Packaging and shipping pharmaceuticals has become like navigating an obstacle course.

There are national and international regulations to follow, the recipient’s requirements, the common-sense factor (are they going to a cold or hot place, are they made from chemical compounds or biological materials) and ensuring medications’ safety from adverse conditions and theft.

“The biggest challenge we hear from customers is the need to be compliant,” said Richard Wood, design manager for Peli BioThermal, a UK-based company that specializes in designing, testing and certifying Temperature Control Packaging (TCP) for healthcare products.

Not long ago, the European Union passed new regulations that in part specify temperature ranges for shipping and storing drugs.

“It’s a matter of understanding what type of packaging they need to maintain that temperature,” Wood continued. “If they are shipping just within Europe, some might be okay, but if it is to a different region, how do they maintain the temperature if there are delays?”

Advances in TCP design

The development of biological pharmaceuticals, which can be protein-based and are very temperature sensitive and valuable, has led to advances in temperature-controlled packaging (TCP) design, Wood added. For example Peli BioThermal has developed a single-use TCP that can be configured to keep products frozen (<-20°C), refrigerated (+2°C to +8°C) or at room temperature (+15°C to +25°C) depending on the storage requirements of the temperature sensitive products being shipped.

This new generation of packaging utilizes high performance Vacuum Insulation Panels (VIPs) coupled with advanced Phase Change Materials (PCMs). Wood said, to ensure the temperature of the pharmaceutical products are maintained within tight thermal limits during transport.

“Another advantage of this new generation of packaging design is that the use of the advanced materials allows us to create compact, lightweight, high performance shipping systems,” added Woods.

Track and trace system

Beside keeping up to date on EU and other regulations, companies are dealing with marketing requests from clients, developing more efficient and less costly ways to ship products, as the size of the text on the package inserts has been increasing; and thwarting counterfeiters, according to Bo Hilligsøe, vice president, finished goods production for Lundbeck.

Prescription drugs have been stolen and thieves have copied the pills’ shape, color and packaging to create counterfeit versions, which they can sell independently, or use to replace authentic drugs.

To prevent that, “packaging is being designed so a doctor, patient or pharmacist can tell if a package has been opened,” Hilligsøe explained. Companies also are adopting a “track and trace” system to follow drugs all the way through the supply chain. A unique identifying number is put on each sales pack and the number has to be recorded through each step of the process. Currently, though, there is no international standard for the serial numbers; some places use bar codes, others don’t—and no standardized process for submitting data to interested parties.

Limit shipping costs

Another challenge is making packaging as small as possible to limit shipping costs, while at the same time meeting authorities’ requirements to increase the text size in package inserts, which can add pages.

Clients’ preferences also are influencing packaging decisions. “When we’re developing a tablet, some customers want a specific shape or color and triangular pills are harder to package,” noted Hilligsøe. Different continents also have different ideas of what a package of medication should look like. In Europe, blister packs are preferred, while in the U.S., plastic bottles are standard. In other countries, “there are different perceptions of aesthetics; the package must have a certain appearance to it; it must look nice, it must look like an iPhone box, which costs five times more than the European packaging,” according to Hilligsøe. “We also need to take into account if it will fit on the pharmacy shelves. If the package is not seen as quality, then they view the product as not having quality.”

So while the challenges keep coming, so do new packaging materials and designs. “They [pharmaceutical companies] need to make sure they meet very strict guidelines,” Wood said. “We have been working with companies to make sure the pharmaceutical products reach patients in the best condition possible.”