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
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© 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
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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
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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.