Agilent Technologies 8000 Operator's Manual
Agilent 8000
Dissolution Sampling
Station
Operator’s Manual
Agilent Technologies
Notices
CAUTION
WARNING
© 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 translation into a foreign language) without prior
agreement and written consent from Agilent 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 document is provided “as is,” and is
subject to being changed, without
notice, in future editions. Further,
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Safety Notices
A CAUTION 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 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.
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
Contents
Figures 7
Tab le s 9
1Safety 11
Electrical Hazards 12
Warni ng 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
8000 Operator’s Manual 3
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
4 8000 Operator’s Manual
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
Contents
8000 Operator’s Manual 5
Contents
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6 8000 Operator’s Manual
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
8000 Operator’s Manual 7
Figures
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8 8000 Operator’s Manual
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
8000 Operator’s Manual 9
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
10 8000 Operator’s Manual
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.
Agilent Technologies
11
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.
12 8000 Operator’s Manual
Warning
WARNING
CAUTION
NOTE
Caution
Safety 1
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.
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).
8000 Operator’s Manual 13
Note
A ‘Note’ appears in the manual to give advice or information.
1Safety
Information Symbols
I
0
Switches main power on
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.
14 8000 Operator’s Manual
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
Agilent Technologies
15
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.
16 8000 Operator’s Manual
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.
Introduction 2
8000 Operator’s Manual 17
2 Introduction
Serial Number Format
Syntax Code Meaning Description
CC Country of origin 2 alpha characters matching the required trade designation for
12 Year of manufacture ‘09’ for 2009, ‘10’ for 2010, etc.
34 Week of manufacture ‘01’ for week 1 to ‘52’ for week 52
The serial number contains 10 characters and follows this syntax:
CC1234xxxx
the country of origin
18 8000 Operator’s Manual
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
Agilent Technologies
19
3 Setting Up the 8000
WARNING
WARNING
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.
For all configurations, ensure the equipment is configured for
the voltage supplied.
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.
20 8000 Operator’s Manual
Unpacking Your 8000
WARNING
Figure 1 Agilent 8000 Dissolution Sampling Station
Setting Up the 8000 3
8000 Operator’s Manual 21
The 8000 is shipped in foam-filled cartons. The number of cartons may
vary depending on your configuration.
1 Carefully remove the 8000 and accessory kit(s) from their shipping
cartons. Remove all cushioning material and tape.
2 Place the 8000 on a clear, dry, level section of the bench top close to
the dissolution apparatus. The preferred placement of the 8000 is on
the right side of the dissolution apparatus.
Unscrew and remove the two clamps which secured the 8000
dispensing arm during shipping. These clamps are located on
both sides of the right dispensing support arm where it connects
to the 8000 main body. Failure to remove the two clamps prior to
powering up the 8000 may damage the unit.
3 Setting Up the 8000
Unpacking / Setup of 8000 & Peristaltic Pump
Environmental Requirements for Peristaltic Pump
Installation
• Altitude: max 2000m;
• Humidity: max relative humidity 80% for temperatures up to 31 ºC
decreasing linearly to 50% relative humidity at 40 ºC
• Indoor use only
• Temperature: 5 ºC to 40 ºC
• Main supply voltage fluctuations are not to exceed ± 10% of the
nominal supply voltage
• Operating conditions: 3 mins ON Max; 5 mins OFF Min
Figure 2 Peristaltic Pump
Installation
1 Carefully remove the peristaltic pump from its shipping carton.
Remove all cushioning and tape.
2 Place the peristaltic pump on a clear, dry, level section of the bench
top between the 8000 and the dissolution apparatus.
3 Remove the two screws on top of the pump. Lift off the plastic cover
and set it aside.
4 Remove the cartridges from the pump by pressing down the levers on
the right side. Lift the cartridges up and away from the pump.
22 8000 Operator’s Manual
Setting Up the 8000 3
NOTE
NOTE
WARNING
5 Loosely fit the peristaltic pump tubing along the inside groove of the
first cartridge, locking the tubing clips on the outside notches.
Ensure that all pump cartridges are installed. It is not necessary to install
tubing on any unused positions.
6 Refit the cartridge to the pump by hooking the clip on the bottom left
of the cartridge into the groove on the left side of the pump.
7 Push down the right side of the cartridge, ensuring that the tubing
remains under the cartridge, and pull up the lever to lock the
cartridge in place. If desired, trim the excess tubing to within one
inch of the tubing clips.
The cover does not fit unless the cartridges are positioned with the
levers on the right side.
8 Repeat Steps 5 - 7 for each remaining cartridge.
9 Refit the cover and replace the two screws. If the cover is not
replaced correctly, the pump will not operate.
8000 Operator’s Manual 23
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.
10 Refer to the following example diagram to correctly make cable
connections for the 8000, peristaltic pump, and dissolution
3 Setting Up the 8000
apparatus:
Figure 3 Cable Connections for 8000, Peristaltic Pump, and VK
7000 / 7010
11 Connect the five-pin cable (#2, P/N 5075-0033) between the jack on
the 8000 rear panel labeled PUMP and the jack on the peristaltic
pump rear panel labeled PUMP CONTROL.
12 If the system configuration includes the 705-DS, connect the 9-to-25
pin cable to the RS232 port on the dissolution apparatus and the
RS232 COMPUTER port on the 8000 rear panel.
Otherwise, connect the RS232 cable (#1, P/N 5075-0042) between
the RS232 port on the dissolution apparatus and the RS232
COMPUTER port on the 8000 rear panel.
24 8000 Operator’s Manual
Setting Up the 8000 3
NOTE
sample cannula
resident probe housing
13 The 8000 is shipped with all sample tubing attached to the valves
inside the dispensing arm.
Do not remove the nylon tie wraps securing the tubing into bundles.
The direction of the peristaltic pump can be set via a switch on its rear
panel. It does not matter at this point to which side the bundles go, as
long as all lines in the bundle from the sampling cannulas are connected
to one side, and all lines in the bundle from the valve inlets to the other.
14 If your system configuration includes the 705-DS, connect the
resident probes (see Figure below) to the tubing and attach the lines
to the tubing on one side of the appropriate peristaltic pump
cartridges.
Otherwise, connect the tubing from the dissolution apparatus sample
cannulas to the tubing on one side of the appropriate peristaltic pump
cartridges.
8000 Operator’s Manual 25
Figure 4 Resident Probe
15 Connect another length of tubing between the remaining side of the
peristaltic pump cartridges and the tubing coming from the left
positions of the 8000 solenoid valves. Ensure each cartridge has
identical color tubing connected at both the inlet and the outlet.
3 Setting Up the 8000
WARNING
Unpacking / Setup of 8000 & Syringe Pump
16 Connect the remaining length of tubing coming from the top
positions of the 8000 solenoid valves to the return lines on the
dissolution apparatus. Ensure each line is attached to its identical
color.
Do not tighten the plastic fittings on the ends of the tubing more
than half a turn past finger-tight. Overtightening will damage
the fittings.
17 For a system that includes a 705-DS, connect the return lines to the
return cannulas of the resident probes.
26 8000 Operator’s Manual
Figure 5 806 Syringe Pump
The syringe pump is shipped in individual packaging.
1 Carefully lift the unit out of the box.
2 Remove any cushioning material.
Setting Up the 8000 3
3 Place the 806 Syringe Pump on a clean, dry, level section of the
bench top between the 8000 and the dissolution apparatus.
4 Refer to the following example diagram to correctly make cable
connections for the 8000, syringe pump, and dissolution apparatus:
Figure 6 Cable Connections for 8000, Syringe Pump, and VK 7000 /
7010
5 Connect the single end of the Y cable (#1, P/N 5075-0446) to the
RS232 port on the syringe pump.
6 Connect an RS232 cable (#2, P/N 5075-0252) between the RS232
COMPUTER port on the 8000 and one extension of the Y cable
attached to the syringe pump.
7 If the system configuration includes the 705-DS, connect a
9-to-9-pin cable (P/N 5075-0448) from the RS232 port on the
dissolution apparatus rear panel to the remaining extension of the Y
cable attached to the syringe pump.
Otherwise, connect a second RS232 cable (#2, P/N 5075-0252)
between the remaining extension of the Y cable attached to the
syringe pump and the RS232 port on the dissolution apparatus.
8000 Operator’s Manual 27
3 Setting Up the 8000
NOTE
8 A system configuration that includes a non-Agilent dissolution
apparatus, requires use of an adapter (P/N 5075-0852, see following
Figure). This adapter should be attached to the #2 port of the Y-cable
in place of the cable connected to the dissolution apparatus.
Figure 7 Y Cable 5075-0446 and Adapter 5075-0852
28 8000 Operator’s Manual
9 The 8000 is shipped with all sample tubing attached to the valves
inside the dispensing arm.
Do not remove the nylon tie wraps securing the tubing into bundles.
10 If the system configuration includes the 705-DS, connect the resident
probes to the sample tubing and attach the lines to the left port
(labeled IN) of each syringe starting with Position 1.
Otherwise, connect the tubing from the dissolution apparatus
sampling cannulas to the left port (labeled IN) of each syringe
starting with Position 1.
11 Connect a separate length of tubing between the right port (labeled
OUT) of each syringe to the tubing coming from the left positions of
Setting Up the 8000 3
WARNING
the 8000 solenoid valves. Ensure each line is attached to its identical
color.
12 Connect the remaining length of tubing from the top positions of the
8000 solenoid valves to the return lines on the dissolution apparatus.
Ensure each line is attached to its identical color.
Do not tighten the plastic fittings on the ends of the tubing more
than half a turn past finger-tight. Overtightening will damage
the fittings.
13 If the system configuration includes the 705-DS, connect the return
lines to the return cannulas of the resident probes.
Unpacking / Setup of 8000, Syringe Pump, and Filter Changer
Environmental Requirements for Filter Changer Installation
• Altitude max.2000m;
• Humidity max relative humidity 80% for temperatures up to 31 ºC
decreasing linearly to 50% relative humidity at 40ºC;
• Indoor use only
• Temperature: 5 ºC to 40 ºC;
• Mains supply voltage fluctuations are not to exceed ± 10% of the
nominal supply voltage.
• Operating conditions 8 mins ON Max; 5 mins OFF min
8000 Operator’s Manual 29
3 Setting Up the 8000
Installation
Figure 8 808 Filter Changer
30 8000 Operator’s Manual
The filter changer is shipped in individual packaging.
1 Carefully lift the unit out of the box.
2 Remove any cushioning material.
3 Place the unit on a clear, dry, level section of the bench top between
the 8000 and the syringe pump.
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