional waste administration, your local distributor, or Varian, Inc.

Varian, Inc.
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Safety Practices and Hazards Operator’s Manual P/N 70-9033
This page was intentionally left blank, except for this message.

Varian, Inc.
Chapter 2 Introduction
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. In order to allow clear access to the vessels, the drive
unit slides back rather than continuing to move upwards. This compact design has the
evaporation covers attached to the spindle housings on the drive unit and offers
convenient access to the mechanics of the system through a hinged top cover.
The front panel displays the Method Status screen during a run, providing full information
on spindle speed, elapsed time, temperature and more. Most operating parameters are
programmable including spindle speed, test length, bath temperature, and test start
times.
The built-in Report Center Printer provides a complete report, either at pre-programmed
time intervals or on demand, of several important test parameters. Printouts are on plain
paper which will not fade or discolor over time or with exposure to chemical fumes.

Page 16 VK 7025 Dissolution Apparatus Revision H, 11/10
Introduction Operator’s Manual P/N 70-9033
Varian, Inc.
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)
• TruCenter Vessels, 1000 mL, with upper and lower magnetic ring flanges
• Standard evaporation covers
• Complete set of alignment tools to ensure full USP compliance
• Built-in Report Center Printer
• Sampling cannulas
• Dosage Delivery Module (DDM)
• AutoTemp Vessel Temperature Sensing System
These features are optional on the VK 7025:
• Individual clutches
• Fiber optic probes
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.
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.

Revision H, 11/10 VK 7025 Dissolution Apparatus Page 17
P/N 70-9033 Operator’s Manual Introduction
Varian, Inc.
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”.
• To perform functions that require making selections from the display screen, for
example, “select MANUAL OPERATION” means to press the key to the left or
right of MANUAL OPERATION.
• Key sequences you are asked to press appear like this: 0> ENTER.
Note
Remember to return the warranty card supplied with this
manual. Completing and returning the card ensures your right to
protection under the terms and conditions of your warranty. It
also enables us to better assist you in the event of any
problems. Additionally, it guarantees you will be informed of any
issues that arise concerning your equipment, such as upgrades,
retrofits, or regulatory changes.

Page 18 VK 7025 Dissolution Apparatus Revision H, 11/10
Introduction Operator’s Manual P/N 70-9033
Varian, Inc.
Quick Key Guide
Screen Saver
The VK 7020 / 7020 S / 7025 screen saver initiates after 30 minutes of inactivity and no
program running. Press any key to reactivate the dissolution apparatus.
If security has been disabled, the last screen displays.
If security has been enabled, a screen requesting the current user’s password displays.
Enter the password and press ENTER. The last screen displays.
ESC 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.
STOP / PAUSE Press STOP / PAUSE to pause or abort the present program.
RUN To manually begin operations that were not programmed to delay
start, press RUN.
CLEAR Press CLEAR to instantly clear an entry.
DRIVE UP Press DRIVE UP to raise the drive unit. The drive unit
automatically rises to the home position unless another key is
pressed. Pressing DRIVE UP or DRIVE DOWN stops the upward
movement of the drive unit.
DRIVE DOWN Press and hold DRIVE DOWN to lower the drive unit. Release
the key when the drive unit is in the appropriate position.

Varian, Inc.
Chapter 3 Setup
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. Open the carton and check the contents for damage which may have
occurred during shipping. Shipping damage rarely occurs, but if it does
contact both the carrier who delivered the instruments and the
Dissolution Systems Service Department. Though claims for damage
should be filed with the carrier, we can help you file a claim.

Page 20 VK 7025 Dissolution Apparatus Revision H, 11/10
Setup Operator’s Manual P/N 70-9033
Varian, Inc.
Step 2. Remove all packing from the dissolution apparatus.
Step 3. There are four lifting straps included with the dissolution apparatus. One
is positioned around each of the four legs.
Step 4. Place the straps around your wrist as indicated in Figure 1, “Lifting
Straps,” below.
FIGURE 1. Lifting Straps
Step 5. Use the lifting straps to lift the dissolution apparatus off of the packing
platform. Place the dissolution apparatus on the ground.
Warning
The VK 7025 weighs approximately 200 pounds and therefore
requires special handling.
Warning
Because of its heavy weight, two people should lift the tester. Do
not lift the tester by the drive unit. Lift by holding the base plate.