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…

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.

Used 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

The 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

Connect 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.

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.

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...

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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

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.

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.

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...

Freeze Drying Validation

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

Hardware Systems

TQSoft™ Features

TQSoft™ Summary

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

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.

MadgeTech Loggers

Any models supported by MadgeTech 4 standard.

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

Batch programming and downloading of MadgeTech Loggers

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.

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.

Lyophilization Validation

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