Above: Organ Shipment Container
A recent article in the latest edition of Pharmaceutical Commerce (Link to article) titled “The Convergence of Environmental Condition Monitoring and Supply Chain Visibility” describes a robust system designed to provide visibility to the location and environmental conditions of temperature sensitive products during shipment and transit. The system uses a combination of GPS technology with a 24/7/365 asset tracking service for pharmaceutical and biological materials companies worldwide.
Backed by a $60B technology conglomerate, this package certainly offers a high level of monitoring and security. Still, what about the small and midsized Bio/Pharma labs, hospitals, and medical centers? What are their options for a robust environmental monitoring system for the cold chain, particularly if budgets cannot support the additional expenses from continuously staffed services? In the end, cellular communication technology in combination with a cloud service may provide one answer. The cloud service will typically provide SMS text, email, and phone alert capabilities to complement the hardware.
The use of monitoring systems for sensitive products (within the cold chain) is an established practice. Regulations have either been previously established, or are under current review/consideration. These regulations are tailored to geographic locations (US or International), and differ by application type (e.g: vaccines vs. organs for donation) The Pharmaceutical Commerce article outlines several of these quite well. Aside from regulatory requirements, many makers of such materials have implemented or are considering risk management strategies and policies to insure product safety and efficacy. Still, the challenge lies in the cost of implementation, wherein these strategies and policies (between the time the product leaves their shipping dock and the time it arrives and is received) can be tricky to follow.