Kaye Validation For AutoClave
Autoclave means “auto lock”. Autoclave validation is required for all machines used for biological sterilization, in the biomedical and pharmaceutical industries within the FDA, WHO & EU controlled areas.
A quality assurance procedure used to ensure that the autoclave reaches adequate temperature for an adequate amount of holding time to sterilize biological agents and wastes.
Life would be different for the pharmaceutical industry if they did not have autoclaves (or steam in place). Sterilization would involve fire (or heat), chemicals, filtration or radiation. Microbiological media would have a shorter shelf life and there would be a greater risk of contamination. 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, and Air Removal have an impact on the sterilization results.
The Kaye equipment
The Kaye equipment has long been associated with thermal validation in the pharmaceutical manufacturing industry, so reliable is the Kaye Validator 2000 self-contained thermal validation device with high accuracy sensor measurement hardware and secure data recording capability. Kaye temperature references provide the stable temperature required for sensor calibration.
HTR-400 Recommended for calibration of sensors used in steam autoclaves, dry heat ovens and tunnel sterilizers.
Need to show that sterile equipment is being taken into sterile core
- do not want to contaminate production (which could lead to adulterated product)
– For micro testing (both bacteriological and Viable Environmental Monitoring).
– Need to show that decontamination cycles are effective.
Calibrating over a more limited range will also increase accuracy. Since regulations require calibration for the temperature range of a process, an autoclave, for example, can be calibrated from 90°C to 120°C
Feed-thru for Autoclave Applications
Easy way to seal the autoclave port when introducing thermocouples into the chamber. Standard 1.5" TRI-CLAMP process connection. Installing is simple without the need of any tools, fitted with safety release mechanism.
Pressure Transducer for Autoclaves
Comply with current standards to measure pressure in parallel to Temperature with qualifying autoclaves. The pressure sensors is optimized to work with autoclaves and the Validator.