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Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Static applications such as dry heat ovens provide a reliable method for sterilizing surgical instruments, glass vials, and other medical devices through the even distribution of hot air. This uniform temperature distribution is essential for an optimal sterilization outcome.

Key standards and guidelines include Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). Additional specific standards, such as ISO 13485 for medical devices and the WHO guidelines for vaccine storage, provide detailed quality control requirements.

We are pleased to support you with tailored solutions for your specific requirements in the pharmaceutical and biotechnology sectors. Kaye has multiple solutions for validating steam-in-place sterilizers, from the Validator AVS to the ValProbe RT wireless system.

Find quick-start guides for Airmar’s advanced marine and industrial products. Access step-by-step instructions, setup tips, and troubleshooting advice to get started with your Airmar technology quickly and efficiently.

Trust Kaye's autoclave validation solutions to ensure effective steam sterilization in pharmaceutical and medical industries. Get reliable validation data today.

In-depth scientific and technical papers to help you better understand the technical fundamentals and innovations in the industry. Practice-oriented documentation that shows you how to use our products effectively in various applications.

We are happy to support you with tailored solutions for your specific requirements in the pharmaceutical and biotechnology industries. Kaye has multiple solutions for water-cascade sterilizers, from the Validator AVS to the ValProbe RT wireless system.

Cold rooms play a central role in the pharmaceutical and biotechnology industries when it comes to storing temperature-sensitive semi-finished and finished products. These specialized storage units are designed to ensure the integrity and safety of sensitive products such as vaccines, medications, and scientific samples.

Discover the Kaye Validator AVS, a temperature validation system designed for accurate autoclave temperature mapping, ensuring regulatory compliance and process safety. Achieve reliable results with our leading solutions.

The 3-in-1 data logger from the Kaye ValProbe RT product line offers the capability to measure critical parameters such as CO (carbon dioxide), relative humidity (RH), and temperature with a single device.

Observing this practice paves the way for dependable and precise readings that reflect the true pressure values in a given setting. They Kaye pressure transducers used in validation studies for a steam sterilizer will be calibrated at 121°C to achieve the best accuracy during use.

The CTR-40 is a portable temperature bath designed to meet the calibration and validation needs of the Kaye ValProbe RT system. Combined with the IRTD and ValProbe RT software, the CTR-40 provides ValProbe RT calibration /verifications for the ValProbe RT temperature sensor.

The ValProbe family of temperature loggers is designed for accurate, convenient and reliable process measurement for pharmaceutical and medical device applications. The wireless design greatly simplifies monitoring and validation of serve and hard-to-reach environments.

We provide tailored solutions for pharmaceutical and biotechnology needs. The Validator AVS is the solution for validating liquid-nitrogen freezers that are normally used in extremely low temperatures.

Get accurate temperature measurements with Kaye's IRTD 400 - high-accuracy temperature reference standard, ideal for calibrating temperature sensors across a broad range, ensuring reliable measurement performance.

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We offer Gold and Silver Equipment Maintenance Agreement programs designed to meet your critical calibration and maintenance needs.