0% found this document useful (0 votes)
78 views97 pages

850-DS Dissolution Sampling Station Operator's Manual

Uploaded by

Pimlaphatmh Song
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
78 views97 pages

850-DS Dissolution Sampling Station Operator's Manual

Uploaded by

Pimlaphatmh Song
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 97

850-DS

Dissolution Sampling Station


Operator’s Manual
Notices
Manual Part Number Warranty Safety Notices
70-9074 Rev F The material contained in this document
February 2020 is provided “as is,” and is subject to being
changed, without notice, in future
CAUTIO N
Copyright editions. Further, to the maximum extent
permitted by applicable law, Agilent A CAUTION notice denotes a
© Agilent Technologies, Inc. 2020 disclaims all warranties, either express or hazard. It calls attention to an
No part of this manual may be implied, with regard to this manual and operating procedure, practice, or
reproduced in any form or by any means any information contained herein, the like that, if not correctly
(including electronic storage and retrieval including but not limited to the implied performed or adhered to, could
or translation into a foreign language) warranties of merchantability and fitness
result in damage to the product or
without prior agreement and written for a particular purpose. Agilent shall not
consent from Agilent Technologies, Inc. be liable for errors or for incidental or loss of important data. Do not
as governed by United States and consequential damages in connection proceed beyond a CAUTION
international copyright laws. with the furnishing, use, or performance notice until the indicated
Agilent Technologies, Inc.
of this document or of any information conditions are fully understood
contained herein. Should Agilent and the and met.
3501 Stevens Creek Blvd.
user have a separate written agreement
Santa Clara, CA 95052 USA
with warranty terms covering the
material in this document that conflict WARNING
with these terms, the warranty terms in
the separate agreement shall control. A WARNING notice denotes a
hazard. It calls attention to an
Technology Licenses
operating procedure, practice, or
The hardware and/or software described the like that, if not correctly
in this document are furnished under a performed or adhered to, could
license and may be used or copied only in
accordance with the terms of such
result in personal injury or death.
license. Do not proceed beyond a
WARNING notice until the
Restricted Rights Legend indicated conditions are fully
U.S. Government Restricted Rights.
understood and met.
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).
Content

1 Safety 7
Electrical Hazards 8
Warning 9
Caution 9
Note 9
Information Symbols 10

2 Introduction 11
Serial Number Format 13

3 Setting Up the 850-DS 15


Initial Setup 16
Equipment Ratings / Environmental Requirements for Installation 17
Specification 18
Equipment, Parts, and Accessories As Shipped 19
Parts and Accessories 19
Wetted Parts List 20
Connections 21
Tubing 22
Power Cord 23
Apparatus Control Cable 23
Synchronized Start 24
Initial Power Up 25
Sample Tray Installation 25
Updating 850-DS Language Screens 26

850-DS Operator’s Manual 3


Content

Optional Filter Module 27


Changing Trays / Needle Replacement 28

4 Operating the 850-DS 29


Startup Screen 30
Main Screen 32
Menu Screens 36
Methods 36
Method Properties (Apparatus 1/2/5/6) 38
Sample Collection Parameters (Apparatus 1/2/5/6) 40
Method Properties (Apparatus 3/7) 43
Timepoint Number Selection 45
Timepoint Parameter Entry (Apparatus 1/2/5/6) 46
Timepoint Parameter Entry (Apparatus 3/7) 47
Run Method Screen 1 48
Run Method Screen 2 49
Run Method Screen 3 51
Run Method Screen 4 52
Run Method Screen 5 52
850-DS Method Transfer (to another 850-DS) 53
Alarms 55
Calibration 56
Cleaning 60
Diagnostics 63
Diagnostics Screen 2 65
Diagnostics Screen 3 66
Diagnostic Screen 4 (Apparatus 1/2/5/6) 68
Diagnostic Screen 4 (Apparatus 3/7) 70
Instrument Settings 71
Instrument Settings Screen 2 73
Manufacturing Configuration 77
Reports 78
User Access 79

4 850-DS Operator’s Manual


Content

Dialog Screens (Blue) 82


Warning Screens (Yellow) 84
Error Screens (Red) 86

5 Maintenance and Troubleshooting 91


Preventive Maintenance 92
Clean System 92
Periodic Maintenance 92
Printer Maintenance 93
Removing a Thermal Paper Roll 93
Inserting a Thermal Paper Roll 94
Thermal Printer Test 95
Obtaining Warranty and Other Services 96

850-DS Operator’s Manual 5


Content

This page was intentionally left blank, except for this message.

6 850-DS Operator’s Manual


1 Safety
Electrical Hazards 8

850-DS Operator’s Manual 7


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.
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.

8 850-DS Operator’s Manual


1 Safety

Warning

A ‘Warning’ message appears in the manual when failure to observe instructions


WARNING or precautions could result in death or injury.
Read all warnings and cautions carefully and observe them at all times.

Caution

A ‘Caution’ message appears in the manual when failure to observe instructions


CAUTION could result in damage to equipment (Agilent supplied and / or other associated
equipment).

Note

A ‘Note’ appears in the manual to give advice or information.


NOTE

850-DS Operator’s Manual 9


1 Safety

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.

10 850-DS Operator’s Manual


2 Introduction
Serial Number Format 13

850-DS Operator’s Manual 11


2 Introduction

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 96-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 of the features of the instrument.

In manual control as it is possible to pump volumes greater than


CAUTION 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, the 850-DS will fully control
the dissolution apparatus through a serial interface.

The dissolution apparatus contains electrical circuits, devices,


WARNING 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


CAUTION use of a tool for removal may be opened only by Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers.

12 850-DS Operator’s Manual


2 Introduction

Serial Number Format

The serial number contains 10 characters and follows this syntax:

CC1234xxxx

Syntax Code Meaning Description

CC Country of origin 2 alpha characters matching the required trade designation for the
country of origin

12 Year of manufacture ‘16’ for 2016, ‘17’ for 2017, etc.

34 Week of manufacture ‘01’ for week 1 to ‘52’ for week 52

850-DS Operator’s Manual 13


2 Introduction

This page was intentionally left blank, except for this message.

14 850-DS Operator’s Manual


3 Setting Up the 850-DS
Initial Setup 16
Equipment, Parts, and Accessories As Shipped 19
Connections 21
Optional Filter Module 27
Changing Trays / Needle Replacement 28

850-DS Operator’s Manual 15


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 40 cm (60 cm with Filter Module)

Width 39.0 cm (48.0 cm with filter waste bin)

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.

16 850-DS Operator’s Manual


3 Setting Up the 850-DS

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 17


3 Setting Up the 850-DS

Specification

Parameter Specification

Operating Environment 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 27 kg

Interface 7” color touchscreen (English, Simplified Chinese, Spanish, Japanese, German,


Hungarian, Portuguese, Russian) or PC controlled

Pumping system and speed Rotary piston syringe pump, 8 syringes with adjustable 6-12 mL/min.

Sampling accuracy 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 from 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.

18 850-DS Operator’s Manual


3 Setting Up the 850-DS

Equipment, Parts, and Accessories As Shipped

Parts and Accessories

Locate the following items, as applicable, for your system configuration:

Base Unit Components


Part Number Quantity Description
G7930-64000 1 850-DS base unit
K1005-02066 1 Rack for 15mL test tubes
K3090-00155 7 1/4-28 Male to 1/8" barb fitting
3090-0160 8 1/4-28 Male to 1/4-28 Male tubing adapter
33-9019 3 25’ of 1/8" silicone tubing
K1003-00232 1 2.5mm Hex key
K1003-00233 1 3mm Hex key
K1003-00234 1 1/4" slotted screwdriver
K1003-00235 1 #1 Phillips screwdriver
1150-7997 1 Stylus for touchscreen
17-5001 1 Box of 100 15mL test tubes
5075-0042 1 DB25 communications cable
77-0001 1 Safety Manual and Documentation CD
Power cord 1 Country-specific power cord

Optional Accessory Kits


Part Number Quantity Description
K1005-05187 1 850-DS printer kit
G7931A 1 850-DS filtration module
K1001-01202 1 Kit for 2, 54-position LC trays, 2mL vials
K1001-01203 1 Kit for 100-position LC tray, 2mL vials
K1001-01204 1 Kit for well plate LC tray, 2 mL x 96 wells
K1005-05212 1 Sample tray for 2mL vials (8 x 12)

850-DS Operator’s Manual 19


3 Setting Up the 850-DS

Wetted Parts List

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

Polypropylene Bulkhead and media reservoir

FEP Tubing

PTFE Syringe plunger

Glass Syringe

PEEK Valve manifolds and filter module blocks

FKM/FFKM Valves

FKM or PTFF Filter module O-rings

Stainless Steel Needles

Silicone Replacement media/rinse ports

Santoprene Replacement media/rinse ports

Novoprene Peristaltic pump heads

20 850-DS Operator’s Manual


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

850-DS Operator’s Manual 21


3 Setting Up the 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.

Ensure that the waste connection is not capable of siphoning


CAUTION 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.

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,


NOTE 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.

22 850-DS Operator’s Manual


3 Setting Up the 850-DS

Power Cord

Ensure the correct voltage has been supplied prior to connecting


CAUTION 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 to the Operator’s
Manual or the help files in the software for the applicable system.

850-DS Operator’s Manual 23


3 Setting Up the 850-DS

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.

Figure 2. Start Options

24 850-DS Operator’s Manual


3 Setting Up the 850-DS

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.

Before operating the Agilent 850-DS, a sample collection tray with


NOTE 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.

Do not attempt to insert or remove the sample tray until


CAUTION movement of the platform has completed.

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

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, contact your
Agilent representative.

26 850-DS Operator’s Manual


3 Setting Up the 850-DS

Optional Filter Module

The 850-DS Filter Module should only be installed by a certified


NOTE Agilent representative.

Figure 3. 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 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.

850-DS Operator’s Manual 27


3 Setting Up the 850-DS

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 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.

28 850-DS Operator’s Manual


4 Operating the 850-DS
Startup Screen 30
Main Screen 32
Menu Screens 36

850-DS Operator’s Manual 29


4 Operating the 850-DS

Startup Screen

Figure 4. 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.

30 850-DS Operator’s Manual


4 Operating the 850-DS

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..

Figure 5. Startup Screen with Error

850-DS Operator’s Manual 31


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.

32 850-DS Operator’s Manual


4 Operating the 850-DS

Figure 6. Main Screen in Idle Mode

Figure 7. Main Screen with 2 mL Vial, 54-position Blocks Installed

850-DS Operator’s Manual 33


4 Operating the 850-DS

Figure 8. Main Screen with 96-well Plates Installed

Figure 9. Main Screen with 2 mL, 100-position HPLC Tray Installed

34 850-DS Operator’s Manual


4 Operating the 850-DS

Figure 10. Main Screen with BIO-DIS (Apparatus 3)

Ensure the front door is open prior to ejecting the sample tray.
CAUTION Failure to do so may damage the door or cause injury.

850-DS Operator’s Manual 35


4 Operating the 850-DS

Menu Screens

Option Function

Methods See “Methods” on page 36..

Alarms See “Alarms” on page 55..

Calibration See “Calibration” on page 56..

Cleaning See “Cleaning” on page 60..

Diagnostics See “Diagnostics” on page 63..

Instrument See “Instrument Settings” on page 71..

Mfg Config See “Manufacturing Configuration” on page 77..

Reports See “Reports” on page 78..

User Access See “User Access” on page 79..

Methods

Press Methods from the Main screen to create sample-collection methods.

Figure 11. Method Properties Screen

36 850-DS Operator’s Manual


4 Operating the 850-DS

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.

Only the memory-location numbers are touchable on screen. The


NOTE software will not respond if the method details in the box next to
each memory location are touched.

850-DS Operator’s Manual 37


4 Operating the 850-DS

Method Properties (Apparatus 1/2/5/6)

This screen is applicable to Apparatus 1/2/5/6 only. For Apparatus


NOTE 3 or 7, advance to “Method Properties (Apparatus 3/7)” on
page 43.

Figure 12. Instrument Parameters

38 850-DS Operator’s Manual


4 Operating the 850-DS

Option Function

Name 30-character field for the name of this method.

Vessel Temp Desired vessel temperature for this method.

Bath Temp Desired bath temperature for this method.

Spindle Speed Desired spindle speed for this method.

Media Volume Volume of media initially in the vessels.

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.

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 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.

RPM Rotational speed used for the Final Spin.

Duration Duration the final spin will be executed.

Clear Erases all values entered and returns them to default values.

Import Allows user to import method from SD card.

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.

850-DS Operator’s Manual 39


4 Operating the 850-DS

Sample Collection Parameters (Apparatus 1/2/5/6)

Figure 13. Sample Collection Parameters - Screen 1

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.

40 850-DS Operator’s Manual


4 Operating the 850-DS

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.

Figure 14. Sample Collection Parameters - Screen 2

850-DS Operator’s Manual 41


4 Operating the 850-DS

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.

The volume removed from the dissolution vessels at each sample


NOTE timepoint equals the sample volume (mL) + waste drop volume
(mL) + 0.2 mL (fixed needle purge). The sum of these values
should be entered in mL if this option is selected for Media
Replacement.
Example:
Sample volume = 1.5 mL; Waste drop volume = 0.3 mL; Needle
purge (fixed) = 0.2 mL; Calculation: 1.5 + 0.3 + 0.2 = 2.0 mL
Media replacement = 2.0 mL

42 850-DS Operator’s Manual


4 Operating the 850-DS

Method Properties (Apparatus 3/7)

Figure 15. Sample Collection Parameters (Apparatus 3/7)

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.

850-DS Operator’s Manual 43


4 Operating the 850-DS

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.

Figure 16. Prefill Tubes / Vials Apparatus 3 / 7

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.

44 850-DS Operator’s Manual


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 17. Timepoint Number Selection (Apparatus 1/2/5/6)

Figure 18. Timepoint Number Selection (Apparatus 3/7)

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.

850-DS Operator’s Manual 45


4 Operating the 850-DS

Timepoint Parameter Entry (Apparatus 1/2/5/6)

This screen specifies the time and the parameters to use for each sample
collection.

Figure 19. Timepoint Properties Screen (Apparatus 1/2/5/6)

Option Function

Timepoint # An indicator of the currently selected timepoint.

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.

46 850-DS Operator’s Manual


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.

Figure 20. Timepoint Properties Screen (Apparatus 3/7)

Option Function

Interval The memory slot of the timepoint being configured.

Dip Interval Duration of dipping time for each row.

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.

Row Enter the desired row number.

Speed Enter the desired DPM.

Bath Temp Enter the desired bath temperature.

850-DS Operator’s Manual 47


4 Operating the 850-DS

Run Method Screen 1

Figure 21. 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:

Option Function

Next Advances to the next page of available methods.

Back Returns to the previous page.

Return Returns to the Main screen without any selections made.

48 850-DS Operator’s Manual


4 Operating the 850-DS

Run Method Screen 2

Figure 22. 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
installed.

Option Function

Operator 25-character field for operator name entry.

Lot 25-character field for lot information.

Batch 25-character field for batch information.

Note 25-character field for additional notes.

Dissolution Allows the Agilent 850-DS to control a dissolution apparatus.


Apparatus Control
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.

Instant Start a method instantly.

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.

850-DS Operator’s Manual 49


4 Operating the 850-DS

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.

Time-delayed method starts are not permitted with the


NOTE Synchronized Start option.

50 850-DS Operator’s Manual


4 Operating the 850-DS

Run Method Screen 3

Figure 23. Run Method Screen 3

Option Function

RPM Current spindle speed.

ºC Current bath temperature.

Elapsed Time Current elapsed time since the start of the method.

Next Sample Time to the next sample collection time.

Remaining Time Time required to complete the current 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.

850-DS Operator’s Manual 51


4 Operating the 850-DS

Run Method Screen 4

Figure 24. 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.

Figure 25. Run Method Screen 5

52 850-DS Operator’s Manual


4 Operating the 850-DS

850-DS Method Transfer (to another 850-DS)

You must use a 2GB or smaller SD card formatted as FAT16 or


NOTE FAT32 to complete this procedure.

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.

Figure 26. 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.

850-DS Operator’s Manual 53


4 Operating the 850-DS

6 Select the 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 27. Import Method

54 850-DS Operator’s Manual


4 Operating the 850-DS

Alarms

Press Alarms from the Main screen to configure alarms on the 850-DS.

Figure 28. Alarm Screen

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.

Moving 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 55


4 Operating the 850-DS

Calibration

Press Calibration from the Main screen to calibrate the 850-DS.

Figure 29. Calibration Screen

56 850-DS Operator’s Manual


4 Operating the 850-DS

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..

Agilent recommends calibrating using a volume of 10 mL. If that


NOTE 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.

850-DS Operator’s Manual 57


4 Operating the 850-DS

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.

mL / Stroke 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.

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

Stop Stops the volume calibration procedure.

58 850-DS Operator’s Manual


4 Operating the 850-DS

Full Range Volume Dispense


This function allows the user to verify the full range accuracy of the pump and is
only supported for 15 mL test tubes. Begin with a tray containing seven rows of
clean, dry test tubes whose initial weight has been taken. Pressing Run will start a
pumping cycle where 0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL, 4.0 mL, 10 mL, and 15 mL
will be dispensed into the corresponding first seven rows. When complete,
gravimetric analysis may be done as above to determine the actual volumes
delivered.

Option Description

Full Range Volume Run Starts the Full Range Volume Dispense cycle.
Dispense

Stop Stops the cycle immediately.

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

850-DS Operator’s Manual 59


4 Operating the 850-DS

Cleaning

Press Cleaning on the Main screen to access the cleaning cycle on the 850-DS.

Figure 33. Cleaning Parameters Screen

A validated cleaning method should be performed after each


NOTE dissolution test. This enables the 850-DS to perform at a high level
for an extended period of time while reducing ongoing
maintenance costs. Cleaning methods are formulation dependant.
If you need help determining appropriate cleaning solution and
cycles, contact the Dissolution Hotline at
dissolution.hotline@agilent.com.

60 850-DS Operator’s Manual


4 Operating 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.

Run Starts a cleaning cycle with the entered parameters.

Stop Stops a cleaning cycle.

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.

850-DS Operator’s Manual 61


4 Operating the 850-DS

Ensure that the rinse connection is not capable of siphoning


CAUTION 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.

62 850-DS Operator’s Manual


4 Operating the 850-DS

Diagnostics

Press Diagnostics on the Main screen to access diagnostics on the 850-DS.

Figure 34. 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 63


4 Operating the 850-DS

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.

Up Arrow Increments the current row number by one.

Down Arrow Decrements the current row number by one.

Move Moves the tray to the position indicated in the row indicator field.

Needle Position Up Arrow Raises the needles.

Down Arrow Lowers the needles.

Tray Position Eject Moves the tray to the eject position.

Home Performs a home of the needles, tray, and pump in order.

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.

Rinse Moves the tray to the rinse-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.

Fill Aspirates the requested volume into the syringe pump.

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.

64 850-DS Operator’s Manual


4 Operating the 850-DS

Diagnostics Screen 2

Figure 35. Diagnostics Screen 2

Option Description

Rinse Pump Pump In Activates the pump to fill the rinse row.

Pump Out Activates the pump to empty the rinse row.

Stop Stops the pump.

Media Replacement Pump Pump In Activates the pump to fill the media-replacement row.

Pump Out Activates the pump to empty the media-replacement row.

Stop Stops the pump.

Waste Pump Run Activates the waste pump (empties the waste row).

Stop Stops the pump.

Self Test Results Run Runs the self-test routine.

Print Prints the results of the self-test routine.

Printer Test Print Conducts a test to ensure the printer is functioning properly.

850-DS Operator’s Manual 65


4 Operating the 850-DS

Diagnostics Screen 3

Figure 36. 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.

66 850-DS Operator’s Manual


4 Operating the 850-DS

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.

Eject Moves the filter transport plate to the eject position.

# 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.

Close 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.

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.

850-DS Operator’s Manual 67


4 Operating the 850-DS

Diagnostic Screen 4 (Apparatus 1/2/5/6)

Figure 37. Diagnostics Screen 4 (Apparatus 1/2/5/6)

Option Description

Spindle Setpoint RPM Pressing the RPM indicator will display the numeric entry screen. Enter
the desired RPM and press RETURN.

Run Starts the spindles.

Stop Stops the spindles.

Dosage Drop Module Position Pressing the Position indicator will display the numeric entry screen.
(DDM) Enter the desired number and press RETURN.

Up Arrow Increments the DDM position.

Down Arrow Decrements the DDM position.

Single Actuates the individual DDM selected by the position indicator.

Open All Actuates all DDM modules simultaneously.

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.

Actual Displays the current actual bath temperature.

Vessel Temperatures If a manifold is installed and lowered, the current vessel temperatures
are displayed here.

68 850-DS Operator’s Manual


4 Operating the 850-DS

Option Description

Drive Up Raises the drive unit

Down Lowers the drive unit.

Manifold Up Raises the manifold.

Down Lowers the manifold.

850-DS Operator’s Manual 69


4 Operating the 850-DS

Diagnostic Screen 4 (Apparatus 3/7)

Figure 38. Diagnostics Screen 4 (Apparatus 3/7)

Option Description

Sample Head Home Returns the drive unit to the home position.

Row Enter the desired row number.

Move Moves the drive unit to the entered row.

Sample Speed Enter the desired speed in DPM.

Dip Hold Time Stops the inner sample tubes / sample holders at the bottom of
the stroke for the length of time entered.

Run Begins manual dipping.

Stop Stops manual dipping.

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.

Actual Displays the current actual bath temperature.

70 850-DS Operator’s Manual


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 39. Instrument Settings Screen 1

850-DS Operator’s Manual 71


4 Operating the 850-DS

Option Description

Collector Serial Number Manufacturer-assigned serial number.

LAN MAC Address MAC address that will be used for LAN communications.

Firmware Version Version of the firmware installed on the instrument.

Release Date Release date of the firmware.

Collector Name A 25-character field to describe the instrument.

Collector Comm ID 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.

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.

Comm ID Communications ID of the attached Agilent dissolution apparatus.

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.

100-vial Tray Indicates a rack holding an array of 10 x 10 (offset spacing) for 2 mL


vials is installed.

72 850-DS Operator’s Manual


4 Operating the 850-DS

Figure 40. Vessel Assignment Screen

Vessel Assignments This screen allows you to enter a category for each vessel's usage.
These categories are used for reporting only.

Instrument Settings Screen 2

Figure 41. Instrument Settings Screen 2

850-DS Operator’s Manual 73


4 Operating the 850-DS

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.

LCD Settings Brightness Up Increases the brightness of the LCD backlight.

Brightness Down Decreases the brightness of the LCD backlight.

Speaker Up Increases the volume of the internal speaker.

Speaker Down Decreases the volume of the internal speaker.

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.

74 850-DS Operator’s Manual


4 Operating the 850-DS

Figure 42. Touch Screen Calibration Screen

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.

850-DS Operator’s Manual 75


4 Operating the 850-DS

Option Description

Date / Time Pressing Data / Time will display the Date and Time setting screen.

Figure 43. Date and Time Change 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.

Return Returns to the Instrument Settings screen.

76 850-DS Operator’s Manual


4 Operating the 850-DS

Manufacturing Configuration

The Mfg. Config. menu can only be accessed by a certified Agilent


NOTE representative. The options enabled or disabled on this screen
control functions visible to the user when operating the 850-DS.

Figure 44. Mfg Config Screen

850-DS Operator’s Manual 77


4 Operating the 850-DS

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 45. Reports

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.

Return Returns to the Main screen.

In order to print reports to the printer, the optional printer must be


NOTE enabled. All other functions are available with the Enable Printer
function deselected.

78 850-DS Operator’s Manual


4 Operating the 850-DS

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.

850-DS Operator’s Manual 79


4 Operating the 850-DS

Figure 46. 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.

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.

80 850-DS Operator’s Manual


4 Operating the 850-DS

Figure 47. User Level Setting

Figure 48. Users List

850-DS Operator’s Manual 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.

82 850-DS Operator’s Manual


4 Operating the 850-DS

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 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.

Cleaning Cycle Complete

Displays when the cleaning cycle is complete.

850-DS Operator’s Manual 83


4 Operating the 850-DS

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.

Configure User Authority

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.

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.

84 850-DS Operator’s Manual


4 Operating the 850-DS

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 timepoint, sample collection
will be skipped.

Sample Tray Ejected

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.

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.

850-DS Operator’s Manual 85


4 Operating the 850-DS

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 56) 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.

User Delete Confirmation

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.

Error Screens (Red)

86 850-DS Operator’s Manual


4 Operating the 850-DS

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 93..

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.

850-DS Operator’s Manual 87


4 Operating the 850-DS

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 65.) and close the clamp plates. Once closed, normal pumping is
allowed.

88 850-DS Operator’s Manual


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 65.) and open the clamp plates. Once
opened, normal filter transport movement is allowed.

850-DS Operator’s Manual 89


4 Operating the 850-DS

This page was intentionally left blank, except for this message.

90 850-DS Operator’s Manual


5 Maintenance and Troubleshooting
Preventive Maintenance 92
Printer Maintenance 93
Obtaining Warranty and Other Services 96

850-DS Operator’s Manual 91


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 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

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

92 850-DS Operator’s Manual


5 Maintenance and Troubleshooting

Printer Maintenance

Removing a Thermal Paper Roll

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.

Figure 49. Accessing the Printer Panel

2 Use your fingers to remove the small roll or core.

The empty core is disposable. Each new roll includes a cardboard


NOTE core.

850-DS Operator’s Manual 93


5 Maintenance and Troubleshooting

Inserting a Thermal Paper Roll

Only a 58 mm wide x 13.65 meter (maximum) long thermal printer


NOTE paper roll can be used in the printer. For an FDA environment, it
must also meet the ten-year retention requirement. Ordering
replacement paper from Agilent is recommended.

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.

Figure 50. Inserting a Thermal New Paper Roll

94 850-DS Operator’s Manual


5 Maintenance and Troubleshooting

2 Keeping the paper centered, close the printer panel and snap it into place.

Figure 51. Closing the Printer Chamber

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.

Figure 52. Feeding Paper

Thermal Printer Test

In the second Diagnostics screen, under Printer Test, press to print sample
text and verify the printer is functioning properly.

850-DS Operator’s Manual 95


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.

96 850-DS Operator’s Manual


In This Book
• Chapter 1 Safety
• Chapter 2 Introduction
• Chapter 3 Setting Up the 850-DS
• Chapter 4 Operating the 850-DS
• Chapter 5 Maintenance and Troubleshooting

www.agilent.com
© Agilent Technologies, Inc. 2020
70-9074 Rev F February 2020

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy