Frequently Asked Questions
Are rental solutions available for Kaye validation equipment, either short or long term?
Yes, Kaye offers both short- and long-term rental solutions with full traceability. Our well-maintained rental fleet includes a broad selection of Kaye validation and measurement systems, providing customers with the flexibility to temporarily supplement their equipment during peak validation cycles, qualification projects, or unexpected downtime.
Whether you're facing increased demand, equipment shortages, or scheduled maintenance, renting additional Kaye equipment helps minimize process interruptions and ensures continued system availability — without compromising compliance, reliability, or data integrity.
Rentals are available for key systems such as the Kaye Validator AVS, Kaye ValProbe® RT, IRTDs, and dry wells/calibration baths.
For further details on available rental systems or to request a quote, please contact your local Kaye representative or visit our contact page:
https://www.kayeinstruments.com/de/contact
Are training and product tutorial videos available for Kaye equipment and software?
Yes, Kaye offers a variety of product and training videos to support users in understanding and operating their validation and monitoring solutions. These videos cover key topics such as system setup, software navigation, data analysis, calibration procedures, and feature overviews for platforms including the Kaye Validator AVS, ValProbe RT, and Kaye dry block calibrators.
You can access these resources directly through the Kaye Knowledge Library or the video section on our official website:
https://www.kayeinstruments.com/de/knowledge-library/videos
If you need tailored training or want to schedule a live or virtual session, please contact your local Kaye representative. We’re happy to assist with specific onboarding, application-based walkthroughs, or refresher training for your team.
Visit: www.kayeinstruments.com
How can I obtain IQ/OQ documentation or the latest product updates?
To request Installation Qualification (IQ) and Operational Qualification (OQ) documentation or to access the latest product updates, please contact your local Amphenol or Kaye representative, or reach out to our technical support team. These documents and updates may also be available through the Kaye Customer Portal, accessible with your device’s serial number and Binder password.
If you have any questions or need further assistance, you can always contact Kaye directly or get in touch with one of our certified service partners. We're here to support you at every step of your validation and compliance journey.
For more information, visit: https://www.kayeinstruments.com
How can I request and schedule an on-site product demonstration?
Kaye offers several options for on-site product demonstrations. Depending on your location and the product of interest, our sales or technical service representatives can schedule a visit to your facility. Demonstrations can include live equipment walkthroughs, software overviews, and application-specific discussions—for example, autoclave validation, temperature mapping, or calibration.
If an on-site visit is not possible, Kaye also provides virtual live demonstrations via video conference, tailored to your application needs. This allows you and your team to interact directly with our experts and get a comprehensive understanding of our system capabilities in real time.
To explore your options or schedule a demonstration, please contact your local Kaye representative or submit a request through our website:
Request a demo on: https://www.kayeinstruments.com/de/demo
Find your local contact on: https://www.kayeinstruments.com/de/contact
What are the temperature limitations for battery-operated logger systems, and why do these limits exist?
The temperature limitations of Kaye ValProbe RT battery-powered loggers are primarily defined by the characteristics of the lithium batteries used.
For high-temperature applications above +140 °C, a thermal protective enclosure (insulated canister) must be used. This allows operation in environments up to +400 °C for a limited period of time, depending on the insulation type and setup.
For low-temperature conditions below –40 °C, a battery extension can be used to optimize performance. Additionally, when the logger operates below –40 °C, the real-time RF transmission is automatically disabled to preserve battery life. During this phase, all measurement data is stored in the internal memory. Once the logger returns to above –40 °C, it will automatically reconnect and transmit all stored data to the base station with a complete time stamp.
What IoT and Cloud monitoring solutions does Kaye offer?
Kaye offers the LabWatch® IoT cloud-based monitoring system — a complete solution for critical environmental and facility monitoring. LabWatch IoT enables real-time wired and wireless monitoring (via Kaye Netpac II and Kaye RF ValProbe), primarily measuring temperature and humidity, but also supporting all standard sensor inputs ranging from 0–10 V or 4–20 mA. Data is securely transmitted to the cloud and can be accessed via browser or smartphone using multi-factor authentication. The system provides automatic alarms, real-time sensor readings, and generates audit-ready reports to support compliance with regulatory requirements. It is designed for flexible, paper-free documentation and easy remote access across locations.
What’s the best way to receive automatic updates on new software releases, product features, and customer events?
To stay up to date with the latest from Kaye — including software releases, new product features, webinars, and customer events — we recommend subscribing to our official newsletter and product update notifications:
https://www.kayeinstruments.com/en/newsletter-subscription
Additionally, you can follow us on LinkedIn and other social media platforms, where we regularly post updates about software enhancements, feature launches, customer success stories, and regional events:
https://www.linkedin.com/company/kaye/
If you're an existing Kaye customer, you may also be eligible to receive personalized communications directly from your local sales or support representative, including invitations to training sessions or technical webinars tailored to your application needs.
Staying connected ensures you're always informed about the latest innovations and validation solutions from Kaye.
Where can I find information about upcoming events or trade shows where Kaye will be exhibiting?
Information about upcoming events, trade shows, webinars, and customer workshops that Kaye is participating in can be found on our official website and LinkedIn page. These channels are regularly updated and include details such as event dates, locations, booth numbers, and registration links.
Kaye frequently takes part in key industry events across the pharmaceutical, biotechnology, and validation technology sectors — giving customers the opportunity to connect with our experts and experience our solutions first-hand.
Visit our events page for the latest updates:
https://www.kayeinstruments.com/de/events
To stay fully informed and never miss an announcement, we recommend subscribing to our official newsletter and product updates:
https://www.kayeinstruments.com/en/newsletter-subscription
You can also follow us on LinkedIn and other social media platforms for regular updates on events, software releases, feature improvements, and product launches:
https://www.linkedin.com/company/kaye/
We encourage you to subscribe or follow us to stay informed about future opportunities to engage with the Kaye team — whether online or in person.
Where can I find technical support for my Kaye validation or monitoring system?
Kaye operates a global network of certified service centers and a highly experienced field service organization to support our customers worldwide. We offer professional assistance with equipment repairs, returns (RMA), ISO/IEC 17025-accredited calibrations, technical troubleshooting, product evaluations, and a full range of original Kaye spare parts.
Whether you need help with software updates, system diagnostics, or on-site servicing, our regional experts are ready to provide fast, reliable, and traceable support — tailored to your application environment.
To request technical support, simply visit our official support portal:
https://www.kayeinstruments.com/en/services-rental/technical-support/request-technical-support
Are all Kaye calibration laboratories accredited to ISO/IEC 17025 standards?
Yes – Kaye calibration laboratories located in St. Marys (USA), Pforzheim (Germany), Changzhou (China), and Hyderabad (India) are accredited to ISO/IEC 17025, the international standard that defines the general requirements for the competence of testing and calibration laboratories.
These accredited facilities perform calibrations in accordance with strict quality and technical guidelines, ensuring reliable, traceable, and audit-compliant calibration services for customers operating in GxP-regulated environments.
In addition to these Kaye-operated sites, we also work with a trusted network of accredited calibration partners in other countries to support our global customer base.
For a full list of accredited locations and certificates, please contact your local Kaye representative or visit our website
How does NABL accreditation of the Kaye R&D Center enhance trust in the accuracy of validation measurements?
NABL (National Accreditation Board for Testing and Calibration Laboratories) accreditation demonstrates that the Kaye R&D Center operates in compliance with ISO/IEC 17025 – the international standard for testing and calibration laboratories. This accreditation ensures that all measurement, testing, and calibration procedures performed at the center meet globally recognized quality and technical standards.
For customers in GxP-regulated industries such as pharmaceuticals, biotechnology, and medical devices, this level of accreditation provides added confidence that Kaye’s validation and calibration equipment, including systems like the Kaye AVS, ValProbe RT, and IRTD references, is developed and tested under strictly controlled, reliable, and traceable conditions.
NABL accreditation also supports Kaye`s broader commitment to quality, innovation, and regulatory compliance across its global subsidiaries. It reinforces that our validation solutions are not only technically advanced but also meet the highest standards of measurement integrity expected by regulators and customers worldwide.
For further information, please visit our Quality & Compliance section or explore our certification downloads on:
https://www.kayeinstruments.com
Are Kaye’s RF-based real-time systems certified for use in ATEX-rated (explosive) environments?
Currently, Kaye’s RF-based real-time systems – such as the Kaye ValProbe® RT – are not certified for use in ATEX-rated zones or explosive environments as defined by the ATEX Directive (2014/34/EU). These systems are intended for use in GxP-regulated cleanroom, laboratory, and production environments where explosive atmospheres are not present.
Can the AVS be used for validating parameters other than temperature and pressure?
Yes, the AVS is designed to support a wide range of validation applications beyond just temperature and pressure. It is compatible with all linear analog signals with standard outputs of 0–10 V or 4–20 mA. This allows the integration of various sensor types, including thermocouples, Pt-100 RTDs, relative humidity (RH) sensors, CO₂ sensors, and other transducers. The flexible input module architecture of the AVS enables accurate monitoring and documentation of numerous environmental parameters, making it suitable for complex validation requirements in GxP-regulated environments
Can the AVS system be used to measure CO₂? If so, how is it implemented?
Yes, the AVS system can be used to measure CO₂ levels by integrating compatible CO₂ sensors that provide standard analog outputs, such as 0–10 V or 4–20 mA. Using the 4–20 mA SIM (Signal Input Module), such transducers can be directly connected to the AVS system. For detailed setup instructions and supported configurations, please refer to the AVS user manual.
What are the benefits of real-time data in thermal validation and environmental monitoring?
Real-time data is essential for immediate visibility into process conditions, helping to detect issues early and ensure compliance. Kaye AVS and ValProbe RT systems provide real-time monitoring and alerts, enabling faster decisions and reducing validation risks in regulated environments.
What does F0 represent in steam sterilization and thermal validation?
F₀ (F-zero) is a standardized measurement used to quantify the microbial lethality of a moist heat (steam) sterilization process. It expresses the accumulated sterilization effect of heat over time, calculated in relation to a reference temperature of 121.1 °C, which is considered optimal for inactivating resistant microorganisms such as bacterial spores.
In practical terms, F₀ represents the equivalent amount of time in minutes that a sterilization cycle maintains an effective microbial kill rate, assuming ideal conditions. For example, an F₀ value of 15 means the process has achieved the same lethality as 15 minutes at 121.1 °C with saturated steam.
F₀ is a critical parameter in the validation of steam sterilizers (autoclaves), especially in GxP- or FDA-regulated environments such as pharmaceuticals, biotechnology, and medical device manufacturing. It provides a consistent basis to evaluate and compare sterilization cycle performance—even when process conditions vary slightly.
Kaye validation systems, such as the Kaye AVS (Autoclave Validation System), include real-time F₀ calculation capabilities as part of their standard software packages. This ensures accurate, fully traceable, and audit-ready documentation of sterilization performance across multiple sensor channels.
What is a suitable alternative to wired systems for depyrogenation tunnel validation?
A proven and efficient alternative to traditional wired thermocouple systems in depyrogenation tunnel validation is the use of the Kaye ValProbe RT High Temperature Wireless Logger system, specifically the 5-channel bendable RTD logger in combination with the dedicated thermal barrier canister.
This solution allows you to perform accurate, GxP-compliant temperature mapping in environments up to 400 °C, without the need for complex thermocouple routing or system-specific wiring constraints. The flexible, bendable RTDs provide excellent placement flexibility across critical tunnel zones (e.g. preheating, hot zone, and cooling sections), while the thermal protection canister ensures that the electronic components remain within their operating limits during exposure to dry heat.
Key advantages of this wireless solution include:
• No feedthrough requirement or wiring setup
• Reduced setup time and simplified logistics
• Full compliance with regulatory standards (e.g. EN ISO 20857, FDA, EU GMP Annex 1)
• Automatic data capture and secure storage
• Seamless integration with the Kaye Common Reporting Tool (CRT) for Pass/Fail analysis and audit-ready documentation
This system is particularly well-suited for depyrogenation tunnels used in pharmaceutical manufacturing, offering a high degree of reliability, accuracy, and operational efficiency.
What is the difference between validation in hospital or laboratory-scale settings versus pharmaceutical production environments?
The physical principles that govern the inactivation of microorganisms—such as temperature, pressure, and time—are universally applicable. As such, the same fundamental validation approach must be followed regardless of whether a steam sterilizer (autoclave) is used in a hospital, laboratory, or pharmaceutical production setting.
There may be practical differences in scale, complexity, and documentation, but from a regulatory and technical perspective, the same internationally accepted standards and methodologies must be applied.
Key applicable standards include:
- EN ISO 17665 – Sterilization of health care products – Moist heat
- EU GMP Annex 1 & Annex 15 – Qualification and validation in sterile manufacturing
- FDA 21 CFR Part 210/211 & Part 11 – cGMP and electronic record compliance
What's different in practice?
• In pharmaceutical production, validation typically involves more extensive documentation, risk assessments, and integration with electronic Quality Management Systems (eQMS).
• In hospital or laboratory settings, the same principles apply (e.g., lethality F₀, equilibration time, spatial distribution), but processes may be simpler and on a smaller scale.
What is the maximum number of loggers that can be used in a single study?
Starting with software version 1.3, the system supports integration with Active Directory and allows for a maximum of 50 loggers or 250 sensors to be used within a single study.
What is the most cost-effective way to perform thermal mapping of a Controlled Temperature Unit (CTU)?
One of the most efficient and cost-effective ways to perform thermal mapping of Controlled Temperature Units (CTUs) — such as refrigerators, freezers, climate chambers, or small warehouses — is by utilizing the Kaye ValProbe RT wireless data logger system.
For typical mapping applications, we recommend the ValProbe RT 5-channel loggers equipped with bendable or flexible RTD sensors. These flexible solutions provide high spatial coverage within the CTU, allowing multiple points to be measured simultaneously using a single logger. This significantly reduces the total number of devices required while still delivering high-resolution mapping results.
Key advantages of this approach:
• Wireless operation — ideal for compact or hard-to-access environments
• Minimized setup time through simplified sensor routing
• Reduced hardware investment per mapping point
• Battery-powered for clean installations (no cables during measurement)
• Flexible/bendable RTDs ensure easy placement around shelves, doors, or product load areas
In cases where your application requires a higher number of simultaneous measurement channels, the Kaye Validator AVS system remains a powerful alternative or complementary tool. AVS supports up to 48 thermocouples in parallel, enabling rapid qualification of multiple CTUs or highly detailed profiles in larger storage environments — particularly when thermal homogeneity is essential.
Additional ValProbe RT logger types (e.g., single-channel, rigid, and RH) can be mixed and matched depending on the layout and regulatory requirements of your qualification protocol.
For a detailed overview of available configurations, accessories, and best practices for warehouse and CTU validation reach out to your Kaye representative.
If you need help choosing the right setup for your validation routine, don’t hesitate to contact Kaye or one of our certified partners.
Which Kaye solution is recommended for temperature monitoring applications down to -80 °C?
For temperature monitoring applications that require performance down to –80 °C — such as ultra-low temperature freezers, pharmaceutical cold storage, or cryogenic processes — either the Kaye AVS Validator in combination with thermocouples or the Kaye ValProbe RT (VP RT) System can be used.
Both systems are compliant with GxP-related regulations.
However, for proper calibration and adjustment of the sensors used, we recommend combining the system with the Kaye IRTD, which serves as a traceable temperature reference standard. In addition, the Kaye CTR-80 calibration bath or the LTR-90 dry well calibration oven are suggested as valuable peripherals.
Why do I have leakage in my thermocouples during steam autoclave cycles, and what solutions are available to prevent this issue?
Steam penetration into the Teflon® insulation of thermocouples is a known phenomenon, caused by micro-porosity in the outer insulation layer due to the manufacturing process. There are several approaches to minimize this effect:
Kaye Ultra Premium Thermocouples – 7-stranded and 3-stranded:
Refer to the user manual for guidelines (see keyword: "drip-cut").
Use of Autobond Thermocouples (available in both 7-stranded and 3-stranded versions):
These are specially designed to improve sealing and reduce steam ingress.
For more information, please contact Kaye directly or reach out to one of our certified partners. You can also visit our website at www.kayeinstruments.com.
Why is an IRTD required during thermal validation and sensor calibration processes?
The IRTD (Intelligent Reference Thermometer Device) is essential for ensuring the accuracy and regulatory compliance of thermal validation and sensor calibration processes — particularly in GMP- and FDA-regulated environments such as pharmaceutical and biotechnological manufacturing.
Developed by Kaye the IRTD serves as a high-precision, ISO/IEC 17025-traceable reference standard. It is specifically designed to be integrated with Kaye validation systems like the Validator AVS and plays a critical role in the automated calibration and adjustment of thermocouples.
Here’s why you need an IRTD:
- It provides a traceable, highly accurate reference (±0.025 °C over –196 to +420 °C)
- Ensures that sensor measurements remain in specification across repeated validation cycles
- Supports automated sensor adjustment routines within the Kaye software environment
- Reduces human error and enhances repeatability in calibration procedures
- Ensures full compliance with ISO, GMP, and 21 CFR Part 11 regulatory requirements
In short, the IRTD is a cornerstone of any compliant thermal validation process and is trusted by Amphenol customers globally to ensure reliable measurement traceability and data integrity.
Why is pressure a critical parameter in steam sterilization?
Pressure plays a key role in the effectiveness and safety of steam sterilization processes such as those used in autoclaves. In saturated steam sterilizers, pressure and temperature are directly linked — increasing the pressure raises the boiling point of water, which enables the generation of high-temperature steam (often at 121 °C or 134 °C). These elevated temperatures are essential to effectively kill microorganisms and spores on equipment, tools, or product surfaces.
Maintaining the correct pressure throughout the sterilization cycle also ensures that steam fully penetrates into load items and eliminates cold spots, ensuring uniform heat distribution. Any deviation from pressure setpoints can affect steam quality, impact sterilization efficacy and potentially leading to failed validation cycles.
At Kaye, pressure monitoring and calibration are essential components of thermal validation when qualifying steam sterilizers, especially in GxP-regulated environments such as pharmaceutical and medical device manufacturing. Our systems support both temperature and pressure sensor integration to ensure full compliance with global regulatory standards like EN 285 and ISO 17665.
Can I perform in-house calibration of my ValProbe® RT loggers for temperature, pressure, and relative humidity?
Yes, as part of a sound risk management process, it is recommended to verify the accuracy of data loggers periodically between annual recalibrations. The ValProbe® and ValProbe® RT software include a built-in feature that supports this type of intermediate verification.
However, please note that this verification process does not include adjustment of deviations (no sensor re-alignment is performed). It serves only to confirm continued accuracy. A full calibration with adjustment can only be performed by the manufacturer.
To ensure valid results during in-house verification, appropriate reference equipment such as certified temperature baths, dry block calibrators, or traceable RH/pressure standards must be used.
Can the IRTD be used as a stand-alone temperature reference standard for calibration or verification purposes?
Yes, the Kaye IRTD (Intelligent Reference Thermometer Device) can be used as a stand-alone temperature reference standard for calibration and verification tasks — even independently of the full Kaye validation systems such as the Validator AVS or Valprobe RT. This flexibility makes it a valuable tool for labs, production environments, and service teams working within GMP-regulated industries.
When combined with the separately available Kaye IRTD Display unit, users can view high-precision temperature measurements in real time without needing to connect to external software. This setup is especially practical for field calibration or on-site sensor checks.
The IRTD itself is traceable to NIST and comes with an accredited calibration certificate, typically with an accuracy of ±0.025°C in the 0°C to 140°C range, making it suitable for use in a wide variety of regulated temperature applications.
For more information on how to configure the IRTD for stand-alone use or to request support with display or software integration, please visit www.kayeinstruments.com or contact your local certified Kaye partner.
Does Kaye offer service and support agreements for its validation equipment?
Yes, Kaye offers customized service agreements tailored to your specific operational needs. These agreements are designed to simplify GMP-compliant calibration, preventive maintenance, and technical support for your Kaye validation and monitoring systems.
Depending on your equipment and service preference, all activities can be performed either on-site or at one of Kaye’s ISO/IEC 17025-accredited calibration laboratories. Service agreements ensure priority access to expert support, faster turnaround times, and full traceability of all maintenance and calibration work — carried out in accordance with Kaye’s strict quality and compliance standards.
These flexible plans are ideal for customers in pharmaceutical, biotech, or medical device environments seeking long-term reliability, regulatory alignment, and minimized downtime.
For more information or to request a personalized service plan, please contact your local Kaye representative or visit:
https://www.kayeinstruments.com/en/services-rental/service-agreements
How often should thermocouples be calibrated and verified, and why is frequent verification necessary?
The recommended frequency for calibrating and verifying thermocouples (TCs) in thermal validation processes depends on several factors — including regulatory requirements, internal quality procedures, and the level of risk a company is willing to manage.
From a best-practice perspective — especially in GMP-/FDA-regulated industries such as pharmaceuticals, biotechnology, and medical device manufacturing — frequent thermocouple calibration is essential to ensure measurement accuracy and data integrity.
RISK-BASED APPROACH:
The decision whether to calibrate TCs before each qualification run and verify after each run or after multiple runs is ultimately a matter of risk management. The more frequently calibration and verification are performed, the lower the risk of undetected measurement drift or sensor failure.
• Some companies may choose to calibrate/ verify only after several qualification campaigns, based on historical stability and internal validation protocols.
• Others — especially those under strict oversight or with critical temperature-sensitive processes — may require calibration before every qualification and verification after each run.
Highest level of assurance:
To achieve the highest level of measurement confidence, regulatory traceability, and audit-readiness, the following calibration cycle is recommended:
1. Calibration & Adjustment before each validation run:
2. Post-calibrate after each validation run:
3. Documentation:
All calibration and verification data should be documented in the GMP calibration report and linked to the batch or qualification file
What calibration equipment does Kaye offer?
Kaye offers a wide range of precise and reliable calibration solutions for temperature, pressure, and relative humidity, along with the associated accessories.
Temperature Block Calibrators and Calibration Baths:
- LN2 Comparator: T = –196°C
- LTR-90: T = –90°C to +140°C
- HTR-80: T = –80°C to +30°C (Halocarbon)
- CTR-40: T = +40°C to +150°C
- LTR-150: T = –30°C to +150°C
- VTR-25: T = –25°C to +140°C
- LTR-200: T = –50°C to +200°C
- HTR-420: T = +30°C to +420°C
Humidity Calibrator:
- HygroCal100: RH = 5% to 95%
Traceable Temperature Standard:
- IRTD-400: T = –196°C to +420°C
For more detailed information on our calibration devices and specifications, please visit our website:
https://www.kayeinstruments.com/de/calibration-references/liquid-bath-dry-block-calibrator
What does the IRTD calibration process involve, and why can it take an extended amount of time?
The full calibration and adjustment process of an IRTD-400 reference thermometer takes approximately 4 working days. This duration is necessary to ensure extremely low measurement uncertainty of ±0.025 °C across the entire temperature range of -196 °C to +420 °C.
The following key steps are included:
As-Found Report
An initial measurement is performed across the full range (-196 °C to +420 °C) to document the sensor’s condition before any adjustment.
Annealing Cycle (60 hours at 420 °C)
This is a critical thermal treatment step that stabilizes the sensor’s performance in the long term. It is often skipped by some calibration labs due to the long duration — however, it is essential to meet the required accuracy and reliability standards.
Why annealing?
Reduces internal mechanical stress in sensor materials
Improves long-term measurement stability
Minimizes sensor drift under thermal cycling
Enhances reproducibility of measurements
Restores and optimizes the crystal lattice structure, especially in platinum RTDs
Ensures consistent electrical and thermal behavior
Adjustment Phase
The IRTD is adjusted at several fixed temperature points from -196 °C to +420 °C to align it to known standards.
Calibration Cycle
After adjustment, the IRTD undergoes a final full-range calibration over 7 temperature points. This step verifies the adjustment and ensures conformity to its specification. The final result is documented in a traceable calibration certificate.
This meticulous process is part of what makes the Kaye IRTD-400 one of the most reliable and stable reference sensors available — fully compliant with the rigorous standards required in GMP/FDA-regulated environments.
What factors should be taken into account when selecting a Kaye calibration bath for use with precision temperature sensors?
Temperature Range
Choose a model that covers the required calibration range
Stability and Uniformity
High thermal stability and temperature uniformity are essential for consistent and reliable calibrations, especially in GxP-regulated environments. Kaye calibration baths are designed to meet stringent stability and homogeneity requirements.
Sensor Compatibility
Consider the types and sizes of the sensors being calibrated (e.g., thermocouples, RTDs, IRTDs). Ensure that the calibration bath can accommodate the sensor dimensions and required immersion depth.
Dry Well vs. Liquid Bath
Select between a dry block (e.g., Kaye LTR-90, LTR-150, LTR-200, or HTR-420) and a liquid bath (e.g., CTR-80 or CTR-40) depending on your application. Dry block calibrators are ideal for fast, clean operation, while liquid baths typically provide better heat transfer and temperature stability, especially for high-accuracy applications.
Regulatory Requirements
In pharmaceutical or biotech settings, choose systems that fully support GxP compliance, FDA expectations, and ISO 17025 traceability. Kaye systems are built with compliance, documentation, and audit readiness in mind.
Portability and Throughput
Consider how and where the calibration will be performed. Some units are optimized for laboratory use, while others are better suited for field calibration or simultaneous multi-sensor setups.
Tip: For best results, pair your calibration bath with a Kaye IRTD (Industrial Reference Thermometer) to ensure measurement traceability and the highest level of accuracy.
What is the difference between DAkkS calibration and in-house calibration of a pressure transducer, and which method is recommended?
DAkkS (German Accreditation Body) calibration is an ISO 17025-accredited and internationally recognized calibration method. It is performed by an independent, certified laboratory and provides full traceability to national and international standards. DAkkS calibration is typically required in strictly regulated industries such as pharmaceuticals, biotechnology, and aerospace — particularly where GxP compliance, audit readiness, and data integrity are critical.
In-house calibration, on the other hand, is performed internally using traceable reference equipment, but it is not accredited by an external authority. While it may be sufficient for general industrial applications or internal quality control, it may not meet the requirements of regulatory bodies or pass external audits in highly regulated environments.
The choice between DAkkS and in-house calibration should be based on your application and regulatory requirements.
If your system is used in GxP environments or must meet global compliance standards, DAkkS calibration is the recommended approach. For internal or non-regulated uses, in-house calibration may be a more cost-efficient solution.
What is the IRTD, and what is its role in temperature validation and calibration processes?
The IRTD (Intelligent Reference Thermometer Device) is a high-precision, DIN ISO/IEC 17025-traceable reference thermometer developed by Kaye: The IRTD is specifically designed to connect seamlessly to Kaye validation systems such as the Kaye Validator AVS and earlier platforms. It is a critical component for enabling the automated calibration and adjustment of temperature sensors (e.g. thermocouples). Once connected, the calibration process is fully integrated and guided within the Kaye software, ensuring regulatory compliance, data integrity, and ease of use.
What is the maximum number of sensors that can be calibrated simultaneously in one oven calibration cycle?
The maximum number of sensors that can be calibrated at the same time depends on the Kaye calibration bath or dry block (dry well) being used, as well as on the calibration insert or sensor holder configuration. Below is an overview of the sensor capacities for various Kaye calibration systems:
Dry Block / Dry Well Calibrators
(Note: Typically used with thermocouples)
LTR-90: Up to 25 thermocouples
LTR-150: Up to 48 thermocouples
LTR-200: Up to 24 thermocouples
HTR-420: Up to 48 thermocouples
Liquid Calibration Baths
(Primarily used with Kaye ValProbe® RT real-time data loggers)
CTR-25: Capacity depends on sensor diameter; up to 10 ValProbe RT loggers with the dedicated holder
CTR-40: Capacity depends on sensor diameter; up to 20 ValProbe RT loggers with the dedicated holder
CTR-80: Capacity depends on sensor diameter; up to 12 ValProbe RT loggers with the dedicated holder
LN2 Comparator: Up to 48 thermocouples
Please note that actual capacity also depends on sensor size, insertion depth, and application-specific requirements. For optimal results, use the appropriate Kaye sensor holders and inserts designed for each system.
What is the measurement range and specified accuracy of the Kaye IRTD?
The Kaye IRTD-400 is a high-precision, ISO/IEC 17025-accredited reference thermometer, with calibration traceable to internationally recognized standards, including:
• NIST (USA)
• DAkkS (Germany)
• CNAS (China)
• NABL (India)
It features an exceptional measurement range from –196 °C to +420 °C and delivers a comprehensive system accuracy of ±0.025 °C across this entire range.
This unique level of precision and global traceability makes the IRTD-400 ideally suited for use in regulated environments such as GMP- and FDA-compliant pharmaceutical and biotechnology manufacturing. As a result, it is trusted by validation experts and calibration laboratories around the world—particularly within industries that rely on Kaye systems, a part of the Amphenol group.
For more information or to request a sample calibration certificate, visit www.kayeinstruments.com or contact your local certified Kaye partner.
What is the process if my Kaye equipment needs repair or calibration?
If your Kaye equipment requires repair or calibration, you should contact your local Kaye Service Center or an authorized distributor. Kaye offers ISO/IEC 17025-accredited calibration and certified repair services for all major systems, including the Validator AVS, ValProbe RT, dry block calibrators, and legacy devices such as the Validator 2000.
To initiate the service process, you can:
• Submit a service request through the official Kaye website:
www.kayeinstruments.com
• Contact your regional Kaye representative directly
• Call or email the appropriate service center listed on the Kaye website
Once your request is received, the team will provide:
Shipping instructions
An RMA number (Return Material Authorization)
An estimated service timeline
For urgent requirements, expedited service options are also available to minimize downtime and support your validation schedule.
What is the recommended calibration interval for data loggers?
According to ISO 9000 principles, the calibration interval for measuring instruments should be determined based on risk and the specific application. While there is no fixed interval, regular calibration is essential to ensure the accuracy, reliability, and consistency of measurement results.
A 12-month interval is commonly used, but this may vary depending on the measurement type and the operating environment. For critical applications, we also recommend performing in-house verifications between the annual factory recalibrations to monitor performance and maintain compliance.
What is the recommended verification frequency for data loggers in validated environments?
According to ISO 9000 principles, the calibration interval for measuring instruments should be determined based on risk and the specific application. While there is no fixed interval, regular calibration is essential to ensure the accuracy, reliability, and consistency of measurement results.
A 12-month interval is commonly used, but this may vary depending on the measurement type and the operating environment. For critical applications, we also recommend performing in-house verifications between the annual factory recalibrations to monitor performance and maintain compliance.
What is the typical Turnaround Time (TAT) for logger calibration?
The turnaround time for calibration in our Kaye calibration laboratories depends on the type of logger and the date of receipt (which determines when the calibration run begins). For temperature and pressure loggers, the average turnaround time is typically 6–8 business days. Due to the specific calibration process, RH (relative humidity) loggers generally require slightly longer, with most units ready for return shipment within 11 business days.
What services does Kaye offer?
Kaye offers a comprehensive range of services designed to support customers in regulated industries such as pharmaceuticals, biotechnology, and medical devices. These services help ensure compliance with global standards for thermal validation, environmental monitoring, and data integrity.
Our key service offerings include:
• Factory calibration and repair services (traceable to NIST) to maintain system accuracy and compliance
• On-site calibrations and validation services, reducing downtime and ensuring qualification continuity
• Service contracts tailored to your needs, including preventive maintenance, audits, and technical support
• IQ/OQ protocols (Installation and Operational Qualification) to support regulatory compliance from project start
• Access to software updates and product documentation via the Kaye Customer Portal
• Technical support and application training from experienced validation experts
• Integration with global and certified service partners to provide localized support around the world
Whether you're performing thermal mapping, equipment qualification, or monitoring critical environments, Kaye provides industry-proven tools and expertise to help you maintain compliance and improve operational efficiency.
You can always contact Kaye directly or reach out to one of our certified partners for personalized assistance.
For more information, visit: https://www.kayeinstruments.com/
What should I consider when deciding between performing validation in-house versus using an external service provider?
It’s important to understand that, regardless of whether validation is performed in-house or outsourced to an external service provider, the facility or equipment owner is ultimately responsible for validation results during regulatory audits. Therefore, external partners should only be selected if they have a proven track record of successful audits and experience in regulated environments. Always request references and ensure that any third party fully understands GxP requirements and relevant international standards.
When deciding between performing validation internally or using an external partner, consider the following key factors:
Expertise & Knowledge
• In-house validation offers full control but requires trained personnel, validated tools (e.g. Kaye ValProbe RT, AVS), and knowledge of applicable standards.
• Certified service providers — including Kaye-qualified partners — bring extensive experience with industry-specific validation, compliance with ISO 17665, EU GMP Annex 1, and FDA 21 CFR Part 11.
Time & Resources
• Internal teams may be limited in time or bandwidth.
• External providers can reduce downtime, quickly mobilize resources, and deliver turnkey qualification services, especially during critical installations or product launches.
Documentation & Compliance
• External services typically provide fully compliant IQ/OQ documentation, audit-ready reports, and traceability to international standards.
• In-house teams must ensure documentation meets GAMP 5 and GDP (Good Documentation Practice) expectations.
Cost Structure
• In-house validation requires investment in equipment, software, and staff training.
• External services can lower initial costs and avoid long-term capital expenditures — especially beneficial for infrequent or one-time validations.
Flexibility & Scalability
• For large-scale facilities with frequent validations, building in-house capacity may be efficient long-term.
• For smaller labs, hospital CTUs, or occasional system upgrades, third-party providers offer scalable and efficient solutions.
Why do thermocouples tend to slip out of the dry block during calibration?
Thermocouples occasionally slide or shift within a block calibrator during calibration due to two main factors:
1. Improper insertion technique by the user – inserting the probe at a slight angle or without full depth may prevent proper contact and alignment.
2. The self-weight of the thermocouples – longer or heavier probes can gradually slip out due to gravity, especially when used in vertical orientation or when the block reaches higher temperatures, causing slight material expansion.
This movement can compromise thermal contact and necessary immersion depth and ultimately affect calibration accuracy.
Solution:
To ensure precise probe positioning and stable insertion throughout the calibration cycle, Kaye (part of Amphenol) offers dedicated TC Holders specifically designed for our dry block calibrators (e.g., LTR-150, CTR-25, HTR-420). These holders:
• Support correct and repeatable insertion depth
• Secure the thermocouples firmly during temperature cycling
• Help prevent measurement drift caused by probe movement
• Comply with best practices for traceable sensor calibration
If you're using Kaye block calibrators and frequently experience sensor slippage, we highly recommend using the matching TC Holder set for your device.
More details and part numbers are available at: https://www.kayeinstruments.com/de/calibration-references/liquid-bath-dry-block-calibrator
Do Kaye systems comply with FDA 21 CFR Part 11 and relevant sterilization standards?
Yes. Kaye systems are fully compliant with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures, making them suitable for use in regulated environments such as pharmaceutical, biotechnology, and medical device manufacturing.
In addition, Kaye solutions support key international sterilization standards, including:
• ISO 17665 – Sterilization of health care products using moist heat
• EN 285 – European standard for large steam sterilizers
• HTM 2010 – Health Technical Memorandum for sterilization in healthcare environments (UK)
These standards are supported across Kaye’s validation platforms — such as the Validator AVS and ValProbe RT — as well as through software tools like the Common Reporting Tool (CRT), which provide audit trails, secure access control, and compliant data storage.
For more detailed information about regulations and supported guidelines, please visit:
Kaye Knowledge Library – Norms & Guidelines
If you have specific compliance requirements, Kaye’s global team and certified partners are available to support you.
How does Kaye software support compliance with EU GMP Annex 1?
Kaye software solutions, including the Common Reporting Tool (CRT) and monitoring platform, are designed to support compliance with EU GMP Annex 1 requirements — particularly those related to sterile manufacturing, environmental monitoring, and data integrity.
Annex 1 emphasizes risk-based contamination control, data traceability, and robust system validation in aseptic environments. Kaye software supports these expectations through key features such as:
• Comprehensive audit trails for all user and system actions
• Role-based access controls (User, Supervisor, Administrator) to prevent unauthorized data modification
• Support for electronic signatures in accordance with FDA 21 CFR Part 11 and Annex 11
• Secure and tamper-proof data storage with time-stamped entries
• Integrated alarm/event logging and reporting for environmental monitoring
• Support for temperature, pressure, humidity, CO₂ and other critical parameters in cleanroom and controlled-zone applications
In addition, Kaye solutions are built to work within GxP-validated environments and undergo rigorous software development lifecycle (SDLC) practices in alignment with GAMP 5.
Please refer to our Knowledge Library for further guidance on validation standards and compliance topics:
https://www.kayeinstruments.com/de/knowledge-library/norms-guidelines
How many thermocouples are recommended for autoclave validation according to relevant standards such as EN 285, DIN EN ISO 17665, DIN 58950, or DIN 58946?
In recent years, many regulatory and technical standards have moved away from prescribing a fixed number of thermocouples (TCs) for autoclave validation. Instead, they increasingly use terms like an “adequate” or “sufficient” number. This shift reflects a risk-based approach, empowering the validation engineer to determine the appropriate number of measurement points based on a documented risk and process analysis.
This means that the number of TCs should be statistically justified to ensure comprehensive coverage of temperature distribution and worst-case locations. In practice, a higher number of measurement points allows for stronger statistical confidence and a more robust qualification process.
Nevertheless, earlier versions of the standards and widely accepted best practices still provide valuable guidance and suggested configurations:
Summary of key standard guidelines:
• EU GMP Annex 15: Recommends an “adequate number” of measurement points, with a minimum of 10 thermocouples generally expected in GMP practice.
• EN 285 (Large Steam Sterilizers): Suggests using 7 thermocouples per cubic meter of chamber volume for temperature distribution studies.
• EN 554 (now largely replaced): Previously specified 12 thermocouples for the first cubic meter, with more added for larger chambers.
• DIN EN ISO 17665-1: Does not define a fixed number, but explicitly states that the number and placement of sensors must be justified through a documented, risk-based rationale.
• HTM 2010 (UK NHS): Recommends using 12 thermocouples, while noting more may be required based on chamber size, configuration, or process complexity.
• DIN 58950 / DIN 58946 (Germany): Both standards point directly to EN 285 for determining thermocouple quantity – typically 7 sensors per m³, following established European guidance.
Sensor placement should always include:
• Corners of the chamber
• The geometric center
• Drain or condensate outlet
• Hard-to-sterilize areas and worst-case points
• Representative load positions (for penetration studies)
Best practice with Kaye systems (such as the Validator AVS):
• Use 12–16 TCs for standard autoclave validation setups
• Up to 48 thermocouple channels are supported for full-scale high-density thermal mapping
• Reduced TC count during requalification is possible if statistically justified by historical performance data and a documented risk assessment
What are the key compliance requirements between GMP / 21 CFR Part 11 and the validation equipment being used?
Good Manufacturing Practices (GMP) and the U.S. FDA regulation 21 CFR Part 11 are critical frameworks that govern how validation equipment should be designed, used, and maintained—especially in regulated industries such as pharmaceuticals, biotechnology, and medical technology.
21 CFR Part 11 specifically addresses the integrity of electronic records and signatures. Therefore, validation equipment must be capable of:
Secure data logging and storage
User access control and audit trails
Electronic signature support
Tamper-proof file formats
Compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available)
GMP regulations further require that all equipment used in validation processes be qualified, calibrated, and maintained according to established procedures to ensure consistent and reliable results.
What are the relevant standards and key criteria for qualifying a steam sterilizer, particularly in terms of temperature and pressure compliance?
There are several internationally recognized standards that define the requirements for qualifying a steam sterilizer (autoclave), particularly in pharmaceutical, medical device, and healthcare environments. These standards help ensure that sterilization processes consistently deliver safe, effective, and compliant results.
The most important and widely accepted standards include:
- EN ISO 17665-1 — Sterilization of health care products – Moist heat: Defines the general requirements for validation and routine control of moist heat sterilization processes.
- EN 285 — European standard for large steam sterilizers used in healthcare and industrial settings. Covers performance tests and equipment qualifications.
- HTM 01-01 / HTM 2010 — UK guidelines providing comprehensive recommendations for steam sterilizer performance in hospitals and healthcare.
In terms of acceptance criteria for qualification the mentioned standards will give more details:
• Typical sterilization temperature: 121 °C or 134 °C (±1°C) depending on cycle type.
• Pressure must correlate with the saturation point (e.g., approx. 2.1 bar at 134°C).
• Equilibration time (temperature homogeneity): usually ≤ 30 seconds between sensors.
• F₀ value requirements for steam sterilization: typically ≥ 15 or higher
For a full overview of applicable norms, definitions, acceptance criteria, and best practices for compliant qualification using Kaye systems, please visit our Knowledge Library:
https://www.kayeinstruments.com/de/knowledge-library/norms-guidelines
What global standards should be followed for temperature and humidity monitoring in warehouses?
Temperature and humidity monitoring in warehouses—particularly in GxP-regulated industries such as pharmaceuticals, biotechnology, and life sciences—must comply with key international standards to ensure product quality, data integrity, and regulatory compliance during storage and distribution.
Commonly applied global guidelines and standards include:
- WHO Technical Report Series 961, Annex 9 – Guide to Good Storage Practices for Pharmaceuticals
- EU GDP (Good Distribution Practice) – Focused on maintaining product integrity across the supply chain
- EU GMP Annex 1 – For warehouses integrated in sterile product handling
- FDA 21 CFR Part 11 – Governing the use of electronic data and audit trails
- EN ISO 14644 – Cleanroom and controlled environment classification, where relevant
- USP <1079> and <1118> – Guidance on temperature monitoring and mapping
These guidelines typically require:
• Continuous monitoring of temperature and/or relative humidity
• Alarm notifications in case of limit excursions
• Secured and validated data storage
• Periodic mapping (e.g., seasonal or upon changes)
• Traceable calibration of sensors
• Reliable power backup and data redundancy systems
At Kaye we offers proven warehouse monitoring solutions — including temperature, humidity, and CO₂ sensors — that are designed to help customers meet these regulatory expectations. Kaye's automated monitoring systems, audit-ready reporting, and compliant software platforms simplify validation and support audits from health authorities worldwide.
To learn more about the specific standards and how our solutions support them, we invite you to visit:
https://www.kayeinstruments.com/de/knowledge-library/norms-guidelines
What international guidelines should be followed when performing autoclave validation?
Autoclave validation in regulated industries such as pharmaceuticals, biotechnology, and medical device manufacturing must follow several international guidelines to ensure compliance, product safety, and data integrity.
Key international standards and regulatory guidelines include:
• EN ISO 17665-1: Sterilization of health care products – Moist heat
• GMP (Good Manufacturing Practice): Especially EU GMP Annex 1 (Sterile Manufacturing)
• FDA 21 CFR Part 210/211: Current Good Manufacturing Practice for drugs
• FDA 21 CFR Part 11: Electronic records and electronic signatures
• Ph. Eur. / USP / JP: Requirements from international pharmacopoeias
• GAMP 5: Good Automated Manufacturing Practice for computerized systems in validation
These standards provide critical direction for thermal mapping, cycle development, performance qualification (PQ), and documentation of the autoclave process.
For a complete overview of relevant norms and guidelines related to autoclave validation and related thermal processes, we recommend visiting the Kaye Knowledge Library:
https://www.kayeinstruments.com/de/knowledge-library/norms-guidelines
Which regulatory standards and compliance requirements does the Kaye validation system adhere to?
Kaye Validation Systems are state-of-the-art solutions specifically designed to meet the rigorous demands of thermal validation in GxP-regulated environments. They ensure full compliance with key regulatory and industry standards, including FDA 21 CFR Part 11, GAMP® 5, and EU Annex 11.
Recognized globally as an industry benchmark, the Kaye systems have become the standard of choice for pharmaceutical, biotechnology, and medical device manufacturers when it comes to high-accuracy temperature and process validation.
As part of the Amphenol Group, Kaye continues to develop innovative, technology-driven solutions that deliver precision, compliance confidence, and operational efficiency across critical validation applications — including autoclaves, depyrogenation tunnels, ultra-low freezers, and lyophilizers.
Can F₀ be calculated after the study is completed if the lethality calculation parameter was not configured during setup?
Yes, the Kaye Common Reporting Tool (CRT) allows you to define a new cycle and apply custom settings after the study has been completed. This means you can retroactively calculate the F₀ (lethality value) even if the lethality calculation parameter was not initially configured during the setup phase.
CRT provides flexible reporting tools to ensure you can generate all critical validation data — including F₀ — in compliance with regulatory requirements.
If you need assistance creating a new cycle or setting F₀ parameters in CRT, please contact Kaye technical support or one of our certified service partners.
Can I combine AVS and ValProbe RT data files for joint analysis or reporting?
Yes, the latest version of Kaye's Common Reporting Tool (CRT) supports merging data files from both AVS and ValProbe RT systems into a single, combined report. This feature streamlines the reporting process and makes it easier to analyze and present validation results from both platforms in one unified document.
If you are not yet using the latest CRT version or need help with the merge function, please contact Kaye Technical Support or your local Amphenol/Kaye representative for assistance.
Can the Common Reporting Tool (CRT) software be installed on a different or additional computer?
Yes, the Kaye Common Reporting Tool (CRT) can be installed and used both on dedicated validation consoles as well as on separate, offline Windows-based PCs. This allows for greater flexibility in workflow, enabling users to perform data analysis and generate reports away from the validated environment or on additional workstations.
If you need guidance on how to install CRT on a separate system, please contact Kaye Technical Support or refer to the installation documentation provided with your software package.
How is MKT (Mean Kinetic Temperature) used in pharmaceutical temperature validation and storage monitoring?
Mean Kinetic Temperature (MKT) is a calculated value used to express the overall effect of temperature fluctuations during the storage or transport of temperature-sensitive products — especially in the pharmaceutical and biotech industries.
Unlike a simple arithmetic mean, MKT gives greater weight to higher temperature excursions, which can have a more significant impact on product stability. This makes MKT particularly relevant for GxP-regulated environments where data integrity and product safety are critical.
Kaye uses MKT calculations as part of its LabWatch™ real-time monitoring software, to help ensure compliance with international guidelines (like ICH Q1A or FDA recommendations). MKT is widely recognized by regulatory authorities as a scientifically sound method to evaluate temperature impact over time.
What is a Pass/Fail report, and why is Excel no longer considered a sufficient solution for regulated environments?
The specific function of a Pass/Fail report is addressed in a separate FAQ entry. Therefore, we will focus here on explaining why Microsoft Excel — despite its widespread use — is no longer considered an adequate or compliant solution for generating and managing such reports in regulated GxP environments.
In pharmaceutical, biotechnology, and other regulated industries governed by standards like FDA 21 CFR Part 11, EU GMP Annex 11, and GAMP 5, maintaining data integrity, security, and traceability is paramount. Although Excel is a powerful spreadsheet tool, it does not meet the technical and procedural control requirements expected in GxP-compliant validation processes.
Key reasons why Excel is considered non-compliant or insufficient:
• Lack of audit trail: Native Excel files do not automatically log who made what change and when — a requirement under 21 CFR Part 11 and Annex 11.
• Easy to manipulate: Data can be edited, overwritten, or deleted without detection, compromising data integrity and traceability.
• No inherent access control or electronic signatures: Unless embedded in a validated environment, Excel cannot enforce role-based access or electronic approval processes.
• No validation by default: Excel is not a validated software system unless placed under formal configuration and lifecycle management — which is complex and resource-intensive.
• Increased audit risk: During audits, regulators often question or reject data stored or reported solely in Excel due to lack of system control and integrity features.
By contrast, dedicated validation software like the Kaye Common Reporting Tool (CRT) provides:
• Built-in audit trails
• Electronic signature management
• User role controls (User, Supervisor, Administrator)
• Predefined Pass/Fail criteria with automated data evaluation
• Compliant, secure, and reproducible reports
Using a validated reporting system like CRT not only ensures compliance with applicable regulations but also significantly reduces audit findings and enhances process transparency.
What is Active Directory and how does it work?
Active Directory (AD) is a Microsoft service used with Kaye validation systems software to centrally manage user accounts, computers, and access permissions within an organization's network. It enables employees to log in securely using a single set of credentials and ensures that they have appropriate access to systems, applications, and files based on their roles.
AD works by storing information in a structured, hierarchical database and authenticating users when they attempt to access company resources.
What is the fastest configurable sampling interval for the 5-channel ValProbe RT logger?
The fastest configurable sampling interval for the 5-channel ValProbe RT logger from Kaye is 2 seconds per channel. Each channel can store up to 100,000 data points, allowing for extended high-resolution studies even with frequent measurements.
What is the function of the Pass/Fail tool within validation software for AVS Validator and ValProbe RT?
The Pass/Fail tool in Kaye validation software — used with both the AVS Validator and ValProbe RT systems — allows users to automatically evaluate measurement data against predefined acceptance criteria. This feature streamlines the validation process by identifying whether individual channels, sensors, or entire qualification cycles meet the required specifications for temperature, pressure, humidity, or lethality (F₀) parameters.
Key functions include:
-Defining upper and lower tolerance limits for each measured parameter
-Automatically flagging out-of-spec data points or cycles
-Generating clear, audit-ready reports showing compliance or deviations
-Supporting regulatory and quality requirements (e.g., GMP, FDA, EU Annex 1)
This tool is especially beneficial when performing thermal mapping in autoclaves, stability chambers, warehouses, or cleanrooms — enabling fast, consistent, and compliant review of measured data without the need for manual calculations or searching.
What is the maximum number of data points that can be recorded per ValProbe RT logger?
Each Kaye ValProbe® RT logger can store up to 100,000 data points per sensor channel. This high-capacity storage allows for extended data collection during long-term thermal validation studies without the need to download or reset the logger frequently. It’s ideal for use in GxP-compliant environments where continuous, high-resolution data is essential.
What types of reporting tools are available in Kaye validation systems?
Kaye offers a wide range of reporting and analysis tools, which vary depending on the specific validation system being used (e.g., AVS, ValProbe RT, LabWatch IoT). These capabilities are continuously improved and expanded through regular software updates.
Due to the dynamic nature of these developments, it is not possible to provide a complete and up-to-date list of all features within a static FAQ entry. For the latest information or to request a personalized software demonstration, please visit our official website or contact your local Kaye representative.
Where can I download the latest software updates and product documentation?
Official software releases, validation documentation, user manuals, and firmware updates for Kaye systems are available through the Kaye Customer Support Portal. This portal provides registered users with access to the most up-to-date materials to ensure reliable system performance and regulatory compliance.
To access the portal, simply visit:
https://www.kayeinstruments.com/de/customer-portal
If you do not yet have access or require assistance, please contact your local Kaye service representative. Our global support teams will be happy to help you register or provide specific documents as needed.
Why is it necessary for the system to have three distinct user levels (User, Supervisor, Administrator)
Implementing three distinct user access levels – User, Supervisor, and Administrator – is essential to ensuring data integrity, traceability, and compliance with regulations such as 21 CFR Part 11, which governs electronic records and electronic signatures in regulated environments like pharmaceutical and biotechnology manufacturing.
Each role has clearly defined permissions:
- User: Can access and perform assigned measurement or validation tasks, but cannot modify critical system settings or data.
- Supervisor: Has authority to approve or oversee User activities, configure tests, and manage workflows within compliance boundaries.
- Administrator: Responsible for system configuration, user account management, and enforcing security policies and audit trails.
This role-based structure prevents unauthorized access, ensures accountability, and supports audit readiness. It also satisfies key regulatory requirements, such as:
• Secure access control
• Separation of responsibilities
• Audit trails linked to user actions
• Minimizing risk of unintentional or unauthorized modifications
Defining these user levels not only supports regulatory alignment but also improves operational security and clarity across your validation processes.
How can I repair an out-of-service AVS tablet or have it evaluated?
The Kaye AVS Validator series was launched in 2015. The first generation was equipped with consoles from the Motion C5m/F5m series. Motion has officially discontinued support for these consoles and ended all services effective July 2024. This means that no further after-sales support is available — neither firmware nor hardware.
For this reason, Kaye transitioned to a DELL-based console solution over the course of 2020/21.
Please contact us directly or reach out to one of our certified distributors to learn more about available upgrade options.
How do I calculate the total system error for a measurement or validation setup?
The total system error — also known as total measurement uncertainty — is a combined value that accounts for all potential sources of deviation within a measurement or validation setup. In regulated environments such as pharmaceutical, biotechnology, or food production, accurate calculation of total system error is essential for ensuring data reliability and compliance with standards (e.g. FDA, GMP, or EN ISO 17025).
To calculate the total system error (TSE) accurately, you typically combine multiple error sources using the root-sum-square (RSS) method:
Total System Error (TSE) = √(E₁² + E₂² + E₃² + ... + En²)
Where:
• E₁, E₂, E₃, etc. represent individual errors from different system components, such as:
o Sensor accuracy (e.g. thermocouple, RTD, wireless logger)
o Logger resolution and accuracy
o Reference standard uncertainty (e.g. IRTD calibration)
o Calibration equipment uncertainty (e.g. dry block or liquid bath)
o Environmental or setup conditions (e.g. thermal gradients, immersion depth)
Example (for Kaye systems such as AVS Validator or ValProbe RT):
Imagine the following typical tolerances:
• Sensor accuracy: ±0.2 °C
• Logger/system accuracy: ±0.1 °C
• Calibration reference (e.g. IRTD): ±0.025 °C
Then: TSE = √(0.2² + 0.1² + 0.025²) = √(0.04 + 0.01 + 0.000625) = √0.050625 ≈ ±0.225 °C
This total system uncertainty represents the combined effect of all included sources, assuming they are independent and normally distributed.
In our Kaye product line we provide documented system accuracy and uncertainty levels in the technical specifications and calibration certificates. Our systems are designed to meet demanding regulatory validation needs, and the total system error is often already defined and validated during IQ/OQ processes.
How does a temperature validator differ from a standard temperature recorder?
A temperature validator is a high-precision system specifically designed for use in validated environments, such as pharmaceutical manufacturing, biotechnology, and food processing — where compliance with regulatory standards like GMP, FDA, or EN ISO 17025 is critical. Temperature validators, such as those offered by Kaye, are engineered to support thermal validation processes by providing traceable, highly accurate measurements along with comprehensive calibration, qualification (IQ/OQ/PQ), and reporting tools.
In contrast, a standard temperature recorder is typically used for general-purpose monitoring applications. These devices capture and store temperature data over time but often lack the accuracy, redundancy, regulatory compliance, and detailed documentation required for official validation protocols.
Key differences include:
- Accuracy & Traceability: Validators use calibrated, traceable sensors (e.g., IRTD) to deliver higher measurement accuracy and meet international validation standards.
- Compliance Features: Validators come with built-in support for regulated environments, including audit trails, data integrity, calibration reports, and secure data handling.
- Multi-point Data Collection: Validators are designed to measure multiple input channels simultaneously for mapping processes like autoclaving, depyrogenation, and cold storage.
- Validation-Ready Software: Tools like the Kaye Common Reporting Tool (CRT) generate compliant reports (e.g., F₀, A₀ calculations) for inspections and audits.
- Service & Certification: Unlike general recorders, temperature validators are often supported with factory calibration, IQ/OQ protocol packages, and service contracts.
Is historical live data reporting available in the Kaye AVS system?
Yes, starting with version 2.1, the Kaye AVS system supports historical live reporting. This includes real-time trend visualization and the ability to generate interim reports during an ongoing qualification run. These features allow users to monitor data as it is collected, ensure process integrity in real time, and make informed decisions without interrupting the validation process.
Is the Kaye Validator 2000 still being manufactured, serviced, or supported for calibration?
The Kaye Validator 2000 is no longer in production, and new system sales officially ended in 2016. However, Kaye continues to offer repair services, calibration, and technical support for the Validator 2000, subject to the availability of spare parts.
Due to the product's age, please note that some components are now end-of-life and may no longer be available, which can affect the feasibility of certain repairs. Despite this, Kaye remains committed to supporting existing customers using the Validator 2000 and offers flexible transition solutions to the next-generation Validator AVS platform.
For more information on available services or upgrade options, please contact your local Kaye representative or visit the Validator 2000 product page:
https://www.kayeinstruments.com/de/validation-systems/wired-systems/kaye-validator-2000
What are the advantages and disadvantages of wired versus wireless?
There are two established approaches to thermal validation: wired systems (e.g. chart recorders with thermocouples) and wireless data loggers (often using Pt100/Pt1000 sensors). Both technologies are commonly used and accepted in GxP-regulated environments, each with its own advantages and limitations.
The choice between these systems should always be based on the specific application. Factors like temperature range, data integrity, ease of handling, calibration needs, compliance requirements, operating costs, and software usability all play a critical role in selecting the right measurement solution. In some cases, a hybrid setup combining both methods may offer the best outcome.
Both solutions have their pros and cons, and we recommend reviewing your individual use case carefully before choosing.
For a full technical comparison and deeper insights, please visit our whitepaper section at:
https://www.kayeinstruments.com/de/knowledge-library/whitepapers
What are the standard color codes for the positive and negative leads on Amphenol two-wire thermocouples?
In Kayes two-wire thermocouples the positive and negative wires are color-coded according to international thermocouple standards. The specific color assignment depends on the thermocouple type (e.g. Type T, K, J) but follows either the ANSI (U.S.) or IEC (International) conventions. Kaye typically provides thermocouples based on the ANSI standard (unless otherwise specified by customer requirements).
Here are the most common color codes used for the positive and negative wires:
ANSI Color Code (commonly used in Kaye applications):
o Type T: Positive Lead blue/ Negative Lead red
o Type K: Positive Lead yellow/ Negative Lead red
o Type J: Positive Lead white/ Negative Lead red
Color Code Notes: The negative lead is typically red for all ANSI thermocouple types.
These color codings help technicians during installation, calibration, and replacement to ensure correct polarity and sensor compatibility.
Incorrect connection of the positive and negative leads can result in reversed readings or calibration errors. Always cross-reference the cable colors and sensor documentation when installing or verifying thermocouples in Kaye Validator systems.
What is a Pt100 or Pt1000 sensor, and how does it differ from a thermocouple (TC)?
A Pt100 or Pt1000 is a platinum resistance temperature detector (RTD) that measures temperature based on changes in electrical resistance. "Pt" stands for platinum, and "100"/"1000" indicates the resistance in ohms at 0 °C. Pt100 = 100 Ω, Pt1000 = 1000 Ω.
In contrast, a thermocouple (TC) measures temperature by generating a small voltage due to the thermoelectric (Seebeck) effect between two dissimilar metals.
As a reference, please also visit our Knowledge Library for more detailed information.
What is a thermocouple, and how does it function in temperature measurement applications?
As a reference, please also visit our Knowledge Library at https://www.kayeinstruments.com/en/knowledge-library/whitepapers for more detailed information
A thermocouple is a highly reliable temperature-sensing device that measures temperature based on the thermoelectric (Seebeck) effect. It consists of two dissimilar metal wires joined at one end to form a measuring junction. When this junction experiences a temperature different from the other ends (the reference junction), a small voltage is generated that correlates directly to the temperature difference between the two ends.
How it works in simplified terms:
• Two dissimilar metals (e.g., copper and constantan in Type T TCs) are joined to form a thermal junction.
• When heated or cooled, the junction generates a millivolt-level signal
• That signal is interpreted by high-precision electronics (such as those in Kaye systems) to determine the exact temperature.
Key advantages for Thermocouples applications:
• Passive operation (no external power required)
• Fast response time and small sensor size
• Wide temperature range support as a function of the TC material combination (e.g., –200 °C to +600 °C)
• High durability in harsh environments (steam, vacuum, dry heat)
Kaye thermocouples meet stringent manufacturing and insulation standards (e.g., Teflon®, Kapton®, stainless steel sheathing), ensuring outstanding performance in critical validation applications.
What is the difference between AutoBond thermocouples and standard thermocouples?
The primary difference between Kaye AutoBond™ thermocouples and standard thermocouples lies in their construction, sealing technology, and long-term performance in high-humidity or saturated steam environments, such as those found in autoclave validation processes.
AutoBond thermocouples are specifically designed for enhanced moisture resistance. They feature a hermetically sealed bonding process between the individual thermocouple wires and the outer PTFE or Teflon® insulation. This process effectively prevents steam and moisture from penetrating the cable structure
In contrast, standard thermocouples may contain microscopic pores between wires and insulation materials due to the manufacturing process. Over time, especially under repeated exposure to humidity and high temperatures, these micro-gaps can allow moisture to infiltrate the insulation.
Kaye AutoBond TCs are available in both 3-stranded and 7-stranded configurations and are fully compatible with Kaye Validator systems such as the AVS. Their improved reliability makes them a preferred choice for regulated validation processes in pharmaceutical and biotech environments.
Learn more at: www.kayeinstruments.com or contact your local certified Kaye partner for details and availability.
What is the difference between thermocouple and RTD technology, and how does it affect my qualification process?
The differences are multifaceted and go beyond the scope of this FAQ page. Therefore, we refer you to a dedicated white paper on our website, where the distinctions in terms of accuracy, handling, and calibration are explained in detail.
The short answer for this page: Both systems have specific characteristics. When these are known and properly considered, both types of sensors can be effectively used in qualification processes.
For more information, please visit:
https://www.kayeinstruments.com/de/knowledge-library/whitepapers
What is the highest sampling frequency supported by the AVS system?
The AVS system features an improved scan time of 1 second for up to 48 input channels, meeting industry standards such as EN 554 and ISO 17665 for validation applications. In addition to faster data handling, the AVS provides four levels of data redundancy, expanded sensor input capabilities (including voltage, current, thermocouples, and RTDs), and can operate as a stand-alone unit with a dedicated console docking station for flexibility across validation environments.
What is the maximum recommended length for thermocouples used in Kaye validation systems?
The maximum recommended length of thermocouples (TCs) used in Kaye validation systems depends on several factors — including thermocouple type, wire gauge, environment, and required measurement accuracy. However, as a general guideline for Kaye systems (such as the Validator AVS or temperature mapping setups), the standard maximum cable length for thermocouples is:
Up to 30 meters (≈100 feet) with proper installation and minimal signal interference.
Longer thermocouple lengths may still operate, but they can be more susceptible to signal degradation, increased electrical noise, and voltage drop. These factors may affect measurement accuracy, particularly in high-resolution validations required in regulated environments (e.g., GMP/FDA).
Key considerations when using longer TCs:
• Use appropriate shielded or twisted-pair thermocouple extension wire.
• Avoid routing alongside high-voltage or EMI-generating equipment.
Kaye offers pre-configured thermocouples in standardized lengths and special lengths upon request.
What is the operating temperature range of Kaye thermocouples?
The operating temperature range of Kaye thermocouples depends largely on the type of insulation material used. Kaye offers thermocouples with different insulation options to match specific application requirements:
Teflon®-insulated thermocouples
• Temperature range: approximately –196 °C to +200 °C
• Ideal for: steam sterilization, cleanroom applications, and general thermal mapping
Kapton®-insulated thermocouples
• Temperature range: approximately –196 °C to +350 °C peak and short term
• Ideal for: dry-heat applications, ovens, tunnels. Not ideal for wet and moisture environmental
Stainless steel (SS) or metal-sheathed thermocouples
• Temperature range: approximately –196 °C to +400 °C
• Ideal for: dry-heat applications, ovens, tunnels and freeze dryer and cry applications.
In all configurations, Kaye thermocouples are constructed according to Type T, the preferred thermocouple type for thermal validation due to its superior stability and reliability in the –200 °C to +400 °C range.
Selecting the right insulation depends on your process requirements. For example:
• Use Teflon® for steam autoclaves or humidity-prone areas.
• Use Kapton® for dry applications such as dry-heat ovens.
• Use stainless steel when robustness or exposure to extreme temperatures is required.
What types of thermocouples and related accessories are available from Kaye?
Kaye, offers a wide range of thermocouples (TCs) and specialized accessories tailored to pharmaceutical, biotech, and life science applications.
Thermocouple Types Available:
Kaye thermocouples are primarily Type T (copper-constantan), selected for their excellent stability and suitability for a wide temperature rangeThey are offered in multiple configurations:
o 3-stranded or 7-stranded construction
o Standard or AutoBond sealed versions (moisture-resistant construction)
o Pre-assembled with drip-cut or smooth-cut ends
o Thermocouples with bare wire or mini-TC plugs
o Standard lengths or customized lengths or as a spool of 1000 or 2000 ft
Insulation Materials:
Thermocouples are available with different types of insulation based on application:
• Teflon® (PTFE): For general use and steam sterilization (autoclaves) – up to 260 °C
• Kapton®: For dry-heat applications – up to approx. 350 °C
• Stainless steel sheathed (metal jacket): For harsh or high- and low temperature environments
Accessories Available:
Kaye also provides a broad selection of accessories to support proper installation, calibration, and documentation:
• TC Holders
• Feedthroughs
• Label kits and ID tags
• Dry-block adapters and calibration sleeves
• High-accuracy mini T-type connectors
For detailed specifications, configuration guidance, or ordering part numbers, please contact your local Kaye representative or visit https://www.kayeinstruments.com for detailed information.
Which Kaye validation systems are available as wired or wireless versions, and what are the main differences between them?
When selecting between wired and wireless validation systems from Kaye the specific application should ultimately determine the optimal solution. Factors such as installation environment, number of measuring points, required flexibility, and budget considerations all play a role. In many cases, the best fit can be identified through an on-site consultation and, ideally, a live demonstration or trial setup with one of our experts or certified partners.
Wired Validation Systems
Kaye’s wired systems (e.g., Kaye Validator AVS and legacy Validator 2000) are designed for high-precision, real-time data acquisition, which is critical in temperature mapping and thermal process validation for autoclaves, ovens, tunnels, and lyophilizers.
In addition to precision and immediate feedback, these systems provide clear advantages in terms of cost of ownership — especially when a larger number of sensors are required. For example, the Kaye AVS supports configurations up to 48 thermocouple channels, making it a cost-effective solution for large-scale studies. Unlike wireless systems, where each data logger represents a full measurement unit, wired systems allow individual thermocouples to be replaced if damaged or broken — with minimal cost and downtime for the user.
Wireless Validation Systems
Kaye’s wireless solutions, such as the Kaye RF ValProbe II and Kaye Realtime ValProbe RT Loggers, are designed for scenarios where flexibility, mobility, or installation constraints make wired systems impractical — such as rotating autoclaves, hard-to-access tunnels, warehouses, or interim validations in remote locations.
RF-based wireless systems allow real-time monitoring, while standalone loggers collect data for post-process download. These systems minimize setup time and reduce physical interference with the process.
In summary:
Both wired and wireless systems have unique strengths. Wired systems are particularly advantageous for applications with many measurement points and for users who value live data feedback and simple maintenance. Wireless systems offer exceptional mobility and convenience where cabling is limited.
For guidance on choosing the right system for your specific needs, we recommend a site assessment and application review. Please contact Kaye directly or reach out to one of our official partners — such as Orion in Brazil — to schedule a consultation or live trial.
Visit: www.kayeinstruments.com for more information.
Which port on the back of the Kaye AVS Validator should be used to connect the IRTD?
There are three 4-pin DIN connectors on the back of the Validator AVS: two labeled for IRTD input and one for the Temperature Reference.
Important: The Validator AVS can accept input from only one IRTD at a time. For customer calibration procedures, only the upper IRTD port is active and should be used.
Do Kaye ValProbe RT loggers support pressure and humidity measurements?
Yes, Kaye ValProbe® RT loggers are available in different configurations to support various measurement types beyond temperature. These include:
• Temperature (single, dual, or 5-channel configurations with flexible, bendable, or rigid probes, as well as surface sensors)
• Temperature + Relative Humidity (RH)
• Temperature + Pressure
This versatility makes the ValProbe RT system ideal for diverse thermal validation and environmental monitoring applications.
How do I calculate the total system error for a measurement or validation setup?
The total system error — also known as total measurement uncertainty — is a combined value that accounts for all potential sources of deviation within a measurement or validation setup. In regulated environments such as pharmaceutical, biotechnology, or food production, accurate calculation of total system error is essential for ensuring data reliability and compliance with standards (e.g. FDA, GMP, or EN ISO 17025).
To calculate the total system error (TSE) accurately, you typically combine multiple error sources using the root-sum-square (RSS) method:
Total System Error (TSE) = √(E₁² + E₂² + E₃² + ... + En²)
Where:
• E₁, E₂, E₃, etc. represent individual errors from different system components, such as:
o Sensor accuracy (e.g. thermocouple, RTD, wireless logger)
o Logger resolution and accuracy
o Reference standard uncertainty (e.g. IRTD calibration)
o Calibration equipment uncertainty (e.g. dry block or liquid bath)
o Environmental or setup conditions (e.g. thermal gradients, immersion depth)
Example (for Kaye systems such as AVS Validator or ValProbe RT):
Imagine the following typical tolerances:
• Sensor accuracy: ±0.2 °C
• Logger/system accuracy: ±0.1 °C
• Calibration reference (e.g. IRTD): ±0.025 °C
Then: TSE = √(0.2² + 0.1² + 0.025²) = √(0.04 + 0.01 + 0.000625) = √0.050625 ≈ ±0.225 °C
This total system uncertainty represents the combined effect of all included sources, assuming they are independent and normally distributed.
In our Kaye product line we provide documented system accuracy and uncertainty levels in the technical specifications and calibration certificates. Our systems are designed to meet demanding regulatory validation needs, and the total system error is often already defined and validated during IQ/OQ processes.
Is the battery in the ValProbe RT logger field-replaceable?
Yes, the ValProbe RT logger from Kaye supports on-site battery replacement. It is equipped with a field-replaceable 3.6 V Lithium Thionyl Chloride ½ AA battery, allowing for easy and efficient maintenance without needing to return the device to the factory.
The ValProbe RT software also includes an integrated battery indicator that helps users monitor battery status and plan timely replacements based on remaining battery life.
Is the Kaye ValProbe® Reader and standard (non-Cryo) logger still supported or available?
While the Kaye ValProbe® Reader and standard (non-Cryogenic) data loggers have not been available for new purchase since the end of 2023, they remain fully supported by Kaye in terms of service, calibration, and spare parts—provided components are still available.
We highly recommend upgrading to the ValProbe® RT system for improved functionality and long-term support. Please contact your local Kaye representative for further assistance.
What are the advantages and disadvantages of wired versus wireless?
There are two established approaches to thermal validation: wired systems (e.g. chart recorders with thermocouples) and wireless data loggers (often using Pt100/Pt1000 sensors). Both technologies are commonly used and accepted in GxP-regulated environments, each with its own advantages and limitations.
The choice between these systems should always be based on the specific application. Factors like temperature range, data integrity, ease of handling, calibration needs, compliance requirements, operating costs, and software usability all play a critical role in selecting the right measurement solution. In some cases, a hybrid setup combining both methods may offer the best outcome.
Both solutions have their pros and cons, and we recommend reviewing your individual use case carefully before choosing.
For a full technical comparison and deeper insights, please visit our whitepaper section at:
https://www.kayeinstruments.com/de/knowledge-library/whitepapers
What is a Pt100 or Pt1000 sensor, and how does it differ from a thermocouple (TC)?
A Pt100 or Pt1000 is a platinum resistance temperature detector (RTD) that measures temperature based on changes in electrical resistance. "Pt" stands for platinum, and "100"/"1000" indicates the resistance in ohms at 0 °C. Pt100 = 100 Ω, Pt1000 = 1000 Ω.
In contrast, a thermocouple (TC) measures temperature by generating a small voltage due to the thermoelectric (Seebeck) effect between two dissimilar metals.
As a reference, please also visit our Knowledge Library for more detailed information.
What is the difference between thermocouple and RTD technology, and how does it affect my qualification process?
The differences are multifaceted and go beyond the scope of this FAQ page. Therefore, we refer you to a dedicated white paper on our website, where the distinctions in terms of accuracy, handling, and calibration are explained in detail.
The short answer for this page: Both systems have specific characteristics. When these are known and properly considered, both types of sensors can be effectively used in qualification processes.
For more information, please visit:
https://www.kayeinstruments.com/de/knowledge-library/whitepapers
What is the typical battery life of an RT logger during continuous operation?
The battery life of the Kaye ValProbe RT logger depends on several factors, including the sampling rate, ambient temperature, and whether RF transmission is enabled. Under normal conditions and with a standard configuration, the logger—equipped with a field-replaceable 3.6 V Lithium Thionyl Chloride ½ AA battery—can provide up to 5,000 hours of operation.
The ValProbe RT software continuously monitors battery status and estimates remaining life with an accuracy of ±10%, helping prevent unexpected interruptions during studies. It calculates battery life based on energy output over the temperature range. However, due to changes in battery chemistry, remaining battery capacity estimated at room temperature may be reduced when used in colder environments.
For the highest accuracy, battery life estimates are most reliable when the logger is used exclusively in either room temperature or low-temperature applications—not in a mix of both.
Which Kaye validation systems are available as wired or wireless versions, and what are the main differences between them?
When selecting between wired and wireless validation systems from Kaye the specific application should ultimately determine the optimal solution. Factors such as installation environment, number of measuring points, required flexibility, and budget considerations all play a role. In many cases, the best fit can be identified through an on-site consultation and, ideally, a live demonstration or trial setup with one of our experts or certified partners.
Wired Validation Systems
Kaye’s wired systems (e.g., Kaye Validator AVS and legacy Validator 2000) are designed for high-precision, real-time data acquisition, which is critical in temperature mapping and thermal process validation for autoclaves, ovens, tunnels, and lyophilizers.
In addition to precision and immediate feedback, these systems provide clear advantages in terms of cost of ownership — especially when a larger number of sensors are required. For example, the Kaye AVS supports configurations up to 48 thermocouple channels, making it a cost-effective solution for large-scale studies. Unlike wireless systems, where each data logger represents a full measurement unit, wired systems allow individual thermocouples to be replaced if damaged or broken — with minimal cost and downtime for the user.
Wireless Validation Systems
Kaye’s wireless solutions, such as the Kaye RF ValProbe II and Kaye Realtime ValProbe RT Loggers, are designed for scenarios where flexibility, mobility, or installation constraints make wired systems impractical — such as rotating autoclaves, hard-to-access tunnels, warehouses, or interim validations in remote locations.
RF-based wireless systems allow real-time monitoring, while standalone loggers collect data for post-process download. These systems minimize setup time and reduce physical interference with the process.
In summary:
Both wired and wireless systems have unique strengths. Wired systems are particularly advantageous for applications with many measurement points and for users who value live data feedback and simple maintenance. Wireless systems offer exceptional mobility and convenience where cabling is limited.
For guidance on choosing the right system for your specific needs, we recommend a site assessment and application review. Please contact Kaye directly or reach out to one of our official partners — such as Orion in Brazil — to schedule a consultation or live trial.
Visit: www.kayeinstruments.com for more information.