Since no wiring is required, DataTrace probes can be readily used to measure temperature and pressure directly inside an autoclave for full validation with FDA 21CFR11 compliance and minimal equipment downtime. Traditional autoclave validation involves the complex and protracted task of introducing many thermocouple wires into an autoclave chamber.
Taking an autoclave apart to fit wired probes through a port and then placing them securely within a load can prove extremely time-consuming. Furthermore, such thermocouples are not robust and require pre and post verification to identify any offset. “I knew there had to be an easier way of testing and validating autoclaves, which can take up to four hours when using wired thermocouples;
“By using DataTrace, the whole process can take as little as 45 minutes - an autoclave cycle - since there is no need to calibrate the system and the wireless probes are compact and tough and can be simply placed directly inside the autoclave chamber,” added Scott Renshaw-Harris. “Our own customer convenience is very important to us and Cherwell’s solution means we can minimise their disruption. Not only can we cut our time on-site by hours, but now that we don’t have to take a unit apart and rebuild it, we can completely eliminate potential risk of subsequent leak issues.”
JPen Medical engineers have also found the Cherwell system to be very portable and easy to use with minimal training required. “Set up is very straight forward and takes just 5 minutes on the laptop, with readily accessible help files if ever needed. Additionally, before purchasing DataTrace, we knew Cherwell were a well-respected company and they have certainly proved to be very proactively helpful and knowledgeable about our business and needs,” confirmed Scott Renshaw-Harris.
Following its highly successful application of DataTrace wireless dataloggers for autoclave validation in medical environments, JPen Medical is also considering their use for further applications, such as fridge and freezer validation. Future plans also include additional enhancements to customer convenience. Due to the simplicity of Cherwell’s system, the company aims to provide on-site validation report print outs, so giving customers real-time results.
For more information about Cherwell Laboratories and DataTrace wireless data loggers, please visit www.cherwell-
Link to the press release online: http://www.cherwell-