Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

MASTERSIZER 3000 SOFTWARE: v3.81

(PSS0223-28)

SOFTWARE UPDATE NOTIFICATION

Introduction

This document details the release of software PSS0223-28: version 3.81 of the software for the Mastersizer 3000 laser

diffraction system and the Mastersizer 3000E 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.

This software release contains important security and compliance updates. As such, we strongly recommend that you

upgrade to this version of the software at your earliest convenience.

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.

Recommended System Requirements

The recommended computer system requirements for running this software are highlighted in table 1 below. The

software can be operated using Windows 10 (Pro and Enterprise), Windows 7 32 bit (Pro, Enterprise and Ultimate) and

Windows 7 64 bit (Pro, Enterprise and Ultimate). However, it has been fully tested using Windows 10 Pro (64 bit) (v1903).

Windows 10 Pro (64 bit) is therefore the preferred operating system.

Supported Languages

The Mastersizer 3000 software currently supports operation in the following languages:

• English

• French

• German

• Japanese

• Chinese (simplified)

• Russian

• Polish

• Spanish

2 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

The language used by the application is automatically configured based on the operating system settings. If you want to

force the application to use English instead of the operating system language, you need to start the application using

the

Mastersizer 3000 (English) start menu shortcut.

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

Feature Specification

Processor Type Intel Core i7 Processor

(Quad Core, 4

generation or higher)

Memory 8GB

Hard Disk Storage 250GB

Additional Storage

Media

CD-ROM or DVD +/-RW drive

Display Resolution 1920 x 1080 (Minimum 1440 x 900)

Connectivity 1 USB2.0 or USB3.0 port

Operating System Windows 7 (32 bit - Pro, Enterprise and Ultimate)

Windows 7 (64 bit - Pro, Enterprise and Ultimate)

Windows 10 Enterprise (64 bit - Pro and Enterprise) *

* Preferred Operating System

Note:

In order to address Windows 7 vulnerabilities associated with driver signing, this software only uses the latest

driver authentication protocol recommended by Microsoft (SHA 256 certification). As a result, a Windows OS

update may be required in order for the system to work. Please refer to Microsoft Knowledgebase reference

KB3033929 for details. Any computer system which has been updated with Microsoft patches since March 2015

should operate correctly.

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. If you are installing the software from a web download, then browse to the

folder where the files have been extracted to and then launch the \Mastersizer 3000\setup.exe program.

Note:

It is important that the software is installed before the Mastersizer 3000 / 3000E 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 Panalytical prior to release of the software.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 3

Note:

If you are upgrading from a previous version of the software and have auditing enabled, you may see a

message referring to an audit trail upgrade on the first initialization 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 / 3000E. The MAC software may be installed either on the computer used to control the

instrument or a separate networked computer. Installing on a separate computer 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.

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 a user’s local IT department should review the requirements for use of

the MAC application. An IT representation should also be present during the software installation process.

Note:

Please read

MAN0602-XX

–

Malvern Access Configurator (MAC) User Guide

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. Note that operation in 21CFR Part 11 mode is

not available for Mastersizer 3000E users.

Uninstall Procedure

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

Note:

Downgrading v3.81 with 21CFR11 mode enabled to earlier versions of the software will cause this functionality

to be switched off. 21CFR11 functionality can then be re-enabled once the downgrade is complete by re-

enabling the Features File (navigate to the Options pages and select “Enable Auditing” and “Enable Electronic

Signatures” from the 21CFR Part 11 tab and “Enable Access Control” from the Access Control tab).

We recommend the MAC software is uninstalled in this way before updating to later versions (or even downgrading to

earlier versions).

Software Categorization

GAMP 5

The GAMP 5 guide provides guidance to pharmaceutical companies wishing to understand whether the computerized

systems and software they used are fit for purpose and meet current regulatory requirements. As part of this, the GAMP

4 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

committee has defined a series of software categories which are designed to help users in assessing the risk and

validation requirements associated with using a specific software package.

In its standard mode of operation, the Mastersizer 3000 software provides users with a series of standard interfaces

and functions that enable the software to be configured to meet specific user business requirements. These interfaces

include the ability to define Standard Operating Procedures (SOPs) for sample measurement, create report definitions

using pre-defined functions and develop data export templates using pre-defined parameters. If users apply these

functions, then the software can be considered to be a Category 4 product.

In addition to the standard functions, the Mastersizer 3000 software provides users with the ability to modify the results

reported by the system to fit their application requirements. This is achieved using the custom calculation reporting

functions. These functions are not widely applied within regulated environments. However, if they are used to meet

business requirements then the macros included within the custom calculations should be validated according to GAMP

Category 5 requirements. Users are therefore encouraged to specifically validate any custom calculations applied within

their reports and ensure these are documented. Where possible, we would encourage the use of the standard result

reporting features, as this minimizes the risk of errors in the reported size distribution statistics.

USP<1058>

USP<1058> provides pharmaceutical users with guidance as to how the qualification of analytical systems should be

carried out. As part of this guidance, the USP define a series of instrument categories. These instrument categories

different from those described in GAMP 5, although the principles applied as part of the classification of a system are

similar.

The Mastersizer 3000 is a computerized analytical system where the software provides users with the functions

required to meet specific analytical application requirements. As such, it is a Group C instrument. Users are therefore

recommended to define their requirements for the operation of the system and then compare these requirements to

the claimed capabilities of the software and hardware. This should include an assessment of whether the new features

and bug fixes included in a specific version of the Mastersizer 3000 software are necessary to meet business

requirements.

Validation Support Documents

The Mastersizer 3000 software CD contains the following documents, which are provided to help users who work within

validated laboratories:

• 21CFR Part 11 and Security System guides:

Provide guidance on how to set up the features of the software in order to aid technical compliance to 21CFR

Part 11.

• 21CFR Part 11 and Annex 11 Gap analysis documents:

These detail the capabilities of the software and how these align with the requirements of 21CFR Part 11 and

the equivalent rule set in Europe (Annex 11).

• Malvern Instrument’s ISO Certificates:

Copies of the current ISO9001:2008, ISO14001 and OHSAS 18001:2007 certificates, issued as part of the

independent audit of Malvern’s business management systems. This includes certification of the development of

the Mastersizer 3000 software to TickIT Plus requirements.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 5

• Software Certificates of Conformance:

Copies of the software certificates of conformance for all Mastersizer 3000 software versions, providing a

summary of Malvern’s business management systems which are used for the development of the Mastersizer

3000 software and hardware.

• Software Update Notifications:

Copies of the software update notifications for all Mastersizer 3000 software versions, confirming the new

features and bug fixes introduced for each version.

• Software Update Verification Procedure:

A procedure users can follow for verifying the success of a software upgrade.

Note:

The documents provided on the software CD are those which were current at the date the software was

released. Please contact your local Malvern Panalytical representative if you need to verify if any updated

documents are available.

Software License Files

The Mastersizer 3000 software requires a valid license file to run. When connected to an instrument, the system

automatically generates this file and the user will be asked to accept the license.

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 license.

Sharing a License for Mastersizer 3000 users

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 license, follow the steps below:

1. At the computer 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 License… button.

3. Click on the Share this License… button. The system tells you what information the license 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 computer, install the Mastersizer 3000 software from the CD and start the program. At the

license screen, click the

Install button.

6. Browse to the folder that contains the license file from step 4 above, and select the licensee file. The licensee

details will be shown and you can now accept or decline the license.

Note:

The software license is specific to a given Mastersizer 3000 system. When a license is shared, detailed user

and computer information is stored in the license file, ensuring it can be traced back to its source Mastersizer

3000 system. Users should only share the license with users within their organizations who need to analyze

data off-line.

6 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

Note:

The software license must not be shared with other organizations without the consent of Malvern

Panalytical

Sharing a License for Mastersizer 3000E users

The Mastersizer 3000E system is provided with a simplified, basic version of the Mastersizer 3000 software. This basic

software version is restricted to use on a single computer workstation attached to the Mastersizer 3000E system. As

such, the license sharing facility offered for Mastersizer 3000 users is not available.

Users of the Mastersizer 3000E system who want to be able to use the software on multiple workstations will need to

purchase a software upgrade. This upgrade will enable the premium features associated with the Mastersizer 3000

software, including the ability to create shared licenses. Please contact your local Malvern representative if you would

like to purchase this upgrade.

Software Guides

The Mastersizer 3000 software includes a comprehensive help system, which provides a functional description of each

of the software elements. In addition to this, the software includes a series of ‘MiniGuides’, which provide an

introduction to useful software tools and new features. These are accessed via the MiniGuides option on the Home

ribbon bar:

Fixed issues list

The main issues fixed in v3.81 maintenance release of the Mastersizer 3000 software are confirmed in the table below:

Reference(s) Issue

110089 Locking signatures does not work

110090 Opening the record signature history for a signed record causes software to crash

110344 Signatures are lost between versions of the software

110961

Opening the record signature history after overwriting signatures between versions causes software to

crash

111510 Translation error in Japanese in SOP menu

Note:

This release also contains important security updates. In accordance with industry best practice, details are

not published on these fixes.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 7

Bug reference 110344: Signatures are lost between versions of the software

After the release of v3.80, we became aware of an issue related to the transfer of electronic locking signatures on upgrading

to Mastersizer 3000 software versions 3.70, 3.71, 3.72 (3.7x) and 3.80.

• Any locking signatures applied to records in v3.63 or earlier will not be transferred across when the software is

upgraded to versions 3.7x and 3.80.

• However, these locking signatures can be recovered through this v3.81 software upgrade (because the signature

information associated with each locked record still exists within the record structure), provided you do not re-sign

these records in v3.7x and v3.80.

The issue has arisen due to the introduction of a new software component used to read audit trail information in versions

3.7x and v3.80. This means that audit trail information written in the earlier format is not recognized by the new software

component, causing the signing and locking status to be incorrectly reported.

This software release, v3.81, will reinstate visibility of the locking signatures that were applied in earlier versions of the

software.

If you are on v3.63 or earlier:

• please upgrade to v3.81 (do not upgrade to v3.7x or v3.80).

• you will not see any loss of signatures

If you have upgraded to v3.7x or v3.80 and have not attempted to re-sign records that were previously locked:

• we strongly recommend upgrading to v3.81

• the locking signatures that were applied in version v3.63 or earlier and subsequently lost on upgrade to v3.7x or

v3.80 will have their visibility reinstated

If you have upgraded to v3.7x or v3.80 and have re-signed records that were previously locked in v3.63 or earlier:

• we strongly recommend upgrading to v3.81

• re-signing will cause the original (v3.63 or earlier) locking signature to be superseded by the later (v3.7x or v3.80)

locking signature

• in v3.81, the original (v3.63 or earlier) signed record will be visible in the signature history as an unsupported

signature type, with no signatory detail. The later (v3.7x or v3.80) signature will be visible with the correct signatory

state and full signatory detail

New Features and Fixed Issues in v3.80

The new features and fixed issues introduced in the previous software version 3.80 are given below:

New Features List: v3.80

The features implemented in v3.80 release(s) are confirmed in the table below:

Reference(s) Feature

100465 Pre-clean step added for use with the Hydro MV and Hydro LV

91585 Advanced custom cleaning settings added to the ‘Custom Clean’ settings menu

101963 Cleaning progress bar displayed during the clean process

8 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

98243 Measurement records used to create an average record now visible as a column value for the average

record

90760 Signature state of a non-final signed record now displays ‘signed’ instead of ‘un-locked’ in reports

Details of the new features developed for previous software releases can be found in the Software Update Notification

documents stored on the software CD-ROM.

Fixed Issues List: v3.80

The main issues fixed in v3.80 maintenance release of the Mastersizer 3000 software are confirmed in the table below:

Reference(s) Issue

86716 Software can crash when batch printing

89698

Software crashes when the network connection is lost during the saving of a measurement file to the

network location

90914 Intermittent crash on Reports page when ‘copy as raw data’ crash

91050 Wrong warning message when editing a mix of Mastersizer 3000 and 3000E records

92424 User able to sign off read-only record, but changes are unsaved

92521 Using ‘From Existing SOP…’ functionality allows SOP permissions to be by-passed

92525 SOP prevented from saving or closing when errors exist on inactive functions

92951 Sample identifier text cut-off if on multiple lines

95123 Sample name not applied to SOP Player records from Sample Documentation window

95454 Software intermittently crashes on rare occasions software fails to access the dry accessory status

95532 Validation errors for Ultrasonics page in SOP

95682 Opening multiple records from network locations crashes the software

95717 Invalid report path crashes software at startup

96030

Audit Trail CSV export doesn’t use French-compatible CSV format in French language Mastersizer 3000

software

96579 MS3000 installer is not localized in all support languages

96580 Signature action types are not localized in audit history

96620 ‘Replace this license’ button cut off in Russian

96625 ‘Replace this license’ button text not localised

98511 Report deleted upon edit if no write permissions on folder

100389 Batch Printing can take a long time, resulting in ‘printer time-out’ error

103433 New Report page is blank when cycling through report tabs

103439 Renaming New Report not functioning correctly

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 9

104137 Chinese and Japanese characters do not display correctly in audit export PDF

104324 Audit export translation doesn’t work

104341 Audit export font doesn’t support all Chinese and Japanese characters

106412 Binary audit trail 0 trim deserialization issue

107585 Audit trail export CSV broken for Chinese and Japanese characters

109295 Creation of a new report in Result Overlay results in inability to view data in original report

91263 Aero level sensor test not required on maintenance page

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 3000/3000E system using the

Microsoft Windows security and access settings. Guidance regarding how to set up the security settings is provided in

the Windows Security Settings section of this document.

File Type Extension Default Path Advised security setting for

21CFR Part 11 Mode

21CFR11 mode: Audit

trails (Mastersizer 3000

only)

.mpaf C:\ProgramData\Malvern Instruments\Mastersizer

3000\Audit Trails

Prevent deletion of the files in

this directory. However, read,

write and modify access must

be maintained.

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

3000\User Sizes

No control required as these

settings are stored in SOPs.

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

3000\Materials

No control required as these

settings are stored in SOPs.

User defined

dispersants

.mdis C:\ProgramData\Malvern Instruments\Mastersizer

3000\Dispersants

No control required as these

settings are stored in SOPs.

Data quality addins

(Mastersizer 3000 only)

.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

No control required as the

data quality tool only provides

advice.

Export data .txt.csv.rtf Shared workspace:

C:\ProgramData\Malvern Instruments\Mastersizer

3000\ Workspace\Export Data

Private workspace:

C:\Users\{user_name}\Documents\Malvern

Instruments\Mastersizer 3000\Workspace\Export Data

If data export is a critical part

of the SOP used for your

samples then you should

prevent deletion of the files in

this directory. However, read,

write and modify access must

be maintained.

10 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

Measurement data .mmes Shared workspace:

C:\ProgramData\Malvern Instruments\Mastersizer

3000\ Workspace\Measurement Data

Private workspace:

C:\Users\{user_name}\Documents\Malvern

Instruments\Mastersizer

3000\Workspace\Measurement Data

Prevent deletion of the files in

this directory. However, read,

write and modify access must

be maintained.

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

Prevent deletion of the files in

this directory. However, read,

write and modify access must

be maintained. Note: it is

important that users are

prevented from deleting

reports via the software

interface as well. This can be

done using the MAC

application.

SOP templates .msot Shared workspace:

C:\ProgramData\Malvern Instruments\Mastersizer

3000\ Workspace\SOP Template

Private workspace:

C:\Users\{user_name}\Documents\MalvernInstrument

s\Mastersizer 3000\Workspace\SOP Template

No control required.

SOP .msop Shared workspace:

C:\ProgramData\Malvern Instruments\Mastersizer

3000\ Workspace\SOP

Private workspace:

C:\Users\{user_name}\Documents\Malvern

Instruments\Mastersizer 3000\Workspace\SOP

Prevent deletion of the files in

this directory. However, read,

write and modify access must

be maintained.

Data export templates .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

No control required.

Licence file .licence Mastersizer3000.licence file stored in:

C:\ProgramData\Malvern Instruments\Mastersizer

3000\Configuration Files

Once the system has been set

up and 21 CFR Part 11 mode

engaged then access to this

file must be set to prevent

deletion. However, read, write

and modify access must be

maintained.

Security configuration

file

.xml Exported from the Malvern Access Configurator

(MAC) application. The directory is user-specified.

Malvern advise that the file should be stored in:

Prevent deletion this file once

it is created. However, read,

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 11

C:\ProgramData\Malvern Instruments\Mastersizer

3000\Configuration Files

write and modify access must

be maintained.

Various system wide

configuration files

Various C:\ProgramData\Malvern Instruments\Mastersizer

3000

Full access must be

maintained to this directory

for the program to function

correctly.

Changing the destination path for a file

The following folders can be configured from within the Mastersizer 3000/3000E software:

• SOP

• Measurement

• Data Reports

• Export Data

For Mastersizer 3000 users and those who have upgraded the Mastersizer

3000E software, the default file location for these files can be configured via the

Target Folders section of the Workspace viewer. To do this, click on the pencil

icon which appears when you hover over the directory shortcut:

Changing the directory associated with this shortcut will change the default

directory accessed by the Mastersizer 3000 software for the selected file type.

Configuration of the target directories can also be configured from the User

Preferences-Folders section of the Options menu:

Again, hover over the shortcut and click on the pencil icon in order to change the target directory. Note that this is the

only place in the software where the target directories can be configured when using the Basic software for the

Mastersizer 3000E.

12 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

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.

Windows Security Settings

With a 21CFR11 compliant computer system, one of first concerns to address is the potential for the loss of data; either

accidently, or by intention. Utilizing the built-in security tools of Microsoft Windows®, an IT professional can effortlessly

change user access to specific files and/or folders by simply removing certain file/folder permissions.

For the next part of this document, it is assumed that you have the required administrator rights for the system upon

which the Malvern software is being installed; allowing you to install, or update software and configure windows security

permissions.

Note:

For the following demonstration we have previously created a user group, through the Computer Management

console, called ‘Mastersizer3000 Users’. This user group will later be added into the folder permissions of the

Audit Trails folder to prevent users from deleting records. This process can be applied to any other output

folder requiring limited user access. In the following illustrations, we have not removed default groups such as

‘Everyone’ or ‘Users’ - these can be deleted or used as an alternative to dedicated user group/s. However,

when using these groups, we strongly advise that explicit ‘Denies’ are not used, unless you fully understand

the Microsoft® file/folder security permissions.

Changing the folder security permissions in Windows 10

1. Navigate to one of the folders that needs to be secured - in this case we have selected the folder where the

Mastersizer audit trail files are stored. Right-click on the folder and through the context menu open the folder

Properties.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 13

2. Within the Audit Trails Properties dialogue, left-click on the Security tab and left-click the Advanced button to

open the

Advanced Security Settings.

3. Within the Advanced Security Settings left-click the Disable inheritance button:

4. Within Block Inheritance, left-click on Convert inherited permissions into explicit permissions on this object –

this removes the permission inheritance from the parent folder, whilst keeping the any current users and

groups settings.

5. After returning to the Advanced Security Settings window, left-click to select the Mastersizer3000 Users group

and then left-click the

Edit button.

6. In the Permissions Entry window, left-click the Show advanced permissions to reveal the full permissions list.

14 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

7. Left-click to de-select the check-boxes of Delete subfolder and files, Delete, Change permissions, Take

ownership and finish by left-clicking the OK button to return you to the previous window.

8. Left-click Replace all child permission entries with inheritable permission entries from the object and left-click

the

Apply button.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 15

9. Left-click the Yes button when prompted to replace the permissions and the OK button when you return to the

previous window.

10. Left-click the OK button when you return to original folder properties window.

Changing the folder security permissions in Windows 7

1. Navigate to one of the folders that needs to be secured - in this case we have selected the folder where the

Mastersizer audit trail files are stored. Right-click on the folder and through the context menu open the folder

Properties.

16 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

2. Within Audit Trails Properties, left-click on the Security tab and left-click the Advanced button to open the

Advanced Security Settings.

3. Within the Advanced Security Settings left-click the Change Permissions button. This will open an identical with

the options to change the inheritable permissions.

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 17

4. In the second the Advanced Security Settings window, left-click to deselect the Include inheritable permissions

from this object’s parent check-box and when prompted left-click the Add button to convert and add the

inherited permissions from parent.

5. Left-click to select the Mastersizer3000 Users group and left-click the Edit button to open the Permissions Entry

window.

18 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

6. Left-click to deselect the Delete subfolders and files, Delete, Change permissions and Take ownership check-

boxes and finish by left-clicking the

OK button. Warning, do not select the check-box Apply these permissions to

objects and/or containers within this container only.

7. Returning to the previous window, left-click the Replace all child object permissions with inheritable permissions

from this object check-box and when prompted to confirm left-click the OK button.

8. Left-click OK on the remaining windows to close them.

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-around for each issue when operating the software.

Issue Work Around Comment

Accessory status bar is green but

SOP and Manual measurement

options greyed out.

From time to time the SOP and manual

measurement options are still greyed out even

when the accessory status bar is green. To re-

enable these options, right-click on the accessory

status bar and reselect the accessory.

Intermittent Observation

Reporting of zero measurements. In rare cases a zero measurement can occur in

both wet and dry measurements. The

measurement record contains background and

data but no signal information. A zero

distribution is recorded in the measurement file.

No work-around available.

Medium risk issue

Software can crash when batch

printing

When selecting too many reports and/or too

many records for batch printing, an error can

occur causing a crash exception.

Low risk issue

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 19

Restricting the total number of pages printed to

220 or less (equivalent to 13 results batch printed

with 10 reports) will mitigate this issue occurring

Aero S and Aero M sample feed

control

When carrying out manual measurements it is

possible to enable the sample feed for the Aero

dispersion unit with the vacuum and dispersion

air switched off by clicking the Feed button twice

within the accessory controls. After

approximately ten seconds the system will switch

back into standby mode and an ‘insufficient

exhaust vacuum / air achieved’ error message will

be displayed. However, some sample may be lost.

Error can be avoided procedurally

(avoid double-clicking the feed

button).

Corrupt report settings file causes

software crash on start-up

It has been observed that the global report

settings file may become corrupt. This file holds

the company name and logo used across all

reports in the software. A symptom of this issue is

the software crashing on start-up with an

exception “hexadecimal value 0x00, is an invalid

character”. The workaround is to delete the

contents of folder at C:\ProgramData\Malvern

Instruments \Malvern.Reporting. This will trigger a

new fresh settings file to be created – you will

have to reconfigure your company name and logo

in reports.

Medium risk issue

Warnings are displayed about

corrupt measurement files

The software has built in detection of when

measurement files are at risk of being corrupted.

If you see one of these messages, you are

probably creating too large a measurement file.

Intermittent Observation

Instrument disconnects after

firmware upgrade

An issue has been seen for some installations

whereby the instrument will become

disconnected from the computer following a

firmware upgrade. Turning the instrument off

and on again will cause it to successfully

reconnect to the software.

Intermittent Observation

The manual measurement

settings do not match the

connected/active dispersion unit.

See known issue description below. Intermittent Observation

Some text still appears in English

when running with a different

language selected.

The translation of all software text will continue in

future releases.

Low risk issue

Software does not open all files

selected when they are opened

using Windows Explorer.

Use the Open menu option in the Mastersizer

3000 software to open multiple files.

Low risk issue

The system audit trail displays

duplicated columns for each

language under which the system

No work-around available. Low risk issue

20 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

has been run when auditing has

been enabled.

Various fields in the Edit result

window lose their ‘edited’ blue

background appearance when a

different page in the editor is

selected.

No work-around available. This is a display issue

only, as the software correctly applies the edit

values when the OK button is pressed.

Low risk issue

Trend table print out is limited by

paper size

Report widgets are designed to fit on one page,

and will not wrap over pages. If you select lots of

measurement records, the trend table widget will

expand to fill the page. However, if you select

more measurement records than can fit in a

trend table on a single page then the displayed

records will be truncated at the page boundary.

The only work around for this issue is to print the

report on a larger paper size. Paper size A4 has a

limit of 56 records in a trend table, whereas paper

size A3 has a limit of 86 records.

Low risk issue

Some parameters are not

imported from Mastersizer 2000

measurement records

When importing Mastersizer 2000 measurement

records into the Mastersizer 3000 software, some

SOP parameters from the Mastersizer 2000

records do not get imported. However, all of the

parameters required for result review or

recalculation are present.

Low risk issue

Manual measurement errors are

reported if the Aero dispersion

unit configuration has changed

between measurements

The manual measurement feature in the software

stores the last used settings. This includes

configuration of the Aero dry powder disperser. If

you change the configuration between

measurements and then open a manual

measurement, the software will report an error

stating that configuration is wrong. If this

happens, close and re-open the manual

measurement window and change the manual

measurement settings to match your new Aero

configuration.

Low risk issue

Software exception is reported if

the software is closed when a

macro is running

All currently running macros must be closed

before closing the software.

Low risk issue

Some report widgets are

truncated in the print preview

view

Some report widgets may not be displayed

correctly within the print preview screen.

However, if the report is printed all of the

information within the widget will be shown.

Low risk issue

Software may crash when

exporting data with custom

sample identifiers which start

with a number

Exporting measurement data with custom sample

identifiers beginning with a number will cause the

software to crash when you select an export

template that contains sample identifiers. The

Low risk issue

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 21

only work- around is to prefix sample identifiers

with letters.

Ultrasound SOP option

‘Continuous (From Measurement

Start)’ does not turn off in SOP

playlist

If you use an SOP with the ultrasound option

‘Continuous (From Measurement Start)’ in an SOP

playlist, when running a subsequent SOP with no

ultrasound turned on, the ultrasound will not turn

off as expected. The work around is to use the

‘Continuous (From Sample Addition)’ option in the

SOP rather than ‘Continuous (From Measurement

Start)’. When this playlist is run, then the

ultrasound will turn off when executing a

subsequent SOP which does not require

ultrasound.

Low risk issue

Cannot load old custom

calculations from file

When trying to load a custom calculation created

in v3.30 software or earlier, the software may

report error and the calculation will not load. The

workaround is to re-export the custom

calculation from the original report in a recent

version of the software.

Low risk issue

Data quality tab is not displayed

immediately when selected from

the extended features list

Given that the software has just been installed

and the option to enable the extended software

features is selected. Then when the application is

restarted the data quality tab will not be

displayed if the default view is selected. The work-

around is to select the 2-pane vertical view which

will display the data quality tab. Then reverting to

the default view will display the data quality tab.

Low risk issue

Ultrasound level applied during

clean reported as 0%

You may find that the measurement manager

reports that 0% ultrasound is being applied

during cleaning when you have set an ultrasound

demand of greater than 0%. Evidence suggests

that ultrasound is applied correctly as per the

configured ultrasound demand, but the value

shown in the measurement window is incorrect.

Low risk issue

“Some data may be missing” error

message on attempting to resign

records created in v3.30 or earlier

This is a false-positive error message, a

consequence of a design issue fix implemented in

v3.40 onwards.

In earlier versions of the software (v3.30 and

earlier), duplicate parameters were written to the

measurement record. From v3.40 onwards, a fix

was applied which enabled the duplicate

parameters to be disregarded. However, this

means that when a measurement is created in

v3.30 or earlier, and then signed in a later version

of the software, the signature information is

written over the top of the duplicate data, causing

the false-positive error message to be generated.

Low risk issue.

The error message is a false-

positive (data is not missing) and

locking signatures are not lost on

v3.81, so it is unlikely a user will

need to resign a record.

22 Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28)

Downgrading v3.81 with 21CFR11

mode enabled to earlier versions

of the software will cause this

functionality to be switched off

Re-enable 21CFR11 functionality once downgrade

is complete

Medium risk

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.

Measurement File Format

In v3.40 of the Mastersizer 3000 software

we have re-introduced the file format

used in older versions of the software

(v3.10 and earlier) due to an

incompatibility issue we discovered when

the software’s 21 CFR Part 11 features are

enabled. This format is now selected by

default and offers the advantage that it is

compatible with all earlier versions of the

software.

Note that files created using v3.20 and

v3.30 of the Mastersizer 3000 software

can still be opened, edited and saved

using v3.40. The software will

automatically switch to the correct file

format if you select a file created in these

versions. If you want to specifically create

a file in the same format used by v3.20 and v3.30, select the

Measurement file (special compatibility) option when

creating a new measurement file:

Measurement File Size and Corruption Warnings

Version 3.20 and higher of the Mastersizer software includes the ability to detect when measurement files are at risk of

becoming corrupted. If you see one of these messages, you are probably creating too large a measurement file. We

Software Update Notification for Mastersizer 3000 software v3.81 (PSS0223-28) 23

recommend that you keep measurement files to a maximum size of 100 records, and advise that you try to remember

to regularly create and use new files to store measurement records.

Note that Malvern are currently investigating possible alternative measurement file formats for use in future software

releases, with the goal of increasing the maximum number of records which can be robustly stored within a single file.

Backward Compatibility

This software is only compatible with the Mastersizer 3000 (MAZ3000) and Mastersizer 3000E (MAZ3010) systems, and

cannot be used with the Mastersizer 2000 (APA2000) or Mastersizer 2000E systems. It is possible, however, to review

Mastersizer 2000 / 2000E results within the Mastersizer 3000 / 3000E software. Please refer to the user manuals and

software help for guidance as to how this is achieved.

Analysis Error codes

The following error codes may be returned by the analysis routine as a result of data collection or result calculation

errors:

Error Code Description

Error detected with the selected material or dispersant optical properties.

Unable to load or generate a scattering matrix.

8 Unable to initialize the result calculation routine.

9 There is no raw data to analyze.

10 Unable to apply the selected analysis settings.

Error occurred during generation of the scattering matrix.

13 Error occurred during raw data handling.

Unable to configure the result calculation routine.

Unable to generate a result based on the input raw data.

Could not find any particle size distribution modes in the result.

19 The analysis residual is greater than 99.9%.

Error occurred when using the Fraunhofer analysis model.

25 Corrupt analysis settings detected.

Scattering matrix calculation settings errors detected.

43 Error occurred while generating the scattering matrix.

45 Matrix generation is currently busy.

MALVERN PANALYTICAL

Malvern

Panalytical Ltd.

Grovewood Road, Malvern,

Worcestershire

, WR14 1XZ,

nited Kingdom

Tel: +44 1684 892456

Fax: +44 1684 892789

Malvern

Panalytical B.V.

Lelyweg 1, 7602 EA Almelo,

Netherlands

Tel: +3

1 546 534 444

Fax: +3

1 546 534 598

[email protected]

www.malvernpanalytical.com

Disclaimer: Although diligent care has been used to ensure that the information in this material is accurate, nothing herein can be construed to imply any

representation or warranty as to the accuracy, correctness or completeness of this information and we shall not be liable for errors contained herein or for

damages in connection with the use of this material. Malvern Panalytical reserves the right to change the content in this material at any time without notice.