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Agilent 280-DS Tester Operator's Manual PDF

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Summary of Content for Agilent 280-DS Tester Operator's Manual PDF

280-DS (G7980AA) Mechanical Qualification System

Operators Manual

Notices Manual Part Number 70-9071 Rev D May 2019

Copyright Agilent Technologies, Inc. 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 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).

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.

Content

1 Safety 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

280-DS Operators Manual 3

Content

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

4 280-DS Operators Manual

1 Safety Notes, Cautions, and Warnings 6

280-DS Operators Manual 5

1 Safety

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.

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1 Safety

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.

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1 Safety

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

8 280-DS Operators Manual

2 Introduction

280-DS Operators Manual 9

2 Introduction

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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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

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3 Setting Up the 280-DS

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: 1 Remove all system components from the packing material. 2 Inspect the equipment and accessories to ensure there has been no damage

during shipment. 3 Place the base unit and accessories on a clear, dry, level section of the bench

top close to the dissolution apparatus.

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3 Setting Up the 280-DS

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

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3 Setting Up the 280-DS

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

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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

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3 Setting Up the 280-DS

Setting up the 280-DS

Cable Connections

1 Connect the USB cable from the USB port on the Instrument Module to a USB port on the measurement computer.

2 Connect the 280-DS Vessel Module to the Instrument Module via the module intercommunication cable.

3 Optionally, 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

1 Connect 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 computers 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.

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2 Connect 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.

3 Turn on the PC and dissolution apparatus.

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3 Setting Up the 280-DS

Requirements and Configuration

Environmental Requirements for Use

Humidity: max relative humidity 75% non-condensing Indoor use only Temperature: 10 C to 35 C

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

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3 Setting Up the 280-DS

Software Installation

1 Insert the 280-DS Workstation CD and access the files contained on the CD. 2 Execute setup.exe and follow the on-screen prompts.

Upgrading 280-DS Workstation

1 Back up the original/current database using MSDE Manager (see Backing up the Database on page 93). Store this backup file in a safe location.

2 Log on to the PC as user with Administrator privileges. 3 Launch setup.exe from the 280-DS Workstation installation media and follow

the instructions on screen.

Post-upgrade Cleanup Steps (Optional)

1 Go to Control Panel > Programs > Programs and Features. 2 Select 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.

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3 Setting Up the 280-DS

Migrating 280-DS Data to different PC

1 For 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.

2 Back up the original/current database using MSDE Manager (see Backing up the Database on page 93). Store this backup file in a safe location.

3 On the original computer launch setup.exe from the installation media of the new version of 280-DS Workstation and follow the instructions on screen.

4 After upgrading 280-DS Workstation on the old computer, go to Programs > Agilent > Dissolution > MSDE Manager to create another backup of this database.

5 Transfer this database backup file (.bak) to the new computer (e.g. via USB stick).

6 On 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.

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Local Security Policy

1 Click Start > Run. 2 Type secpol.msc and click Enter to run the Local Security Settings Manager.

The Local Security Settings screen displays. 3 Click Security Settings > Account Policies > Password Policy and set the

applicable security policy configuration.

NOTE For 21 CFR Part 11 compliance purposes (physical requirement section 11.300 b), you must ensure that the following minimum requirements are met by your system's security policy.

Internal IT requirements may differ from the settings outlines in this section. It may be necessary to coordinate this configuration with the domain controller.

Policy Security Setting

Enforce Password History

3 passwords remembered

Maximum Password Length

30 days

Minimum Password Length

6 characters

Password Must Meet Complexity Requirements

Enabled

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3 Setting Up the 280-DS

4 Click Security Settings > Account Policies > Account Lockout Policy. Configure the options.

5 Click Security Settings > Local Policies > Audit Policy and set the options.

Policy Security Setting

Account lockout duration

0 minutes (infinite)

Account lockout threshold

3 invalid login attempts

Reset account lockout counter

99999 minutes

Policy Security Setting

Audit account logon events

Success, Failure

Audit account management

Success, Failure

Audit login events Success, Failure

Audit policy change Success, Failure

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Starting 280-DS Workstation

Starting 280-DS Workstation

1 Double-click the 280-DS Workstation icon on the Windows desktop to start the software.

2 If your system has Windows Firewall enabled, the Windows Security Alert screen displays. Click Unblock to enable the program.

NOTE You must log on to the computer as an administrator to set up the software and run it for the first time.

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3 Setting Up the 280-DS

280-DS Workstation Logon

Figure 5. Logon

1 From the logon screen, enter your credentials in the User ID and Password boxes.

2 Click OK. 3 Click Logon to initiate the software.

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Adding Users to the Application

1 After successfully logging on to the software, click Tools > Options. The Configuration Dialog screen displays.

2 To add a user to a group, select the Security tab on the Configuration Dialog screen.

Click User Administration at the bottom of the screen. The Local Users and Groups screen displays.

Figure 6. Local Users and Groups

3 Double-click the Groups folder to expand the list of groups. 4 Double-click all eight of the groups that begin with Vk and ensure that your

username is logged in and is identified as a member of these groups.

NOTE To complete this section, you must be logged on as an administrator

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3 Setting Up the 280-DS

5 To add a user to a group, click Add... from the respective group screen. The Select Users, Computers, Services Accounts, or Groups screen displays.

Figure 7. Adding a User

6 Enter your user identification in the empty box and click Check Names. Ensure your user identification and domain populate the empty field. Click OK.

7 Close the Local Users and Groups screen. 8 Click OK to close the Configuration Dialog screen.

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4 Operating the 280-DS 280-DS Workstation Logon 28 280-DS Operation 30 Security (21 CFR Part 11 Compliance) 87

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4 Operating the 280-DS

280-DS Workstation Logon

1 Double-click 280-DS Workstation icon. The Logon screen displays.

Figure 8. Logon

2 Enter your Windows credentials in the User ID and Password boxes. 3 Verify the domain and the dissolution server are correct and click Logon. The

280-DS Workstation screen displays:

Figure 9. 280-DS Workstation Homescreen

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The following options are available in the navigation bar on the 280-DS Workstation homescreen:

Option Function

Dissolution Apparatus

Create a file for each dissolution apparatus. All relevant data including configuration and component serial numbers are stored within this file. See Dissolution Apparatus on page 30..

Method Editor Create a test method to define parameters to be measured and their respective tolerances. See Method Editor on page 36..

Run Method Begin a test using previously created apparatus and method. See Run Method (Method Execution) on page 41..

Diagnostics Verify communication or view real-time data from the modules. See Diagnostics on page 78..

Test Reports Search and retrieve previously executed tests based on various filtered criteria. See Test Reports on page 82..

Trends Create custom reports showing performance over time for a particular dissolution apparatus, operator, or date range. See Trends on page 85..

Change User Log on to the 280-DS Workstation software as a different user. See Change User on page 87..

Lock Application Lock the 280-DS Workstation software. See Lock Application on page 87..

Audit Trail Verify, filter, or create reports of logon information for the 280-DS Workstation software. See Audit Trail on page 88..

Permissions View the rights and privileges for the current user of the 280-DS Workstation software. See Permissions on page 89..

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4 Operating the 280-DS

280-DS Operation

Dissolution Apparatus

Click Dissolution Apparatus from the 280-DS Workstation homescreen to add or edit the dissolution apparatus being used for 280-DS test methods.

Option Function

Create Displays the Dissolution Apparatus editor screen to create a new dissolution apparatus entry.

Delete Deletes the selected dissolution apparatus from the viewable list.

Report Displays a summary report for the selected dissolution apparatus.

Properties Displays the current settings for the selected dissolution apparatus.

Recover Deleted Allows you to recover deleted dissolution apparatus which can be selected from a list of deleted items.

Show Audit Trail Displays a list of all revisions to a specific dissolution apparatus with the ability to compare multiple versions and view the differences. Note: To create a report detailing version changes, highlight the desired versions (by clicking and holding the CTRL key) and click Differences.

Verify Integrity Verifies that the data for the dissolution apparatus was not altered outside of the application.

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Figure 10. Dissolution Apparatuses

1 Click Create to enter a new instrument or, simply double-click an existing apparatus file to open the Configuration Editor and edit its current conditions.

NOTE If an Agilent dissolution apparatus is connected to the computer, you can import its serial number and identification information by clicking Download.

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2 Enter the applicable identification information for the dissolution apparatus in the provided fields.

Figure 11. Identification Information

Option Function

Manufacturer Manufacturer of the dissolution apparatus.

Serial Number Serial number associated with the dissolution apparatus.

Apparatus Model Model number of the dissolution apparatus.

Apparatus ID Any internal identification associated with the apparatus.

Location Location of the dissolution apparatus.

Vessels Number of vessels (between 1 and 14).

Temperature Probes Specify temperature-measuring devices: bath and/or vessel.

Vessel Numbering Available vessel-numbering schema (numbering) options.

Edit Custom Schema If Custom Schema is selected from the drop-down options, you can click here to specify the number of vessel positions and how they should be numbered.

Change Management Check the Restrict method editing rights to the system owner box to protect the method from outside editing.

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3 Click Next to proceed to the next screen where you can enter the applicable shaft diameters.

Figure 12. Dissolution Apparatus Shaft Diameters

Option Function

Default Shaft Diameter

Enter the value manually and press Fill with default to fill the fields with the entered value. You can also enter each shaft diameter individually.

Shaft Measurement Device

Enter the model, serial number, and calibration information associated with the measurement device (e.g., caliper) used.

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4 Click Next to proceed to the following screen where you can record serial numbers for any attachable parts such as baskets, paddles, shafts, vessels, or spin on/off shafts.

Figure 13. Component Serial Number

Option Function

Position Select a Position from the drop-down list (1 - 8).

Component Select a Part Type from the drop-down list (Basket Shaft, Basket, Paddle Shaft, Receptor Shaft, Vessel).

Serial Number Enter the serial number for the associated part.

Manufacturer Enter the manufacturer of the accessory or select from the available options of the drop-down list.

Certificate Click ... to upload and link a certificate of conformance to the specified accessory. This file may be a .pdf, .doc, or image file (.jpeg, .gif, .bmp, .png).

Delete Place a check in this box and confirm deletion to remove the specified component.

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5 If you have made any changes, then upon completion of the wizard, you will be asked to explain or provide a reason for the change to comply with 21 CFR Part 11.

Figure 14. Reason for Change

NOTE You can click Cancel at any time and no changes will be saved. You can also click Finish at any time to skip remaining steps.

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Method Editor

From the 280-DS Workstation homescreen, click Method Editor to access the Test Methods screen.

Figure 15. Test Methods

1 If an existing method is displayed in the list, double-click the entry to open the Method Editor. When editing a method, previously saved information displays in the fields.

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2 If the list is blank, click New Method to enter a new method. Option Function

New Method Displays the Method Editor screen.

Copy Method Prepares the selected method to be copied.

Paste Copies the selected method by creating a new method with the product name of the original method with the prefix Copy of before the file name.

Delete Deletes the method from the viewable method list.

Report Displays a printable summary of a particular method version.

Properties Opens the selected method for editing.

Recover Recovers deleted methods from the database.

Show Audit Trail Displays a list of all of the revisions of the method. This allows you to compare two versions of a method and view the differences between them. Note: To create a report detailing version changes, highlight the desired versions (by clicking and holding the CTRL key) and click Differences.

Verify Integrity Verifies that the method data has not been changed outside of the application.

Import Imports an existing method into the Test Methods list.

Export Exports a particular version of the selected method as an XML file.

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Method Editor General Tab

1 Double-click a method or single-click a method and click Properties to open the Method Editor. The General tab is displayed by default.

Figure 16. Method Editor General Tab

Option Function

Method Name Enter a method name.

Notes Enter any applicable notes associated with the method.

Require Comments on Failed Measurements

When this option is enabled, you will be required to enter a comment when a value is acquired outside of the parameter specifications.

Update Qualification Record

When this option is selected, upon successful completion of the method, the dissolution apparatus qualification date is reset to the current date and you are prompted to schedule the next due date. An instrument log is maintained for the dissolution apparatus in the database.

Change Management Check the Restrict method editing rights to the method owner box to protect the method from outside editing.

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Method Editor Specification Tab

1 Click the Specification tab. The Specification page provides the list of available tests and fields for entering specification limits and or nominal values. Many default specifications (e.g., USP, FDA, ASTM) are available for your convenience. The pre-entered options will change and/or will be grayed out depending on your configuration.

2 Edit the default specifications by clicking on each one and modifying the values. If any adjustment is made to the pre-loaded specifications, Custom will display as the Compliance Specification. Place a check in the n/a box to exclude that test from the method.

Figure 17. Specification Tab

3 You can click OK or Cancel on any page of this sequence. If you have changed the method, you will be asked for a reason for the change. After you enter a reason for the change, the method data, new or modified, is saved to the database. If you created a new method, the method version will be indicated by the number 1. If you modified a method, its version will be increased by 1

NOTE Separate additional RPMs in the Rotational Speed box by using a comma, space, or semicolon.

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instead.

Figure 18. Reason for Change

NOTE You can click the Cancel at any time and no changes will be saved.

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Run Method (Method Execution)

From the 280-DS Workstation homescreen, click Run Method to run a method.

Select Test Method

The illustration in the figure below depicts the connection between the 280-DS modules and the PC. 1 Ensure the 280-DS IM and VM cables are connected. 2 Click Next to open the connection.

Figure 19. Select Test Method

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Preparing the Dissolution Apparatus

Figure 20. Prepare the Dissolution Apparatus

The preparation screen allows you to select either online (connected to an Agilent, Varian, or VanKel dissolution apparatus) or offline testing. 1 Select Online Testing or leave it unchecked.

2 Click Next to continue.

NOTE If Online Testing is enabled, the software will search for an available dissolution apparatus. If this option is left disabled, you will be prompted to select the Dissolution Apparatus from the list of existing configurations. Online Testing is only available with Agilent and supported Varian or VanKel dissolution apparatus.

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Selecting the Dissolution Apparatus

1 Select the dissolution apparatus to be measured, if applicable. 2 Click Next to continue.

Figure 21. Select the Dissolution Apparatus

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Selecting Test Method

The screen displays a list of available methods. 1 Select the method to be executed. 2 Click Next to continue.

Figure 22. Select the 280-DS Test Method

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Selecting the Stirring Element

1 Select the applicable stirring element for the test and check the boxes next to the positions you want to test.

2 Click Next to continue.

Figure 23. Stirring Element and Vessel Positions

NOTE If any of the Active Positions are unchecked, the software will notify you that the dissolution apparatus qualification record will not be updated since no positions are being tested. For any test procedure executed with less than the complete set of active vessels, FOR REFERENCE ONLY will appear on the final test report.

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Method Summary and Dissolution Assembly Summary

1 Review and/or print a report of the method and dissolution apparatus. The Method tab is displayed by default.

2 When finished, click Begin Test to begin testing.

Figure 24. Method Summary Tab

Figure 25. Dissolution Apparatus Tab

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Running a Method

Activity Log

While running a method, an activity log is created. You can check the activity log at any time by clicking the Activity Log tab. You can also print the activity log before exiting the method if Print Activity Log is enabled.

NOTE When you click Begin Test, the software will guide you through the sequence of tests defined within the method. See Method Editor on page 36..

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Instrument Module Position on the Vessel Plate

If a vessel plate level test is required, the software prompts you to place the 280-DS Instrument Module (IM) on the vessel plate as shown in the figure below. 1 Position the IM on the vessel plate in an appropriate location. 2 Click Run to start data collection.

Figure 26. IM Position on Vessel Plate

NOTE The AS FOUND values displayed on the lower left of the screen will be recorded on the test report when you click Run. This data is updated in real time.

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Vessel Plate Level Measurement

1 While on the Vessel Plate Level Measurement page, you can adjust the vessel plate if it is not level. A green check mark displays on the screen if an acceptable level has been verified.

2 Click Accept to record the result.

Figure 27. Vessel Plate Level Measurement

NOTE If you select Require Comments on Failed Measurements when setting up a method, you will be required to enter a comment with an explanation for any failed result.

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Vessel Module Vessel Centering Arm Placement

If any of the shaft/vessel alignment tests are required then the software prompts you to zero the encoder of the diameter arm of the Vessel Module. 1 Hold the Vessel Module in a way that does not restrict the movement of the

diameter arm (Figure 28 on page 51).

2 Click Zero to continue the test.

CAUTION Ensure the manifold and evaporation covers on the dissolution apparatus are removed prior to using the Vessel Module. Refer to the applicable section in the documentation of your dissolution apparatus for removal instructions.

CAUTION Do not place a finger in the cavity in the bottom of the Vessel Module. Doing so can contaminate the lenses inside and cause invalid readings.

NOTE Prior to measuring parameters within the dissolution vessel, please ensure that the vessel orientation at each active location is properly established.

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Figure 28. Proper Hand Position to Zero Diameter Arm

Figure 29. VM Vessel Centering Arm Placement

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Vessel Module Placement

Figure 30. Position for Vessel Module Placement

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1 Pull back the vessel diameter arm lever and insert the Vessel Module into the dissolution vessel and position it as illustrated by the software. Ensure that the height arm extension reaches the bottom-middle of the dissolution vessel.

Figure 31. Diameter Measurement Arm Lever

CAUTION The diameter measurement arm should be either retracted or held manually during the insertion process.

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NOTE You may need to adjust the height arm of the Vessel Module to allow for the extension to reach the bottom-center of the dissolution vessel. To adjust the travel of this arm, adjust the pin setting as shown in Figure 32.

Figure 32. Height Arm Pin

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2 Slowly lower the Vessel Module into the vessel until it is seated properly.

Figure 33. Inserting the Vessel Module

NOTE For an EaseAlign vessel, ensure that you are lowering it down into the vessel so it is oriented with the vessel diameter arm going into the DDM cutout on the EaseAlign centering ring. Once lowered, turn the Vessel Module so that the arm lever doesnt contact the EaseAlign ring posts.

NOTE For 7025 and 7030 models, evaporation covers must be removed prior to VM insertion. For 708-DS, 709-DS, 7000 and 7010 models, it is necessary to remove the sampling manifold and evaporation covers prior to VM insertion.

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3 Slowly release the vessel diameter arm. Push down until the underside of the top of the Vessel Module touches the top of the vessel collar. Ensure that the Vessel Module height arm extension is touching the bottom of the vessel.

Figure 34. VM Resting at the Bottom of the Vessel

4 Lower the paddle or basket to the operating position. 5 Check the AS FOUND values to ensure the shaft has been detected and the

VM is properly seated. The AS FOUND values are displayed to ensure proper placement. The AS FOUND values will be stored and displayed on the final report when you select Run.

6 Click Run to move on to the first in-vessel test.

WARNING The Vessel Module contains several components that are spring loaded. Use care to avoid pinching or damaging the vessel when releasing the diameter arm.

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Paddle or Basket Height

1 To measure the height, push the height lever to move the height arm extension to the bottom of the paddle or basket.

2 Hold for a few seconds until the Accept button is available for selection and release it. The maximum reading is recorded as basket/paddle height.

Figure 35. Paddle or Basket Height

3 Click Accept to store the value and continue to the next screen.

NOTE If a basket or paddle is not at the desired position, you can adjust and re-measure it by clicking Reset to repeat the test. Ensure that the Vessel Module height arm extension is touching the bottom-center of the vessel.

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Figure 36. Paddle / Basket Height

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Vessel / Shaft Verticality and Vessel Centering

The following tests will be executed simultaneously on this screen: Vessel Verticality - 2 points, 90 deg. apart Shaft Verticality - 2 points, 90 deg. apart Vessel / Shaft Centering (Upper and Lower) - Upper and Lower vessel

position

Figure 37. Verticality and Centering Measurement

1 Once satisfactory results have been achieved, you can document the Vessel Orientation in the open text field. The description you enter will be displayed on the report and stored for future reference.

2 Click Accept to continue to the next screen.

NOTE You can make adjustments to the dissolution apparatus at any time prior to clicking Accept to optimize the performance of the instrument.

NOTE Comments entered under the Common tab apply to all of the tests while comments entered under the Vessel Verticality, Shaft Verticality, or Vessel/Shaft Centering tabs apply only to the individual test.

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Shaft Wobble Test Preparation

After alignment is complete, the shaft wobble test begins.

Figure 38. Shaft Wobble Test Preparation

1 Place the magnetic clip in the appropriate position as illustrated by the software. Click the desired radio button to specify 20 or 50 RPM.

2 Click Run to continue to the next screen where the test begins.

NOTE If the dissolution apparatus is used in Offline Mode, the prompt page instructs you to start the spindle rotation at the predefined speed.

NOTE If the dissolution apparatus is offline then the rotation has to be manually initiated before you click Run.

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Shaft Wobble Measurement

The shaft wobble test measures wobble above the paddle blade or basket over a stability period while the spindles rotate with a predefined speed of 20 or 50 RPM.

Figure 39. Shaft Wobble Measurement

1 Once the value stabilizes, click Accept to store it and continue to the next screen.

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RPM Detection Magnetic Clip Placement

1 If applicable, place the magnetic clip in the appropriate position as illustrated by the software.

2 If the dissolution apparatus is offline, you will be prompted to start the spindle rotation with an appropriate speed. Otherwise, rotation will begin automatically.

Figure 40. RPM Detection Magnet Placement

3 Click Run to continue to the next screen and start the test.

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RPM Measurement

The Rotational Speed Test measures actual RPM against the target RPM over a stability period until the value sufficiently stabilizes.

Figure 41. RPM Measurement

1 Click Accept to store the RPM value and continue to the next screen.

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Basket Rim Wobble Test (Baskets Only)

1 Position the lower rim of the basket at the level of the basket wobble sensor as illustrated by the software. If the dissolution apparatus is offline, it is necessary to manually initiate spindle rotation at the pre-selected speed of 20 or 50 RPM.

Figure 42. Basket Placement for Rim Wobble Test

2 Click Run to continue to the next screen and start the test.

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Basket Wobble Measurement

The Basket Wobble test measures the runout at the lower rim of the basket over a stability period while the spindles rotate at the specified RPM. 1 Click Run to start this test.

Figure 43. Basket Wobble Measurement

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Figure 44. Basket Rim Wobble Measurement

2 Click Accept to continue to the next screen.

NOTE The steps previously described for VM measurements are repeated for each position specified during the method setup. See Method Editor on page 36.

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Paddle / Basket Shaft Removal

1 Raise the drive unit or individual shaft (if possible) to raise the paddle or basket out of the vessel.

Figure 45. Paddle / Basket Raise

2 Click Next to continue to the next vessel position, if applicable.

CAUTION If paddles are installed, it is necessary to orient the paddle blade so it fits through the opening of the 280-DS VM prior to raising the dissolution apparatus or shaft.

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Completion of the Mechanical Qualification for the Position

1 Raise the drive unit as instructed by the software.

Figure 46. Completion of the Mechanical Qualification

2 The Mechanical Qualification for the individual vessel position is complete. Click Next to continue to next action of the test sequence.

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Temperature Probe Placement

1 If the dissolution apparatus has a water bath and a probe to monitor its temperature, you will be prompted to set the temperature to the target value. If the dissolution apparatus is in the Online Mode, the temperature will be set automatically.

Figure 47. Temperature Probe Placement

2 Click Run to continue to the next screen and run the test.

NOTE Heating the water bath can be a lengthy process so it is recommended to preheat the bath prior to beginning the measurement sequence.

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Bath Temperature Measurement

The Bath Temperature Measurement page displays the reading of the 280-DS temperature probe and the bath temperature reading of the dissolution apparatus, if it is online. 1 If the dissolution apparatus is offline, then you must enter the bath

temperature as reported on its display. Although a successful test requires reaching the target temperature, you can accept the result at anytime.

Figure 48. Bath Temperature Measurement

2 After 30 seconds, the reading stabilizes. Click Accept to continue to the next screen.

NOTE If applicable, do not remove the bath temperature probe of the dissolution apparatus from the water bath for this measurement. Instead, remove one of the rear dissolution vessels for access to the water bath.

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Vessel Temperature Probe Placement

1 If the dissolution apparatus has vessel temperature probes, lower them into position. You will be prompted to wait until the temperature of the water in the vessel reaches the target value. If the dissolution apparatus is online, the temperature will be detected automatically.

Figure 49. Vessel Temperature Probe Placement

2 Click Run to continue to the next screen and start the test.

NOTE Since heating is a lengthy process, it is recommended to preheat the water bath before using the 280-DS.

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Vessel Temperature Measurement

The vessel temperature measurement page displays the reading of the 280-DS temperature probe and the vessel temperature reading of the dissolution apparatus if it is online. 1 If the dissolution apparatus is offline, enter the vessel temperature as it is

displayed on its front panel or elsewhere. Although a successful test requires the target temperature to be reached, you can accept the result at any time.

Figure 50. Vessel Temperature Measurement

2 Click Accept to continue to the next page.

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Instrument Module Placement for Vibration

If a vibration test is required, it will be the last test in the sequence. 1 The 280-DS Test tab is selected by default. Use the check boxes to specify the

desired RPMs for the vibration test.

Figure 51. IM Placement for Vibration Test

2 Click Run to continue to the next screen. If more than one RPM has been selected, the software will proceed through each test individually.

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Vibration Measurement

The Vibration test identifies three frequencies with the highest acceleration and calculates the velocity and displacement for these frequencies.

Figure 52. Resultant Vibration Display

1 Click Accept to store the vibration values and continue to the next screen. The software will continue to guide you through all selected RPMs.

Option Function

X-Axis Vibration Measures and displays vibration recorded on X-axis.

Y-Axis Vibration Measures and displays vibration recorded on Y-axis.

Z-Axis Vibration Measures and displays vibration recorded on Z-axis.

Resultant Calculates and displays resultant vibration of all axes.

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Test Completion

1 Upon completion of the test sequence: If the method has the Update Qualification Record option selected

(Update Qualification Record on page 38) and all of the parameters have passed the specification, you can specify the next qualification due date.

If any of the tests failed, then the dissolution apparatus is marked Out of Calibration and the old calibration due date cannot be updated.

If Update Qualification Record is not selected then the old qualification due date remains and will be displayed for reference only.

Figure 53. Test Completion Screen - Successful

2 Click Complete to update the physical parameters and display the Method Completion screen. When the test is complete, the report is compiled and displayed on screen. See Test Reports on page 82..

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Figure 54. Test Completion Screen - Unsuccessful

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Test Cancellation

You can cancel the method any time by clicking Cancel. Before exiting the method run, you will be required to provide an explanation or reason for the cancellation.

Figure 55. Method Cancelling

NOTE Until the first test and its results are accepted you may cancel the test without providing an explanation.

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Diagnostics

Current Status Tab

Click Diagnostics from the 280-DS homescreen to access software diagnostics. When you select Diagnostics, the software automatically connects to the 280-DS if it is present and live data streams are initiated.

Figure 56. Current Status Tab

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Advanced Tab

The Advanced tab provides advanced diagnostic features for the Instrument Module and Vessel Module and displays the values coming from the connected 280-DS modules. From this tab, you can start and stop the stream of data, change the rate of collection, switch between full precision (no calibrated data values applied), and raw data (normal operation) modes. You can also send zeroing commands and turn on/off the auxiliary LEDs for basket wobble measurement. Any of the streaming values can be plotted on the running chart by clicking on grid value. All the communication with 280-DS can be monitored, saved, and exported to a tab-delimited spreadsheet.

Figure 57. Advanced Tab

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Vibration Tab

When you select the Vibration tab, the vibration data stream from 280-DS Instrument Module starts and other measurement data streams from Vessel Module and Instrument Module stop. This allows you to stop and restart the vibration data in order to take a snapshot of the data.

Figure 58. Vibration Tab

The vibration data can be recorded and replayed. When you click and select the output file, the accelerometer data is saved as the tab-delimited, three column spreadsheet. Each column represents acceleration on the X-, Y-, and Z-axis. To stop the recording, click and to see the recorded data, click .

NOTE You can record up to 60 seconds of the data stream.

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Module Information Tab

When you select the Module Information tab, Instrument Module and Vessel Module manufacturing and calibration data is downloaded from the devices. Each device can hold up to 20 previous calibration records.

Figure 59. Module Information Tab

If an Agilent dissolution apparatus is connected to the same PC, it can be controlled from the software through the dialog box.

When you click from the Advanced or Vibration tab, the software automatically tries to connect to the dissolution apparatus. If the dissolution apparatus connection is successful, you are able to set up a temperature and spindle speed that can be monitored.

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Test Reports

Click Test Reports from the 280-DS Workstation homescreen to set up and access reports. Various filtering criteria is available to display the desired test reports stored in the database.

Report Selection

Date range (inclusive), apparatus serial number, for operator, laboratory Due date (all dissolution apparatus) Date range and 280-DS module serial numbers Test ID / Status

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Figure 60. Reports Selection Screen

Option Function

Filter Testing data / results reports can be displayed based on date range, dissolution apparatus serial number, 280-DS module, operator, laboratory, due date, report status, test ID, and test status by selecting the applicable option and clicking Filter.

Print Search List Creates a printable version of the report selection list, which is visible on screen.

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Show Report

When you double-click a row in the table, the results report displays. The results report consists of a compliance Mechanical Qualification Report Sheet and detailed report.

Figure 61. Show Result

Option Function

Sign Select to electronically sign the report. You will have to enter your User ID and Password to sign the report.

Verify Executes data verification.

Options Select Options to select which options will display (Show Report Sheet, Show Detailed Report, Show Run Log).

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Show Report Options

Check the box next to the data to be displayed on each report (Show Report Sheet, Show Detailed Report, Show Run Log).

Verify Report Integrity

To verify report Integrity, return to the 280-DS Workstation homescreen and click Test Reports.... The Verify Report Integrity option at the top of the screen prompts the software to check the checksum of the results data to verify that it was not altered from outside of the application. See Verify Integrity on page 30..

Trends

When you select Trends from the 280-DS Workstation homescreen, a menu displays that allows you to define which trend graphs to plot. Trend graphs are plotted per dissolution apparatus, per measurement (all by default), over a time period (previous year by default).

Figure 62. Trend Measurements

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For each test, the overall trending and per-position trending is displayed.

Figure 63. MQ Measurements Trends

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Security (21 CFR Part 11 Compliance)

Change User

1 To change the current user account logged in to the software, click Change User from the 280-DS Workstation homescreen.

2 Enter login information and click Logon.

Lock Application

1 To lock the application, click Lock Application from the 280-DS Workstation homescreen.

2 To unlock, click the lock icon and log back into the software.

Figure 64. Lock Application

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Audit Trail

Click Audit Trail from the 280-DS Workstation homescreen to access the Security Audit Trail screen.

Figure 65. Security Audit Trail

Option Function

Show Report Creates a detailed report of Security Audit Trail activity based on the date range specified.

Retrieve Records Allows for record retrieval of the specified Security Audit Trail activity.

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Permissions

Review the permissions granted to the current user.

Figure 66. Permissions

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Tools

Configuration Dialog

Select Tools > Options from the 280-DS Workstation homescreen to display the Configuration Dialog screens.

Figure 67. Configuration Dialog Security Tab

Option Function

User Groups Review the permissions granted to each user group.

User Administration Modify the permissions granted to each user and/or group.

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Database Tools

1 Select Tools > Options from the 280-DS Workstation to display the Configuration Dialog screen.

2 Select the Database tab to view the following screen:

Figure 68. Database Tools

Option Function

Dissolution Server Name of the dissolution server where the database is located.

Integrated Security Allows you to assume responsibility for administrating database access.

Change DB Settings Updates the current settings of the database.

NOTE Database backup and restore functions can be performed manually (Database Backup and Restore Functions on page 93) or automatically using scripts provided by Agilent. If this utility is desired, please contact an Agilent representative for guidance.

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Figure 69. Configuration Dialog Miscellaneous Tab

Option Function

Use Simulated Instruments

Runs the software in a simulation mode where the 280-DS modules do not have to be connected. No official data is acquired in this mode.

Idle Minutes Amount of time before the software locks automatically. Setting this value to 0 disables this feature.

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Database Backup and Restore Functions

Backing up the Database

1 From the PC desktop, click Start > All Programs > Agilent > Dissolution > MsdeManager. The MSDE Manager screen displays.

Figure 70. MSDE Manager

2 Select the appropriate Server where the database is located and click Connect. The DB Utility screen displays indicating the database is connected successfully.

3 From the Backup tab, click "" to browse for the desired backup location. The default location is:

C:\Program Files\Microsoft SQL Server\MSSQL$DISSO\Backup\ DissoWkStn.bak. 4 Click Backup to initiate the database backup process. A DissoWkStn.bak file

will be created in the specified destination.

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Restoring the Database

1 From the PC desktop, click Start > All Programs > Agilent > Dissolution > MsdeManager. The MSDE Manager screen displays.

Figure 71. MSDE Manager

2 Select the appropriate Server where the database is located and click Connect. The DB Utility screen displays indicating the database has connected successfully.

3 Click the Restore tab and click "" to browse for the desired backup file (.bak). 4 Click Restore to restore the database to the specified destination.

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5 Troubleshooting and Maintenance Preventive Maintenance 96 Troubleshooting 97

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Preventive Maintenance

Recalibration

Agilent recommends the 280-DS be calibrated on a 6-month interval. In addition, the documentation of the calibration cycle due date should be consistent with the procedures of the end user and in consideration of the proper handling and care of the system. The calibration interval should be consistent with your SOPs and documented on the individual Instrument Module (IM) and Vessel Module (VM) certificates.

To keep the instrument at optimum performance within the calibration period, please refer to the following information:

The unit is designed to be stored, transported, and shipped in its original carrying case.

As with any delicate instrument or calibrated device, excessive shipping or mishandling may warrant more frequent recalibration.

Ultimately the end-user is responsible for establishing a calibration interval and Agilent will accommodate more or less frequent calibrations based on usage or needs.

Agilent provides AS FOUND measurements for each parameter upon recalibration to assist you in assuring the integrity of your mechanical parameter measurements.

Recalibration of the 280-DS must be performed by an Agilent repair center. To initiate this process, please contact Agilent's Customer Service to initiate a Service Request.

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Troubleshooting

The following is a troubleshooting guide which may help you with common problems. For other problems, 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.

NOTE See Diagnostics on page 78. for basic troubleshooting.

Symptom Probable Cause Suggested Solution

The 280-DS is not responding.

There might be a problem with the connection between the 280-DS and the computer.

Ensure the USB cable is plugged in.

Ensure the IM cable is plugged in. Look inside the VM and confirm

that the red LEDs are flashing.

The 280-DS driver is not installed properly.

In Windows Device Manager, verify that the 280-DS is located on a COM port when it is plugged into a USB port.

Ensure the USB port on the computer is functioning.

Diagnostics is not working properly.

Problem with Windows OS or VM/IM cable connections.

Reboot the PC Ensure all module connections are

secure and the red LEDs are flashing within the VM.

Improper centering / verticality values or any other unexpected values from measurements.

VM diameter arm was not zeroed.

Ensure it is zeroed properly. See Vessel Module Vessel Centering Arm Placement on page 50.

Module not properly installed.

Re-zero the VM and reseat the module within the vessel.

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Dirty lenses on the Vessel Module.

Clean the lenses inside of the Vessel Modules with a lens-cleaning cloth.

Cant connect to the dissolution apparatus.

The dissolution apparatus is not supported (i.e., non-Agilent/ Varian/VanKel) or the firmware version on the dissolution apparatus is not supported.

Contact Agilent to update the firmware on the apparatus (if possible).

Serial-to-USB cable drivers were not installed properly.

Reinstall the cable drivers, if necessary.

Serial port not functioning properly.

Verify status of serial port using Device Manager (Control Panel > Administrative Tools > Computer Management).

RPM value is not displaying.

The magnetic clip is not in the proper position.

The top of the RPM clip needs to be slightly above the VM. See RPM Detection Magnetic Clip Placement on page 62..

Paddle/Basket height is not reading properly.

Height arm extension not seated on bottom middle of the dissolution vessel. Need to select the proper pin height.

Ensure that the height arm extension is oriented in the center of the VM. Ensure the proper pin setting of the VM is selected. See Height Arm Pin on page 54..

The VM doesnt fit in the vessel.

Need to use a 1L and/or an open-head apparatus.

Ensure 1L vessels are being used. The VM should fit any open-head

design apparatus. The VM will not fit on a dissolution apparatus with a closed-head design.

The sampling manifold and/or evaporation covers must be removed.

Remove the manifold and evaporation covers of your dissolution apparatus. Please consult the Operators Manual of your dissolution apparatus for applicable instructions.

Symptom Probable Cause Suggested Solution

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Cannot perform functions within the software (e.g., create system/method, run method, etc.).

User does not have proper rights/access to desired function.

Administrator must add desired user to individual Vk groups to grant access/privileges to specific software functions via User Administration (Tools > Options). See Adding Users to the Application on page 25.

User cannot log on to software.

Incorrect password or domain.

Verify the correct password has been entered and the proper domain is selected from the software login screen.

Data not updating in real-time or SIMULATED is displayed as the serial number of dissolution apparatus.

Use Simulated Instruments option enabled.

Disable the Use Simulated Instruments option under Tools > Options > Miscellaneous. See Use Simulated Instruments on page 92..

Symptom Probable Cause Suggested Solution

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6 Service and Warranty Service and Warranty Information 102

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Service and Warranty Information

The warranty is provided by Agilent Technologies, Inc. or one of its authorized representatives.

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.

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www.agilent.com Agilent Technologies, Inc. 2019

70-9071 Rev D May 2019

In This Book Chapter 1 Safety Chapter 2 Introduction Chapter 3 Setting Up the 280-DS Chapter 4 Operating the 280-DS Chapt

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