With the US Center for Disease Control’s (CDC) Vaccine for Children (VFC) temperature monitoring requirements making their way into many pharmaceutical regulatory body requirements, many pharmacies and medical practices are contemplating purchasing automatic temperature monitoring devices such as data loggers and devices that provides real time data logging and alert messages or alarms when temperatures exceed specified ranges. And these devices can automatically generate digital temperature logs, graphs and reports compliant with regulatory requirements, replacing manual logs in some cases.
So what happens if you don’t follow best practices? Sometimes not much, other times confusing data, and still other times potential problems. Take the case of a before and after installation. Initially a glycol vial buffered digital sensor was placed on the top shelf of a refrigerator near the cold air outlet (below). Temperature readings from Sensor Cloud show an average between 35°F and 36°F with lows approaching 30°F and highs near 42°F. The CDC’s VFC guidelines call for a range of 35°F to 46°F (2°C to 8°C). This installation is below the CDC minimum approximately 40% of the time. If the temperatures were any colder freezing of the vaccine is very likely.
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