850-DS Dissolution Sampling Station Operator's Manual
850-DS Dissolution Sampling Station Operator's Manual
1 Safety 7
Electrical Hazards 8
Warning 9
Caution 9
Note 9
Information Symbols 10
2 Introduction 11
Serial Number Format 13
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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
Warning
Caution
Note
Information Symbols
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, the 850-DS will fully control
the dissolution apparatus through a serial interface.
CC1234xxxx
CC Country of origin 2 alpha characters matching the required trade designation for the
country of origin
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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.
Depth 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.
Specification
Parameter Specification
Operating Environment 5 to 40 °C
Weight 27 kg
Pumping system and speed Rotary piston syringe pump, 8 syringes with adjustable 6-12 mL/min.
Number of samples per test Up to 36 (with manual tray exchange after every 12 samples)
The following list of materials are those which come into contact with the media.
Please ensure your media is compatible with these materials prior to use.
Material Component/Location
FEP Tubing
Glass Syringe
FKM/FFKM Valves
Connections
Complete the following sections to connect the necessary tubing and cables for
the Agilent 850-DS.
Tubing
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.
Power Cord
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 on one of the 850-DS units. The
identical method to be executed must be loaded in the same method slot of each
sampling station.
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.
4 Verify the unit passed the initialization and is at the Main screen.
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.
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 25 mm 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. Contact Agilent for assistance with filter validation or visit
www.gelifesciences.com for complete filter plate availability and ordering.
The 850-DS can support various sample tray configurations. The standard needle
block can support two trays - for test tube or 2 mL 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.
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.
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 96..
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.
Ensure the front door is open prior to ejecting the sample tray.
CAUTION Failure to do so may damage the door or cause injury.
Menu Screens
Option Function
Methods
The first four screens of Method Properties show memory locations 1 through
40. Ten methods are displayed per page and 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.
Option Function
Rotation Start Delay Time after the start of the method before the spindle rotation begins.
Profile Print Interval Specifies the frequency that dissolution apparatus operational parameters are
printed on the optional printer.
Initial Temp Takes a temperature reading of the vessels prior to dropping a dosage at the
start of a method.
Initial Sample Takes a sample prior to dropping a dosage at the start of a method.
Final Temp 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.
Clear Erases all values entered and returns them to default values.
Cancel Exits the method entry screens and returns to the Main screen without saving
any parameters.
Save Saves all method parameters and returns to the Main screen.
Option Function
Sample Volume Volume to be collected into the sample test tubes / vials.
Prime Volume Volume used to prime all of the sample collection lines prior to collecting a
sample.
Purge Volume Volume used to purge all of the sample collection lines after collecting a sample.
Waste Drop Volume 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.
Dual Sample 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.
Estimated Min This is a calculated estimate, based on the previously entered sample collection
Transfer Time parameters, of how frequently samples may be taken.
Prefill Tubes / Vials 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 timepoints of the method. Ensure the media
replacement line is connected and sufficient volume is available in the container
to maintain initial vessel volume.
Media Change When enabled, allows you to manually intervene for a media modification.
Option Function
Full Media Change 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.
Media Addition 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.
Enable Cleaning When enabled, executes a cleaning cycle after the test has finished. The
Cycle parameters for the cleaning routine are taken from the stored values on the
Cleaning screen (“Cleaning” on page 60). A validated cleaning method
should be performed after each dissolution test. This enables the 850-DS
to perform at a high level for an extended period of time while reducing
ongoing maintenance costs.
Clear Erases all values entered and returns them to default values.
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 filters 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 greater than 2.
Type 25-character field used to describe what type of filter is being used. Typically
porosity and membrane type are described.
Enable Media When enabled, pumps a specified amount of media back to the vessels after
Replacement each timepoint. Media for this step is provided by the user via an external beaker
or vessel.
% of Sample Specifies that the volume to replace will be a percentage of the sample volume.
mL Specifies that the volume to replace will be this absolute. For complete
replacement, the sample + waste drop volume should be entered here.
Option Function
Sample Volume Volume to be collected into the sample test tubes / vials.
Prime Volume Volume used to prime all of the sample collection lines prior to collecting a
sample.
Purge Volume Volume used to purge all of the sample collection lines after collecting a sample.
Waste Drop Volume 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.
Dual Sample 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.
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 25-character field used to describe what type of filter is being used. Typically
porosity and membrane type are described.
Option Function
Enable Cleaning When enabled, executes a cleaning cycle after the test has finished. The
Cycle parameters for the cleaning routine are taken from the stored values on the
Cleaning screen (“Cleaning” on page 60). A validated cleaning method
should be performed after each dissolution test. This enables the 850-DS
to perform at a high level for an extended period of time while reducing
ongoing maintenance costs.
Clear Erases all values entered and returns them to default values.
Save Saves all method parameters and returns to the Main screen.
Option Function
Prefill Tubes / Vials 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 timepoints of the method.
Ensure the media replacement line is connected and sufficient volume is
available in the container to maintain the initial vessel volume.
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.
Option Function
Clear Erases all values entered and returns them to default values.
Save Saves all method parameters and returns to the Main screen.
Cancel Exits the timepoint entry screen and returns to the Main screen without saving
any parameters.
This screen specifies the time and the parameters to use for each sample
collection.
Option Function
Timepoint The amount of time to wait after the method starts before the sample will be
collected.
Spindle Speed The spindle speed to use just after this sample collection finishes.
Next Media Volume The nominal volume present in the vessels after each sample cycle. This volume
is used to determine the proper sample manifold position if used with an Agilent
708-DS. The Auto Calculate option can be enabled to automatically determine
this value.
Media Change Indicates that you will be performing either a full media change or a media
addition after this timepoint.
Auto Calculate Enable this option to have the firmware automatically determine the Next Media
Volume based on the method parameters. If enabled, the Next Media Volume
field will become inaccessible.
This screen specifies the time and the parameters to use for each sample
collection.
Option Function
Hold Time Duration the inner sample tubes / sample holders are stopped at the bottom of
the stroke before dipping begins.
Drain Time Duration the inner sample tubes / sample holders drain over the outer media
tubes after being lifted from the media.
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:
Option Function
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
installed.
Option Function
Vessel Temperature Will start a method once the vessels have achieved a stable temperature as
specified in the method. For USP Apparatus 1 methods, you may install the 3-fin
baskets to better equilibrate the media; the user will then be prompted to install
the standard baskets with dosage forms to begin the test.
Option Function
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.
Note: Time-delayed method starts are not allowed with the Synchronous Start
option.
Synchronized Start 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 850-DS)” on page 53.). A 9-9 pin null
modem cable (5075-0449) connects one instrument to the other using the AUX
RS-232 port.
Option Function
Elapsed Time Current elapsed time since the start of the method.
View Samples Graphical indication of the method progress. The shaded circles indicate filled
test tubes or vials.
View Timepoints Provides a view of the timepoints in the current running method.
Stop Press STOP to display the dialog screen confirming the choice to stop or
continue the method.
Eject 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 timepoint;
otherwise, the sample will not be taken.
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.
1 Insert an SD card into the SD card slot on the back of the 850-DS.
2 Select the Reports tab from the 850-DS main 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.
Alarms
Press Alarms from the Main screen to configure alarms on the 850-DS.
Option Function
Timer Alarm 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.
Pause Duration This option sets the duration that you are allowed while performing media
Alarm changes and additions. The duration of a pause is recorded and printed on the
optional printer.
Delayed Start Beeps prior to starting a method when you have selected Delayed Start.
Calibration
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 73..
Option Description
Volume Calibration mL to Dispense Enter volume (in mL) to be collected in sample tubes / vials during the
volume calibration procedure.
Row Number Specify the row where the sample volume should be collected.
Actual mL Enter the average sample volume collected (in mL) during the volume
calibration procedure.
Prime 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.
Dispense Dispenses the programmed volume (in mL) into the specified row.
Pressing Dispense displays an onscreen dialog that guides the user
through the volume calibration process.
Figure 30.Volume
Calibration Pre-check
Figure 31.Volume
Calibration Completion
Option Description
Full Range Volume Run Starts the Full Range Volume Dispense cycle.
Dispense
Notifications Calibration Due Date 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.
Preventative Maintenance Enter the date that preventative maintenance is due. On the due date, a
Due Date 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.
History This screen displays the details of the previous 20 volume calibrations
performed on the instrument including date, time, pump speed, and
operator. The complete log of calibrations may be printed pressing
PRINT on this screen.
Figure 32.Volume
Calibration History
Cleaning
Press Cleaning on the Main screen to access the cleaning cycle on the 850-DS.
The Agilent 850-DS can perform a manual or 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.
Option Description
Cleaning Cycle Volume Enter the volume that will be pumped though the tubing.
# Cycles to Run This controls how many times the above volume will be repeated.
Source Rinse Port 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.
Sample Cannula 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.
Reservoirs Rinse Media Replacement Enable this option to rinse the internal media replacement reservoir
after each test with rinse solution. The reservoir will be filled and
emptied based on the number of cycles defined.
Rinse Waste Enable this option to rinse the internal waste reservoir after each test
with rinse solution. The reservoir will be filled and emptied based on the
number of cycles defined.
# Cycles to Run This value defines how many times the appropriate reservoirs will be
filled and emptied with rinse solution at the conclusion of each test.
Rinsing of these reservoirs serves to prepare the system for the next
test as well as flush the internal volume sensors to prevent long term
damage.
Diagnostics
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.
Option Description
Row Position Row Indicator Pressing the numeric row indicator will display the numeric entry
screen. Enter the desired row number and press RETURN.
Move Moves the tray to the position indicated in the row indicator field.
Waste Moves the tray to the waste row of the waste block.
Media Moves the tray to the media-replacement row of the waste block.
Current Position 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.
Pump Control Volume Press the numeric indicator and enter the volume to be dispensed.
Dispense Pumps the contents of the syringe pump to the selected location.
To: Needles The requested volume is aspirated from the sample cannula and
pumped out to the needles.
To: Sample Return The requested volume is aspirated from the sample cannula and
pumped out to the return lines.
Diagnostics Screen 2
Option Description
Rinse Pump Pump In Activates the pump to fill the rinse row.
Media Replacement Pump Pump In Activates the pump to fill the media-replacement row.
Waste Pump Run Activates the waste pump (empties the waste row).
Printer Test Print Conducts a test to ensure the printer is functioning properly.
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.
Option Description
Filter Transport Load Moves the filter transport plate to the load position. This is the location
of the filters that are placed in the inlet stack.
Media Repl 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.
Filter 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.
# Filters to Eject Pressing the # Filters to Eject indicator will display the numeric entry
screen. Enter the number and press RETURN.
Cycle Filters 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.
Filter Clamp Open Opens the filter clamp plates. The clamp mechanism will stop
automatically when it reaches its open position.
Caution: Care should be used with this function as damage may occur
if there are any obstructions in the clamping path.
Stop Turns off the clamp motor. The plates remain in their current position.
Clamp Force Control 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.
Option Description
Spindle Setpoint RPM Pressing the RPM indicator will display the numeric entry screen. Enter
the desired RPM and press RETURN.
Dosage Drop Module Position Pressing the Position indicator will display the numeric entry screen.
(DDM) Enter the desired number and press RETURN.
Bath Setpoint 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.
Vessel Temperatures If a manifold is installed and lowered, the current vessel temperatures
are displayed here.
Option Description
Option Description
Sample Head Home Returns the drive unit to the home position.
Dip Hold Time Stops the inner sample tubes / sample holders at the bottom of
the stroke for the length of time entered.
Bath Setpoint 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.
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.
Option Description
LAN MAC Address MAC address that will be used for LAN communications.
Collector Comm ID A 2-digit numeric field that is used when a PC or other instrument is
communicating with the Agilent 850-DS.
Prime Loss Volume 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.
Number Active Vessels Enter the number of active vessel positions on the dissolution
apparatus. This value is important if the vessel temperature start is
used.
Dissolution Apparatus Apparatus 1/2/5/6 Sets the operating mode to expect an Apparatus 1/2/5/6 instrument
to be connected to the Agilent 850-DS.
Apparatus 3/7 Sets the operating mode to expect an Apparatus 3/7 instrument to be
connected to the Agilent 850-DS.
Sample Format Test Tubes Indicates a rack holding an array of 8 x 12 test tubes or vials is installed.
Vial Blocks Indicates a rack holding two 9 x 6 blocks with 2 mL vials is installed.
Well Plate Indicates a rack holding two 96-position well plates is installed.
Vessel Assignments This screen allows you to enter a category for each vessel's usage.
These categories are used for reporting only.
Option Description
Tolerances Temperature Tolerance 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.
Speed Tolerance 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.
Leak Detect Options Continue Method If a leak is detected, a notification will be shown on the Main screen, but
otherwise all running methods will continue uninterrupted.
Stop Immediately If a leak is detected a notification will be shown and any currently
running method will be aborted.
Timepoint This value controls the auto populate feature of method timepoint
Auto-increment entry. After the first timepoint is entered, all subsequent timepoints will
have this value added to them.
Pump Speed 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.
Aspiration Dwell Time 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.
Option Description
Align 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.
Option Description
Date / Time Pressing Data / Time will display the Date and Time setting screen.
Option Description
Operator 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.
Time Time Field Pressing the time will display the numeric entry screen. Enter the
desired time and press Return.
Time Format Select either 12- or 24-hour time format to be used in all displays and
printouts.
Date Date Field Pressing the date will display the numeric entry screen. Enter the
desired date and press Return.
Date Format Select one of the three date formats to be used in all displays and
printouts.
Audit Log The audit log shows the last ten time or date changes and who made
them. The up and down arrows scroll through the list.
Manufacturing Configuration
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.
Option Function
Last Run Results Prints the last run results. Select the destination by pressing the appropriate
button.
Print Method 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 Prints the instrument settings. Select the destination by pressing the
Settings appropriate button.
Enable Printer A toggle function that enables or disables the printer. If the printer is not enabled,
all printing functions are suppressed.
User Access
Press User Access from the Main screen to assign the system access level,
modify functionality of the User Levels and, if enabled, regulate individual user
access. The 850-DS firmware supports a system-based level of control or access
to specific functions based on individual users. This distinction is governed by
the Username/Password Access feature (see User Access screen on page 80).
If the Username/Password Access feature is enabled, individual users are
assigned a Name, Password, and User Level and must log in to access the
850-DS firmware. Specific functionality is based on their User Level which is
defined by an Administrator of the system.
If the Username/Password Access feature is disabled, an Administrator may
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.
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.
User Level Setting This screen allows an Administrator to define access to specific functions of the
850-DS based on the User Group assigned to the system or individual user. The
system settings are stored when Save is pressed.
Users List This screen allows an Administrator to create, modify and define access for
users of the 850-DS. A total of 20 individual users may be stored. Each user is
assigned a User Level (Administrator, Advanced User, or User) that determines
what functions may be accessed. An individual Name and Password is
assigned to each user at the time of creation.
Password Reset
Displays after the Administrator Access password has been reset to factory
default.
Memory Access
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.
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.
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.
Reading Temperatures
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 55) 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.
User Login
Displays when Lock s pressed from the 850-DS Main screen if the
Username/Password Access feature is enabled. The individual user must enter
their Name and Password to gain access to their predefined functions.
Displays when a number is pressed from the Users List screen. This screen is
used to create, modify or delete users. Each user is assigned a Name, Password,
and User Level from this screen.
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.
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.
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 timepoint, sample collection
will be skipped.
Displayed if the tray is ejected during an program. Press RETURN to retract the
tray prior to the next timepoint. If the tray is not retracted prior to the next
timepoint, sample collection will be skipped.
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 an attempt is made to delete a user from the Users List using the
Configure User Authority screen. Only an Administrator has the ability to delete
users from the 850-DS.
Method Error
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.
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.
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 93..
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.
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.
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.
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.
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Preventive Maintenance
Clean System
The Agilent 850-DS can perform an automated flush of all the tubing. Refer to
“Cleaning” on page 60 for instructions on how to run the cleaning cycle. A
validated cleaning method should be performed after each dissolution test. This
enables the 850-DS to perform at a high level for an extended period of time while
reducing ongoing maintenance costs.
Periodic Maintenance
Printer Maintenance
A red line on the side of the paper roll indicates the paper supply is
NOTE 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.
1 Place fingers on each side of the printer panel and pull forward to expose the
paper chamber and the paper roll, or empty core inside.
1 With the paper chamber exposed, insert the paper roll so the leading edge of
the paper will feed over the top of the printer panel.
2 Keeping the paper centered, close the printer panel and snap it into place.
3 To verify that the paper is not skewed or jammed, press the button on the
top-left of the printer panel to feed some paper. If paper does not feed,
re-open the panel and re-center the paper.
In the second Diagnostics screen, under Printer Test, press to print sample
text and verify the printer is functioning properly.
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.
www.agilent.com
© Agilent Technologies, Inc. 2020
70-9074 Rev F February 2020