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This page contains the official AI-readable Q&A manual for TQSoft.
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 <pre>
[
  {
    “question”: “Where are the list of users in TQSoft?”,
    “answer”: “The user list is in the Edit Security option. The user list starts with a ‘default’ user called demo. As long as demo is active the Login window will not appear at TQSoft startup. Once demo user is de-activated in Edit Security, the Login window will appear at startup and valid credentials must be entered. Be sure that an Administrator is correctly setup before de-activating demo! If access to TQSoft is lost through ID\/Password errors then download the emergency security patch from www.tqsoftware.com. Instructions are there.”
  },
  {
    “question”: “How do I start configuring TQSoft my thermal validation requirements?”,
    “answer”: “This consists of several easy steps: 1. You can (optional) setup a Chamber Record. a. Go to Setup Database Entries and select Chamber Records. b. Right click on Chambers to create a new record. c. In ID tab just enter Serial number and Name. (They can be the same) d. In Details tab enter Manufacturer and Model. Everything else can be left for now until your report content requirements are fully known. e. Press Seve Changes then exit. 2. Logger Connection and Channel Configuration. a. Decide if you need to setup a user list in Edit Security. b. Consider each of your thermal validation projects and select one to start with. c. Navigate to Equipment Connections\/Select Type of Logger and select your logger type and connection parameters. See the relevant TQSoft manual Appendix for full connection information. d. With successful connection TQSoft will know how many channels the logger is configured for. e. Navigate to Equipment Connections\/Edit Channel Configuration, create a new one with right click on Channel Configurations. f. Click on the new file (eg Channel configuration 9) and change the name on the right. g. Setup each channel with the required sensor type, decimal places and chart color. Use the Duplicate option for speed. g1. For pressure, humidity, or some other measurement you will likely want to set a voltage input. g2. Scaling uses the same correction registers as the thermocouple calibration procedure outlined below. g3. See 3c below for the scaling procedure. h. Press Quit when finished. If you answer ‘yes’ to the question ‘Use channel configuration now?’, the settings are uploaded to the logger. If answer ‘no’ the settings are juat saved. 3. Calibrating your thermocouples with a thermal bath. This step may not apply to all projects, it depends on your sensors and customers requirements. a. Setting up Automatic Calibration a1. This is optional, with no thermal bath connected operator is prompted to set temperature on the bath. With no reference probe connected operator will need to enter the stable reference displayed on the bath or reference unit. a2. With no connection to thermal bath or reference channel proceed directly to the Calibraion Corrections then Calibration. a3. If you wish to connect to a thermal bath then go to Equipment Connections then Select Type of Thermal Bath. See the relevant TQSoft manual Appendix for full connection information. a4. Some baths have a build in reference probe and may allow TQSoft to use it. a5. Use the drop down option Thermal Bath Control to check the unit is communicating. a6. If measurements are not displayed use Windows Device Manager to check COM ports, check COM settings on the bath. a7. If you wish to connect to a separate reference unit then go to Equipment Connections then Select Type of Reference. See the relevant TQSoft manual Appendix for full connection information. a8. Use the drop down option Reference Control to check the unit is communicating. a9. If measurements are not displayed use Windows Device Manager to check COM ports, check COM settings on the unit. b.\tCalibration Procedure. b1. Proceed to Calibraion Corrections then Calibration (Logger must be connected). b2. Select which calibration file will be used to store the offset results of the calibration, and press OK. b3. Select the channels that you want to calibrate. b4. At the Test Equipment window select the equipment you are using. b5. At the calibration Setup window enter the high, low, and check point of the procedure. b6. The stability panel settings will be familiar to experienced technicians, see section 2.5 of the general manual for full details. b7. Press OK to proceed. b8. If the calibration is automatic TQSoft will wait for sensor stability criteria to be achieved, and proceed to completion. b9. For non automatic calibration user is prompted to set thermal bath temperatures and change reference setpoints. c.\tScaling voltage channel inputs for pressure and humidity etc. c1. Go to Calibration adjustments then Calibration Files Manual Adjust. This option may need to be added to your user profile in Edit Security. c2. Click on the same calibration file that you used for the calibration process above, and open the treeview to see all channels. c3. Click on the voltage channel, then enter a scaling on the right. For example, Measured 0 volts, Actual 1 Bar. c4. Press Add SetPoint, then click on channel again and repeat, for example, Measured 4 volts, Actual 4 bar. c5. Press Add SetPoint again and open the treeview for that channel. There should be 2 setpoints. Close the window and click Save. 4. Checking that all setpoints are being used. a. Go to Equipment Connections then Select Type of Logger dropdown option Test Connection. b. If the logger is successfully started the Inputs Display window should show scanned measurements. c. Values shown green have corrections or scaling applied, the operational calibration file is shown in the window caption. d. Values shown red do not have corrections or scaling applied. e. Hover over a measurement value to see the actual correction applied. 5. Preparing for a test by setting up a Test Specification. a. Test Specifications have many parameters but this guide will instruct on creating a new simple one. b. Go to Testing then Test Specifications. Click New then No for Use as basis for new one. c. Click Next. Then change the Name to something like Test 1. d. If using Fluke click Measurement Rate Fast. e. Select the calibration file used in previous steps. f. Select the channel configuration file used in previous steps. g. Click on Probes tab and Select Probes button. Select desired probes. h. Press OK to save the Test Specification and exit. 6. Running a Test. a. Go to Testing then Start Logging. b. Select a chamber name and enter a number for this test. Press Next c. Select the required Test Specification and press Next. d. Enter a Job Reference or press the Auto button. f. Press Start Logging. The chart will appear showing real time data being updated. g. To stop exit the chart and press Stop Logging. h. The data will be available in ‘Reports and Data File Management’.”
  },
  {
    “question”: “Whay is the page numbering of my PDF generated by TQSoft incorrect?”,
    “answer”: “You do have to make the PDF twice before the correct page x of y will appear. Is this the problem or you have, or some other paging error? Also you can find your report files in TQSoft\/Reports, so you could locate a particular set of report files and send them I can have a look.”
  },
  {
    “question”: “When logging the Fluke logger nearly always loses communication with TQSoft, how can we fix this?”,
    “answer”: “1.\tWhen we have Fluke connected to TQSoft in our office with LAN or USB we are able to log data for weeks without issue. 2.\tWhen system is used on site the real time data can stop in TQSoft. Sometimes it can stop after minutes and sometimes after many hours. 3.\tSometimes the Fluke unit also freezes, and needs to be rebooted, but usually the Fluke unit continues storing data, and it can be imported to TQSoft at completion. 4.\tWith USB connection the Fluke drivers create a COM port in PC. We found that when communications issue occurs the COM is affected and will usually need re-install by disconnecting USB and re-connecting. 5.\tWith LAN connection we found that port is also affected by communications issue, but less so than the COM port. In fact after a period of minutes, real time data in TQSoft re-appears! However, complete data must be recovered from Fluke memory afterwards. 6.\tWe concluded that the communications issue is caused by electrical noise impacting Fluke firmware and this cannot be addressed by a PC application, in this case TQSoft. 7.\tWe advise customers to try a different electrical circuit and use Fluke memory. 8.\tWe don’t believe that Windows version has any effect on this issue. There is extra code in latest TQSoft versions to try to recover real time communications. This works a bit with LAN but Fluke download is still required because real time data is not complete, some is lost.”
  },
  {
    “question”: “Our TQSoft user assigned as Administrator has forgotten his password, how can we get access to the software again?”,
    “answer”: “Its simple to resolve, go to www.tqsoftware.com then Downloads and download the ‘Emergency Security Patch’, then copy it (Operat3.ini) to the TQSoft folder replacing the existing file. But you will have to re-enter user accounts.”
  },
  {
    “question”: “Can I get a trial of TQSoft or TQAero?”,
    “answer”: “The customer can go to www.tqsoftware.com and login with………….Username: TQTrial….Password: TQTrial00001. Then in the Downloads you should find full installs for TQSoft and TQAero 9.x.x. To install right click on setupTQSoft90x.exe and choose ‘Run as Administrator’. When running the software first time the registration window should appear, please make the ‘Trial’ selection. Please be aware that you will need to verify your email address by checking your email.”
  },
  {
    “question”: “Is it a way that we read the Fluke 1586A channel configured with the  mx+b function? We need it for relative humidity and other non-temperature measurements.”,
    “answer”: “Yes the Fluke channels can be directly programmed with mx+b function. But TQSoft can have multiple setpoints added for each channel, and 2 setpoints is an mx+b. The way TQSoft works is to do all adjustments in TQSoft, so the Fluke is not programmed with the mx+b through TQSoft. If you use Fluke memory, the adjustments are done when the data is imported to TQSoft.”
  },
  {
    “question”: “Is TQSoft limited to maximum 2 set points?  What I meant by points was the points in the oven space. Let’s say we want to calibrate the oven at 9 different temperature locations and 1-2 RH sensor locations. But we want to calibrate at those locations at multiple temperatures and RH set points eg -70 deg C, -20 deg C, 0 deg C, 50 deg C, 150 deg C, 5% RH \/ -10 Deg C, 20% RH \/ 20 deg C, 95% \/ 80 deg C. Can it be done with TQsoft?”,
    “answer”: “We are talking at cross purposes. By setpoint I mean a temperature value (or humidity) at which a calibration adjustment is calculated. I will try to use your meaning and use calibration points! I think you are confusing calibration in TQSoft with your calibration of a chamber. They are separate. 1.\tIn TQSoft you can add calibration points for your sensors connected to the Fluke. These calibration points can be used to adjust temperatures or scale voltage to pressure or humidity. 2.\tFrom the data you collect I think you want to calculate calibration data\/adjustments for the chambers you are working on. Here is the process: 1.\tIn TQSoft setup a channel configuration and calibration file so that 9 temperatures and 2 humidity sensors are functional. (Test it with Inputs Display) 2.\tSetup a simple test specification that uses correct channel configuration and calibration files and will log 9 temperatures and 2 humidities. 3.\tTry the test spec in a simple scenario, check data. 4.\tPut the sensors into a chamber and try to log a complete data set at all setpoints and temperature\/stability points. Be sure to use Fluke memory option in case the TQSoft communications are disrupted. If disruption occurs data can easily be imported into TQSoft at completion. 5.\tSend data to me and we can then discuss what calculations you wish TQSoft to make and report.”
  },
  {
    “question”: “How can I make it so it will provide us with data every 1 minute in the data list?”,
    “answer”: “The Data List print interval is controlled by stage settings, for example… 08:12:35 Cycle Started [INT:02.00 CODE:1] INT:02.00 means a 2 minute print interval. Each stage has its own setting. This is separate from the scan interval in the Test Specification. The scan interval is the rate the logger scans and sends data to TQSoft, and is the rate at which TQSoft stores data.”
  },
  {
    “question”: “I encountered a problem while using the software. When I clicked on Calibration, it prompted that Calibration curently NOT active in Pc. What could the cause of this issue and what should I do?”,
    “answer”: “This message indicates that a user has switched off calibration in TQSoft. To switch it back on use Calibration Files Manual Adjust, and this may need enabling in your user profile, use Edit Security to do that. Then click on Calibration Files in the treeview and you should see the option box on the right. Latest 29\/4\/25”
  }
]
</pre>
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Storage Area Validation

Most phases of processing of product within the pharmaceutical and food industry specify controls parameters for temperature, pressure, and humidity. Thus thermal mapping is essential to control these processes.

Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers. Most types of chambers require this treatment from incubators and storage areas and warehouses to autoclaves, EtO chambers, stability chambers, tunnels, dry heat sterilizers. Mapping must be performed on a quality schedule and in special circumstances.

Thermocouples can be used in some cases but often it is easier to use battery powered remote loggers. In both cases TQSoft™ thermal validation software can be used to calibrate before a mapping test, and calibration check during or at the end of the mapping process using the Calibration and Calibration Check feature.

Three mapping tests are required, and if there is a discrepancy between tests another mapping must be performed.

Large areas require many more mapped points than small areas or chambers to a minimum of 12. TQSoft™ can handle 128 separate loggers in a single mapping. MadgeTech Loggers are used for this procedure and have a batch handling interface in TQSoft™ to greatly improve setup and download times.

Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users to create smaller map files and then merge data to create the whole picture up to 128 channels.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and calibration checking operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically, every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

TQSoft™ Interval Calculations feature can be used to setup Mean Kinetic Temperature calculations on any group of sensors over any interval of time.

TQSoft™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.

Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users...

MadgeTech Loggers

TQSoft™ with MadgeTech Loggers

Any models supported by MadgeTech 4 standard.

hitemp150Used together with the TQSoft™ validation software tools for calibration, calibration checking, programming, downloading, analysis and reporting, the MadgeTech solution presents an extremely effective, accurate and cutting edge solution for a range of thermal validation applications.

MadgeTech temperature data loggers  are rugged, submersible battery powered stand alone loggers for use with 21CFR Part 11 compliant TQSoft™ software…

  • Thermal Mapping Validation
  • Storage Area Validation
  • Sterilizer Validation/Autoclave Validation
  • Stability Chamber Validation
  • Incubator Validation
  • Food Validation

Loggers can be quickly programmed by TQSoft™ software in batches to automatically record up to 32,767 temperature measurements. The loggers have a 2 inch rigid external fast response probe. It can be used in harsh environments. It has a real time clock for time stamping all measurements and data is stored in non volatile solid state memory. The memory is protected in the event of a battery problem. TQSoft™ enables quick and easy programming and downloading for large batches of up to 128 loggers.

 HiTemp150FP Temperature RTD -40 to +150ºC with Flexible Probe

hitemp150fpThe HiTemp150 temperature data loggers can be supplied with a 24” (61cm) flexible silicone rubber enclosed cable with 4” (10.16cm) penetration style stainless steel probe and 316 stainless steel body.

Batch programming and downloading of MadgeTech Loggers

  • madgetech interface windowConnect multiple loggers to PC using multiple IFC400’s, limited by only USB expansion capability or number of IFC400’s available
  • Dramatically improves programming and download times
  • Calibrate or Check batches of loggers
  • Test Specifications automatically record serial numbers programmed for data acquisition, making life simpler
  • Reports are automatically generated, showing serial number used, calibration information for each logger
  • Logger usage can be automatically tracked, individual serial numbers can be programmed to alert for re-calibration on date, or time in use, or number of tests performed

Loggers can be quickly programmed by TQSoft™ in batches to automatically record up to 32,767 temperature measurements.

Washer Disinfector Validation

ISO 15883-1:2006 specifies general requirements for washer disinfectors validation and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance.

TQSoft™ thermal validation system and Reporting and Report Management module has been specifically designed to assist manufacturers, validation organizations and users meet requirements for washer disinfector validation, routine control and monitoring and re-validation, periodically and after essential repairs.

Washer Disinfector designs are varied, and consequently so are the requirements for washer disinfector validation. Multi chamber washers can require a combination of thermocouples (for sump, walls, and control locations) and remote battery powered loggers for the load (as it travels through the chambers), and pressure transducers for chamber pumps. A TQSoft™ thermal validation system can easily merge data from different devices to compile an integrated report.

The TQSoft™ thermal validation system is used by most leading washer disinfector validation companies, and at leading training establishments in the UK for ISO 15883 and HTM 2030/2031 compliance.

 

TQSoft™ thermal validation system and Reporting and Report Management module has been specifically designed to assist...

Steam Sterilizer Validation

The process of sterilization within a chamber is a critical process and there is
a regulatory requirement for validation of the process in most countries.

Although validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Process sterilization temperature with steam is carried out at 134°C at a pressure of 3 bar. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility.

In order to achieve good steam penetration of porous loads it is necessary to remove as much air as possible from the chamber and load prior to the sterilization hold phase. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

Steam quality can also be a critical factor in the efficiency of a steam sterilization. Steam test kits can be used to measure steam quality. Some companies claim that correlating measured chamber temperature with measured chamber pressure using standard saturated steam tables can monitor steam quality by controlling the Lethality & Pasteurization calculation based on correlation limits. TQSoft™ thermal validation software provides configuration options for this.

Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its Interval Calculations feature.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

Generally thermocouple accuracy is required to be +/- 0.5°C.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracksthermocouple and logger usage and allows engineers to set limits.

Because of the variety and variation of processes run within steam sterilizers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments in the UK for HTM2010 HTM01-01 and EN554 and EN285 compliance.

TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of...

Lyophilization Validation

The freeze drying or lyophilisation process requires both monitoring and validation of the process chamber.

This will give assurance that the specified critical parameters of temperature and pressure are achieved, thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21CFR 610.13 will be satisfactory.

Although thermocouples and pressure transducers can be connected to a logger/recorder outside the process chamber for lyophilization validation, this can be difficult because of the very low pressures, typically in the range of microbars, or fractions of a Pascal, required by the process.

Loggers such as TMI-Orion NanoVacq 1Tc-2Td (-80°C to +130°C) are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.

For more details please visit our Thermal Validation Systems page.

 

This will give assurance that the specified critical parameters of temperature and pressure are achieved, thereby increasing assurance...

Freeze Drying Validation

The freeze drying or lyophilisation process requires both monitoring and validation of the process chamber.

This will give assurance that the specified critical parameters of temperature and pressure are achieved; thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21 CFR 610.13 will be satisfactory.

Although thermocouples and pressure transducers can be connected to a logger/recorder outside the process chamber during freeze drying validation, this can be difficult because of the very low pressures, typically in the range of microbars, or fractions of a Pascal, required by the process.

Loggers such as TMI-Orion NanoVacq 1Tc-2Td (-80°C to +130°C) are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.

For more details please visit our Thermal Validation Systems page.

 

Loggers such as TMI-Orion NanoVacq 1Tc-2Td (-80°C to +130°C) are better suited to the application. TQSoft™ thermal validation software...

Depyrogenation

The removal of pyrogens from glass and lab equipment in dry heat autoclaves is called Depyrogenation.

Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels can be achieved by holding temperature at 250°C for 30 minutes within a dry heat sterilizer.

The process of Depyrogenation is a critical pharmaceutical process and there is a regulatory requirement for validation of the process in most countries. Although depyrogenation validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that depyrogenation has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the depyrogenation process has been and will be consistently effective.

For more details please visit our Thermal Validation Systems page.

 

Most pyrogens are endotoxins, and although endotoxins are relatively thermally stable, a significant reduction in endotoxin levels...

Temperature Mapping Validation

Most phases of processing of product within the pharmaceutical and food industry specify controls parameters for temperature, pressure, and humidity. Thus thermal mapping is essential to control these processes.

Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers. Most types of chambers require this treatment from incubators and storage areas and warehouses to autoclaves, EtO chambers, stability chambers, tunnels, dry heat sterilizers. Mapping must be performed on a quality schedule and in special circumstances.

Thermocouples can be used in some cases but often it is easier to use battery powered remote loggers. In both cases TQSoft™ thermal validation software can be used to calibrate before a mapping test, and calibration check during or at the end of the mapping process using the Calibration and Calibration Check feature.

Three mapping tests are required, and if there is a discrepancy between tests another mapping must be performed.

Large areas require many more mapped points than small areas or chambers to a minimum of 12. TQSoft™ can handle 128 separate loggers in a single mapping. MadgeTech Loggers are used for this procedure and have a batch handling interface in TQSoft™ to greatly improve setup and download times.

Storage areas and very large chambers are sometimes sub-divided into smaller areas. TQSoft™ Mapping Features allow users to create smaller map files and then merge data to create the whole picture up to 128 channels.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and calibration checking operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically, every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

TQSoft™ Interval Calculations feature can be used to setup Mean Kinetic Temperature calculations on any group of sensors over any interval of time.

TQSoft™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.

Excel is often used to handle large mapping projects but 21CFR Part 11 must be complied with and the excel macros and procedures employed must be continuously adjusted and re-validated and audited. TQSoft™ offers built in thermal mapping and auditing. Moreover TQSoft™ handles calibration information and final reports as an integral part of a mapping project.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

TQSoft™ Interval Calculations feature can be used to setup Mean Kinetic Temperature calculations on any group of sensors over any...

Stability Chamber Validation

Stability chambers are designed to control environmental parameters such as temperature, humidity and radiation levels.

Naturally it is essential to demonstrate that a chamber can in fact control these parameters within a specified accuracy, at all points in and around the chamber, over a time period specified.

Stability chamber can vary in size, and often they are used to store critical pharmaceutical product. After the initial validation exercise many companies proceed to monitor these chambers with alarms on the critical parameters. Strictly these chambers should operate with levels of assurance similar to those achieved in the validation of autoclaves. So a periodic re-validation exercise is necessary.

Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard recorders such as those from Yokogawa. Recorders are often the best choice because they can be setup easily with TQSoft™ to calibrate and map temperature, humidity and luminescence with one unit.

TQSoft™ with MadgeTech can be used to map temperature and TQSoft™ with TMI can be used for temperature and humidity.

TQSoft™ offers the validation engineer great flexibility because it can combine data from different measurement sources into a single 21CFR compliant audited chart and data report.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and calibration checking operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate, automated Calibration and Calibration Check procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

TQSoft™ Interval Calculations feature can be used to setup Mean Kinetic Temperature calculations on any group of sensors over any interval of time.

TQSoft™ Interval Calculations feature can be used to track critical parameters and immediately highlight any test data that is not within specification.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

Stability chamber temperature ranges can vary from 40°C to -80°C. TQSoft™ can perform validation studies with industry standard...

Incubator Validation

Laboratory Incubators require validation according to the normal pattern of installation qualification,
or IQ, operational qualification, or OQ, and performance qualification, or PQ.

Incubators operate in the range 25°C to 75°C and so TQSoft™ with MadgeTech loggers are ideal for the thermal mapping required for the qualification exercise.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically, every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record...

EtO Sterilization Validation

EtO sterilization is used on heat sensitive products.

Consequently, validation exercises must verify that temperature remains within specified parameters. Other critical parameters are pressure and humidity.

Because of the concerns about the chamber seals, remote battery powered loggers are generally preferred for EtO sterilization validation over thermocouple and transducers cabled to an exterior data acquisition device. Loggers such as TMI-Orion NanoVacq Ex are better suited to the application. TQSoft™ thermal validation software is compatible with TMI loggers.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration check procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks Sensor Usage and allows engineers to set limits.

There is a wide variation in the size of EtO chambers and the processes specified within the chamber. Because of this, validation engineers performing EtO sterilization validation should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and Audit Trail Management and has been developed and maintained according to GAMP. Tamperproof File Security is implemented.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and...

Data Logger Calibration

Calibration is the process of establishing the relationship between a measuring device and the units of measure.

This is done by comparing a device or the output of an instrument to a standard having known measurement characteristics. Once the relationship is known, the device is calibrated and can be used to measure the output of other devices.

For many operations the quality of the data logger calibration needs to be known and is quantified by an uncertainty estimate for the calibration. This is so important for the scientific community and manufacturing operations that it has been proposed that an evaluation of the measurement uncertainty be added as part of the calibration process.

To improve the quality of the data logger calibration and have the results accepted by outside organizations it is desirable for the calibration and subsequent measurements to be "traceable" to the internationally defined measurement units. Establishing traceability is accomplished by a formal comparison to a standard which is directly or indirectly related to national standards (NIST in the USA), international standards.

Quality management systems call for an effective metrology system which includes formal, periodic, and documented calibration of all measuring instruments. ISO 9000 and ISO 17025 sets of standards require that these traceable actions are to a high level and set out how they can be quantified.

TQSoft™ thermal validation software can play an important role in such a quality management system. TQSoft™ has a Test Equipment Database, and can track Sensor Usage, calibration due dates and uncertainty of each piece of equipment. It can also produce equipment audit reports for the use of any item of calibration equipment through to a set of validation tests performed, where the tests rely on the calibration performed with the item. This is the kind of feature vital to a good quality system.

TQSoft™ thermal validation software can interface to many leading Calibration and Calibration Check manufacturers' equipment to read Reference Standard straight into the data logger calibration data. The process and report is 21 CFR Part11 compliant. At the same time TQSoft™ can collect and compare data from many types of data acquisition equipment to perform multi point (up to 12) data logger calibrations and calibration checks. It then stores data logger calibration results and reports, and can automatically apply the correct calibration information to test runs. It can apply straight line or polynomial fits to raw uncalibrated data, or it can download calibration set points to recorders and loggers.

For more information please visit our Thermal Validation Systems page.

TQSoft™ thermal validation software can play an important role in such a quality management system. TQSoft™ has a Test Equipment Database...

Sterilizer Validation

The process of sterilization within a chamber is a critical process and there is
a regulatory requirement for validation of the process in most countries.

Although validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Process sterilization temperatures can vary from 121°C for a fluid sterilization to over 300°C for dry heat sterilization processes. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its I-Calc feature.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

Generally thermocouple accuracy is required to be +/- 0.5°C. For Dry Heat Sterilization (or Hot Air Sterilization or Depyrogenation 200°C to 400°C) accuracy is generally required to be +/- 1.0°C.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

Because of the variety and variation of processes run within sterilizers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments in the UK for HTM2010 HTM01-01 and EN554 and EN285 compliance.

Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its I-Calc feature...

Oven Dryer Validation

Dry heat is sometimes used for sterilization instead of the much more efficient
moist heat because some materials are sensitive to moisture.

Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material.

The process of sterilization within an oven dryer is a critical process and there is a regulatory requirement for validation of the process in most countries. Although validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation consists of accurately measuring the temperature at critical points within the oven dryer chamber throughout the process. Dry heat generally employs a temperature between 250°C and 400°C for varying time. The oven dryer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its Interval Calculations feature.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

For dry heat accuracy is generally required to be +/- 1.0°C.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

Because of the variety and variation of processes run within sterilizers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

The process of sterilization within an oven dryer is a critical process... and there is a regulatory requirement for validation of the process...

Hot Air Tunnel Validation

Dry heat is sometimes used for sterilization instead of the much more efficient moist heat
because some materials are sensitive to moisture.

Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material.

The process of sterilization within a hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Although validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Dry heat generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations. Many companies have their own ideas on analysis, and TQSoft™ thermal validation systems can provide flexibility with its Interval Calculations feature.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensable to normal acceptable validation practice, no matter what sensors are used (RTD’s, thermistors or thermocouples). The validation report must show that thermocouples, sensors, calibration and data acquisition equipment have been checked against a traceable standard at regular intervals. Thermocouples should be checked before and after a validation study. RTD’s and thermistors require less frequent checking, usually periodically every 6 months.

For dry heat, accuracy is generally required to be +/- 1.0°C.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate, automated calibration and calibration checking procedures and reports. TQSoft™ also stores all validation and calibration equipment details in a Test Equipment Database management system. Before a validation study the engineer can tick the items of equipment in use and TQSoft™ stores this information in each validation record. This allows users to create audit reports on individual items of the calibration or validation equipment.

Thermocouples have a limited life span and remote logger batteries can run low causing expensive problems during the validation process. TQSoft™ thermal validation software tracks thermocouple and logger usage and allows engineers to set limits.

Because of the variety and variation of processes run within sterilizers, validation engineers should have a method to store test parameters and calculations to be able to repeat tests and reproduce reports quickly and efficiently. This is periodic revalidation. TQSoft™ thermal validation systems provide a database of ‘Test Specifications’ which can be re-used and easily adapted to new requirements.

TQSoft™ thermal validation software provides a Reporting and Report Management module which can provide a large degree of automation to report production, and allow reports to be built, managed, converted to PDF, emailed and archived.

TQSoft™ thermal validation software provides compliance with FDA regulation on electronic signatures in 21CFR Part 11 and has been developed and maintained according to GAMP.

TQSoft™ thermal validation software can help achieve these accuracies by providing simple to operate automated calibration and...

Dry Heat Sterilizer Validation

Dry heat is sometimes used for sterilization instead of the much more efficient moist heat.

Dy Heat Sterilization is used because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material.

The process of sterilization within a chamber or hot air tunnel is a critical process and there is a regulatory requirement for validation of the process in most countries. Although dry heat sterilizer validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the dry heat sterilization process has been and will be consistently effective.

Dry heat sterilizer validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process. Dry heat process generally employs a temperature between 250°C and 400°C for varying time. The sterilizer is required to heat all parts of its load up to the specified temperature for a specified period, long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

For more information please visit our Thermal Validation Systems page.

TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations...

Autoclave Validation

The process of sterilization within an autoclave chamber is a critical process!

There is a regulatory requirement for autoclave validation in most countries. Although autoclave validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process. Process sterilization temperatures can vary from 121°C for a fluid sterilization to over 300°C for dry heat sterilization processes. The autoclave is required to heat all parts of its load up to the specified temperature for a specified period long enough to achieve the desired sterility. The confidence of degree of sterility can then be expressed by a lethality formula or ‘thermal death time’. TQSoft™ thermal validation systems can automatically calculate and alert critical operational parameters with its Interval Calculations feature.

For more information please visit our Thermal Validation Systems page.

The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments in the UK for HTM2010 HTM01-01 and EN554 and EN285 compliance.

The TQSoft™ thermal validation system is used by most leading autoclave validation companies, and at leading training establishments…