FDA-compliant wireless temperature monitoring

130 SensiNet wireless temperature monitoring points are used to collect temperature data from a pharmaceutical manufacturing plant production line, with data integrated into existing software systems

All monitoring systems at a leading-edge, specialty pharmaceutical company comply with FDA regulations for monitoring and documenting their production process.

A new requirement arose, where the manufacturer wanted to deploy an FDA-compliant temperature monitoring system on an existing production line: the system had to be capable of meeting temperature measurement accuracy requirements as well as data logging reliability requirements.

In addition, the customer already had existing production management software and wanted the new temperature system to integrate directly with what they had, in order to avoid the expense of deploying new software.

Because this was an existing facility, the customer also wanted to avoid the expense and downtime of installing a wired network which would entail new data network wiring.

The company chose the SensiNet solution to provide centralised data collection and to integrate with its existing software infrastructure on their production line.

130 SensiNet monitoring points were installed in 3 manufacturing buildings.

SensiNet met all the customer requirements in terms of cost, reliability, and specific temperature monitoring capabilities, while providing data collection which was validated to comply with FDA regulations.

SensiNet was installed over a period of several days without bringing down the production line.

The system was certified for FDA 21 CFR Part 11 monitoring requirements and is in use now at this production plant.

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