Software Update Notification

PSS0223-08: Mastersizer 3000 v2.01

Abstract
This document details the release of software PSS0223-08: version 2.01 of the software for the Mastersizer 3000 laser
diffraction system. It covers software issues fixed and new features introduced. This information is required to perform a risk
analysis to determine if the software should be installed. In this risk analysis the benefits of the new features provided and
resolved software issues must be weighed against the risk of new issues that may be introduced to vital areas of the software
or possible changes to the results of future analysis. Installation instructions are provided.

Installation
It is assumed that you have authority to install or update software within your facility. It is also assumed that you have
Administrator rights for the system upon which the software is installed, as this is a requirement of the installation process. If
you do not have this authority please consult with your I.T. support department before proceeding.

Minimum System Requirements

The minimum requirements for running this software are highlighted in table 1.

Table 1: Minimum system requirements for the Mastersizer 3000 software.

Feature Specification
Processor Type Intel Core i5 Processor
Memory 4GB
Hard Disk Storage 250GB
Additional Storage Media CD-ROM or DVD +/-RW drive
Display Resolution 1024 x 768
Connectivity 1 high speed USB port
Operating System Windows XP Professional TM with Service Pack 3 installed
Windows 7 Professional (32 bit)
Windows 7 Ultimate (64 bit)
Windows 8 Enterprise (64bit)

Although the software can run using Windows XP Professional and Windows 8 Enterprise, it has been fully tested under
Windows 7. Windows 7 is therefore the preferred operating system.

Note: The Malvern Access Configurator (MAC) security software cannot be used with Windows 8. If you need to use this
security system then you must install the software using Windows 7 or Windows XP.

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Installation Instructions

The software suite comes on an auto-loading CD-ROM. Inserting the drive into a system configured to Auto-run a CD will run
the installation program automatically. If your system does not support this feature, run the \Mastersizer 3000\setup.exe
program from your CD drive.

Note: It is important that the software is installed before the Mastersizer 3000 instrument is connected to the computer
and switched on. This will ensure that the instrument drivers are enabled, and that the firmware updates associated with
this release are correctly downloaded to the instrument.

Note: Any firmware updates required for your system will be installed at the same time as the software. It is important to
keep the firmware and software ‘in sync’, since this is the configuration that will have been tested by Malvern Instruments
prior to release of the software.

Installing the Malvern Access Configurator (MAC) Application

The software suite includes a copy of the Malvern Access Configurator tool that allows you to manage the security aspects of
the Mastersizer 3000. The MAC software may be installed either on the PC used to control the instrument or a separate
networked PC. Installing on a separate PC allows you to manage the security centrally.
Note:
The MAC software does not auto-install. To install this software, navigate to the \Malvern Access Configurator folder on
the software CD-ROM and run the setup.exe file.
If you are installing the MAC software on a Windows XP system then you must make sure that the Microsoft .NET
framework 3.5 is installed first. To install this, navigate to the \Malvern Access Configurator folder and run the
dotNetFx35setup.exe file.

As with all Windows applications, the MAC software must be installed by a user who is an administrator on the host
computer. In addition, the MAC software uses the existing Microsoft Windows users and groups configured on the host
computer to control access to the Mastersizer 3000 application. As such, prior to installing the MAC, it is important to ensure
that the computer running the Malvern software is installed on its host network. If the computer is a stand-alone system, the
required users and groups must be configured on the computer prior to the use of the MAC.
Given the above requirements, it is advised that the local IT department review the requirements for use of the MAC
application, and are present during the software installation process.

Note: Please read MRK1828-xx - Guide to setting up access permissions in the Malvern Access Configurator
application and MRK1747-xx - Mastersizer 3000 - 21 CFR Part 11 Guide for more information as to how to use the
MAC application, particularly when operation is required in a 21CFR Part 11 compliant environment.

Uninstall Procedure
The software can be uninstalled using the standard Add/Remove Programs feature in the Windows ‘Control Panel’.

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Software License Files
The Mastersizer 3000 software requires a valid licence file to run. When connected to an instrument, the system
automatically generates this file and the user will be asked to accept the licence.

Note: If you wish to install the Mastersizer 3000 software on additional computers, you will need to follow the procedure
below for sharing a software licence.

Sharing a license
In order to enable the use of the Mastersizer 3000 on a computer which is not connected to a system, it is necessary for
users to create a license. This can then be shared with other users, allowing them to gain access to the software.
To share a licence, follow the steps below:

1. At the PC that is connected to the instrument, run the Mastersizer 3000 software and click on the

Application Menu icon at the top left of the screen.

2. Select ‘About’ and click on the View Licence.. button.
3. Click on the Share this Licence.. button. The system tells you what information the licence file contains.
4. To accept that information click Yes and choose a location to copy the file to (e.g. a memory stick).
5. At the separate PC, install the Mastersizer 3000 software from the CD and start the program. At the licence
screen, click the Install button.
6. Browse to the folder that contains the licence file from step 4 above, and select the licence file. The licence
details will be shown and you can now accept or decline the licence.

Note: The software licence is specific to a given Mastersizer 3000 system. When a licence is shared, detailed user and
computer information is stored in the licence file, ensuring it can be traced back to its source Mastersizer 3000 system.
Users should only share the licence with users within their organisations who need to analyse data off-line. The software
licence should not be shared with other organisations without the consent of Malvern Instruments.

New Features
The following features have been implemented in v2.01 of the software:
Reference(s) Feature Comment
Ensure that a manual fill action is demanded for all fill requests when the manual fill SOP
26189 Improvement
option is selected.
Increase communication time-out time to prevent the Mastersizer 3000 system going
26248 Improvement
into sleep mode when saving data over a slow network connection.

In addition to these changes, v2.01 also includes the following features which were included as part of v2.00:

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Reference(s) Feature Comment

11080 Add sample name to graph plot point tool-tips Improvement

Provide a style-sheet for the audit xml files, so that they can be easily read by other
15850 Improvement
applications.
Add level sensor, drain value and dispersant value status to the measurement manager
18496 Improvement
status bar.
Export analysis size classes as part of the header row so that they don't repeat for every
21381 Improvement
row or column.
Extend the report footer to include additional signing and user information when the 21
22133 Improvement
CFR Part 11 features are enabled.
22629 Allow Aero S lid to be opened during clean Improvement
Allow the space bar to be used to progress through the measurement steps in the
22713 Improvement
measurement manager
23011 Move record view focus to the new record when a record is edited Improvement
24224 Change the company information options to be application-wide rather than user specific,
Improvement
24225 and ensure these options can be secured.

24243
Provide a reason for change when carrying out record cutting or record deletion Improvement
24611
The pinned items in the workspace window should always show the pin icon/button as a
24378 Improvement
visual cue to the user that they are pinned.
Consolidate the security permissions provided for the Mastersizer 3000 application, so
24382 Improvement
that similar actions are secured using the same permission.

24609 Add new Measurement Date and Time parameters Improvement

Default upper limit obscuration values for wet and dry changed to more reasonable
24759 Improvement
default values.

24908 Enable "Do not group edited records" option by default. Improvement

10740 Allow size distribution graphs to be displayed using phi units New feature

13593 Pin Recent Documents to Keep them in the workspace ‘recently used’ list New feature

Add ability to turn on the vacuum cleaner when the dry measurement cell is removed, in
16203 New feature
order to aid maintenance.

Add an electronic signature report widget, so that the signature history for a record can
17650 New feature
be viewed.

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 17829 Allow SOP files to be pinned within the recent SOPs list. New feature

22000 Allow undersize and oversize distributions to be plotted with frequency distributions New feature

22617
22618 Provide a Mastersizer 2000 analysis mode. New feature
25061

22628 Add the ability to batch print New feature

22714 Add a reset button in the measurement window New feature

Ensure that the blue light optical properties match the red optical properties if the "Use
23174 Improvement
different values for blue" option is unchecked.

Link edited records to original source record, by providing an ‘Original Source record’
23427 New feature
parameter.

24051 Allow result tables to be copied as text as well as in an image format New feature

24053 Provide user specified data export filenames New feature

24380 Secure export via copy result from reports New feature

Allow the selected data quality calculation to be stored and recalled as part of the view
23763 Improvement
settings

Readability of the fonts used on the measurement manager interface needs to be

24059 Improvement
improved.

Reduce the time taken for the Hydro MV/LV drain valve to respond to an open or close
25152 Improvement
request.
Report feed rate errors as warnings in manual measurement mode, so that the
25502 measurement process does not stop when the feed rate is adjusted by a user during a Improvement
measurement.

Fixed Issues
The main issues fixed in this release of the Mastersizer 3000 software are listed below.
Reference Issue Comment
18576 Sort order can sometimes be in error within the records view Fixed in v2.00
22821

18832 Wet measurements show "venturi type" as "Standard venturi disperser" Fixed in v2.00

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21924 Custom data export template is removed as an option when the default template Fixed in v2.00
is selected
22002 Show the current parameter in the report parameter selection dialogue when Fixed in v2.00
editing an existing report parameter.
22377 It is possible to edit the options under 'Output' when record editing Fixed in v2.00
22616 The ultrasound timings can be changed when the ultrasound system is active Fixed in v2.00
22702 Sometimes the ultrasound timer does not update Fixed in v2.00
22710 Absorption Index shown as 0.000 when configured to be less than 0.001 Fixed in v2.00
22861 Hydro unit stirrer can get into a state where it is running but application says it is Fixed in v2.00
not.
23236 Accessory Name and Type parameters are wrong way around in Record View Fixed in v2.00
23342 Occasional problems with Edit and Export when large numbers of records are Fixed in v2.00
selected
23526 Access control permissions for Material/Dispersant databases not working in Fixed in v2.00
some cases
23821 Hydro MV stirrer rate should be reduced during a drain action Fixed in v2.00

24173 Parameter name is not shown in a logical way when adding sample identifiers to Fixed in v2.00
a parameter grid.
24186 Make the display of the x and y axis settings clearer when selecting trend graph Fixed in v2.00
properties.
24214 Accessory controls does not always appear in the measurement manager Fixed in v2.00
interface for manual measurements.
24216
24232 Cannot change settings on export templates Fixed in v2.00
24379 Signatures and auditing features were disabled after upgrading the Fixed in v2.00
software

24381 All files record view configuration doesn't work Fixed in v2.00
24468 Stirrer speed ramps up too quickly for the Hydro EV following a clean operation. Fixed in v2.00
24475 Laser power is low message appears when a measurement delay is set, even Fixed in v2.00
though the laser power is within acceptable limits.
24704 “Cannot achieve air pressure error” warning occurs during the Aero S clean Fixed in v2.00
sequence
24881 Cleaning steps are not shown to the user during a Hydro EV clean Fixed in v2.00
25082 Software crashes with a “Get Matrix” exception on first measurement Fixed in v2.00
25145 New SOPs are added to the recently used SOPs list even if the user cancels the Fixed in v2.00
SOP save operation
25157 Software crashes when changing themes Fixed in v2.00

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 25266 The Aero S dry disperser is sometimes set to a feed rate which does not agree Fixed in v2.00
with the demanded federate.
25271 Errors can occur when a comma is used as the decimal separator for the Aero S Fixed in v2.00
dispersion pressure.
25418 Modify button in the Export Data dialogue does not work correctly in some Fixed in v2.00
instances.
25423 The data “Snap Collection Percentage” is always blank when this parameter is Fixed in v2.00
included in the records view.
25427 The warning icon for measurement log entries is in the wrong place when Fixed in v2.00
running SOPs

Known Issues
The following software bugs have been discovered within the software, and will be investigated as part of a future release.
Please follow the suggested work-arounds when operating the software.
Issue Work Around Comment
Occasional error message and software crash on
first measurement, during the analysis stage of No work-around available. Crash will only
Intermittent
the measurement sequence, following a software occur once, following which the software will
Software Bug
installation or upgrade. operate correctly.

Fields/cells occasionally appear empty in the Scrolling the Records View or hiding and
Intermittent
Records View. showing the Records View will refresh the
Software Bug
display correctly.
“Failed to reach target air pressure and feeder This bug can be avoided by not
drive phase lock loop out of lock” message continually adjusting the feed rate. If Intermittent
appears when changing the feed rate of the Aero the issue occurs then a software Software Bug
S in Feed Mode. restart is required.

Seen for manual measurements only.

Aero S feed rate doesn’t match the demanded Intermittent
Manually adjusting the feed rate
feed rate, and can jump to 100% feed Software Bug
corrects the issue.

Some text still appears in English when running The translation of all software text will
with a different language selected. Software Bug
continue in future releases.

The Contact Malvern feature in the Maintenance

window causes the software to crash or displays Manually email the maintenance report text
a message about the wrong parameter format file to helpdesk@malvern.com if support is Software Bug
being used. required.

Software does not open all files selected when Use the Open menu option in the
they are opened using Windows Explorer. Mastersizer 3000 software to open multiple Software Bug
files.
The active accessory is not always changed Intermittent
when the changing between wet and dry cells. See know issue description below.
Software Bug

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 An empty error message box is shown in the
measurement window if the Hydro EV accessory
is disconnected during a measurement.
Reports occasionally appear blank or empty
even when the record selection in the Records
View changes.
The software does not warn the user when it
cannot open a measurement file within the
Recently Used list.
Record number and detector number values are
displayed to one decimal place on trend and data
graphs.
The System Audit displays duplicated columns
for each language under which the system has
been run when auditing has been enabled.
When graph symbols are displayed in reports,
they do not show on printouts.
Various fields in the Edit result window lose their
‘edited’ blue background appearance when a
different page in the editor is selected.
Software may crash when using the Save option
when viewing an extracted SOP.
Malvern Access Configurator stops working if
Microsoft .NET Framework 4.5 is installed. It will
also not work using Windows 8, as this
framework is installed as default.
The manual measurement settings do not match
the connected/active dispersion unit.
The Measure Sample stage keeps repeating
when a dry measurement is carried out without
the Auto Start option enabled.
Active accessory does not change when switching between wet and dry measurement cells
Sometimes, the software does not select the correct accessory when users insert the measurement cell into the
instrument bench. If this occurs, users should manually select the accessory by clicking on the accessory icon in the
status bar of the main software window. A menu will be shown of the available accessories:
8 Software Update Notification: PSS0223-08
Accessories should not be disconnected
Software Bug
during measurements.
Adjust the report zoom slider in the bottom
Intermittent
right-hand corner of the report window to
Software Bug
refresh the display.
This will occur if a file has been moved or
deleted. A fix will be provided in a future Software Bug
software release
No work-around available. A fix will be
Software Bug
implemented in a future software release.
No work-around available. A fix will be
Software Bug
implemented in a future software release.
No work-around available. A fix will be
Software Bug
implemented in a future software release.
No work-around available. This is a display
issue only, as the software correctly applies
Software Bug
the edit values when the OK button is
pressed.
Use the ‘Save As’ option instead. Software Bug
This is an issue that we are currently
investigating. Until a solution is in place, the
.NET 4.5 Framework must not be installed Software Bug
using Windows 7 / XP. Operation using
Windows 8 is also not possible.
Intermittent
See know issue description below.
Software Bug
This occurs when manually starting the
sample measurement stage of the dry
measurement sequence, by clicking the
Start/Play button. The work around is to Software Bug
always use Auto Start for dry measurements
until a fix for this issue is implemented in a
future release.
Simply select the accessory from the menu to activate it.

Manual measurement settings do not match the connected / active dispersion unit
Occasionally, users may see the wet accessory related manual measurement settings when a dry unit is attached, or visa-
versa. If this occurs, open the manual measurement settings window and click the New menu item from the Window
Features menu:

This will reset all measurement settings to their defaults for the active accessory type. This issue has been reported after
upgrading from early versions of the software, but does not occur on all systems.

Backward Compatibility
This software is only compatible with the Mastersizer 3000 (MAZ3000) system, and cannot be used with the Mastersizer
2000 (APA2000) system. It is possible, however, to review Mastersizer 2000 results within the Mastersizer 3000 software.
Please refer to the user manuals and software help for guidance as to how this is achieved.

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File Types and Locations
The Mastersizer 3000 software uses a series of different file types in order to store data and measurement
settings. These are described below, in order to help users who wish to secure the Mastersizer 3000 system
using the Microsoft Windows security and access settings.

File type Extension Default path

21CFR11 mode: Audit trails .xml C:\ProgramData\Malvern Instruments\Mastersizer 3000\Audit Trails

User sizes .siz C:\ProgramData\Malvern Instruments\Mastersizer 3000\User Sizes

User defined materials .mmat C:\ProgramData\Malvern Instruments\Mastersizer 3000\Materials

User defined dispersants .mdis C:\ProgramData\Malvern Instruments\Mastersizer 3000\Dispersants
Data quality addins .mdaq Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\Data Quality Addins
Private workspace:
C:\Users\{user_name}\Documents\Malvern Instruments\Mastersizer
3000\Workspace\Data Quality Addins
Export data .txt, .csv, .rtf Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\Export Data
Private workspace:
C:\Users\KBaines\Documents\Malvern Instruments\Mastersizer
3000\Workspace\Export Data
Measurement data .mmes Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\Measurement Data
Private workspace:
C:\Users\KBaines\Documents\Malvern Instruments\Mastersizer
3000\Workspace\Measurement Data
Reports .mrep Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\Reports
Private workspace
C:\Users\{user_name}\Documents\Malvern Instruments\Mastersizer
3000\Workspace\Reports
SOP templates .msot Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\SOP Template

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SOP
Data export templates
Various system wide
configuration files
Private workspace:
C:\Users\{user_name}\Documents\Malvern Instruments\Mastersizer
3000\Workspace\SOP Template
.msop Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\SOP
Private workspace:
C:\Users\{user_name}\Documents\Malvern Instruments\Mastersizer
3000\Workspace\SOP
.mext Shared workspace:
C:\ProgramData\Malvern Instruments\Mastersizer 3000\
Workspace\Data Template
Private workspace:
C:\Users\{user_name}\Documents\Malvern Instruments\Mastersizer
3000\Workspace\Data Template
Various C:\ProgramData\Malvern Instruments\Mastersizer 3000

Changing the destination path for a particular file type

The following workspace folders can be configured from within the Mastersizer 3000 software:
 SOP
 Measurement Data
 Reports
 Export Data

To change the default file location for these files, click on the pencil icon which appears when you hover over the
shortcut to the directory with the Workspace viewer:

Changing the directory associated with this shortcut will change the default directory accessed by the
Mastersizer 3000 software for the selected file type.

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Making a backup of the files
The Mastersizer 3000 software does not create backup copies of any of the file listed above. However, there are
third-party software tools that will allow you to schedule regular backups, if required, for each of the file locations.

Why do you no longer use the Program Files folder?

With the introduction of Windows Vista and Windows 7, Microsoft changed the default permissions for the
Program Files folder to prohibit software maliciously changing files associated with installed software. All
software runs with standard user permissions on Windows Vista/7, even when a user is logged in as an
Administrator. By adhering to these default permissions, Malvern’s software platforms can execute without
additional configuration changes by the end user.

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