What is the Proper Temperature for Pharma?
The requirements for storing and shipping pharmaceutical items vary greatly depending on whether it’s a vaccine, medication, etc. That range is anywhere from -58°F to +46°F. Any variance in either direction of what’s deemed the compliant range can render a medication, sample, or vaccination useless. Therefore, it’s crucial that temperatures be properly monitored and maintained throughout the shipment.
When it comes to drugs, manufacturers also outline specific shipping and storage instructions for their products, including what temperatures and shipping conditions are ideal for maintaining the integrity of their drugs. The FDA supports manufacturer requirements with regulations defining the appropriate storage conditions as outlined within its Code of Federal Regulations Title 21 (CFR 2111).
High and Low Temps Must Be Monitored:
When shipping pharmaceuticals, vaccines, or medical samples, it’s imperative that both high and low temperatures are monitored. Keeping products cold enough to sustain their journey is not enough. By simply packing medicines to ensure they are cold upon arrival, distributors run the risk of shipments getting too cold, or even freezing. This can be damaging to many pharmaceutical products. Therefore, it is crucial to maintain the correct temperature range throughout transportation and delivery. Controlled temperature shipping is a challenge, and without proper care and monitoring, it can be an extremely daunting task.Benefits of Real-Time Temperature Monitoring for Pharmaceuticals:
The unique challenges associated with shipping pharmaceuticals make it essential to use a real-time temperature monitor. This is the best way for manufacturers and distributors to maintain the integrity of pharmaceutical shipments. Monitoring allows distributors to ensure proper temperatures are maintained from packaging through delivery. The most effective solutions not only monitor, but also record temperatures to ensure that compliance is maintained throughout the entire cycle of shipping and distribution. It’s also important that the monitor sends alerts in real time when temperature variance occurs. This provides shippers with the best chance of addressing and correcting the problem before products are compromised or destroyed. More importantly, it helps prevent damaged or compromised drugs from reaching consumers, saving companies from potentially devastating liability issues. tempCube record and send SMS/text message alerts should a temperature variance occur. It is well-suited for samples and vaccines, which are often carried/transported in small cooler boxes with gel packs to keep the samples cool. tempCube is small, compact, and battery powered to last for up to several days. Its portability, long battery life, and easy peel-and-stick option allow the monitor to be secured inside the tote or the cooler box. If you’d like to know more about adding a real-time temperature monitoring solution to your pharmaceutical cold chain, contact us today.