Agilent Technologies 8000 Series User manual

Agilent Technologies
Agilent 8000
Dissolution Sampling
Station
Operator’s Manual

8000 Operator’s Manual
Notices
© Agilent Technologies, Inc. 2014
No part of this manual may be reproduced
in any form or by any means (including
electronic storage and retrieval or transla-
tion into a foreign language) without prior
agreement and written consent from Agi-
lent Technologies, Inc. as governed by
United States and international copyright
laws.
Manual Part Number
70-9060
Edition
Rev C, May 2014
Agilent Technologies, Inc.
3501 Stevens Creek Blvd.
Santa Clara, CA 95052 USA
Warranty
The material contained in this doc-
ument is provided “as is,” and is
subject to being changed, without
notice, in future editions. Further,
to the maximum extent permitted
by applicable law, Agilent disclaims
all warranties, either express or
implied, with regard to this manual
and any information contained
herein, including but not limited to
the implied warranties of mer-
chantability and fitness for a par-
ticular purpose. Agilent shall not be
liable for errors or for incidental or
consequential damages in connec-
tion with the furnishing, use, or
performance of this document or of
any information contained herein.
Should Agilent and the user have a
separate written agreement with
warranty terms covering the mate-
rial in this document that conflict
with these terms, the warranty
terms in the separate agreement
shall control.
Technology Licenses
The hardware and/or software described in
this document are furnished under a
license and may be used or copied only in
accordance with the terms of such license.
Restricted Rights Legend
U.S. Government Restricted Rights. Soft-
ware and technical data rights granted to
the federal government include only those
rights customarily provided to end user
customers. Agilent provides this custom-
ary commercial license in Software and
technical data pursuant to FAR 12.211
(Technical Data) and 12.212 (Computer
Software) and, for the Department of
Defense, DFARS 252.227-7015 (Techni-
cal Data - Commercial Items) and DFARS
227.7202-3 (Rights in Commercial Com-
puter Software or Computer Software
Documentation).
Safety Notices
CAUTION
A CAUTION notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly per-
formed or adhered to, could result
in damage to the product or loss
of important data. Do not proceed
beyond a CAUTION notice until
the indicated conditions are fully
understood and met.
WARNING
A WARNING notice denotes a
hazard. It calls attention to an
operating procedure, practice,
or the like that, if not correctly
performed or adhered to, could
result in personal injury or
death. Do not proceed beyond a
WARNING notice until the
indicated conditions are fully
understood and met.

8000 Operator’s Manual 3
Contents
Figures 7
Tab les 9
1Safety 11
Electrical Hazards 12
Warning 13
Caution 13
Note 13
Information Symbols 14
2 Introduction 15
8000 with Peristaltic Pump 17
Conventions Used in this Manual 17
Serial Number Format 18
3 Setting Up the 8000 19
Unpacking of 8000 and Components 20
Unpacking Your 8000 21
Unpacking / Setup of 8000 & Peristaltic Pump 22
Unpacking / Setup of 8000 & Syringe Pump 26
Unpacking / Setup of 8000, Syringe Pump, and Filter
Changer 29
Setup of 8000 and Components 34
Installing 8000 Full Flow Filters 34
Power and Network Connections 34
Installing the Sample Tray 36

48000 Operator’s Manual
Contents
Installing the Media Rinse Reservoir 36
Installing and Connecting the Autocalibration Block
(Peristaltic Pump only) 37
Installing the RM Module 38
Loading Filters (Filter Changer only) 40
Changing Filter Types (Filter Changer Only) 40
Hidden Key Functions 41
4 Operating the 8000 45
Operating the 8000 with Apparatus 1 / 2 46
8000 Keypad Options 46
8000 Menu Options - Apparatus 1 / 2 48
Creating a Sample Program 61
Starting a 8000 Program 66
Operating the 8000 with Apparatus 3 / 7 72
8000 Keypad Options 72
8000 with Apparatus 3 / 7 - Menu Options 74
Creating a Sample Program 86
Starting a Program 91
Manual Sample 95
Volumetric Calibration (Peristaltic Pump only) 97
Automatic Calibration 97
Manual Calibration 99
Checking the Calibration - Volume Accuracy 101
Daisy Chaining 102
Printer Operation and Communications 103
5 Maintenance and Troubleshooting 105
Preventive Maintenance 106
Clean System with Peristaltic Pump 106
Clean System Function with Syringe Pump 111

Contents
8000 Operator’s Manual 5
Syringe and Seal Replacement 112
Cleaning the Syringes 113
System Cleaning Procedure with Syringe Pump and Filter
Changer (optional) 115
Cleaning the Filter Changer Drip Tray 117
Cleaning the Media Replacement Pump 117
Report Center Impact Printer 119
Installing the Cartridge Ribbon 119
Replacing a Paper Roll 120
Toggling Your Printer Online 121
Printer Self Test 121
Printer Configuration 122
Obtaining Warranty and Other Services 123
Index 125

68000 Operator’s Manual
Contents
This page was intentionally left blank, except for this message.

8000 Operator’s Manual 7
Figures
Figure 1. Agilent 8000 Dissolution Sampling Station 21
Figure 2. Peristaltic Pump 22
Figure 3. Cable Connections for 8000, Peristaltic Pump, and VK
7000 / 7010 24
Figure 4. Resident Probe 25
Figure 5. 806 Syringe Pump 26
Figure 6. Cable Connections for 8000, Syringe Pump, and VK
7000 / 7010 27
Figure 7. Y Cable 5075-0446 and Adapter 5075-0852 28
Figure 8. 808 Filter Changer 30
Figure 9. Cable Connections for 8000, Syringe Pump, Filter
Changer, and VK 7000 / 7010 31
Figure 10. Y Cable 5075-0446 and Adapter 5075-0852 32
Figure 11. Resident Probe Housing and Sample Cannula 33
Figure 12. Internal Media Replacement Module 38
Figure 13. External Media Replacement Module 39
Figure 14. 8000 Keypad 46
Figure 15. 8000 Keypad 72
Figure 16. The Cleaning Process 108

88000 Operator’s Manual
Figures
This page was intentionally left blank, except for this message.

8000 Operator’s Manual 9
Tables
Table 1. Hidden Key Functions 41
Table 2. Front Panel Options (Apparatus 1 / 2) 47
Table 3. Main Menu Options (Apparatus 1 / 2) 49
Table 4. Set Clock and Alarms Options (Apparatus 1 / 2) 51
Table 5. Disso Parameters Options (Apparatus 1 / 2) 53
Table 6. Set Syringe Pump Parameters (Apparatus 1 / 2) 55
Table 7. Disso Control/Monitor Options (Apparatus 1 / 2) 57
Table 8. Manual Operations Options (Apparatus 1 / 2) 58
Table 9. Operate Syringe/Filter Changer Options (Apparatus 1 /
2) 59
Table 10. Program Variables Options (Apparatus 1 / 2) 62
Table 11. Select Start Mode Options (Apparatus 1 / 2) 68
Table 12. Disso Options (Apparatus 1 / 2) 69
Table 13. Select Disso Program Start Mode Options (Apparatus
1 / 2) 71
Table 14. Front Panel Options (Apparatus 3 / 7) 73
Table 15. Main Menu Options (Apparatus 3 / 7) 75
Table 16. Set Clock and Alarms Options 77
Table 17. Set App 3/7 Parameters Options (Apparatus 3 /
7) 79
Table 18. Set Syringe Pump Parameters Options (Apparatus 3 /
7) 81
Table 19. App 3/7 Control/Monitor Options 83
Table 20. Manual Operations (Apparatus 3 / 7) 84
Table 21. Operate Syringe/Filter Changer Options 85
Table 22. Program Variables Options (Apparatus 3 / 7) 88
Table 23. Select Start Mode Options (Apparatus 3 / 7) 93
Table 24. App 3/7 Options 94

10 8000 Operator’s Manual
Tables
Table 25. Manual Sampling Options 95
Table 26. Volume Accuracy Parameter Options 101
Table 27. Print Selections Options 104
Table 28. Program Auto Clean Variables 110
Table 29. Disso Parameters. 115
Table 30. Program Variables 116

11
Agilent Technologies
Agilent 8000 Dissolution Sampling Station
Operator’s Manual
1
Safety
Electrical Hazards 12
The Agilent 8000 has been designed and tested 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 Agilent 8000 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.

12 8000 Operator’s Manual
1Safety
Electrical Hazards
The 8000 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 Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers. Consult the
manuals or product labels supplied with the 8020 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.

Safety 1
8000 Operator’s Manual 13
Warning
WARNING
A ‘Warning’ message appears in the manual when failure to observe
instructions or precautions could result in death or injury.
Read all warnings and cautions carefully and observe them at all times.
Caution
CAUTION
A ‘Caution’ message appears in the manual when failure to observe
instructions could result in damage to equipment (Agilent supplied and /
or other associated equipment).
Note
NOTE
A ‘Note’ appears in the manual to give advice or information.

14 8000 Operator’s Manual
1Safety
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 specific equipment meets standards of
safety. These products are safe for use in the
workplace for North America.
Indicates that this product must not be disposed
of as unsorted municipal waste.
All Agilent 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 in
accordance with European Standard EN 50419.
For more information on collection, reuse, and
recycling systems, please contact your
local/regional waste administration, your local
distributor, or Agilent.
Indicates the product complies with regulatory
compliance requirements of New Zealand and
Australia.

15
Agilent Technologies
Agilent 8000 Dissolution Sampling Station
Operator’s Manual
2
Introduction
8000 with Peristaltic Pump 17
Conventions Used in this Manual 17
Serial Number Format 18

16 8000 Operator’s Manual
2 Introduction
The 8000 Dissolution Sampling Station provides an unattended solution
for automated sampling from a dissolution apparatus. The instrument
may be configured to control any instrument setup with a USP apparatus
1 (Baskets), 2 (Paddles), 3 (Reciprocating Cylinder), 5 (Paddle over
Disk), 6 (Rotating Cylinder), or 7 (Reciprocating Holder) offered by
Agilent Technologies, Inc. The firmware can store up to 15 different
sampling programs. Dissolution apparatus parameters are entered as
part of the 8000 program. These parameters are downloaded to the
dissolution apparatus when beginning a test with the 8000.
The 8000 fail-safe sample delivery uses either the 810 Peristaltic Pump
or 806 Syringe Pump optionally coupled with the automated 808 Filter
Changer. Hard-copy documentation is provided by the built-in Report
Center Printer which prints all essential parameters for proof of proper
operation and compliance with current GMPs.
The 8000 may be configured with a replacement media (RM) module
which replenishes any sample volume removed with fresh media.
Sample is delivered into test tubes or pre-capped HPLC autosampler
vials for direct transfer of samples to an HPLC system. Sample trays are
available in a variety of sizes to accommodate various sizes of vials or
test tubes.
The 8000 is automation ready. An RS232 port permits integration with
other automated systems. Sampling runs can be activated with an
external switch closure or TTL signal. The 8000 has a programmable
TTL output to control the instruments in the system.

Introduction 2
8000 Operator’s Manual 17
8000 with Peristaltic Pump
The 8000, when used in conjunction with the peristaltic pump, is
capable of performing unattended sampling from a dissolution
apparatus. All parameters of operation are controlled by the 8000.
Sampling is carried out automatically and takes into account all relevant
variables in the sample flow path such as tubing length, tension, and
diameter. The volume calibration may be performed manually or
automatically using an autocalibration block supplied with the unit.
Samples may be delivered into open test tubes or pre-capped
autosampler vials.
Conventions Used in this Manual
•Items you are asked to press are in bold. For example, “press H on
the keypad”.
•Key sequences you are asked to press appear like this: MENU >7.

18 8000 Operator’s Manual
2 Introduction
Serial Number Format
The serial number contains 10 characters and follows this syntax:
CC1234xxxx
Syntax Code Meaning Description
CC Country of origin 2 alpha characters matching the required trade designation for
the country of origin
12 Year of manufacture ‘09’ for 2009, ‘10’ for 2010, etc.
34 Week of manufacture ‘01’ for week 1 to ‘52’ for week 52

19
Agilent Technologies
Agilent 8000 Dissolution Sampling Station
Operator’s Manual
3
Setting Up the 8000
Unpacking of 8000 and Components 20
Setup of 8000 and Components 34
Hidden Key Functions 41

20 8000 Operator’s Manual
3 Setting Up the 8000
Unpacking of 8000 and Components
Check the contents for any damages due to shipping. The packaging
used to ship your equipment ensures that damage rarely occurs, but if it
does, contact both the carrier who delivered the instrument and the
Dissolution Systems Service Department. Though claims for damage
should be filed with the carrier, we will be glad to help you file a claim
and get you up and running as quickly as possible.
WARNING
For all configurations, ensure the equipment is configured for
the voltage supplied.
WARNING
The electrical connection at the back of the 8000 is the primary
disconnect for the instrument. The instrument should be
positioned to allow accessibility to the power cords for easy
disconnection.