Agilent Technologies 280-DS User manual

280-DS (G7980AA) Mechanical Qualification System
Operator’s Manual

Notices
Manual Part Number
70-9071 Rev D
May 2019
Copyright
© Agilent Technologies, Inc. 2019
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Safety Notices
CAUTION
A CAUTION notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly
performed or adhered to, could
result in damage to the product or
loss of important data. Do not
proceed beyond a CAUTION
notice until the indicated
conditions are fully understood
and met.
WARNING
A WARNING notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly
performed or adhered to, could
result in personal injury or death.
Do not proceed beyond a
WARNING notice until the
indicated conditions are fully
understood and met.

280-DS Operator’s Manual 3
Content
1Safety 5
Notes, Cautions, and Warnings 6
Warning 6
Caution 6
Note 6
Information Symbols 7
2 Introduction 9
3 Setting Up the 280-DS 11
Unpacking Your Equipment 12
280-DS Components 13
Vessel Module 13
Instrument Module 14
Magnetic Clip 15
Temperature Probe 15
Setting up the 280-DS 16
Cable Connections 16
Power Cord Connections 16
Requirements and Configuration 18
Environmental Requirements for Use 18
PC Requirements 18
Software Installation 19
Upgrading 280-DS Workstation 19
Migrating 280-DS Data to different PC 20
Local Security Policy 21
Starting 280-DS Workstation 23
Starting 280-DS Workstation 23
280-DS Workstation Logon 24
Adding Users to the Application 25

Content
4280-DSOperator’sManual
4 Operating the 280-DS 27
280-DS Workstation Logon 28
280-DS Operation 30
Dissolution Apparatus 30
Method Editor 36
Run Method (Method Execution) 41
Running a Method 47
Diagnostics 78
Test Reports 82
Trends 85
Security (21 CFR Part 11 Compliance) 87
Change User 87
Lock Application 87
Audit Trail 88
Permissions 89
Tools 90
Database Backup and Restore Functions 93
5 Troubleshooting and Maintenance 95
Preventive Maintenance 96
Recalibration 96
Troubleshooting 97
6 Service and Warranty 101
Service and Warranty Information 102
Obtaining Warranty and Other Services 102

280-DS Operator’s Manual 5
1Safety
Notes, Cautions, and Warnings 6

1Safety
6280-DSOperator’sManual
Notes, Cautions, and Warnings
Warning
WARNING
A ‘Warning’ message appears in the manual when failure to observe instructions
or precautions could result in death or injury.
Read all warnings and cautions carefully and observe them at all times.
Caution
CAUTION
A ‘Caution’ message appears in the manual when failure to observe instructions
could result in damage to equipment (Agilent supplied and / or other associated
equipment).
Note
NOTE
A ‘Note’ appears in the manual to give advice or information.

1Safety
280-DS Operator’s Manual 7
Information Symbols
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.

1Safety
8280-DSOperator’sManual
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280-DS Operator’s Manual 9
2Introduction

2Introduction
10 280-DS Operator’s Manual
The 280-DS Mechanical Qualification System (MQS) is a device which measures
the critical physical parameters of a dissolution apparatus. A Windows®-based
software interface captures data from and communicates through USB with two
independent modules that comprise the physical part of the device. A hand-held
temperature probe is included as an additional accessory.
The 280-DS MQS is capable of measuring the following parameters on a 1-liter
dissolution apparatus: vessel plate level and vibration, bath or vessel
temperatures, paddle or basket height, spindle shaft centering, spindle shaft
verticality, spindle shaft wobble, spindle shaft speed (RPM), vessel verticality, and
basket rim wobble.
The software interface, which is designed to run on Microsoft Windows 7 or 10
(32-bit and 64-bit), implements controls for the Electronic Records and Electronic
Signatures Rule (21 CFR Part 11) established by the FDA. The interface also
supports the mechanical qualification tests required by the ASTM, USP, Chinese
Pharmacoepeoia and US FDA standards bodies for USP Apparatus 1 (Basket)
and 2 (Paddle) dissolution apparatus.

280-DS Operator’s Manual 11
3 Setting Up the 280-DS
Unpacking Your Equipment 12
280-DS Components 13
Setting up the 280-DS 16
Requirements and Configuration 18
Starting 280-DS Workstation 23

3 Setting Up the 280-DS
12 280-DS Operator’s Manual
Unpacking Your Equipment
The 280-DS consists of the Instrument Module (IM), Vessel Module (VM),
temperature probe, module intercommunication cable, USB cable, and RPM
magnetic clip, all packaged in a rugged, compression-resistant case.
A Windows-based PC running the 280-DS Workstation software powers and is
connected to the Instrument Module (IM) with a USB cable. The IM connects to
the Vessel Module (VM) through the module intercommunication cable. The VM
is inserted into the vessel for all position-specific measurements. The IM is
placed on an applicable flat surface (e.g., the vessel plate) and provides the
temperature-probe interface.
Prior to use:
1Remove all system components from the packing material.
2Inspect the equipment and accessories to ensure there has been no damage
during shipment.
3Place the base unit and accessories on a clear, dry, level section of the bench
top close to the dissolution apparatus.

3 Setting Up the 280-DS
280-DS Operator’s Manual 13
280-DS Components
Vessel Module
The Vessel Module (VM) measures rotational speed, basket/shaft wobble, vessel
centering, shaft verticality, vessel verticality, and basket/paddle height. Once
properly positioned, this module provides reliable, repeatable measurements
using innovative sensing technology.
Figure 1. Vessel Module

3 Setting Up the 280-DS
14 280-DS Operator’s Manual
Instrument Module
The 280-DS Instrument Module (IM) is used to record vessel plate level (x- and
y-axis) and vibration (x-, y-, and z-axis) while also acting as a hub for the Vessel
Module, temperature probe, and connection to the PC. Quantitative values for
each parameter are recorded and visible in real-time via the software interface.
Figure 2. Instrument Module

3 Setting Up the 280-DS
280-DS Operator’s Manual 15
Magnetic Clip
The magnetic clip is used in conjunction with the magnetic tachometer sensor to
measure RPM. Each time the magnet passes the sensor, one rotation is counted.
Figure 3. Magnetic Clip
Temperature Probe
The temperature probe is used to verify the accuracy of the water bath and
vessel temperature probes on the dissolution apparatus. It can also be used to
record individual temperatures prior to beginning a dissolution test.
Figure 4. Temperature Probe

3 Setting Up the 280-DS
16 280-DS Operator’s Manual
Setting up the 280-DS
Cable Connections
1Connect the USB cable from the USB port on the Instrument Module to a USB
port on the measurement computer.
2Connect the 280-DS Vessel Module to the Instrument Module via the module
intercommunication cable.
3Optionally, connect the measurement computer to the dissolution apparatus
using a 9/25 pin RS-232 cable (“Preparing the Dissolution Apparatus” on
page 42).
Power Cord Connections
1Connect or verify connection of the AC power cord between the power
receptacle on the PC and an AC electrical supply of the appropriate voltage. If
using a laptop, the 280-DS can also be used when the laptop is on battery
power.
NOTE
The online testing mode provides direct communication between
the dissolution apparatus and the 280-DS Workstation software.
This feature is only available for Agilent, Varian, or VanKel
dissolution apparatus models.
For PCs without a 9-pin serial port, a USB-to-Serial adapter may be
configured and used to communicate with the dissolution
apparatus.
NOTE
Please ensure your computer’s battery is appropriately charged
before using the 280-DS on battery power. The 280-DS draws
power from the computer connected to it and will drain the battery
faster than normal.

3 Setting Up the 280-DS
280-DS Operator’s Manual 17
2Connect or verify connection of the AC power cord between the power
receptacle on the dissolution apparatus and an AC electrical supply of the
appropriate voltage.
3Turn on the PC and dissolution apparatus.

3 Setting Up the 280-DS
18 280-DS Operator’s Manual
Requirements and Configuration
Environmental Requirements for Use
•Humidity: max relative humidity 75% non-condensing
•Indoor use only
•Temperature: 10 ºC to 35 ºC
PC Requirements
The software is designed to run on a PC-based platform with the following
minimum specifications:
•1.5 GHz or faster Pentium 4 processor
•1 GB of RAM or more
•16X CD-ROM drive
•1 USB port (minimum)
•10 GB of space on the hard drive
•1280 x 960 at 16M colors (minimum)
•Windows 7 or 10 (32-bit or 64-bit) operating system

3 Setting Up the 280-DS
280-DS Operator’s Manual 19
Software Installation
1Insert the 280-DS Workstation CD and access the files contained on the CD.
2Execute setup.exe and follow the on-screen prompts.
Upgrading 280-DS Workstation
1Back up the original/current database using MSDE Manager (see “Backing up
the Database” on page 93). Store this backup file in a safe location.
2Log on to the PC as user with Administrator privileges.
3Launch setup.exe from the 280-DS Workstation installation media and follow
the instructions on screen.
Post-upgrade Cleanup Steps (Optional)
1Go to Control Panel > Programs > Programs and Features.
2Select Microsoft SQL Server 2005 and click Uninstall. Follow the on-screen
instructions to remove this program.
NOTE
You must log on to the computer as an administrator to set up the
software and run it for the first time.
NOTE
If Windows User Access Control (UAC) displays during the
installation process, click Allow to continue installation.
NOTE
When asked if you want to install the Microsoft .Net Framework,
you are required to click Yes.
NOTE
The following steps are not required to run the 280-DS
Workstation software, but they will remove unnecessary programs
and free some disk space on the computer.

3 Setting Up the 280-DS
20 280-DS Operator’s Manual
Migrating 280-DS Data to different PC
1For a clean installation (e.g. no previous version of the software exists on the
PC) of 280-DS Workstation, launch setup.exe from the installation media and
follow the instructions on screen.
2Back up the original/current database using MSDE Manager (see “Backing up
the Database” on page 93). Store this backup file in a safe location.
3On the original computer launch setup.exe from the installation media of the
new version of 280-DS Workstation and follow the instructions on screen.
4After upgrading 280-DS Workstation on the old computer, go to Programs >
Agilent > Dissolution > MSDE Manager to create another backup of this
database.
5Transfer this database backup file (.bak) to the new computer (e.g. via USB
stick).
6On the new computer go to Programs > Agilent > Dissolution > MSDE
Manager to restore the database.
NOTE
To move 280-DS Workstation software and data to another PC
and use the latest version, you have to upgrade the
previous/current installation first and then move the data to the
new computer.
CAUTION
This step will delete any data in the database of the new
computer.
NOTE
It is not possible to merge data from two previously created
databases.