OVERVIEW
GE Kaye, as part of the GE Infrastructure Sensing business is a recognized leader in high accuracy thermal process measurement. Primarily focused on the biopharmaceutical applications, GE Kaye technology is relied upon by the worlds leading drug manufacturers to verify critical sterilization processes as required by governing regulatory bodies. With over 35,000 systems installed around the world, GE Kaye has become the standard for validating thermal processes and documenting the results.
Founded in 1959 by Dr. Joseph Kaye of MIT, initial projects focused on advancements in thermocouple measurement accuracy. Early advances led to the introduction of the Universal Temperature Reference (UTR) and Ice Point Reference systems, which remain important technologies to this day. Building upon these early developments, Kaye redirected its energy towards system development and introduced the first integrated digital data logger in 1970. With this, the company's focus shifted from supporting research to serving industrial market needs for high accuracy process measurement.
In the early 1970's a series of health care related fatalities attributed to improper sterilization led the FDA to develop a set of guidelines and regulations called Good Manufacturing Practices (GMPs). Of particular importance were the GMPs relating to the manufacture and sterilization of parenteral drugs. As these regulations called for documented proof of sterilization process performance, the practice of sterilization process validation was born.
Recognizing an open market opportunity, Kaye developed the Digistrip Recorder, a standalone device that incorporated on-line calculations of bacteria kill factors. The system provided a convenient means for mapping temperatures within a sterilization chamber. With an understanding of internal temperature distribution, mathematical modeling tools are applied to ensure sufficient energy to effectively kill harmful microorganisms. The Digistrip measured temperature with 0.01° C resolution and accuracy, unheard of levels of precision for the time, and quickly gained acceptance within several large pharmaceutical manufacturers for validating sterilization practices. Word of the new technology spread through the marketplace and Kaye was on its way to becoming the industry standard for sterilization process measurement and validation
Building upon a heritage of high accuracy measurement, today's systems combine intuitive operation with extensive reporting capabilities and high levels of system security. All tailored to meet the demands of governmental regulatory agencies.
Core offerings include:
- Integrated systems for pharmaceutical process measurement and analysis
- Kaye Validator ® (wired thermocouple technology)
- Kaye Valprobe™ (wireless technology
- LabWatch™ monitoring / alarming / reporting system for drug stability testing
- Metrology grade temperature calibration equipment
- TruTemp™ jet engine and turbine test cell monitoring system
A dedication to technology leadership coupled with an unwavering commitment to customer service and satisfaction has helped the business prosper. Looking ahead, we see tremendous opportunities for growth serving the needs of the health care market with regulatory harmonization driving improvements in global manufacturing practices and quality programs. Ultimately, we'll continue to leverage our position to identify new challenges and deliver best-in-class solutions based on precision measurement, analysis and documentation.
With operations around the world, GE Infrastructure Sensing is an industry leader in the design and manufacture of multiple sensing elements, devices, instruments and systems that enable our customers to monitor, protect, control and ensure the safety of their critical applications. GE's comprehensive sensing offerings include precision sensors for temperature, pressure, humidity, gas, infrared and ultrasonic applications; as well as high-quality handheld and portable field calibrators, stand alone measurement instrumentation and systems that provide the end-to-end solutions necessary to verify, validate or certify vital processes.
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