Cherwell confirms autoclave validation using DataTrace
DataTrace wireless, high precision data logging systems
Following its recent securing of a UK distribution agreement for DataTrace patented, high-tech data logging systems, Cherwell Laboratories has verified a rapid autoclave validation application.
The self-contained, wireless, high precision, data loggers are designed specifically for use in critical manufacturing, quality control and validation applications. Since no wiring is required, DataTrace probes can be readily used to measure temperature, humidity and pressure directly inside an autoclave for validation with full 21CFR11 compliance and minimal production downtime.
Traditional autoclave validation involves the complicated task of introducing many thermocouple wires into an autoclave chamber. This can be extremely time-consuming, not only in fitting the probes through a port, but also in placing them securely within the load. Such thermocouples also require qualification before and after use to identify any offset.
As a wireless device, DataTrace offers many benefits, says Cherwell Laboratories. Its probes are quick and easy to place within the autoclave load, either within the product or just located within the chamber. As DataTrace uses thermistor and RTD technology temperature probes, rather than thermocouples, pre and post verification is not necessary. Both these factors mean that full load mapping and autoclave validation can be completed far quicker than via traditional thermocouples, so minimising downtime.
“Since DataTrace probes are extremely compact and tough, we have confirmed that they are ideal to place anywhere we choose in an autoclave load so that we know exactly what conditions a product is experiencing,” said Andy Whittard, managing director, Cherwell Laboratories. “Furthermore, as DataTrace software is fully 21CFR11 compliant, it meets all FDA requirements for electronic signatures and audit trails.”
The DataTrace product range includes high quality, compact loggers for temperature and pres-sure. For example, the MicroPack III loggers can with-stand temperatures of 140ºC and even higher if placed inside a Thermal Pack. The MPRF real time wireless loggers have the added benefit of displaying real time data during a cycle, even within an autoclave chamber.
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