TQ Software

Version 8 Released

Version 8.0.2

IR2452TQAero I-Calcs modified by the graphic window now use hard coded ID rather than the user modifiable name.
IR2453Fix for use of HPDAQ902A 16 channel card with KeySight 970A.

Version 8.0.1

IR2449Correction to battery logger driver where non Madgetech loggers were being checked for claim status with meaningless messages.
IR2450Correction to Test Spec editing where new test spec is duplicated.

Version 8.0.0

IR2119TQSoft now allows for a set of calculations to be repeated on sections of a test. For example, min, max and average I-Calcs can be applied separately to heat up, sterilization and cooling stages, and three calculation sheets can display results for each stage.There is a sample test (Penetration) that illustrates this functionality. There is also a sample report Dist & Penetration that illustrates the reporting sheets.
IR2120Groups can now be used to generate separate chart, data list and position diagram for each group in reports manager.
IR2125The row calculations in the Data List are no longer restricted to temperature. If all channels are humidity, then calculations are for humidity. If a mix of channels, then first channel shown will determine the calculation type.
IR2150Rate of change I-Calc can now insert stages precisely where a change of state occurs by back tracking to pinpoint a change of state. For example, when an increasing pressure is detected, the software can now backtrack to when pressure was either stable or stopped dropping, and insert a stage precisely.
IR2149The audit trail now records use of logger and sensor calibration file at start of test or at start of CSV file import.
IR2151During manual calibration the operator is alerted for bath setting change.
IR2153Report Manager can now allow selection from calibration report or cal check reports lists, rather than just from cal reports linked to tests.Also included now is a generic calibration certificate template in Report Manager/Add Sections/TQSoft Reports.
IR2170Modification for Graphtec driver for variable number of channels.
IR2176Saturation pressure now uses same decimal place setting as a pressure channel (if one is setup) so that chart works correctly.
IR2178Fix for situation where sterilization analysis hysteresis moves the sterilization start stage, nut code that deletes calculation stages does not activate.
IR2180Historic tests selection window now includes a drop down for memory of user folder selections.
IR2181SIKA baths now supported.
IR2183Added support to read Grant Squirrel data files.
IR2184When TQSoft analyzes a vacuum stage and the vacuum hold is perfectly held, the start of the hold is now correctly located.
IR2185Added support for Gemini View2 and Plus2 data loggers.
IR2186Correction to make sterilization/target/disinfection description correct in Test setup report.
IR2187If users adds the folder ‘\TQSoft’ or ‘\TQAero’ to the archiving & synching target folder, software now strips that off since it will be duplicated.
IR2192The test specification ‘test notes file’ field can now reference a USER MESSAGE that can be displayed to remind operator about validation tasks.
IR2193Correction for reports where channel value at a particular stage is required. Non sequential channels were not handled correctly.
IR2194Historical tests selection window enabling now no longer requires a software restart.
IR2195The test specification ‘test notes file’ field can now reference a ‘reports sections’ (RLF) file so that reports sections will be auto added to a report when the test is added to a report.
IR2196Correction for far east characters in the job reference field.
IR2204Correction for Min Lethality I-Calc which did not check for full range channels returning zero.
IR2205Patch for a program freeze caused by corrupt data in chart with xmax less than xmin.
IR2207Correction to merge window where first test in the list would not expand channels.
IR2211Max number of stages in a test increased to 2000 to allow for the extra requirements of multiple stage analysis.
IR2216THP battery pressure logger is now supported.
IR2217Multiple zoom views can now be setup from reports manager window.
IR2226Added driver for thermal bath Ametek CTC155.
IR2228Bath uncertainty no longer included in cal report uncertainty calculations, just logger and reference unit uncertainty.
IR2238Correction for average I-Calc when a dependent stage is moved during analysis.
IR2242When importing CSV file if units row is found the channel type is set to Type T regardless. Now it is set to type T only if the channel config channel type conflicts with units in CSV.
IR2243In I-Calc spec tab its now possible to change a selected group of I-Calcs for settings stage start/end and all the hide settings.
IR2249Report signatures can now be controlled with more options in setup options window.
IR2251The cal check report will now display the date/time of the calibration that is being checked. (Will only work on cal checks performed with new version.)
IR2252Now 60 characters are allowed for channel location field. But only 40 can be displayed in test setup report because of space.
IR2253TQSoft now stores data in a new format TQD file which allows use of floating point numbers thus removing the resolution limitation of 32000 in version 7.
IR2269Fix for advanced cal reference countdown timer which did not work in certain circumstance.
IR2270The TeamViewer quick support link was updated.
IR2271The advanced calibration report now does not repeat cal point operator information.
IR2276Software no longer allows a corrupted baud rate to be used (without error message) but instead defaults back to 9600.
IR2281In manual calibration adjust its now possible to edit the calibration time and date in usage section. Changes are audited. This is for transducers.
IR2282The Job Reference now allows special character (for far east languages) but cycle number auto replaces special chars with underscore.
IR2283Additional fix for IR2256 Anville logger scan times.
IR2287Enhancements for legacy Kaye Digistrip unit including support for more channels and scan interval control for calibration.
IR2289Correction for MODBUSTCP, Anville, Kaye loggers used in the ‘log in another TQSoft’.
IR2290Test Equipment now has its own secured file that can be managed with data management options.
IR2293Cal report out of range measurements now denoted by ‘—-’ along with dependent calculations.Rounding ‘away from zero’ now used in cal reports, and all calculations now use rounded values to avoid 0.01 discrepancies.
IR2294Reference values now uses 3 decimal places.
IR2302Corrections for text spacing for Spanish translation.
IR2305For users with large number of I-Calcs that are related to the sterilizing/target/disinfection temperature, an adjustment to this temperature can now auto adjust I-Calc limits.
IR2306Advanced cal reports now include a column shown maximum deviation of each channel during check phase.
IR2307Correction for pressure calibration procedure where software asks user to adjust thermal bath!
IR2308Correction for advanced pressure calibration where check points were using uncalibrated data.
IR2309On start-up TQSoft 7 loads all the report references in Reports folder. With many reports this becomes very slow. Version 8 delays full loading until necessary.
IR2310Support for T&D loggers TRZ file format and T&D imports now create audit trail entries.
IR2313Export to CSV function is back which is a much faster export than the full export to Excel.
IR2315A continuously monitored I-Calc can now have a hysteresis in time format (hh:mm:ss) which allows limit checking only after a delay from start of monitoring.
IR2316Support for Graphtec firmware 1.28.Dead backup battery causing issues is addressed.Now allows 2 decimal places for thermocouples.More support for reading secure GDB data files from the unit.
IR2317EA04/02 NIST amendment to Combined Uncertainty calculations.
IR2318If Fluke loggers not connected it is now possible to nevertheless edit up to 60 channels.
IR2319Modifications to Data List allow extra decimal place resolution on new file format to be shown on Data List up to 10 digits numbers.
IR2320Scan intervals less than 1 second are not now auto adjusted.
IR2322If a Test Spec notes file is setup to use an RLF (reports list) file as a pre-configured report, TQSoft will now auto import data at stop logging.
IR2323Correction to eliminate risk of endless loop freeze when TQSoft searches for its data files.
IR2324Support for humidity from dewpoint sensor. Its now possible to connect a dewpoint sensor to the logging unit and locate the sensor in the chamber. An I-Calc can be setup for each temperature and TQSoft calculates the humidity at that location without use of humidity sensors.
IR2324This update involves the inclusion of ‘continuously monitored I-Calcs’ in the chart and data list. A feature many engineers will appreciate as it allows calculations like deviations and averages on groups to be put on data list (in place of the basic calculations tab that uses all channels.)
IR2325Its now possible to mix THP and Gemini battery loggers with both time starting at zero and 24 hour format.
IR2326Correction for battery logger interface when assigning a logger to a test spec position.
IR2327Correction for THP loggers for estimated time set zero, where time was adjusted to 1 day limiting logging to 1 day.
IR2331Correction for I-Calc limit signature where the signature window must appear on top of all other windows.
IR2332Correction for advanced calibration root sum squared uncertainties.
IR2334The Export to Excel/CSV functions no longer exports defective channels.
IR2335If a Test Specification has no probe positions setup TQSoft will use the probe positions setup in the chamber database.
IR2337Correction for data list showing analysis messages when showing continuous I-Calcs.
IR2341The max deviation I-Calc will now show both the max and min measurements in the result stage.
IR2343An I-Calc fail that uses the display message action will now make an audit trail entry of the message and test details.
IR2344The start logging process now has a ‘More’ button on the final stage allowing the historic test spec to be edited, not affecting the original test spec.
IR2347Correction for @TEXT and @DATA in TQExpress import data.
IR2349Modification for use of T&D Graph application under Win 10 updates. Windows registry EnableLUA now needs to be set to zero.
IR2350Merged tests can that contain mismatched scan times will now still calculate lethality’s correctly.
IR2351Data List preview can now contain 250 pages.
IR2355Using a comma in test equipment serial number field is now auto replaced by underscore because the comma is treated as a delimiter character in other parts of TQSoft.
IR2356The delay in Start Logging window is extended to allow for days.
IR2357Its now possible to enable a corrections window in a user profile so that fully audited corrections can be made to some fields prominent in the reports. All corrections are fully audited.
IR2358Correction to the audit trail window in case its screen position is set outside the current screen.
IR2359Removed specific reference to AMS2750 because TQAero enables compliance with a number of specs such as CQI-9, AFNOR etc.
IR2360The INT:00:00 setting for a stage will no longer interrupt the interval of scans either side of it.
IR2361In TQAero the parameter graphic window will now audit any parameter changes.
IR2366Data management deleting files not allows a cancel if deletion fails for some reason.
IR2369Correction for T&D data file import where locations were mistakenly assigned to labels.
IR2372Driver for Isotech Millik reference unit.
IR2375Export to Excel and CSV will no longer export defective probes.
IR2380Sensor positions diagram now allows extra items to be added to the diagram, the name of each item can be specified.
IR2382Correction for Fluke LAN option where a previously selected COM port will interfere with opening LAN.
IR2383Chinese characters now allowed in the cycle number and job reference boxes for start test.
IR2385KeySight 970A driver.
IR2391Continuous I-Calcs included in Excel export with method to improve speed and summary option added to Excel export.
IR2395Continuous monitoring is no longer interrupted by ‘no cal file’ alert.
IR2398Correction for Calibration Files upload function if logger connection was not previously initiated.
IR2399Correction for Chinese/Japanese units translation immediately after language switch.
IR2402Correction for analysis of I-Calcs that reference a group containing no probes. The stage result is not created.
IR2404TQSoft now supports Madgetech RFC1000 for distributed monitoring projects. TQSoft can now read battery status of MadgeTech loggers.
IR2405Excel export is now able to use more than AZ column.
IR2407Adjustment to data list landscape format so that the righthand vertical is always printed.
IR2413Oversized diagnosis file AgilentError DLOG file is now automatically managed on startup.
IR2414Fix for rare corruption of data that can cause chart freeze.
IR2419Update for recent versions of Adobe DC Reader where it requires modified Registry references.
IR2420Fix for blank page after sensor position diagram in PDF print function.
IR2424Fix for lower limit checkbox being auto set after use of TQAero graphic.
IR2425Added ability to remove marker for extra items in the sensor positions diagram.
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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…