Pharmaceuticals Require Strict Temperature Controls

Pharmaceutical products are considered one of the fastest growing and most valuable cargo commodity categories handled by air carriers. It is estimated that biotech and pharmaceutical products represent the highest value per air lifted pound of any cargo shipped by the airlines. And taking into account that many temperature-sensitive pharmaceutical products will at some point during the distribution process travel by air, the significance of maximizing shipper confidence in every aspect of the quality and reliability of the shipping process is of utmost importance.

Pharmaceutical industry confidence in air cargo can be further gained by using state-of-the-art equipment packaging and containers, tracking systems and highly-trained personnel. Processes that provide detailed documentation or proof that these sensitive products have been well- maintained throughout the shipping process allow pharmaceutical companies the control they need to manage their products effectively.

Protecting these valuable assets with proven, precise handling and strict temperature-control can literally save companies millions of dollars in lost inventory. This is also ultimately essential for protecting patients and end- users of the pharmaceutical products.

Therefore, it is imperative for pharmaceutical companies, freight forwarders and air carriers alike to understand and overcome the challenges of cost- effectively delivering high-value, temperature-sensitive pharmaceuticals across widely varying climates to their customers worldwide.

Requirements-Driven Approach

The International Air Transport Association (IATA), which promotes safe, reliable, secure and economical air service practices, has developed additional regulatory requirements for the handling of temperature-sensitive pharmaceutical products. Effective July 1, 2007, the IATA published a separate chapter to its 7th Edition of the Perishable Cargo Regulations, specifically addressing air transport logistics for temperature-sensitive healthcare products, changing its previous passive guidelines to a more strict requirements-driven approach

The IATA regulations for the air transport of temperature-sensitive pharmaceuticals were carefully developed using the following information:

• Scientific data from research institutions, and field experience from major airlines and freight forwarders
• International and local regulations for goods shipped and stored under optimal conditions in on- and off-airport locations from key    pharmaceutical companies
• Comprehensive classification of perishable commodities, including temperature/humidity requirements, packaging references and    incompatibility/segregation information
• Airlines contact information, dedicated websites, and specific rules regarding perishable cargo
• Pharmaceutical product information based on World Health Organization (WHO) guidelines

Additionally, pharmaceutical and biotech materials are closely governed by specific federal requirements that must to be observed, including growing requirements for more advanced equipment, permits, and training in order to move medical material and pharmaceuticals.

With the growth of pharmaceutical manufacturing internationally, it is increasingly common for a drug to start as an active pharmaceutical ingredient (API) and go to a finished product in multiple steps across multiple countries. As a result, the requirements have increased for packaging, storing, transporting and distributing pharmaceutical ingredients and finished products. The shipping process must be as reliable and sophisticated as the manufacturing process for these products.