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Make Your Mark

Thu, 04/11/2013 - 10:17am
Jonnatha Mayberry, Associate Editor

Many trends that happened in the 1980s stayed in the 1980s. Feathered hair, army boots, and legwarmers are just a few of the fads that emerged, and for the most part remained, in the “hair band” decade.

However, the 1982 Tylenol incident - in which seven people died after taking poisoned Tylenol - prompted a safety movement that is far from a temporary fad. The Tylenol murders challenged America’s perception of packaging safety within the pharmaceutical industry. If Tylenol could be adulterated so easily, other medicines could be compromised in the future. How would the pharmaceutical industry help protect consumers?

Tamper-evident packaging emerged as a solution to the safety conundrum, and its importance continues to grow.

Packaging is indispensible for manufacturers. Across many industries, packaging serves as not only a protective transport mechanism for products, but also as a marketing tool for companies, thanks to the wide variety of available design options.

In the pharmaceutical industry, while aesthetics are a consideration, one of packaging’s most important offerings is its tamper-evident and safety capabilities. While almost every form of packaging can become tamper evident, pharmaceutical manufacturers need to consider their product’s qualities (including its transportability and shelf life), and the consumers’ perception of the packaging option, before they select the right package for their product.

To get up to date on solid-dosage packaging trends that are emerging in 2013, Pharmaceutical Processing spoke with tamper-evident packaging insider Angela Roggenhofer, sales and marketing manager at Tekni-Plex Inc., a manufacturer of films and foils for pharmaceutical blister packaging.

Solid-Dosage Packaging Basics

One option is blister packaging, which consists of cavities made from thermoformed plastic (or another formable web), and backed with a lidding seal of aluminum foil or plastic.

Blister packaging offers both tamper evidence and child resistance. The FDA continues to request that the pharmaceutical manufacturing industry uses packaging that makes tampering as difficult to get away with as possible, and blister packs have emerged as a popular solution to compliance.

While some packaging solutions need to be modified to achieve tamper evidence (a bottle, for example, is not tamper evident until a tamper-evident seal is added), blister packaging is inherently tamper evident. When it comes to blister packs, “The individual compartment must be torn or broken to obtain the product. The backing materials cannot be separated from the blisters or replaced without leaving visible evidence of entry,” the FDA states in its Compliance Policy Guide for tamper evidencei.

Some manufacturers find that this quality makes the blister pack an ideal solution for their product. “The moment that you try to open a thermoform blister, you cannot make it unseen,” explains Roggenhofer. “That’s a big difference between bottles and blisters — any thermoform blister is inherently tamper evident. Any time you access at least one unit, you can never make it unseen.”

For that reason, Roggenhofer explains that calling a blister pack “tamper evident” is a redundant statement. “When you talk about blister packaging, nobody says ‘this is a tamper-evident blister,’ because it is self-explanatory. No matter what materials you choose … you cannot make it look as if it hasn’t been opened before.”

Bottles, on the other hand, are not inherently tamper evident, but a number of safety solutions help them become a tamper-evident solution.

“When it comes to bottles, there are tamper-evident shrink bands and other safety components,” says Roggenhofer. Shrinking liners that use heat seals on the bottle’s neck turn bottles into a tamper-evident solution. “Many of the heat-sealed liners can only be removed by using a tool, or they leave a residue at the bottleneck so you can see that it has been removed,” Roggenhofer explains. Just like blister packs, “it cannot be put back on to make it look like it hasn’t been opened before.”

Pick Your Package

Since every packaging option offers its own set of unique qualities, how do pharmaceutical manufacturers choose the right solution? It all comes down to what’s in the package.

“Common sense would say that the more toxic a product is, the more effort it takes to make it safe,” says Roggenhofer. Toxicity is not the only important consideration - cost is also critical, since the more expensive a product is, the more worthwhile it is for a thief to attempt to steal the product, or replace the product with a potentially dangerous substitute.

“Certainly products that are either very expensive, or products like lifestyle drugs - like Viagra, for example - where there’s large volume and large brand recognition, those are all targets for tampering,” says Roggenhofer. “That’s where pharmaceutical manufacturers put the most effort into trying to avoid something happening to their packaging. These efforts go hand in hand with child resistance and anti-counterfeiting.”

Communication Is Key

Consumers have kept a watchful eye on their medicines’ packaging since the Tylenol incident and manufacturers make every effort to deliver the safety consumers expect.

This effort increasingly includes effective communication with consumers. Roggenhofer observes that recently, “manufacturers are actively striving to make consumers alert, so packaging is a topic that they increasingly address with consumers.”

Companies are now taking the time to say “‘here’s a new packaging solution and here’s how it will help protect you,’ or ‘it has a unique opening, security, or safety feature,’” says Roggenhofer, “This communication has tremendously increased over the last couple years - packaging is becoming a topic in and of itself.”

Safety in the Driver’s Seat

What tamper-evident packaging developments are around the corner?

Roggenhofer believes that tamper evidence may become as natural as breathing. As consumers grow accustomed to tamper-evident packaging, they may increasingly expect to see evidence of safety in every packaging solution.

“A growing trend is that as the consumer becomes used to a lot of tamper-evident packaging, we might come to a stage where if you have a package that doesn’t have a shrink band or a tamper-evident seal, the consumer says ‘hey, something is wrong with this package,’ and doesn’t take it from the shelf or returns it to the pharmacy,” Roggenhofer hypothesizes.

In other industries, consumers have grown to expect a certain amount of safety features from the products they buy, and the pharmaceutical packaging industry is no different. Roggenhofer explains that “it’s the same concept as seatbelts. These days, nobody would drive a car without them.”

References

i http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074391.htm

 

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