Pharmaceutical companies typically spend 15 years and $1 billion developing a successful drug or vaccine. In fact, for every 1,000 compounds initially developed, only 1 makes it to market. Given these costs and risks, drug company leaders need to direct more attention than ever toward the appropriate storage and transit of pharmaceutical products to maintain their integrity.
Cold Chain Distribution: Not as Simple as it Seems
Preserving the high quality of your products depends significantly on how you maintain their transportation and storage temperatures along the “cold chain.” In its simplest form, the product ships directly from manufacturer to end user or customer. In reality, however, the chain is rarely this short (see figure below). Distribution usually requires many storage locations (e.g. airports, docks) and transit methods (e.g., aircraft, ships, trucks).
Optimal Temperatures: What’s the Required Range?
Proper storage temperatures aren’t just recommendations. They’re requirements to ensure optimum quality of your products throughout their shelf life. Increasingly, drugs and vaccines should be stored and transported within a specific temperature range: between 2 ̊ and 8 ̊, or between 20 ̊ and 25 ̊.
In particular, vaccines, insulin, and biotechnology-derived products must be protected from freezing. Even a brief period at sub-zero temperatures may cause an irreversible loss of efficacy. These products should be maintained within a narrow temperature range above freezing but below maximum temperature.
Proper Measurement in the Absence of Regulation
Drug manufacturers, transporters, and wholesalers measure temperatures differently. Methods run the gamut from simple mercury-based thermometers to sophisticated continuous temperature monitoring systems. But that’s not surprising given the meager guidance and regulations governing manufacture, transport and storage.
Your products are valuable. Too valuable not to assess their temperatures for accuracy and responsiveness with the proper technology. It is important to remember that USP does not mandate any specific device for assessing temperature of pharmaceuticals. It does, however, recommend that accuracy be validated with a device from the National Institute of Standards and Technology (NIST).
Download our white paper, The Importance of Temperature Monitoring for Medication Safety and Efficacy.