Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Manufacturers bear ultimate cold chain responsibility

Compared to time and temperature, humidity is often overlooked as a factor in cold chain shipments.

• Before agreeing to long-term contracts, a military supply center now requires manufacturers to include validated packaging and temperature monitoring process details in their shipments.

• Extended stability studies are desirable for manufacturers shipping pharmaceutical and biologic products through cold chain distribution.

These were among the nuggets gleaned from the 7th Cold Chain Distribution for Pharmaceuticals conference Sept. 21-23 in Philadelphia (see p. 20). What I heard frequently was that no matter how many companies handle your product through the pharmaceutical distribution chain, if the product is not effective—perhaps due to time and/or temperature excursions—the ultimate responsibility that a safe, effective medication reaches a patient rests with the manufacturer.

Arminda Montero, distribution QA program manager, global pharmaceutical operations at Abbott, acknowledged that responsibility from a manufacturer's perspective. She noted, "It's important to follow current Good Manufacturing Practices and Good Distribution Practices.” Montero was one of several speakers who stated, “colder isn't always better,” when it comes to how companies throughout the chain store and distribute cold chain pharmaceuticals.

Representatives from refrigerated and/or frozen cargo carrier companies made it clear they want to do a good job delivering medications for manufacturers. Even though the pharmaceutical business may be small compared to other industries, these carriers know there's money to be made in this sector, as evidenced by the growing involvement by carriers such as American Airlines Cargo, FedEx Custom Critical, UPS Healthcare Logistics, and Delta Cargo.

Another interesting tidbit came from one event attendee who recommended I keep on the alert for medical device products requiring cold chain distribution.
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences