Kaye has multiple solutions for Autoclave Validation. Steam Sterilization has been used for more than a century in the pharmaceutical and biotech industry.

Application in a Glance

Steam Sterilization has been used for more than a century in the pharmaceutical and biotech industry to effectively sterilize products and materials withstanding moisture and higher temperatures.
Critical parameters such as Time, Temperature, Pressure, Direct Steam Contact, Air Removal have an impact on the sterilization results. Achieving Saturated Steam conditions is key and allows a proper temperature and pressure controlled process.
Depending on the product and packaging characteristics different sterilization temperatures are utilized.

Autoclave Validation is one of the most critical and widely studied processes for the sterilization of drug products, liquids in sealed containers, and hard goods used in the testing or manufacturing of Pharmaceutical, Biotech, and Medical Device products.

The purpose of the Autoclave Validation process is to ensure the destruction of all bacteria, viruses, and other viable microorganisms. The destruction of a microbial population subjected to a sterilization process follows a logarithmic progression based on the Thermal Death Curve.

In the pharmaceutical industry, in order to define a unit as sterile one must be able to certify that less than one unit in a million is exposed to the risk of not being sterile. The probability of finding a nonsterile unit (Probability of Non Sterile Unit, or Sterility Assurance Level SAL) must therefore be smaller (as mathematical value) than 10−6.

The critical parameters that affect a successful Autoclave Validation are:

• Temperature
• Pressure
• Time
• Saturated Steam
• Air Removal
• Steam Penetration
• Drying

Regulatory requirements worldwide require the Validation of all GMP Autoclaves to provide documented evidence that the sterilization process, developed in process design, can reliably and repeatedly deliver the prescribed sterilization process as well as the attainment of the required Sterility Assurance Level SAL of the products.

Autoclave /Steam Sterilizer Validation can be divided into two main phases: Process Design and Process Qualification.

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Highly accurate traceable temperature reference standard for calibrating sensors from -196 to 420¡C with an accuracy of +/- 0.025, the IRTD temperature standard probe provides a 4 to 1 ratio for calibrating sensors to 0.100¡C. Easy to read data with the Kaye IRTDWinª software.

Kaye IRTD-400

The IRTD is a high accuracy traceable temperature standard probe used as part of the Kaye Validation systems for calibrating sensors. During sensor calibration / verification, sensors are compared against the IRTD and offsets are automatically calculated and stored. The broad temperature range from -196 to 420¡C, enables it to be used in virtually all temperature validation applications.

Temperature Reference Standard

The IRTD is an integral part of Kaye's automated sensor calibration system and communicates directly with all Kaye Validation systems. With an accuracy of +/- 0.025, the IRTD temperature standard probe provides a 4 to 1 ratio for calibrating sensors to 0.100¡C. With this accuracy this temperature reference standard is one of the most accurate industrial temperature reference standards in the market.

The temperature reference standard probe can be used for confirming the accuracy of other temperature devices. For this purpose, Kaye has developed IRTDWinª software. The IRTDWinª software is one convenient interface screen lets you track probe stability, numerically and graphically, and confirm system accuracy.

See real time data of your IRTD using the calibration interface and the Kaye IRTD Console software. The calibration interface connects directly to your computer using USB and to up to two IRTDs. The software immediate shows the temperature of the IRTDs with an accurate resolution to the thousandths degree. The interface is simple, easy to use, and does not need a power source, as it is powered by the computer.

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Kaye Dry block calibrator, liquid bath calibrator, and IRTD Temp Standards offer unparalleled accuracy over a wide temperature range and reliability to meet your validation and calibration needs.

When it comes to pharmaceutical and biotech processing, there is no place for uncertainty in measurements. System performance data is only as good as the accuracy of the baseline measurement, such as a dry block calibrator or liquid bath calibrator.

Good calibration practices using precise, traceable references are critical for achieving the highest level of measurement accuracy and complete understanding of process parameters. Kaye dry block calibrators, liquid bath calibrator, and IRTD temperature standards offer unparalleled accuracy over a wide temperature range and reliability to meet your validation and calibration needs.

Kaye Validation systems also offer software which directly communicates to the liquid bath calibrators and dry block calibrators, as well as the and IRTD, offering completely automated calibration process. This eliminates human interaction and provides accurate and repeatable calibration of your validation sensors. Simple and Easy-to-use menus allow the user to specify calibration setpoints, stability and deviation criteria. Concise and detailed reports are then available to document the calibration process.

The advanced systems, liked the LTR-150 and HTR-420 dry block calibrators, can perform automatic sensor calibration or be used stand-alone via their easy-to-use touchscreen display. Kaye's line of dry block calibrators have a wide range of temperatures, from the ultra-cool LTR-90 to the high temperature HTR-420 model. This allows metrology laboratories and validation professionals to choose from an entire fleet of dry block calibrators when looking for the right solutions for their facilities.

The Kaye LTR-150 isn't just a dry block calibrator, but rather is an all-in-one, multi-purpose calibrator that can also work as a liquid calibrator and surface temperature calibrator. The multi-purpose temperature calibrator is also ideal for calibrating RTD's as well as a range of other process sensors. This make it ideal for the calibration lab as well as for your validation needs.

The HTR-420 is the most advanced high temperature calibrator designed specifically for thermal validation. Our drywells calibrate up to 48 thermocouples at one time, saving hours of time during a validation.

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Kaye LabWatch IoT - Cloud Environmental Monitoring is a complete cloud-based solution for critical stability, environmental, and facility monitoring system that detect alarms and alerts personnel.

The LabWatch IoT Cloud-based environmental and facility monitoring system is a complete solution for critical stability, environmental, and facility monitoring applications. LabWatch IoT connects to your sites through secure VPN, detects alarm conditions and alerts personnel wherever they are, documents any number of chambers without generating stacks of paper, protects data with secure Cloud storage, and lets you access data easily for analysis.

With the LabWatch IoT system, current alarm status and sensor values can easily be retrieved by using any internet browser or smart phone. Simply log into the secure Cloud service, using your own companies' linked user name and password, together with Multi Factor Authentication pass codes, and the LabWatch IoT facility monitoring system will give all monitored area information - conveniently displayed either for browser, or mobile phone Application.

The LabWatch IoT Cloud environmental and facility monitoring system provides the flexibility to generate reports automatically and on demand. By maintaining a secure archive of monitored values from your chambers, the system can readily provide the information you need for internal and regulatory-required documentation.

LabWatch IoT is now available with the Kaye Netpac II and the Kaye RF ValProbe data-collection system for both real-time wired and wireless monitoring. Both style of these facility monitoring systems collect various environmental parameters, but primarily temperature and humidity information and securely transmit them to the Labwatch IoT Cloud system.

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The Kaye RF ValProbe II wireless data logger integrates RF mesh technology to get wireless, high-accuracy measurements of temperature humidity in a warehouse or facility.

Wireless High accuracy measurement of temperature and humidity

The Kaye RF ValProbe II wireless data logger integrates breakthrough RF Mesh technology with enhanced technology for Thermal Validation. The operating range of the loggers of -40¡C to +60¡C and temperature sensor range of -200¡C to +200¡C make them ideal for real-time RF validation and monitoring of environmental chambers, warehouses, freezers, refrigerators and steam-in-place (SIP) applications.

The RF ValProbe II wireless data logger system utilizes a 2.4 GHz RF Mesh network and multiple redundant data storage to provide ultra- reliable and robust communications and storage of critical validation data. Additional safeguards guarantee data integrity, storage and compliance with regulatory requirements. The RF ValProbe II wireless data logger system is comprised of RF wireless data loggers, a base station and software. The wireless data loggers provide high accuracy measurement of temperature, humidity, and any 4 to 20mA or 0 to 10V output.
RF ValProbe's wireless data logger software enables support for 2-Channel and 5-Channel RF Temperature loggers for validation.

The RF ValProbe II wireless data logger software provides ease of use by incorporating features such as self-configuring of the mesh network and automatic data collection. Extensive graphing, reporting and calculation capabilities minimize data analysis and provide regulatory-compliant reports.

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The Kaye LTR-150 is the most advanced multi-purpose temperature calibrator specifically designed to address the capacity and flexibility needs for thermal validation.

Kaye LTR-150 Temperature Calibrator - Dry Block and Liquid Bath

All-in-One Temperature Calibrator; flexible - easy to use from -30 to 150¡C
48 Thermocouple Capacity

The Kaye LTR-150 is the most advanced multi-purpose temperature calibrator specifically designed to address the capacity and flexibility needs for thermal validation. From its ability to calibrate 48 thermocouples capacity, to its versatility to function as a Dry Block, Liquid Bath or Surface temperature calibrator, the LTR-150 saves hours of time and effort when calibrating or verifying validation sensors.

The new Thermocouple Fixture slide into the well of the temperature calibrator and guarantee easy handling of up to 48 TCs ensuring that all are securely held at full immersion depth.

The LTR-150 temperature calibrator is backward compatible with the Kaye Validator AVS, Kaye Validator 2000, Kaye ValProbe or Kaye RF ValProbe software for automatic sensor calibration. The multi-purpose temperature calibrator is also ideal for calibrating RTDs as well as a range of other process sensors. This make it ideal for the calibration lab as well as for your validation needs.

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The Kaye Log - Cold Chain Monitoring NFC Data Logger enables full temperature traceability during the transport of temperature, or temperature/humidity sensitive products. With one movement, from anywhere of the world, it is possible to instantly read, send store data and receive alert by e-mail.

A recent study by the Center of Excellence for Independent Validators in Pharmaceutical Logistics found that nearly 25% of vaccines become degraded and lose efficacy by the time they reach their destination, mainly due to improper shipping procedures.

With the recent focus on vaccines as well as the continuously growing number biologics and healthcare products and more global manufacturing, regulatory bodies from around the world have released enhanced GSP (Good Storage Practices) and GDP (Good Distribution Practices) to ensure the safety and efficacy of temperature-sensitive medicinal products.

At Kaye we understand the extreme importance of keeping track of your supplies across the cold chain. Whether you're transporting lifesaving pharmaceutical medicines and vaccines, or keeping track of biotech assets that are heading to a blood bank. Each junction and every mile of transport is putting your assets at more risk of experiencing an excursion. That's why Kaye has created some of the most reliable and robust equipment to help monitor the cold chain.

Kaye's cold chain monitoring solutions leverage the use of Internet of Things (IoT) tech and intuitive sensors and probes to protect assets across the entire cold chain transit. From the when the pharmaceutical or biotech asset is created in the laboratory, to when its put into storage, to when its brought out and cycled into production, to when it is transported to a warehouse to be sorted, and finally sent out for distribution, Kaye's solutions can track it throughout the entire process. And our solutions include hardware and software that's capable of tracking both humidity and temperature-sensitive products.

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Kaye offers rental validation equipment solutions to help customers in meeting peak demands, during unexpected situations or calibrations, and to minimize downtime of important processes.

The small and flexible sensor of the real time data logger allows usage in most of the Pharma applications and it can also be used in combination with very small vials.

Single, dual, and 5-channel flexible wireless loggers for use in most pharma applications and in combination with small vials.

The Kaye ValProbe RT Real Time Data Loggers come in many different configurations with rigid, bendable, and flexible sensors. The flexible Real Time Data Loggers are available with Single, Dual or 5 sensor configurations. Each flexible Real Time Data Logger provides 1000,000 samples per sensor of data storage and backup. The flexible Real Time Data Logger comes with a 40 inch flexible Teflon coated extension wire and a stainless tip for protection of the RTD sensor. The temperature range of the Logger is -85¡C to +140¡C.

The 5 Sensor Real Time Data Logger is ideal for validation of shelves where 1 logger can provide sensors for the corners and center of the shelf without the cost and space for needing 5 separate loggers. The flexibility and length of the sensor make it ideal for sterilizer drains, SIP applications, penetration studies in vials etc.

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