April 15, 2005 Volume 1, Number 1
 
 

Inhalation Products Expert Groups: Helping to Fill the Gaps
Outsourcing Outlook-Orient Express
Packaging Forum-Cold Chain Concerns
Washington Report-Generic Drug Battles Heat Up
Contracts, Mergers, and Announcements
People
Calendar
Contact
 
   


Cold Chain Concerns
Packaging Forum
Cold Chain Concerns
 
Hallie Forcinio and Christopher Wright
 
Managing the cold chain not only keeps products at the proper temperatures, but it also can increase supply chain efficiency and reduce costs. A close-up look at the cold-chain operations of Mayne Pharma (Melbourne, Australia, www.maynegroup.com) illustrates these benefits. Raymond Jenkins, global demand and logistics manager at Mayne Pharma’s regional head office in New Jersey, cut shipping time from the company’s manufacturing site in Australia to Dallas, Texas, from 10 days to less than 72 hours, saving his company $300,000 per year. Drawing on 20 years of materials management experience, Jenkins did his homework and discovered that goods were sitting idle in customs waiting for import clearance. So he created a shipment template harmonized to the tariff schedule. It clearly lays out each product’s chemical abstract and FDA identification numbers, the name of each drug, and how it is used. As a result, customs inspectors immediately see the information they need to speed up the clearance process, (e.g., that the contents contain no animal products and are the finished goods for human use not intended for further processing). In the first six months after instituting this procedure, only one Mayne Pharma shipment out of more than 70 was held up for examination at the point of entry.

For cold deliveries, Jenkins had relied on foam sheeting inside corrugated cases. This packaging provided an R-value of less than 10 and only protected the product for ~10–12 hours. He currently uses custom-designed expanded polystyrene (EPS) inserts. The top and bottom inserts measure 2-in. thick and the side inserts are 1-in. thick. By helping prevent gravity from pulling the coldness right through the bottom of the box, the extra thickness  produces an R-value of 18–22 and keeps products at the proper temperature for 36–48 hours.
Jenkins outsourced validation testing to an independent third party. First, he got his quality assurance and compliance departments to agree to a protocol incorporating relevant standards (e.g., IATA DGR Section 2.7.9) that cover such specifics as positioning of the temperature monitors inside the packaging. Then, summer and winter trials were conducted at a target product temperature of 2–8 °C. Although keeping products from freezing in winter can be difficult, Jenkins says that summer is the biggest challenge. “The temperature inside trucks can exceed 120 °F in a very short time,” he says.

Relative humidity also was monitored during the trials because it makes cold packs sweat and lose cooling capacity more quickly. Jenkins used no-sweat gel packs, which come with cloth wrappings that absorb moisture and prevent product damage. Through a combination of package testing and drug-stability studies, Jenkins found he could economize by using EPS packaging and second-day air to protect his products in winter conditions.

Jenkins now is considering whether to switch to condensed foam and foil packaging (True Pack, New Castle, DE, www.truepack.com). The multiple layers deliver a superior R-value of 40 and keep the contents cold for five days. This packaging would allow product to be shipped by ground transportation if the quality assurance department approves, he says.

In another project, Jenkins is testing packaging that uses battery power to effectively turn containers into little refrigerators. These packages can be plugged into an airplane’s electrical system to maintain refrigeration and monitoring during a flight (Kelvin Technologies, Dallas, TX, www.kelvintechnologies.com). (continued)

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