Contents

Introduction. 2

Easy menu system and Toolbar system... 2

Data Security and Login. 3

Test Equipment. 3

Chamber Records. 4

Adding Chamber equipment. 5

Test Preparation. 5

Connecting to Data Acquisition Unit. 5

Channel Configurations. 6

Modifying the channel configuration for different sensors. 6

Performing automatic or semi automatic thermocouple calibrations. 7

The Calibration Check. 10

Scaling a channel for pressure, humidity or other sensors. 10

Verifying Calibration Adjustments are correctly applied. 11

Test Specifications. 12

Starting a Test. 13

Reports and data management. 15

Reports. 15

Data Management. 16

Introduction to Test Specification Edit Window.. 17

 


Introduction

This document is aimed at helping users to get TQSoft setup and start testing. It assumes user will use the TQSoft ‘easy’ menu interface.

Training videos are available on the www.tqsoftware.com web site on the Support and training menu for Operator and Administrator. They go through the software features outlined in this document step by step. But please be aware that the training videos use the TQSoft ‘toolbar’ interface to access the windows covered here.

User can start TQSoft thermal validation documentation by setting up…

        Data Security

        Test Equipment

        Chamber records

        Calibration for thermocouples and pressure transducer

        Test Specifications

        Reports

Easy menu system and Toolbar system

TQSoft now defaults to using a new menu system which is aimed at making it easier to setup and navigate. Its easy to switch back to the TQSoft toolbar menu from the left panel. Progress down the items in the left panel, and use the small dropdown arrows on the right to access the full range of options.

Data Security and Login

TQSoft checks data files when they are used to produce reports. Any changes made other than by a person authorized via a TQSoft ID and Password will render records unusable.

All changes made by an authorized user in TQSoft are audited with full details of the changes made and actions performed.

TQSoft now offers two options with respect to user Logon.

1.      TQSoft can use the Windows user account name, so no separate TQSoft ID and Password is required. This is the default method.

2.      TQSoft Edit Security option can be used from the Setup\Login dropdown menu to create TQSoft user accounts and access profiles. (See manual 2.1 for full details)

Test Equipment

Note: Wait until after connecting to equipment to create these database records……When TQSoft connects to Fluke equipment in following sections, it automatically creates a new Test Equipment record containing the model, serial number and cal date (if available). To add information, or to make new records for other equipment, go to the Setup menu and Test Equipment option.

To create a new item of test equipment, right click on the main Test Equipment node.

To create a new Logger or Ref Unit or Bath record right click on the relevant node.

To tell the software which equipment is currently being used, right click on the item and choose the Select option. Selected item information is copied to calibration and test records.

When adding information, be sure to use the Save changes button that appears.

 

Chamber Records

A Chamber can refer to any space being thermally tested. So it could be an autoclave, furnace, oven, storage area, climate chamber, thermal bath etc.

On the Setup menu the Edit Chamber Records option allows chambers to be added by right clicking the main Chamber node. It’s probably best to use the serial number of the chamber (but alphanumeric characters only) as the reference.

The site name can be used when a group of chambers are located on one site and the name can be used to identify each chamber. The rest of the entries in the ID, Details and Custom tabs are quite self explanatory.

All the chamber record information is also stored in the chamber section of Test Records and may be automatically displayed in reports. Reports can be designed in TQExpress or Word or Excel, but support is required from TQSolutions when importing data from Test Records.

The Schedules tab is used  for heat treatment requirements. For calibration of chamber instrumentation the Next Calibration Date may be useful to include in reports.

The Sensors tab is also used  for heat treatment requirements. It can be used to store the sensor positions in the chamber. But for general thermal validation requirements, the sensor positions may be load or process dependent, and are  better setup in a Test Specification individual to each load or process type.

The Test Specification tab may be used to reduce the Test Specification selection list for an operator when a test is to be started. This will make it easier for the operator and harder to make a mistake. Click in the small box to indicate that a particular test specification is to be available in the Start Logging window.


Adding Chamber equipment

Many chambers are fitted with control and monitoring equipment that may also need calibrating and have reporting requirements. Double click on a chamber node to show the Equipment node. Right click on the equipment node to create a new item of equipment and enter the information for the item similar to that shown here.

 

Test Preparation

Connecting to Data Acquisition Unit.

TQSoft has drivers for a number of data loggers.

For Fluke 2638A or 1586A units, ensure the USB adaptor driver is loaded from the Fluke CD, start TQSoft, go to equipment connections then Inputs Display on the Select Type of Logger dropdown. A connection is automatically made when user starts a calibration, a test, or starts inputs display.

For all other loggers the model must be selected in equipment connections then Select Type of Logger. Many loggers need special drivers loaded or Ethernet settings setup and it is necessary to check the relevant appendix in the main manual with the help button in the Select Logger window.

The default communications settings will match the factory default settings. You will need to select the correct COM port, and the Test Connection button will help check if the COM port is the right one.

 

Channel Configurations

Most loggers must be configured for the sensor or thermocouple connected to each channel. TQSoft is preset with a number of channel configuration files that will fit most requirements. A channel configuration file has a selection (eg Thermocouple Type K) for each channel. Every time you start a test with TQSoft, every channel is automatically programmed correctly.

The channel configuration also controls the channel label, number of decimal places, and the trace color of each channel.

After connecting with the logger you should see this window….

The configurations can be modified and new ones added in the Edit channel configuration option. You may need to modify the channel configurations to suit your thermocouple type or if you are using PRT, pressure or humidity sensors.

Modifying the channel configuration for different sensors.

To access this window select Edit Channel Configurations on the Setup menu.

The left hand panel lists the configurations available. Click on one to access the list of channels and click on a channel to access its settings on the right.

The channel configuration name shown bold is the one currently selected for use in calibration and the Inputs Display window. Right click a configuration to select it. When the window is closed you are given the option to download selected configuration to the logger.

Note that when a test is stared TQSoft will automatically switch to and download the channel configuration selected in the test specification (which is dealt with later in this guide).

Pressure and humidity sensors will normally require a voltage or 5-20mA selection. Note that these inputs will also require a scaling procedure to convert the voltage measurement into required pressure or humidity units. The scaling uses a modified calibration procedure and is covered at the end of the next section on calibration.

The PRT selections will allow 2,3,4 wire selection. TQSoft also allows ITS-90 coefficients to be entered and downloaded to a 1586A unit.

Performing automatic or semi automatic thermocouple calibrations

To perform an automatic thermocouple calibration in TQSoft a thermal bath and reference sensor must be connected to TQSoft. These can be setup with the Select Type of Bath and Select Type of Reference options. Connections can be checked using the Inputs Display, or equipment control options.

To perform semi automatic thermocouple calibrations the thermal bath and/or reference need not be connected, and the operator will need to enter reference display values and/or set bath temperatures when stability criteria are met.

To start use the Calibration or Calibration Checking options, and select  the calibration file to store results.

The Job Ref is used to link calibrations, tests and report together. Use a different Job Ref for each validation project.

TQSoft is installed with a calibration file (Calibration Set 1) for storing thermocouple corrections. If you are planning to always calibrate thermocouples before testing then you can always use the default calibration file for storing results, older results are overwritten. Calibration reports are stored separately and never overwritten.

If for some reason you wish to use multiple calibration files, the Calibration Files Manual Adjust window will allow new calibration files to be created. Access to this option is not available on installation needs to be enabled in Edit Security/Setup tab

Next, select the channels to be calibrated. If there are too many thermocouples to calibrate in one go TQSoft allows multiple calibrations (not concurrent), and will automatically manage all corrections and reports.

Next, the test equipment window may appear to allow the correct equipment information to be put into the report. TQSoft does not as yet link connected equipment serial numbers to the test equipment database.

Next, the calibration setup window appears:


At this point the yellow highlight option can be used to switch between a calibration and a calibration check. Both options are very similar from user perspective with the important difference that the calibration calculates and stores new corrections, whereas cal check applies old corrections and checks against the reference.

Regards the Stability criteria, the blue underlined parameters are for thermocouple stability, and the red underlined is for reference stability. It is essential to get stability criteria to work well for your equipment. Very inaccurate corrections can result if temperature in bath is still in fluctuating phase.

If reference is not connected then the reference criteria are not used and the operator will need to check reference stability and then enter reference value when thermocouples and reference are stable.

Next, press OK to start, and the calibration progress window will appear:

This window shows a summary of the channels being calibration, only the slowest to stability and the largest deviation are shown. The box highlighted in yellow is where the reference value must be entered and confirmed with ENTER key when the reference unit is not connected to TQSoft.

In an automatic calibration the Proceed button will not appear and the next stage of calibration will proceed when the timers both countdown to zero. In a semi automatic calibration the operator will wait for thermocouple and reference stability, and then enter the reference value and press ENTER and then Proceed button. Then operator will adjust thermal bath for next setpoint.

Next the Post Calibration Report window may appear if report duration is set in the criteria:

Now the process will repeat for each set point. At the end the calibration report window will appear and the report can be printed:

Now, if there are more thermocouples to calibrate than the bath can accommodate in one go another calibration can be performed selecting a second set of channels. Another report will be produced.

It is important to remember that when a test is started TQSoft will copy all required calibration reports to the ‘test record’. The ‘test record’ is a set of files (10-20) that contain all the information for that test. When a test record is copied or archived, all the required calibration and calibration check reports are copied too.

The Calibration Check

When a test or set of tests is complete many users want to perform a calibration check with the thermocouples put back into the bath. The calibration check was mentioned earlier and the process is very similar to a calibration.

When the check if finished a question ‘Are you finished checking’ appear. The calibration check report will automatically be copied to the test record of all tests since the date/time of the last answer YES.

Scaling a channel for pressure, humidity or other sensors

When a channel has been configured for a voltage or current and it has no adjustment in the calibration file it will appear in the channel configuration with its voltage units like this channel yellow highlighted:

 

To scale this value to psi units there are 2 options.

First way is used when a pressure calibrator is available, start a calibration procedure and select just the pressure channel. For high and low enter the top and bottom of the range the transducer will cover. Start the calibration and attach the transducer to the calibrator and set the calibrator pressure to the low value. Wait for the readings to stabilize and press Proceed. Repeat for the high of the range. After calibration is complete the Inputs Display should show the scaled pressure value in green.

Any tests that you want to use the pressure channel will need to have the test specification reference the correct channel configuration file and correct calibration file. See below for help the test specification.

A second way can be used when a calibrator is not available and you know what the transducer is specified to read. For example if you know that 1V should read zero psi and 4V should read 40psi.

After initial installation the Calibration Files Manual Adjust option will need to be enabled in Edit Security, or alternatively an Administrator account created in Edit Security. Then open the Calibration Files Manual Adjust window and click the calibration file. Click the channel that is setup for the transducer. Enter the numbers as shown below, press Save and then click on the channel again and enter Set Point 2 using 4V and 40.

 

Verifying Calibration Adjustments are correctly applied

The Inputs Display will breakdown which adjustments are being made on which channels. In addition to this check, the service engineer should be aware that the Test Specifications will decide which calibration file is actually applied during a study.

The example display here (yellow rectangle) shows a window caption indicating the active calibration file is Calibration Set 1, then the logger serial number is 234726347 .

The green rectangle shows channel T2 in green meaning that thermocouple setpoint adjustments are being applied. Measurements in red have no setpoint adjustments.

The blue rectangle appears when the curser is held over T2 reading. It shows the uncalibrated reading, the thermocouple correction, and the logger correction, separated by commas.

Test Specifications

The Test Specification contains selection settings for target temperature, channel configuration, all calibration information, and all temperature parameters. When starting a test, once you select the Test Specification, all setting are automatically applied by the software, and a report can be automatically generated at the end of the test.

TQSoft is installed with some sample Test Specifications which can be used to become familiar with the system. A later section will introduce the Test Specification Edit window.

The sample Test Specifications use the Universal Channel Configuration °C. If you have setup another for use then you will need to change each Test Specification to reference the one you setup.

If you have calibrated thermocouples and want to use the corrections then you will need to change each Test Specification to reference the calibration file you used.


Starting a Test

To start a test click on the Testing option and then Start Logging. First the item to be tested can be selected, and the cycle number (or test number) can be modified…..

Next the required Test Specification must be selected….

Next a reference can be entered.

The Auto button allows various default references to be added. The reference should remain the same in a series of tests are performed on a chamber and all the tests are to be included in a single validation report.

Leave the Add Test to Report unchecked. The reason for this option will be clearer when reporting is covered after the test is complete.

Finally the Start Logging button will appear and a delay timer is an option.

Once test is started the real time chart is displayed and can be resized for the screen. To return to the easy menus quit the chart.

During a test the testing easy menu button will be labeled Stop Logging in red and the drop down menu to the right of the button will show the real time data display options. The Chart + Calculations display and inputs display will be updated with each data scan.

Select Chart + Calculations from the drop down menu. Click on the Calculations buttons in the Inputs Display window to see real time calculations.

Press Stop Logging to stop the test. Now the button is relabeled Start Logging and the real time data options are not available. Instead the data is now accessed on the next item in the left pane Reports and data management.


Reports and data management

Reports

This panel on the easy menus is headed with the current test record selected, date and time of the test and the name of chamber tested.

The Select historic tests button can be used to select from all tests and the drop down menu on this button can select recently viewed tests.

The Settings and actions for button will allow access to parameter data stored historically for current test selected only.

Similarly Report sections will show the chart and the drop down menu will allow access to all standard reports related to current test only.

TQSoft makes it easy to assemble a complete report from all the report sections. Cover pages, chart, data list, calibration reports, calibration certs…etc are each a report section. TQExpress report manager window is designed to mange and print complete report lists.

The Reports lists will show a report listing in TQExpress if one has been created. If one has not been created the TQExpress window is shown with no expanded folders. A new report listing can be created with the New Report option on the drop down menu or in TQExpress window.

The New Report window is shown here. The list is a list of preconfigured report lists showing number of sections in brackets. This list will look different for different installs and regions and can be customized for service companies with support from TQSolutions.

To start you do not need to make a selection.

If TQSoft knows which test you are working with the Job Ref and chamber will be automatically filled in, so just press OK to create the report listing folder.

You may recall a few pages back at start logging, there was a checkbox add test to report. If ticked then the report listing is created then, and the chart section etc are automatically added into the report list.

This is what the the TQExpress window might look like…………..

The Sample Reference folder might be empty so double click on it will have no effect. To add sections to Sample Reference click the Add TQSoft button and select the sections to add.

A report is considered ‘selected’ if its check box is ticked. To uncheck it, click right inside the small box. Checked reports can be deleted, printed, copied or emailed.

The Add Section can be used to add many other documents such as PDF (cal certs), Word (cover pages) and Excel.

TQSoft has a sheet Designer feature that is considered an Administrator function and can be enabled in Edit Security/Report Lists tab. This document will not cover the customization of reports which will normally require support from TQSolutions.

Making PDF

TQSoft supports PDFfactory or PDF Creator which can be installed when Make PDF button is initially pressed.  PDFfactory requires a license from FinePrint Software but PDFCreator is free.

For PDFCreator please ensure only version 1.7 is installed. Later versions may cause TQSoft to error.

When saving a PDF for the first time using PDFCreator, please set the save folder to c:\Program Data\logsys. This will ensure all PDF’s are saved to the folder that the View PDF button expects.

Data Management

 The Data file management option allows complete test records to be selected for copying and deleting. It also allows TQSoft configuration files to be managed.

The drop down option Archiving is restricted to test records only. It will keep a server location updated with all test records and will only push records to the server location.

Finally the Synchronize option will allow a USB stick or server location to be kept updated with all selected files in the TQSoft installation. This is useful for transferring all or selected components of an installation to another PC.

 

 

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Introduction to Test Specification Edit Window

After becoming familiar with TQSoft most users will need to access the Test Specification function to make modifications and create new Test Specifications. It is certainly advisable that an Administrator is responsible for maintaining and securing Test Specifications.

Test Specifications will be OQ tested for pharmaceutical and biotech use.

The Edit Test Specification window is designed as an Administrator function, therefore after initial installation the Edit Test Specifications option will need to be enabled in Edit Security/Setup tab. In addition some items in the Edit Security/Test Specifications tab will need to be enabled.

The window can be accessed from the Testing menu item (Setup menu in toolbar) on the left or the Reports and data management item (Current Test menu in toolbar). The Testing menu accesses the Test Specification database that the user will select from before starting a test.

The Reports and data file management window has an option Settings and actions for. This option allows access to the historical data for the selected test record. One of these is the Test Specification. Some settings cannot be altered historically.

The yellow Channel configuration and calibration file parameters are essential to select correctly as they affect the raw data stored. Most users should only need to use a one channel configuration file and one calibration file and then ensure that each Test Specification references these files.

The blue scan interval time in seconds will only support intervals achievable by the logger being used. Please check your logger documentation to find out which scan intervals it can manage.

The blue Estimated test duration will only size the real time chart time axis. Once a test is finished the chart is always scaled to span the test time.

The blue Use 24 hour clock will log and display all data timestamps in time of day format. Else time from start of test format is used.

The red Data Listing configure button can be used to tailor the look of the data listing.

The mauve chart configure button can be used to tailor the look of the chart.

The green Analysis setting can be set to ‘Sterilizing temperature’, ‘Disinfection temperature’ or ‘Target temperature’. With stage analysis checked, Sterilizing and Disinfection options can automatically insert the required Sterilization/Disinfection start and end stages into the chart. All other applications should use the target temperature option.

The green tab calculations can configure the row calculations that can be ticked to appear on the data list and chart. Please see section 2.6.2 of main manual for more details.

The mauve tab Lethality can be used to configure lethality calculations that can be made to appear on the data list and chart. Please see section 2.6.3 of main manual for more details.

The probes tab can be used to select which channels to log. It can also store the locations of the sensors and setup a sensor position diagram for this specification. Please see section 2.12 of main manual for more details.

The I-Calcs tab can be used to configure a list of interval calculations. These calculations are different from the calculations tab mentioned earlier. Interval calculations can be used to make a calculation on any group of channels between any 2 stage lines. And they can be programmed to perform various actions such as insert a new stage line when limit is reached. Please see section 2.6.6 of main manual for more details.

Interval calculations are a flexible and powerful tool for any calculation required. They can easily be displayed on chart or data list but support will be required from TQSolutions to import the results to a summary sheet, Word document or Excel sheet.