Agilent Technologies 850-DS Dissolution Sampling Station Operator’s Manual
Below you will find brief information for Dissolution Sampling Station 850-DS. This device allows you to collect samples from a dissolution apparatus. It offers both manual and method control modes, giving you flexibility in your sampling process. The 850-DS can store methods and execute them automatically. You can define multiple timepoints for sample collection within a method, and the device can handle various sample holders, including test tubes, vials, and well plates. For accurate and efficient sample collection, consider using the Agilent 850-DS.
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850-DS
Dissolution Sampling
Station
Operator’s Manual
Agilent Technologies
Notices
© Agilent Technologies, Inc. 2016
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
70-9074
Edition
Rev C, February 2016
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, 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 merchantability and fitness for a particular purpose. Agilent shall not be liable for errors or for incidental or consequential damages in connection 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 material 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. Software and technical data rights granted to the federal government include only those rights customarily provided to end user customers. Agilent provides this customary 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 (Technical Data - Commercial Items) and DFARS
227.7202-3 (Rights in Commercial Computer 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 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.
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.
850-DS Operator’s Manual
Contents
850-DS Operator’s Manual
Figures
1 Safety
9
10
11
12
2 Introduction
15
3 Setting Up the 850-DS
17
18
Equipment Ratings / Environmental Requirements for
Equipment, Parts, and Accessories As Shipped
21
21
24
25
Updating 850-DS Language Screens 26
3
Contents
4
28
Changing Trays / Needle Replacement 29
4 Operating the 850-DS
32
39
Method Properties (Apparatus 1/2/5/6) 40
Sample Collection Parameters (Apparatus 1/2/5/6) 42
Method Properties (Apparatus 3/7) 45
48
Timepoint Parameter Entry (Apparatus 1/2/5/6)
49
Timepoint Parameter Entry (Apparatus 3/7)
50
850-DS Method Transfer (to another 850-DS) 56
58
62
Diagnostic Screen 4 (Apparatus 1/2/5/6)
69
Diagnostic Screen 4 (Apparatus 3/7) 71
72
Instrument Settings Screen 2 74
78
850-DS Operator’s Manual
850-DS Operator’s Manual
82
84
5 Maintenance and Troubleshooting
89
91
Removing a Thermal Paper Roll 91
Inserting a Thermal Paper Roll 94
Obtaining Warranty and Other Services 98
Contents
5
Contents
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6 850-DS Operator’s Manual
Figures
850-DS Operator’s Manual
Figure 1. 850-DS Tubing Connections 22
Figure 2. Filter Module and Filter Plates
28
32
Figure 4. Startup Screen with Error
33
Figure 5. Main Screen in Idle Mode 35
Figure 6. Main Screen with 2 mL Vial, 54-position Blocks
35
Figure 7. Main Screen with 96-position Microtiter Plates
36
Figure 8. Main Screen with 2 mL, 100-position HPLC Tray
36
Figure 9. Main Screen with BIO-DIS (Apparatus 3) 37
Figure 10. Method Properties Screen
39
Figure 11. Instrument Parameters
40
Figure 12. Sample Collection Parameters - Screen 1 42
Figure 13. Sample Collection Parameters - Screen 2 44
Figure 14. Sample Collection Parameters (Apparatus 3/7) 45
Figure 15. Prefill Tubes / Vials Apparatus 3 / 7 47
Figure 16. Timepoint Number Selection (Apparatus
Figure 17. Timepoint Number Selection (Apparatus 3/7) 48
Figure 18. Timepoint Properties Screen (Apparatus
Figure 19. Timepoint Properties Screen (Apparatus 3/7)
50
Figure 20. Selecting a Method (Apparatus 1/2/5/6) 51
Figure 21. Method Start Parameters 52
Figure 22. Run Method Screen 3
54
Figure 23. Run Method Screen 4
55
Figure 24. Run Method Screen 5
55
7
Figures
8
56
57
58
59
Figure 29. Cleaning Parameters Screen 62
Figure 30. Diagnostics Screen 1
64
Figure 31. Diagnostics Screen 2
66
Figure 32. Diagnostics Screen 3
67
Figure 33. Diagnostics Screen 4 (Apparatus 1/2/5/6) 69
Figure 34. Diagnostics Screen 4 (Apparatus 3/7)
71
Figure 35. Instrument Settings Screen 1
72
Figure 36. Vessel Assignment Screen
74
Figure 37. Instrument Settings Screen 2
74
Figure 38. Touch Screen Calibration Screen
76
Figure 39. Date and Time Change Screen 77
78
79
80
Figure 43. Near-empty Paper Roll 91
Figure 44. Accessing the Printer Handle 92
Figure 45. Open Printer Chamber
92
Figure 46. Removing the Thermal Paper Roll
93
Figure 47. Inserting a Thermal New Paper Roll 94
Figure 48. Leading Paper and Closing the Lid
95
Figure 49. Closing the Printer Chamber
95
97
850-DS Operator’s Manual
850-DS Dissolution Sampling Station
Operator’s Manual
1
Safety
Agilent Technologies
9
1 Safety
The Agilent 850-DS Dissolution Sampling Station 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 850-DS 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.
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 Agilent-trained,
Agilent-qualified, or Agilent-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.
10 850-DS Operator’s Manual
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
Safety 1
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.
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.
850-DS Operator’s Manual 11
1 Safety
12
Information Symbols
A depressed power button in the front of the unit
(with green light) indicates main power on.
An extended power button in the front of the unit
(with green light off) indicates 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.
850-DS Operator’s Manual
850-DS Dissolution Sampling Station
Operator’s Manual
2
Introduction
Agilent Technologies
13
2 Introduction
CAUTION
The 850-DS allows you to autonomously collect samples from a dissolution apparatus. Samples may be collected into various sample holders including 15 mL test tubes, 2 mL vials, and 2 mL well plates.
The vials and well plates may be conveniently placed on a sample tray that is compatible with Agilent HPLC autosamplers.
The 850-DS provides two basic modes of collecting samples from a dissolution apparatus; manual control and method control. Manual control provides full control of the instrument through the Diagnostics screens. You can independently control all the features of the instrument.
In manual control as it is possible to pump volumes greater than those that the sample vessels may hold.
Method control allows you to enter all the parameters relevant to a sample collection; prime, sample, and purge volumes, sample collection times, and self cleaning. If using an Agilent dissolution apparatus, then the 850-DS will fully control the dissolution apparatus through a serial interface.
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 Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers
14 850-DS Operator’s Manual
Introduction 2
Serial Number Format
The serial number contains 10 characters and follows this syntax:
CC 12 34 xxxx
Syntax Code Meaning
CC
12
34
Country of origin
Description
2 alpha characters matching the required trade designation for the country of origin
Year of manufacture ‘09’ for 2009, ‘10’ for 2010, etc.
Week of manufacture ‘01’ for week 1 to ‘52’ for week 52
850-DS Operator’s Manual 15
2 Introduction
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16 850-DS Operator’s Manual
850-DS Dissolution Sampling Station
Operator’s Manual
3
Setting Up the 850-DS
Equipment, Parts, and Accessories As Shipped 21
Changing Trays / Needle Replacement 29
Agilent Technologies
17
3 Setting Up the 850-DS
Initial Setup
Complete the following sections to initially set up the Agilent 850-DS and all other system components.
1 Prepare an area next to a dissolution apparatus where the Agilent
850-DS will be placed. The preferred location is on the right side of the dissolution apparatus.
Height
Width
Depth
40 cm (60 cm with Filter Module)
39.0 cm (48.0 cm with filter waste bin)
60.0 cm
2 Remove the Agilent 850-DS and all other system components from the packing material and place on a bench or table.
3 Inspect the equipment and accessories to ensure there has been no damage during shipment.
4 Orient the Agilent 850-DS and all other system components appropriately.
18 850-DS Operator’s Manual
Setting Up the 850-DS 3
Equipment Ratings / Environmental Requirements for
Installation
• Electrical Supply: 100-240 V˜ ±10%, 50/60 Hz, max. 2 A
• Temperature: 5 ºC to 40 ºC
• Humidity: max relative humidity 80% for temperatures up to 31 ºC decreasing linearly to 50% relative humidity at 40ºC
• Altitude: 2000 m
• Pollution Degree: 2
• Installation Category: II
• Indoor use only
850-DS Operator’s Manual 19
3 Setting Up the 850-DS
Specification
Parameter
Operating Environment
Specification
5 to 40 °C
Humidity (non-condensing)
Not more than 80% RH
Power requirements
Voltage: 90-250 V, 50-60 Hz
Current: 2.5-1.0 A
Dimensions
Height: 40.0 cm
Height with filter module: 60 cm
Width: 39.0 cm
Width with filter waste bin: 48.0 cm
Depth: 60.0 cm
Weight
Interface
27 kg
7” color touchscreen (English, Simplified Chinese, Spanish, Japanese,
German, Hungarian, Portuguese, Russian) or PC controlled
Pumping system and speed
Sampling accuracy
Rotary piston syringe pump, 8 syringes with adjustable 6-12 mL/min.
2.5% *
Sample volume per vial/tube
0.1-14 mL
(up to 28 mL with dual sample)
Sample frequency
Minimum of 2 minutes (under certain conditions)
Number of samples per test
Up to 36 (with manual tray exchange after every 12 samples)
Maximum run time
999 hours
* The Sampling Accuracy specification is derived for the following conditions: 10 mL volume, DI H2O, 10 mL/min pump speed and
3-second Aspiration Dwell Time. This percentage may change based on the sampling parameters or volume, product formulation and type of dissolution media or when in line filters are used (depending on the porosity and membrane type).
20 850-DS Operator’s Manual
Setting Up the 850-DS 3
Equipment, Parts, and Accessories As Shipped
Parts and Accessories
Locate the following items, as applicable, for your system configuration:
Base Unit Components
Part Number
G7930-64000
K1005-02066
K3090-00155
3090-0160
33-9019
K1003-00232
K1003-00233
K1003-00234
K1003-00235
1150-7997
17-5001
5075-0042
77-0001
Power cord
1
1
1
1
1
1
1
3
1
7
8
Quantity Description
1
1
850-DS base unit
Rack for 15mL test tubes
1/4-28 Male to 1/8" barb fitting
1/4-28 Male to 1/4-28 Male tubing adapter
25’ of 1/8" silicone tubing
2.5mm Hex key
1
3mm Hex key
1/4" slotted screwdriver
#1 Phillips screwdriver
Stylus for touchscreen
Box of 100 15mL test tubes
DB25 communications cable
Safety Manual and Technical Documentation
CD
Country-specific power cord
Optional Accessory Kits
Part Number
K1005-05187
G7931A
K1001-01202
K1001-01203
K1001-01204
K1005-05212
1
1
1
1
1
Quantity Description
1 850-DS printer kit
850-DS filtration module
Kit for 2, 54-position LC trays, 2mL vials
Kit for 100-position LC tray, 2mL vials
Kit for well plate LC tray, 2 mL x 96 wells
Sample tray for 2mL vials (8 x 12)
850-DS Operator’s Manual 21
3 Setting Up the 850-DS
Connections
Complete the following sections to connect the necessary tubing and cables for the Agilent 850-DS.
Figure 1
850-DS Tubing Connections
22 850-DS Operator’s Manual
Setting Up the 850-DS 3
Tubing
CAUTION
1 Connect the three 1/4-28 male to 1/8" barb fittings to the three ports on the left side, nearest the rear of the instrument.
2 Using a length of 1/4" silicone tubing, connect the waste fitting to a suitable waste collection container. If media replacement will be used, use a length of 1/4" silicone tubing to connect to a suitable media container. The media must be kept at a suitable temperature by a device provided by the user. If the self-cleaning function will be used, use a length of 1/4" silicone tubing to connect to a suitable rinse media container.
Ensure that the waste connection is not capable of siphoning back into the instrument. The inlet tubing must never fall below the level of waste in the container.
The media bottles should be located at the same bench level as the
850-DS or lower.
NOTE
3 Connect up to 8 sample lines from a dissolution apparatus to the input connections on the left side of the Agilent 850-DS.
4 Connect up to 8 return lines from a dissolution apparatus to the output connections on the left side of the Agilent 850-DS. If applicable, connect the male-to-male tubing adapters to the fittings separately; then, attach the return tubing lines. This will prevent possible damage caused by excessive twisting of the tubing.
If connecting a dissolution apparatus using less than 8 positions, attach a barb fitting to the inlet and outlet ports of the unused positions. Cut appropriate lengths of silicone tubing and attach them to each barb fitting and route the tubing to an appropriate waste container.
850-DS Operator’s Manual 23
3 Setting Up the 850-DS
Power Cord
CAUTION
Ensure the correct voltage has been supplied prior to connecting the power cables.
1 Attach the provided power cord to the back of the instrument.
2 Plug the cord into an electrical outlet of suitable voltage.
Apparatus Control Cable
If connecting to an Agilent, Varian or VanKel dissolution apparatus, connect the DB25 communications cable from the RS232 port on the right rear of the Agilent 850-DS to the 25-pin port on the rear of the dissolution apparatus.
For 850-DS setup with an online UV Dissolution system refer the
Operator’s Manual or the help system in the software for the applicable system.
Synchronized Start
To utilize the Synchronized Start feature of the 850-DS, connect a 9-9 pin null modem cable (5075-0449) from the AUX RS-232 port of one
850-DS to another 850-DS. The desired method may be initiated on both units by pressing Synchronized Start on the Start Options screen.
24
Initial Power Up
1 Make sure there are no obstructions inside the sample tray area of the
Agilent 850-DS
2 Make sure the door is fully closed.
3 Turn on power using the front panel power switch. The unit will execute a self test and initialization.
850-DS Operator’s Manual
Setting Up the 850-DS 3
NOTE
4 Verify the unit passed the initialization and is at the Main screen.
Before operating the Agilent 850-DS, a sample collection tray with suitable test tubes, vials or well plates must be inserted. Failure to do so may cause liquids to be pumped into the base of the unit.
Sample Tray Installation
1 From the 850-DS main screen, press Eject to eject the sample tray platform. The sample tray platform moves to the front of the 850-DS.
The movement forward will pause and the unit will beep to alert the user that the tray platform will extend outside the unit.
2 Load the 12 x 8 sample tray (for 16 x 100 mm test tubes) onto the platform.
3 Press Eject. The sample tray platform retracts the sample tray to the home position in the 850-DS.
850-DS Operator’s Manual 25
3 Setting Up the 850-DS
Updating 850-DS Language Screens
NOTE
The 850-DS firmware can support several languages including:
• English
• Simplified Chinese
• Spanish
• Japanese
• German
• Hungarian
• Portuguese
• Russian
English is the default language setting. To update the language, the file containing the new screens should be placed on an appropriate SD card.
The SD card slot on the front right side, just in front of the printer if installed, is used to update the screens. Contact your Agilent representative to obtain the necessary files.
Copying files to the SD card
You must use a 2GB or smaller SD card formatted as FAT16 or FAT32 to complete this procedure.
Copy the files listed below containing the desired language screens from the PC to the SD card. No additional files may be on the SD card.
• Config.ini
• Flash2.ini
• SLCD-850.BIN
26 850-DS Operator’s Manual
Setting Up the 850-DS 3
Downloading screens to the 850-DS firmware
1 Power off the 850-DS.
2 Insert the SD card in the slot at the right front of the instrument and press the card in fully. You may feel a click as the card seats completely.
3 Power on the 850-DS and wait approximately 2 minutes for the images to automatically load. When complete, one of the Main screen images will display on the screen.
4 Power off the 850-DS, wait 30 seconds, and then power it on again.
The update is now complete and the 850-DS should start normally.
850-DS Operator’s Manual 27
3 Setting Up the 850-DS
Optional Filter Module
NOTE
The 850-DS Filter Module should only be installed by a certified
Agilent representative.
28
Figure 2
Filter Module and Filter Plates
The Agilent 850-DS Dissolution Sampling Station can be optionally equipped with a filtering option that greatly improves dissolution sample processing through the use of specifically designed filter plates.
The plates are consistent with filtration membranes and housing materials currently used for dissolution sampling. They are manufactured and sold by GE-Whatman specifically for use with the
Agilent 850-DS. Each plate contains eight disks incorporated on a flat cartridge. The compact arrangement of the filter disks on the plate also make it much easier for the automated equipment to process and filter samples over traditional automation-ready filters.
The Filter Module, when installed, may be easily disabled if not required for all dissolution methods. Media replacement may also be used with the Filter Module installed.
850-DS Operator’s Manual
Setting Up the 850-DS 3
Changing Trays / Needle Replacement
The 850-DS can support various sample tray configurations. The standard needle block can support two trays - for test tube or HPLC vial sample collection. Other alternative sample trays including Agilent
HPLC sample trays and 96-well plates are also compatible. Use of these trays requires a modification to the needle block assembly of the
850-DS. This conversion should only be performed by qualified Agilent personnel. These sample tray kits are meant to be installed for extended use and are not designed for frequent exchanges.
850-DS Operator’s Manual 29
3 Setting Up the 850-DS
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30 850-DS Operator’s Manual
850-DS Dissolution Sampling Station
Operator’s Manual
4
Operating the 850-DS
Agilent Technologies
31
4 Operating the 850-DS
Startup Screen
32
Figure 3
Startup Screen
The Startup screen provides initial information after you power on the instrument. The firmware version, LCD version, serial number and release date are displayed while a self-test is executed in the background. If the self-test completes successfully, a green check mark will be displayed for a few seconds and then the instrument will progress to the Main screen. If an error is encountered during the self-test, a red X will be displayed along with a short text description of the component causing the error. After approximately 10 seconds, the
Startup screen will change over to the Main screen.
850-DS Operator’s Manual
850-DS Operator’s Manual
Operating the 850-DS 4
The following errors may be reported: DataFlash, Real Time Clock
(RTC), Needle Motor, tray Motor, Syringe Pump Motor, Filter Clamp, and Filter Motor. If you encounter any of these errors, please contact
Agilent for service
See “Obtaining Warranty and Other Services” on page 98
.
Figure 4
Startup Screen with Error
33
4 Operating the 850-DS
Main Screen
The Main screen is the home screen for all instrument operations. The screen will configure itself to display the appropriate sample format based on selections from the Instrument screen. The Main screen displays the following information:
• instrument model
• menu bar
• system date
• system time
• current user mode
• screen lock state
• leak notification
• alarm notification
• service due notification
• if connected, status of the dissolution apparatus (except when the apparatus is idle)
The sample tray may be ejected from this screen by pressing Eject. The tray may be retracted by pressing Eject again.
Several configurations are illustrated on the following pages.
34 850-DS Operator’s Manual
Operating the 850-DS 4
Figure 5
Main Screen in Idle Mode
850-DS Operator’s Manual
Figure 6
Main Screen with 2 mL Vial, 54-position Blocks Installed
35
4 Operating the 850-DS
Figure 7
Main Screen with 96-position Microtiter Plates Installed
36
Figure 8
Main Screen with 2 mL, 100-position HPLC Tray Installed
850-DS Operator’s Manual
Operating the 850-DS 4
CAUTION
Figure 9
Main Screen with BIO-DIS (Apparatus 3)
Ensure the front door is open prior to ejecting the sample tray.
Failure to do so may damage the door or cause injury.
850-DS Operator’s Manual 37
4 Operating the 850-DS
Menu Screens
Option
Methods
Alarms
Calibration
Cleaning
Diagnostics
Instrument
Mfg Config
Reports
User Access
Function
.
See “Calibration” on page 59 .
See “Diagnostics” on page 64 .
See “Instrument Settings” on page 72
.
See “Manufacturing Configuration” on page 78
.
See “User Access” on page 80 .
38 850-DS Operator’s Manual
Operating the 850-DS 4
Methods
Press Methods from the Main screen to create sample-collection methods.
NOTE
Figure 10 Method Properties Screen
The first four screens of Method Properties show memory locations 1 through 40. There are 10 methods displayed per page. The method name and last save time and date are shown for all non-blank methods. Blank memory slots are indicated by a series of dashes.
Select a storage location for the method to be entered by pressing one of the numbered memory locations.
Only the memory-location numbers are touchable on screen. The software will not respond if the method details in the box next to each memory location are touched.
850-DS Operator’s Manual 39
4 Operating the 850-DS
Method Properties (Apparatus 1/2/5/6)
NOTE
This screen is applicable to Apparatus 1/2/5/6 only. For Apparatus 3 or
7, advance to
“Method Properties (Apparatus 3/7)” on page 45.
Figure 11 Instrument Parameters
40 850-DS Operator’s Manual
Operating the 850-DS 4
Option
Name
Vessel Temp
Bath Temp
Function
30-character field for the name of this method.
Desired vessel temperature for this method.
Desired bath temperature for this method.
Spindle Speed
Media Volume
Desired spindle speed for this method.
Volume of media initially in the vessels.
Time after the start of the method before the spindle rotation begins.
Rotation Start
Delay
Profile Print
Interval
Specifies the frequency that dissolution apparatus operational parameters are printed on the optional printer.
Apparatus 1/2/5/6
Select the appropriate apparatus type.
Initial Temp
Takes a temperature reading of the vessels prior to dropping a dosage at the start of a method.
Initial Sample
Final Temp
Takes a sample prior to dropping a dosage at the start of a method.
Takes a temperature reading of the vessels at the end of the method.
Enable Final Spin
After the final timepoint, this option runs the spindles at a high speed in order to try to get all remaining drug into suspension.
RPM
Duration
Clear
Import
Cancel
Save
Rotational speed used for the Final Spin.
Duration the final spin will be executed.
Erases all values entered and returns them to default values.
Allows user to import method from SD card.
Exits the method entry screens and returns to the Main screen without saving any parameters.
Saves all method parameters and returns to the Main screen.
850-DS Operator’s Manual 41
4 Operating the 850-DS
Sample Collection Parameters (Apparatus 1/2/5/6)
42
Option
Sample Volume
Prime Volume
Purge Volume
Waste Drop
Volume
Dual Sample
Estimated Min
Transfer Time
Figure 12 Sample Collection Parameters - Screen 1
Function
Volume to be collected into the sample test tubes / vials.
Volume used to prime all of the sample collection lines prior to collecting a sample.
Volume used to purge all of the sample collection lines after collecting a sample.
Volume used to rinse the sample needles prior to delivering each sample. This volume, in addition to the sample volume, should be accounted for if media replacement is enabled.
When enabled, collects two consecutive samples for each timepoint.
Uses the sample volume specified above. This option also halves the total number of timepoints available.
This is a calculated estimate, based on the previously entered sample collection parameters, of how frequently samples may be taken.
850-DS Operator’s Manual
Operating the 850-DS 4
Option
Prefill Tubes /
Vials
Media Change
Full Media
Change
Media Addition
Enable Cleaning
Cycle
Clear
Function
Use this option to fill each test tube or sample vial with the specified volume (in mL). This volume will be taken from the dissolution vessels and automatically replaced using the Media Replacement channel. The number of rows filled is based on the number of time points of the method. Ensure the media replacement line is connected and sufficient volume is available in the container to maintain initial vessel volume.
When enabled, allows you to manually intervene for a media modification.
Signifies that you will be removing the dosage and performing a complete replacement of media. A dialog box will display to prompt you to begin and to keep track of the total elapsed time. This option will pause the elapsed time of the dissolution method during the change.
Signifies that you will be adding a quantity of media to each vessel. A dialog will display to prompt you to begin as well as to keep track of the total elapsed time. This option will continue the elapsed time of the dissolution method during the change.
When enabled, executes a cleaning cycle after the test has finished. The parameters for the cleaning routine are taken from the stored values on the Cleaning screen (
Erases all values entered and returns them to default values.
850-DS Operator’s Manual 43
4 Operating the 850-DS
44
Figure 13 Sample Collection Parameters - Screen 2
Option Function
Enable Filtration
If a Filter Module is installed, this enables filtering samples prior to collection. Ensure an adequate amount of 850-DS filter plates are installed prior to beginning the method.
Samples Per Filter Specifies how many times to use each filter before they are discarded.
The filter plates are designed for single use only and saturation occurs under typical conditions after 3 or 4 uses. The Samples Per Filter setting should be determined for each product and method as part of the system validation.
Type
Enable Media
Replacement
25-character field used to describe what type of filter is being used.
Typically porosity and membrane type are described.
When enabled, pumps a specified amount of media back to the vessels after each timepoint. Media for this step is provided by the user via an external beaker or vessel.
% of Sample mL
Specifies that the volume to replace will be a percentage of the sample volume.
Specifies that the volume to replace will be this absolute. For complete replacement, the sample + waste drop volume should be entered here.
850-DS Operator’s Manual
Method Properties (Apparatus 3/7)
Operating the 850-DS 4
Figure 14 Sample Collection Parameters (Apparatus 3/7)
Option
Sample Volume
Prime Volume
Purge Volume
Function
Volume to be collected into the sample test tubes / vials.
Volume used to prime all of the sample collection lines prior to collecting a sample.
Volume used to purge all of the sample collection lines after collecting a sample.
Waste Drop
Volume
Dual Sample
Volume used to rinse the sample needles prior to delivering each sample. This volume, in addition to the sample volume, should be accounted for if media replacement is enabled.
When enabled, collects two consecutive samples for each timepoint.
Uses the sample volume specified above. This option also halves the total number of timepoints available.
Enable Filtration
If a Filter Module is installed, this enables filtering samples prior to collection. Ensure an adequate amount of 850-DS filter plates are installed prior to beginning the method.
850-DS Operator’s Manual 45
4 Operating the 850-DS
Option
Samples Per Filter Specifies how many times to use each filter before they are discarded.
The filter plates are designed for single use only. The Samples Per Filter setting should be determined for each product and method as part of the system validation. The maximum number of uses per plate is 5 and a warning message will appear for any value > 2.
Filter Type
Function
25-character field used to describe what type of filter is being used.
Typically porosity and membrane type are described.
Enable Cleaning
Cycle
Clear
Save
When enabled, executes a cleaning cycle after the test has finished. The parameters for the cleaning routine are taken from the stored values on the Cleaning screen (
Erases all values entered and returns them to default values.
Saves all method parameters and returns to the Main screen.
46 850-DS Operator’s Manual
Operating the 850-DS 4
Figure 15 Prefill Tubes / Vials Apparatus 3 / 7
Option
Prefill Tubes /
Vials
Function
Use this option to fill each test tube or sample vial with the specified volume (in mL). For Apparatus 3 / 7 units, this volume will be taken from the Row specified and automatically replaced using the Media
Replacement channel. The number of sample tray rows filled is based on the number of time points of the method. Ensure the media replacement line is connected and sufficient volume is available in the container to maintain the initial vessel volume.
850-DS Operator’s Manual 47
4 Operating the 850-DS
Timepoint Number Selection
Up to 36 timepoints may be specified per method. This screen and the next allow you to define when samples are taken. Timepoints must be consecutively numbered. Entering zero for the time will delete a timepoint.
Figure 16 Timepoint Number Selection (Apparatus 1/2/5/6)
48
Option
Clear
Save
Cancel
Figure 17 Timepoint Number Selection (Apparatus 3/7)
Function
Erases all values entered and returns them to default values.
Saves all method parameters and returns to the Main screen.
Exits the timepoint entry screen and returns to the Main screen without saving any parameters.
850-DS Operator’s Manual
Operating the 850-DS 4
Timepoint Parameter Entry (Apparatus 1/2/5/6)
This screen specifies the time and the parameters to use for each sample collection.
Figure 18 Timepoint Properties Screen (Apparatus 1/2/5/6)
Option
Timepoint #
Timepoint
Spindle Speed
Media Volume
Media Change
Function
An indicator of the currently selected timepoint.
The amount of time to wait after the method starts before the sample will be collected.
The spindle speed to use just after this sample collection finishes.
The nominal volume present in the vessels after the sample collection finishes. Typically this volume does not account for the sample volume subtracted from one timepoint to the next. If applicable, sample manifold height will be adjusted accordingly based on this volume.
Indicates that you will be performing either a full media change or a media addition after this timepoint.
850-DS Operator’s Manual 49
4 Operating the 850-DS
Timepoint Parameter Entry (Apparatus 3/7)
This screen specifies the time and the parameters to use for each sample collection.
50
Option
Interval
Dip Interval
Hold Time
Drain Time
Row
Speed
Bath Temp
Figure 19 Timepoint Properties Screen (Apparatus 3/7)
Function
The memory slot of the timepoint being configured.
Duration of dipping time for each row.
Duration the inner sample tubes / sample holders are stopped at the bottom of the stroke before dipping begins.
Duration the inner sample tubes / sample holders drain over the outer media tubes after being lifted from the media.
Enter the desired row number.
Enter the desired DPM.
Enter the desired bath temperature.
850-DS Operator’s Manual
Run Method Screen 1
Operating the 850-DS 4
Option
Next
Back
Return
Figure 20 Selecting a Method (Apparatus 1/2/5/6)
The first four screens of Method Properties represent memory slots 1 through 40 (ten methods are displayed per page). The method name and last save time and date are shown for all non-blank methods. Empty slots are indicated by a series of dashes. You can use the following onscreen commands to navigate the screens:
Function
Advances to the next page of available methods.
Returns to the previous page.
Returns to the Main screen without any selections made.
850-DS Operator’s Manual 51
4 Operating the 850-DS
Run Method Screen 2
52
Figure 21 Method Start Parameters
This screen allows you to enter parameters that are stored with the method run. These parameters are available on a printout if your unit has the optional printer is installed.
Option
Operator
Lot
Batch
Note
Dissolution
Apparatus Control
Function
25-character field for operator name entry.
25-character field for lot information.
25-character field for batch information.
25-character field for additional notes.
Allows the Agilent 850-DS to control a dissolution apparatus.
Instant
Note: Enable this option only if the Agilent 850-DS is connected to another Agilent/Varian/VanKel dissolution apparatus. If connected to a third-party dissolution apparatus with resident probes, do not check this box.
Start a method instantly.
850-DS Operator’s Manual
Operating the 850-DS 4
Option
Vessel
Temperature
Function
Will start a method once the vessels have achieved a stable temperature as specified in the method to be run within the temperature tolerance settings of the 850-DS.
Bath Temperature
Will start a method once the bath has achieved a stable temperature as specified in the method to be run within the temperature tolerance settings of the 850-DS.
Time Delayed
Will start the method at the time and date specified.
Synchronized
Start
Note: Time-delayed method starts are not allowed with the Synchronous
Start option.
Allows two 850-DS collectors to execute the same method simultaneously. Each 850-DS must have the same method loaded in the same memory location. Methods may be transferred between 850-DS units using an SD card (
See “850-DS Method Transfer (to another
). A 9-9 pin null modem cable (5075-0449) connects one instrument to the other using the AUX RS-232 port.
NOTE
NOTE
Time-delayed method starts are not permitted with the Synchronized
Start option.
When connected to an Agilent 709-DS, the DDM option must not be enabled on the 709-DS itself. Leaving the DDM option enabled will cause dosages to be dropped before the vessels are at temperature, thus invalidating the method.
850-DS Operator’s Manual 53
4 Operating the 850-DS
Run Method Screen 3
54
Figure 22 Run Method Screen 3
Option
RPM
ºC
Elapsed Time
Next Sample
Remaining Time
View Samples
View Timepoints
Stop
Eject
Function
Current spindle speed (Agilent/Varian/VanKel apparatus only).
Current bath temperature (Agilent/Varian/VanKel apparatus only).
Current elapsed time since the start of the method.
Time to the next sample collection time.
Time required to complete the current method.
Graphical indication of the method progress. The shaded circles indicate filled test tubes or vials.
Provides a view of the timepoints in the current running method.
Press STOP to display the dialog screen confirming the choice to stop or continue the method.
Press Eject to access the sample tray. The sample tray may be ejected during an active program as long as the system is not taking a sample.
Press RETURN (on the screen displayed) to retract the tray prior to the next sample time point; otherwise, the sample will not be taken.
850-DS Operator’s Manual
Run Method Screen 4
Operating the 850-DS 4
Figure 23 Run Method Screen 4
Run Method Screen 5
This screen displays at the conclusion of a method when no errors have been encountered. The total elapsed time, the current time, and the current date are displayed.
850-DS Operator’s Manual
Figure 24 Run Method Screen 5
55
4 Operating the 850-DS
850-DS Method Transfer (to another 850-DS)
NOTE
You must use a 2GB or smaller SD card formatted as FAT16 or FAT32 to complete this procedure.
1 Insert an SD card into the SD card slot on the back of the 850-DS.
2 Select Reports tab from the 850-DS main screen.
Figure 25 Reports Screen
3 Press SD Card in the "Print Method..." row. Allow the method to save to the SD card.
4 Eject the SD card.
5 On 850-DS where you want to import the method, insert the SD card on the back of the unit.
56 850-DS Operator’s Manual
850-DS Operator’s Manual
Operating the 850-DS 4
6 Select Methods tab from the 850-DS main screen.
7 Select an open location where the imported method should be stored
(press number).
8 Press IMPORT. Allow method to upload from SD card.
Figure 26 Import Method
57
4 Operating the 850-DS
Alarms
Press Alarms from the Main screen to configure alarms on the 850-DS.
58
Figure 27 Alarm Screen
Option
Timer Alarm
Pause Duration
Alarm
Function
This alarm acts in a manner similar to a laboratory countdown timer.
Once a value is entered and you press RETURN, the alarm will start a countdown to zero. You do not need to remain on this screen for the alarm to remain active. Once the timer value reaches zero, an alarm will sound and a dialog box will display to indicate that the alarm has expired.
This option sets the duration that you are allowed while performing media changes and additions. The duration of a pause is recorded and printed on the optional printer.
Delayed Start
Moving
Beeps prior to starting a method when you have selected Delayed Start.
Beeps prior to any tray movements of the Agilent 850-DS.
Sample Complete
Beeps at the end of each sample timepoint.
Program
Complete
Beeps at the conclusion of a method.
850-DS Operator’s Manual
Operating the 850-DS 4
Calibration
Press Calibration from the Main screen to calibrate the 850-DS.
Figure 28 Calibration Screen
850-DS Operator’s Manual 59
4 Operating the 850-DS
NOTE
Volume Calibration
The Agilent 850-DS uses a syringe pump to deliver accurate volumes from 0.1 mL to 14.0 mL. A volume calibration function is available to compensate for pump delivery speed, tubing length, and media viscosity. Volume accuracy is a function of pump speed and aspiration dwell time. To improve volume accuracy, try using slower pump speeds.
The pump speed and aspiration dwell time are set on the second
Instrument Settings screen.
See “Instrument Settings Screen 2” on page 74
.
Agilent recommends calibrating using a volume of 10 mL. If that does not provide acceptable performance, you may perform a calibration at the typical sample collection volume. Although the Agilent 850-DS can dispense volumes as low as 0.1 mL, it is not recommended to calibrate with volumes less than 2 mL.
Option
Volume
Calibration mL to Dispense
Row Number
Actual mL mL / Stroke
Prime
Dispense
Stop
Description
Enter volume (in mL) to be collected in sample tubes / vials during the volume calibration procedure.
Specify the row where the sample volume should be collected.
Enter the average sample volume collected (in mL) during the volume calibration procedure.
Automatically calculated value based on volume calibration parameters. This value is stored until the next volume calibration is performed. No user entry is required/permitted.
Primes (fills) the sample tubing lines prior to executing the volume calibration procedure. This ensures the lines are sufficiently filled and an accurate sample volume is collected.
Dispenses the programmed volume (in mL) into the specified row.
Stops the volume calibration procedure.
60 850-DS Operator’s Manual
Operating the 850-DS 4
Full Range Volume Dispense
This feature works only with 15mL test tubes. You must place a rack with at least 7 rows of clean, dry, and weighed test tubes in the appropriate space. At the conclusion of the cycle, you may calculate volume dispensed.
Option
Full Range Volume
Dispense
Run
Stop
Calibration Due Date
Preventative
Maintenance Due Date
Description
Starts the Full Range Volume Dispense cycle.
Stops the cycle immediately.
Enter the date that instrument calibration is due. On the due date, a reminder notification (wrench icon) will display. The wrench icon will remain visible on the Main screen as long as the current date is past the calibration date. Enter a future date to remove the reminder icon.
Enter the date that preventative maintenance is due. On the due date, a reminder notification (wrench icon) will display. The wrench icon will remain visible on the Main screen as long as the current date is past the PM date. Enter a future date to remove the reminder icon.
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4 Operating the 850-DS
Cleaning
Press Cleaning on the Main screen to access the cleaning cycle on the
850-DS.
NOTE
Figure 29 Cleaning Parameters Screen
Cleaning methods are formulation dependant. If you need help determining appropriate cleaning solution and cycles, contact the
Dissolution Hotline at [email protected].
62 850-DS Operator’s Manual
Operating the 850-DS 4
Option
Cleaning Cycle
Source
Volume
# Cycles to Run
Run
Stop
Rinse Port
The Agilent 850-DS can perform an automated flush of all of the tubing.
This screen allows a manual cleaning cycle to be started. If Enable
Cleaning Cycle is selected in a method, the parameters entered on this screen are used to control the cleaning cycle.
Sample Cannula
Description
Enter the volume that will be pumped though the tubing.
This controls how many times the above volume will be repeated.
Starts a cleaning cycle with the entered parameters.
Stops a cleaning cycle.
This selects the rinse port as the source of the rinse media.
Connect an appropriate container to the Agilent 850-DS rinse port with a length of 1/4 inch tubing. At the start of the cleaning cycle, an internal pump fills the rinse reservoir on the tray assembly. The needles are lowered into the rinse media and the specified volume is pumped from the needles through the sample tubing and then through the return tubing. All lines will then be purged with air to eliminate as much liquid from the tubing as possible.
Selects the sample cannula as the inlet source. At the start of a cleaning cycle, the syringe pump moves the volume specified from the sample cannula through the return tubing. A smaller fixed volume of 0.7 mL will be pumped through the needles into the waste row. All lines will then be purged with air to eliminate as much liquid from the tubing as possible. It is the responsibility of the user to properly submerge the sample cannulas in the appropriate rinse solution prior to this cycle.
CAUTION
Ensure that the rinse connection is not capable of siphoning back into the instrument. The inlet tubing must never fall below the level of rinse in the container.
The media bottles should be located at the same bench level as the
850-DS or lower.
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4 Operating the 850-DS
Diagnostics
Press Diagnostics on the Main screen to access diagnostics on the
850-DS.
64
Figure 30 Diagnostics Screen 1
This screen allows manual control of all the sample handling parameters. Tray movement, needle position, and syringe pump control are available. The tray image on the left side will change to indicate which tray type is currently configured. As the tray is moved to valid rows, the appropriate row in the tray image will be filled to provide feedback for row position.
850-DS Operator’s Manual
Operating the 850-DS 4
Option
Row Position
Needle Position
Tray Position
Row Indicator
Up Arrow
Down Arrow
Move
Up Arrow
Down Arrow
Eject
Home
Waste
Media
Rinse
Current Position
Pump Control Volume
Fill
Dispense
To: Needles
To: Sample Return
Description
Pressing the numeric row indicator will display the numeric entry screen. Enter the desired row number and press Return.
Increments the current row number by one.
Decrements the current row number by one.
Moves the tray to the position indicated in the row indicator field.
Raises the needles.
Lowers the needles.
Moves the tray to the eject position.
Performs a home of the needles, tray, and pump in order.
Moves the tray to the waste row of the waste block.
Moves the tray to the media-replacement row of the waste block.
Moves the tray to the rinse-row of the waste block.
An indicator that shows the current position of the tray. If the tray has been moved to a particular row number, this indicator will be blank and the tray position will be indicated on the tray image.
Press the numeric indicator and enter the volume to be dispensed.
Aspirates the requested volume into the syringe pump.
Pumps the contents of the syringe pump to the selected location.
The requested volume is aspirated from the sample cannula and pumped out to the needles.
The requested volume is aspirated from the sample cannula and pumped out to the return lines.
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4 Operating the 850-DS
Diagnostics Screen 2
Option
Rinse Pump
Media Replacement Pump
Waste Pump
Self Test Results
Printer Test
Pump In
Pump Out
Stop
Pump In
Pump Out
Stop
Run
Stop
Run
Figure 31 Diagnostics Screen 2
Description
Activates the pump to fill the rinse row.
Activates the pump to empty the rinse row.
Stops the pump.
Activates the pump to fill the media-replacement row.
Activates the pump to empty the media-replacement row.
Stops the pump.
Activates the waste pump (empties the waste row).
Stops the pump.
Runs the self-test routine.
Prints the results of the self-test routine.
Conducts a test to ensure the printer is functioning properly.
66 850-DS Operator’s Manual
Diagnostics Screen 3
Operating the 850-DS 4
Figure 32 Diagnostics Screen 3
This screen allows manual control of the optional Filter Module (if installed). The filter may be moved to one of four positions and the filter clamp may be opened and closed.
850-DS Operator’s Manual 67
4 Operating the 850-DS
Option
Filter Transport
Filter Clamp
Load
Media Repl
Filter
Eject
# Filters to Eject
Cycle Filters
Open
Close
Stop
Clamp Force Control
Description
Moves the filter transport plate to the load position. This is the location of the filters that are placed in the inlet stack.
Moves the filter transport plate to the media replacement position. This position allows the filter clamp plates to clamp on themselves. This position is not directly under the new filters in order to minimize any carryover or contamination between a used filter and the new ones in the stack. This position is used when a media replacement is being performed.
Moves the filter transport plate to the filter position. This position allows the filter clamp plates to seal on the filter and pump samples through it.
Moves the filter transport plate to the eject position.
Pressing the # Filters to Eject indicator will display the numeric entry screen. Enter the number and press Return.
Will cycle the filter transport plate between the load and eject position for # Filters to Eject times. This may be used to empty the inlet stack or verify operation.
Opens the filter clamp plates. The clamp mechanism will stop automatically when it reaches its open position.
Closes the filter clamp plates.
Caution: Care should be used with this function as damage may occur if there are any obstructions in the clamping path.
Turns off the clamp motor. The plates remain in their current position.
This parameter adjusts the amount of power the motor receives from 90 to 100%. Values below this result in poor clamping and are thus not allowed.
68 850-DS Operator’s Manual
Diagnostic Screen 4 (Apparatus 1/2/5/6)
Operating the 850-DS 4
Option
Spindle
Dosage Drop
Module (DDM)
Bath
Setpoint RPM
Run
Stop
Position
Up Arrow
Down Arrow
Single
Open All
Setpoint
Actual
850-DS Operator’s Manual
Figure 33 Diagnostics Screen 4 (Apparatus 1/2/5/6)
Description
Pressing the RPM indicator will display the numeric entry screen. Enter the desired RPM and press Return.
Starts the spindles.
Stops the spindles.
Pressing the Position indicator will display the numeric entry screen. Enter the desired number and press Return.
Increments the DDM position.
Decrements the DDM position.
Actuates the individual DDM selected by the position indicator.
Actuates all DDM modules simultaneously.
Pressing the Setpoint indicator will display the numeric entry screen. Enter the desired temperature and press Return. The dissolution apparatus bath setpoint will be updated to the value entered.
Displays the current actual bath temperature.
69
4 Operating the 850-DS
Option
Vessel
Temperatures
Drive
Manifold
Up
Down
Up
Down
Description
If a manifold is installed and lowered, the current vessel temperatures are displayed here.
Raises the drive unit
Lowers the drive unit.
Raises the manifold.
Lowers the manifold.
70 850-DS Operator’s Manual
Diagnostic Screen 4 (Apparatus 3/7)
Operating the 850-DS 4
Option
Sample Head
Sample
Bath
Home
Row
Move
Speed
Dip Hold Time
Run
Stop
Setpoint
Actual
Figure 34 Diagnostics Screen 4 (Apparatus 3/7)
Description
Returns the drive unit to the home position.
Enter the desired row number.
Moves the drive unit to the entered row.
Enter the desired speed in DPM.
Stops the inner sample tubes / sample holders at the bottom of the stroke for the length of time entered.
Begins manual dipping.
Stops manual dipping.
Pressing the Setpoint indicator will display the numeric entry screen. Enter the desired temperature and press Return. The dissolution apparatus bath setpoint will be updated to the value entered.
Displays the current actual bath temperature.
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4 Operating the 850-DS
Instrument Settings
The following screens show the parameters that influence the setup and operation of the Agilent 850-DS. These parameters apply to all methods and modes of operation.
Figure 35 Instrument Settings Screen 1
72 850-DS Operator’s Manual
Operating the 850-DS 4
Option
Collector
Dissolution
Apparatus
Sample Format
Serial Number
LAN MAC Address
Firmware Version
Release Date
Collector Name
Collector Comm ID
Prime Loss Volume
Number Active Vessels
Apparatus 1/2/5/6
Apparatus 3/7
Comm ID
Test Tubes
Vial Blocks
Well Plate
100-vial Tray
Description
Manufacturer-assigned serial number.
MAC address that will be used for LAN communications.
Version of the firmware installed on the instrument.
Release date of the firmware.
A 25-character field to describe the instrument.
A 2-digit numeric field that is used when a PC or other instrument is communicating with the Agilent 850-DS.
Note: If multiple instruments are connected together, each unit must have a unique Comm ID.
The volume in mL that is pumped at the beginning of each sample point. This volume represents the volume in the tubing between the sample collector and the needles. Pumping this volume to the return lines first ensures that the volume aspirated at the sample time is what is actually delivered to the sample tubes / vials instead of the volume remaining in the lines after prime.
Enter the number of active vessel positions on the dissolution apparatus. This value is important if the vessel temperature start is used.
Sets the operating mode to expect an Apparatus 1/2/5/6 instrument to be connected to the Agilent 850-DS.
Sets the operating mode to expect an Apparatus 3/7 instrument to be connected to the Agilent 850-DS.
Communications ID of the attached Agilent dissolution apparatus.
Indicates a rack holding an array of 8 x 12 test tubes or vials is installed.
Indicates a rack holding two 9 x 6 blocks with 2 mL vials is installed.
Indicates a rack holding two 96-position well plates is installed.
Indicates a rack holding an array of 10 x 10 (offset spacing) for
2 mL vials is installed.
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4 Operating the 850-DS
Vessel Assignments
Figure 36 Vessel Assignment Screen
This screen allows you to enter a category for each vessel's usage. These categories are used for reporting only.
Instrument Settings Screen 2
74
Figure 37 Instrument Settings Screen 2
850-DS Operator’s Manual
Operating the 850-DS 4
Option
Tolerances
Leak Detect
Options
Timepoint
Auto-increment
LCD Settings
Pump Speed
Aspiration Dwell
Time
Temperature Tolerance
Speed Tolerance
Continue Method
Stop Immediately
Brightness Up
Brightness Down
Speaker Up
Speaker Down
Description
Displays the numeric entry screen. Enter the desired tolerance and press Return. Temperatures that are outside of this tolerance to their respective setpoints will raise an error condition. These errors will be reported through dialog screens and on the optional printer.
Displays the numeric entry screen. Enter the desired tolerance and press Return. Spindle speeds that are outside of this tolerance to their respective setpoints will raise an error condition. These errors will be reported through dialog screens and on the optional printer.
If a leak is detected, a notification will be shown on the Main screen, but otherwise all running methods will continue uninterrupted.
If a leak is detected a notification will be shown and any currently running method will be aborted.
This value controls the auto populate feature of method timepoint entry. After the first timepoint is entered, all subsequent timepoints will have this value added to them.
Increases the brightness of the LCD backlight.
Decreases the brightness of the LCD backlight.
Increases the volume of the internal speaker.
Decreases the volume of the internal speaker.
Sets the speed of the syringe pump to the selected rate. Use slower speeds for higher viscosity media or media containing surfactant. Higher pump speeds may be used for less viscous media. The pump speed may also be reduced to improve volume accuracy.
Sets the time (in seconds) that the syringe pauses after pulling in liquid prior to dispensing. This setting may need to be increased to maintain volume accuracy for certain types of dissolution media. The Dwell Time is automatically adjusted
(3-second minimum) when filtration is enabled.
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4 Operating the 850-DS
Align Screen
Figure 38 Touch Screen Calibration Screen
Starts the touchscreen alignment routine. Follow the instructions on the screen to calibrate the touchscreen. If the screen is not touched for 10 seconds, the Agilent 850-DS will return to the Instrument Settings screen.
76 850-DS Operator’s Manual
Date / Time
Operating the 850-DS 4
Pressing Data / Time will display the Date and Time setting screen.
Operator
Time
Date
Audit Log
Return
Time Field
Time Format
Date Field
Date Format
Figure 39 Date and Time Change Screen
30-character field for the operator name. Any change of the date or time requires an operator's name. The name is used in the audit log as described below.
Pressing the time will display the numeric entry screen. Enter the desired time and press Return.
Select either 12- or 24-hour time format to be used in all displays and printouts.
Pressing the date will display the numeric entry screen. Enter the desired date and press Return.
Select one of the three date formats to be used in all displays and printouts.
The audit log shows the last ten time or date changes and who made them. The up and down arrows scroll through the list.
Returns to the Instrument Settings screen.
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4 Operating the 850-DS
Manufacturing Configuration
NOTE
The Mfg. Config. menu can only be accessed by a certified Agilent representative.
Figure 40 Mfg Config Screen
78 850-DS Operator’s Manual
Operating the 850-DS 4
Reports
Press Reports from the Main screen to print or export reports on the
850-DS. Reports can be printed on the optional printer, exported through the auxiliary serial port (AUX RS-232), or saved to an SD card inserted in the back SD card slot.
Figure 41 Reports
Option
Print Method
Function
Last Run Results
Prints the last run results. Select the destination by pressing the appropriate button.
Displays the select method screen. Once a method has been selected, prints the method parameters. Select the destination by pressing the appropriate button.
Print Instrument
Settings
Enable Printer
Return
Prints the instrument settings. Select the destination by pressing the appropriate button.
A toggle function that enables or disables the printer. If the printer is not enabled, all printing functions are suppressed.
Returns to the Main screen.
NOTE
In order to print reports to the printer, the optional printer must be enabled. All other functions are available with the Enable Printer function deselected.
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4 Operating the 850-DS
User Access
Press User Access from the Main screen to toggle between the three available access levels available on the 850-DS. The current access level is indicated by a green circle. Any user may change the access level to a lower setting (e.g., Advanced User to User) without entering a password. Any changes to a higher level (e.g., Advanced User to
Administrator) require a password.
80
Figure 42 User Access
Option Function
Change Password
Allows an administrator to change the password. Displays the password change screen. The new password must be entered correctly twice before it will be changed. The default password is 12345.
850-DS Operator’s Manual
850-DS Operator’s Manual
Operating the 850-DS 4
Option
Create / Edit / Delete Methods
Timer Alarm
Pause Duration Alarm
Notifications
Calibration - Volume
Calibration - Cal and PM Due
Dates
Cleaning Cycle - Parameters
Cleaning Cycle - Run
Diagnostics
Instrument Settings - Basic
Settings
Instrument Settings - LCD Settings
Instrument Settings - Date / Time
Instrument Settings - Align Screen
Reports
Run Method
Lock Screen
Yes
Yes
Yes
Yes
Yes
Yes
Admin Advanced
User
User
No
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
81
4 Operating the 850-DS
Dialog Screens (Blue)
Password Reset
Displays after the Administrator Access password has been reset to factory default.
Memory Access
Displays when memory is being accessed. Typically it will be displayed when saving or retrieving methods.
Waiting on Heating - Vessel Temperature Start
Displays when a method is running and the 850-DS is waiting on the dissolution apparatus for temperatures to reach a setpoint or become stable. The current temperature, the target temperature, and the vessel temperatures are displayed.
Waiting on Heating - Bath Temperature Start
Displays when a method is running and the 850-DS is waiting on the dissolution apparatus for temperatures to reach a setpoint or become stable. The elapsed time, current temperature, and the bath temperature are displayed.
Time Delayed Start
Displays when a time delayed method start has been selected. The expected start time is displayed so you know how long it will be until the method begins.
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Reading Temperatures
Displays during any temperature-read events on an Agilent dissolution apparatus. Temperature-read events typically last about 40 seconds.
Method Stop Confirmation
Displays after you have pressed STOP while a method is running. It allows you to confirm your intentions to stop or continue running the method.
Change Media
Notifies you that it is time to add or change media during a method. The
elapsed time is shown in the dialog. If the Pause Duration Alarm ( “Pause
Duration Alarm” on page 58) time entered in the Alarms screen is
exceeded, then an error will be generated and noted in the method log.
Access Control
Used when changing access levels or when locking the display. It serves as a generic password entry screen. You must enter access codes correctly twice before any changes will be accepted.
Cleaning Cycle Complete
Displays when the cleaning cycle is complete.
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4 Operating the 850-DS
Warning Screens (Yellow)
Apparatus 1 / 6 Auto Head
Displayed for USP Apparatus 1 or 6 that have an automated drive-unit lift. You are prompted to attach the appropriate dosage form. The head is automatically lowered after you press RETURN.
Apparatus 1 / 6 Manual Head
Displayed for USP Apparatus 1 or 6 methods on units that have a manual drive-unit lift. You are prompted to attach the appropriate dosage form and lower the drive unit manually. The method will resume after you press RETURN.
Manual Dosage Drop
Displayed for USP Apparatus 2 or 5 methods on units that do not have the dosage delivery modules (DDMs) installed. After you insert the dosage and press RETURN, the method will resume.
Head Raised
Generic message on units that have a manual head lift. At any time the head is not fully lowered, this prompt will display.
Sample Tray Full
Used on methods that have more timepoints than will fit on one sample rack. After you replace the rack with a fresh one and press RETURN, the method will continue. If the tray is not retracted prior to the next time point, sample collection will be skipped.
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Sample Tray Ejected
Displayed if the tray is ejected during an program. Press RETURN to retract the tray prior to the next time point. If the tray is not retracted prior to the next time point, sample collection will be skipped.
709-DS Preheat Special Condition
Displays when connected to an Agilent 709-DS running an Apparatus
1/6 method. In order to achieve reliable start conditions, finned baskets must be used during pre-heat. Press RETURN to start the pre-heat cycle.
Alarm Time Expired
Notifies you that the alarm time has expired.
Clear Method Confirmation
Confirmation that all data from a method will be erased and replaced with default values. This prevents you from accidentally erasing methods.
Service Due
Displays when either the Calibration Date Preventative Maintenance
Date ( “Calibration” on page 59) has passed. This dialog appears once.
After this screen has been cleared, the service due wrench icon appears in the lower right corner of the Main screen. The service due icon will remain visible until the corresponding date has been updated in the
Calibration Screen.
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4 Operating the 850-DS
Error Screens (Red)
Method Error
This screen appears at the conclusion of a method when errors have been encountered. The total elapsed time, the current time, and the current date are displayed
.
Invalid Data
Displayed when data has been entered that is outside of the acceptable limits. Press RETURN to re-enter the data. The prompts in the data entry screens will inform you of the valid data ranges.
Method Not Supported
Displayed when the loaded method requires hardware or options that are not installed. For example, if a method requires filtration and no Filter
Module is installed.
Printer Out of Paper
This dialog is displayed when the printer is out of paper. The paper status is only checked at the beginning of a print request, not continuously during a print.
See “Printer Maintenance” on page 91 .
Timepoints Too Close
This dialog is displayed when entering timepoints and the minimum transfer time is not met. Increase the timepoint spacing or reduce the sampling volume parameters to meet the minimum transfer time parameter.
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Not Valid Tray Position
This dialog is only displayed when in Diagnostics. It is displayed if the tray is not in a valid position when a pumping action has been requested
(e.g. dispensing a volume through the needles, but the tray is in the home or eject position). Moving the tray to a valid row will resolve this issue.
Clock Audit Log
Displayed if a change to either the time or date has been requested and no operator has been entered. Operator names are required for clock changes and for saving into the audit log.
Filter Clamp Plates Open
This dialog is displayed on units with a Filter Module installed. If a pumping action has been requested and the filter clamp plates are in the open position, this error will appear. Usually, this is encountered during diagnostics. Navigate to the Filter Module section of the Diagnostics screen (
See “Diagnostics Screen 2” on page 66
) and close the clamp plates. Once closed, normal pumping is allowed.
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4 Operating the 850-DS
Filter Plate Warning
Displayed if a value > 2 is entered for the number of samples to filter prior to filter plate replacement. Saturation may occur and volume inaccuracy or system performance could deteriorate under certain conditions. Proper filter validation should be performed to ensure acceptable performance.
Filter Transport Conflict
This dialog is displayed on units with a Filter Module installed. If in the
Diagnostics Screen, a filter transport move is requested and the clamp plates are closed, this error will be displayed. The transport can't move while the clamp plates are closed. Navigate to the Filter Module section
of the Diagnostics screen ( See “Diagnostics Screen 2” on page 66 ) and
open the clamp plates. Once opened, normal filter transport movement is allowed.
This page was intentionally left blank, except for this message.
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Operator’s Manual
5
Maintenance and Troubleshooting
Obtaining Warranty and Other Services 98
Agilent Technologies
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5 Maintenance and Troubleshooting
Preventive Maintenance
Preventive maintenance intervals may vary depending on the frequency of instrument usage.
Clean System
The Agilent 850-DS can perform an automated flush of all the tubing.
Refer to
“Cleaning” on page 62 for instructions on how to run the
cleaning cycle.
Periodic Maintenance
During a visual inspection of unit, check for:
• Loose or missing hardware
• Signs of wear on pulleys and belts
• Tubing blockages
• Operation of needles
• Signs of wear in the syringes
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Printer Maintenance
Removing a Thermal Paper Roll
NOTE
Figure 43 Near-empty Paper Roll
A red line on the side of the paper roll indicates the paper supply is almost exhausted. Replacement is recommended when the red line is visible. If the paper roll is not changed and the paper supply is exhausted, the 850-DS gets an out-of-paper signal from the printer, and displays an error on the screen.
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5 Maintenance and Troubleshooting
1 Place fingers underneath the light-colored handle and pull forward to pop out the front of the printer.
Figure 44 Accessing the Printer Handle
Opening the chamber reveals the paper roll or empty core inside.
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Figure 45 Open Printer Chamber
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Maintenance and Troubleshooting 5
NOTE
2 Internal side levers hold the roll in place. Since it is empty or nearly empty, use your fingers to pull out the small roll or core.
The empty core is disposable. Each new roll includes a cardboard core.
New rolls may be ordered using part number 12-9988 (10 rolls) or
12-9989 (100 rolls).
Figure 46 Removing the Thermal Paper Roll
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5 Maintenance and Troubleshooting
Inserting a Thermal Paper Roll
NOTE
Only a 58 mm wide x 25 meter (maximum) thermal printer paper roll with a 13 mm core size can be used in the panel-mount printer.
1 With the paper chamber open, insert the paper roll until the levers snap the roll into place. Load the paper so the leading edge of the paper feeds from over the roll and not from under it.
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Figure 47 Inserting a Thermal New Paper Roll
2 Lead the paper out for a few inches and close the top lid of the chamber.
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Maintenance and Troubleshooting 5
Figure 48 Leading Paper and Closing the Lid
3 Keeping the paper centered, close the bottom lid of the chamber and snap it into place.
850-DS Operator’s Manual
Figure 49 Closing the Printer Chamber
4 To verify that the paper is not skewed or jammed, press the upper-right hand button on the printer to feed some paper. If paper does not feed, re-open the chamber and re-center the paper.
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5 Maintenance and Troubleshooting
Figure 50 Feeding Paper
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Maintenance and Troubleshooting 5
Thermal Printer Test
In the second Diagnostics screen, press Print Test Sheet to print sample text and verify the printer is functioning properly.
Figure 51 Printer Test
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5 Maintenance and Troubleshooting
Obtaining Warranty and Other Services
To place a service order (warranty or other services), please contact your local Customer Care Center. Contact information can be found at www.agilent.com under your country using the Contact Us link. Place your service request using the displayed phone number or E-mail address.
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Key features
- Collect samples from dissolution apparatus
- Manual and method control modes
- Store and execute methods automatically
- Define multiple timepoints
- Handle various sample holders
