Agilent Technologies 280-DS Manual de usuario

280-DS (G7980AA) Mechanical Qualification System

Operator’s Manual

Notices

Manual Part Number

70-9071 Rev D

May 2019

No part of this manual may be

reproduced in any form or by any means

(including electronic storage and retrieval

or translation into a foreign language)

without prior agreement and written

consent from Agilent Technologies, Inc.

as governed by United States and

international copyright laws.

Agilent Technologies, Inc.

3501 Stevens Creek Blvd.

Santa Clara, CA 95052 USA

Warranty

The material contained in this document

is provided “as is,” and is subject to being

changed, without notice, in future

editions. Further, to the maximum extent

permitted by applicable law, Agilent

disclaims all warranties, either express or

implied, with regard to this manual and

any information contained herein,

including but not limited to the implied

warranties of merchantability and fitness

for a particular purpose. Agilent shall not

be liable for errors or for incidental or

consequential damages in connection

with the furnishing, use, or performance

of this document or of any information

contained herein. Should Agilent and the

user have a separate written agreement

with warranty terms covering the

material in this document that conflict

with these terms, the warranty terms in

the separate agreement shall control.

Technology Licenses

The hardware and/or software described

in this document are furnished under a

license and may be used or copied only in

accordance with the terms of such

license.

Restricted Rights Legend

U.S. Government Restricted Rights.

Software and technical data rights

granted to the federal government

include only those rights customarily

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license in Software and technical data

pursuant to FAR 12.211 (Technical Data)

and 12.212 (Computer Software) and, for

the Department of Defense, DFARS

252.227-7015 (Technical Data -

Commercial Items) and DFARS

227.7202-3 (Rights in Commercial

Computer Software or Computer

Software Documentation).

Safety Notices

CAUTION

A CAUTION notice denotes a

hazard. It calls attention to an

operating procedure, practice, or

the like that, if not correctly

performed or adhered to, could

result in damage to the product or

loss of important data. Do not

proceed beyond a CAUTION

notice until the indicated

conditions are fully understood

and met.

WARNING

A WARNING notice denotes a

hazard. It calls attention to an

operating procedure, practice, or

the like that, if not correctly

performed or adhered to, could

result in personal injury or death.

Do not proceed beyond a

WARNING notice until the

indicated conditions are fully

understood and met.

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

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

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

280-DS Operator’s Manual 9

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.

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