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Successful Temperature Mapping Tips with Kaye Validators

Estimated reading time: 4 minutes

For decades, Masy BioServices has relied on Kaye validation equipment. For years, we have sold, rented and calibrated Kaye equipment. Due to our experience, our experts are frequently asked about these instruments and how to use them effectively. Here are the most common validator questions and answers to help you make informed purchase decisions

  • What are the differences between the Kaye Validator 2000 and the Validator AVS?

The Kaye Validator 2000 is a datalogging system that utilizes a Windows laptop for its primary user interface and supports up to 3 SIMs (“Sensor Input Modules”), allowing for data collection from up to 36 thermocouples. Additional sensors (CO2, RH, pressure, etc.) are also supported. The Validator 2000 (also known as “V2K”) is no longer being manufactured by Kaye. Masy continues to offer repair and accredited calibration services as this equipment is still widely used in the biopharma industry. To compare, the Validator AVS (“Advanced Validation System”) uses a wireless tablet as its user interface, eliminating the need for a dedicated laptop. It has capacity for 4 SIMs/48 data channels. AVS is the current model offered by Kaye which contains features like enhanced reporting customization and a revised user interface designed to accelerate common validation tasks.

  • What can I map with my Kaye validator?

Refrigerators, all freezers including stability chambers, small rooms, sterilizers, autoclaves, bioreactors, lyophilizers, trucks, and trailers. These validators are not used for warehouses or large rooms. Both the Validator 2000 and the AVS have sensor input modules that allow for a variety of wired sensors to be attached. For temperature mapping, Ultra-Premium Grade Type-T validation thermocouples (22 or 28 awg, 7-strand cables) are recommended because of their high accuracy (±0.18°C), resistance to damage caused by bending and a wide temperature range (-200°C to +200°C), making them appropriate for the majority of IQ/OQ/PQ validations in the biopharma industry. Once wired into the validator, test your thermocouples or other sensors for correct functionality before placing them within the chamber or vessel being tested. For more information on sensor placement, read this recent article.

The V2K and AVS samples and records the temperatures sensed by the tip of the thermocouple. Multiple samples are taken during different states of chamber operation (empty, with product inside, with doors open, etc.) to ensure the equipment is operating within acceptable parameters outlined in the validation protocol.

  • Why do validators need to be calibrated?

Calibration of the validator ensures measurement accuracy. When the validator is confirmed to be performing as designed, the results it provides can be trusted to be accurate, and reports created from the data can be relied on for operational decision making.

Calibration is a regulatory requirement; annual calibration is recommended. Calibration by an NVLAP accredited company ensures traceable, repeatable, accurate results that you can depend on.

  • How do I calibrate thermocouples for use in my validator?

With the appropriate materials, your in-house team can calibrate the thermocouples. Dry-block calibrators, also known as baths, both high temp and low temp, may be required depending on the temperature points desired. For example, the Fluke 9190A offers a temperature range of -95°C to +140°C and may cover the desired performance range. The bath is used to calibrate the sensors to a reference standard, such as a calibrated IRTD. The bath, IRTD and thermocouples are linked to the Validator for calibration. These products are available for purchase or rent from Masy.

Masy offers two options for calibrating thermocouples. Regardless of whether the user is renting or owns the equipment, we can calibrate the thermocouples prior to a mapping project. With both the SIMs and the thermocouples in hand, Masy can attach the thermocouples to the SIM and calibrate them using a dry-block calibrator (also known as a temperature bath), such as a Fluke 9190A, and a temperature reference IRTD (“Intelligent Resistance Temperature Device”), such as a Kaye IRTD-400 or Masy Scientific Temperature Standard. The thermocouples are then calibrated to the customer’s requested temperature setpoints. A calibration report is supplied with the calibrated thermocouples when they are returned to the owner for use.

  • Where can I purchase or rent a Kaye validator?

Both Validator 2000 and Validator AVS are available for rental or purchase from Masy. Our large equipment fleet can serve any size project and each unit comes with an accredited calibration certificate. Lead times for rentals are short with a fresh certificate for purchase.

Final Thoughts

A well-functioning validator paired with the right companion equipment is crucial for a successful temperature mapping validation project. Become as familiar as possible with the use of the validator and its capabilities and consider using Ultra-Premium Grade validation thermocouples for maximum accuracy, durability, and long-term stability. Use a quality dry-block calibrator/temperature bath and IRTD if performing your own calibrations to ensure measurement accuracy.

Contact us if you have additional questions or would like a quote. Our friendly, knowledgeable staff is ready to help.