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nanodac with 21 CFR Part 11 for Electronic Data Recording for HACCP

Eurotherm have served the Food and Beverage industry well for many years

Paper records, such as the Eurotherm 392 circular chart recorder have served the Food and Beverage industry well for many years, but the mechanical nature of the printing mechanism can compromise reliability and accuracy. It is also easy to lose or damage paper, and HACCP requires that original records are maintained on-site for several years – copies are not permitted.

Electronic record-keeping solves these problems: data is automatically forwarded to supervisory systems for reporting and recording, and solid-state electronics are intrinsically more reliable in a production environment.

HACCP regulations mandate that electronic records are not subject to falsification, and have electronic signatures, but many low cost data loggers do not provide this security level.

The “gold standard” for data recorders in the food and beverage industry is US FDA 21 CFR 11, but chart recorders meeting this standard can be expensive, so plant managers often continue with old paper recorders.

Happily, new options are becoming available. The Eurotherm nanodac™ recorder/controller offers four channels of precision analogue batch recording, easily meeting the requirements of regulators for accuracy and repeatability, and data logging requirements of 21 CFR 11. For more demanding applications, the Versadac recorder provides a back of panel solution with almost unlimited capacity. Both allow alarm and discrete input logging, communications with other devices, results available in the data record, electronic signatures and batch data recording.

A hybrid such as nanodac also has high quality PID control, including advanced cascade with unique auto tune. Such units can control a retort or autoclave and associated equipment, such as variable speed drives, and record the results. The standard 96x96mm panel size will retrofit in place of an older PID controller. A high quality TFT display assures a perfect operator interface for interaction and alarm visualisation.

For an independent perspective, read Campden BRI’s recent publication on “Electronic Process Records in Thermal Processing”. Or contact Eurotherm for more information on how a switch to electronic records can ease your compliance headaches.

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