Fridge & Freezer Temperature Monitoring, Alarming & Reporting for GxP Compliance

Data logging a biological sample freezer

Low temperature environments in life science applications require secure, 24/7 monitoring to maintain specified temperatures and ensure the safety, purity and efficacy of pharmaceutical/biotech products. As worldwide regulatory organizations refine guidelines for storing, processing, and transporting temperature-controlled pharmaceuticals and biotechnology, there is an increasing need for better temperature data recording, more customizable reporting, and easy-to-use remote monitoring solutions.

“I like the wireless RFL100 data loggers because they are easy to place and easy to configure. [They] also have a digital display, so we can quickly check conditions and see whether the device is working properly...Data integrity is extremely important to us. In viewLinc, the audit trail ensures you can't edit any of the data, which is ideal for GMP. In terms of alarming, viewLinc is relentless. It will not stop the alarm until it’s been responded to."
Dan Gabrault, LSNE Plant Engineer

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Key to compliance with GxP regulations for temperature-controlled products is the ability to respond quickly to undesirable conditions in freezers, fridges and cold rooms. The Vaisala monitoring system is ideal for cold room, fridge and freezer monitoring applications,  sending alerts to designated personnel if temperatures go out of specification, or if sensor communication with the system is lost.

The system software  is browser-based and easy to use for remote monitoring, alarming and reporting. Reports are customizable, easily exported to a spreadsheet for analysis, and 21 CFR Part 11 compliant. Trend and historical reports can be scheduled or generated on demand for any monitored fridge, freezer or cold room, simplifying the audit/inspection process by customers and regulating agencies.

We invite you watch our on-demand webinars on measurement, monitoring and mapping.

 

5 Ways to Treat a Misbehaving Refrigerator

In this blog, Vaisala's Senior Regulatory expert offers some advice on troubleshooting problem spots in refrigerators. In short:

  • Go high-end
  • Tune it up
  • Block off hot/cold spots
  • Know the Worst-Case Scenarios
  • Change the Set-point
Worst Case Mapping Validation Fridge Interior

Temperature Mapping Worst-Case Scenarios in Refrigerators

In this blog, Vaisala's Senior Regulatory expert answers a question we received a pharmaceutical customer on re-qualifying a recently repaired refrigerator.
 

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