23rd June 2009

Turnkey Solutions to warehouse or storage monitoring compliant with GAMP/FDA 21 CFR Pt.11 with real time display of results and alarms

Our partner, Mesa Laboratories, manufacturers of the Datatrace range of wireless dataloggers, have written (in conjunction with the US Food and Drug Administration) a paper on the use of wireless dataloggers for temperature uniformity studies in an ISO 17025 accreditation program.

^{Abstract: Validation of controlled temperature equipment (incubators, autoclaves, water baths, ovens, refrigerators, and freezers) is an important part of an ISO 17025 accreditation program, involving temperature and/or humidity testing for uniformity and stability. For temperature, many validation studies are performed using wired, thermocouple-based systems. Setting up a wired system is time consuming and tedious, and thermocouples are prone to failure, causing difficulty in interpreting results. An alternative to wired systems are wireless dataloggers which are small, self-contained, measurement and recording devices that eliminate the disadvantages of the wired systems.}

"Wireless dataloggers maintain their stability for a longer period of time than wired systems"

Wireless dataloggers are very useful for validation studies of temperature controlled chambers as a part of a laboratory's ISO/IEC 17025 accreditation program. The wireless dataloggers used in the study demonstrated a marked and definite improvement in accuracy and use over the other options that are available to perform temperature uniformity and stability studies. In addition, wireless dataloggers maintain their stability for a longer period of time than wired systems and chambers don’t need to be modified for their use, as with wired systems. Wireless dataloggers have the additional advantage of being able to be placed inside the material under study in order to obtain accurate heat penetration data. They provide a "hands off" process which is neither labour intensive, requires training or additional staff time to implement. The proper operation of temperature-controlled chambers can be verified with the use of a wireless datalogger system.