Medical Device Link.

Originally Published PMPN September 2004

Blister Packaging

Ben Van Houten

N’Crypt from Alcan Packaging is a high-security printing technique for blister foils.

A quick glance at today’s pharmaceutical industry reveals a market in the midst of unprecedented change. Fast-dissolving drugs and other moisture-sensitive products are more popular than ever. Drug manufacturers want their products in the marketplace with shorter turnaround times. And bar coding of unit-dose packages is growing at a strong pace.

While these developments are certainly exciting, they present big challenges for manufacturers and designers of blister packaging. Whether it’s the costs associated with high-barrier materials, the difficulty of designing effective anticounterfeiting packages, or the attempts to meet the ongoing challenge of child-resistant/senior-friendly (CR-SF) designs, converters and engineers are dealing with some big obstacles these days. “There’s no doubt that blister packaging has become much more complex,” says Michiel van den Berg, director of global pharmaceutical packaging development for Tekni-Films (Somerville, NJ).

However, many manufacturers are finding new ways to control costs and meet these demands while creating innovative materials and package design.

Blister Demand Increasing

The overall demand for blister packaging across all industries is currently on the rise. A recently published industry report from Plastics Custom Research Services stated that blister packs were worth about $1 billion, or 14% of the 2001 North American output of thermoformed packaging. By 2006, blister packs are predicted to account for $1.25 billion, according to the report.

“Carded blister demand is really high right now,” says Scott Denley, marketing manager for Alcan Packaging (Shelbyville, KY). One of the reasons for that is FDA’s recent bar coding regulation. “The bar-coded unit-of-use requirements are driving a lot of the demand,” he adds.

Cardinal Health (Philadelphia) is one contract packager working on meeting that demand. “Unit-dose bar coding is here to stay,” says Renard Jackson, Cardinal’s executive vice president, sales and business development, packaging services. Cardinal has already redesigned two of its customers’ packages to accommodate bar codes, making the packages larger and redoing the tooling. The company has also installed bar code printers on several lines.

And it isn’t just pharmaceutical manufacturers who are turning to blisters. “Nutritional supplement companies are turning to blister packaging as a way to differentiate and portray a more upscale image,” says Joe Groppenbacher, vice president of sales and marketing, Legacy Packaging (Earth City, MO).

New Materials

One of the biggest pharmaceutical trends of the last few years has been the advent of moisture-sensitive drugs. Fast-dissolving tablets, for example, are becoming more popular. “There are a lot more soft gels and more sensitive drug products right now,” says Howard Thau, president of Sonic Packaging (Westwood, NJ). He adds that the softness of traditional fast-dissolving tablets lends itself by nature to blister packaging. 

“As a response to the influx of quick-dissolving drugs coming on the market, we’re looking at using more peelable materials,” says Angela Roggenhofer, healthcare marketing manager, Hueck Foils (Wall, NJ). “That marks a switch from push-peel.”

As the demand for such products grows, so does the requirement for higher-barrier blister films. Ticona (Summit, NJ) is one company looking to meet the demand. “There is a clear trend toward the use of higher barrier packaging to reduce water vapor transmission to retain drug efficacy and extend shelf life,” says Bernd Sparenberg, global segment manager for packaging and films, Ticona. 

The company has created cyclo-olefin copolymer (COC) blends that allow blister packaging made from Topas COC film to be steam sterilized. These blends enable the Topas film to be used as a barrier material for sterile products, such as single-dose liquid medications and other drugs.

Sparenberg also mentions that converters are creating blister films that mix and match COC with other polymers. “This includes halogen-free polypropylene/COC films, as well as PVC/COC films, which offer the same contact layer as is currently used with many drugs and an enhanced structure,” he says.

Other companies are continuing to develop high-barrier films as well. “Over the past year, we have consistently seen a continuous increase in the level of barrier that is required,” notes van den Berg of Tekni-Films. “You look at PVC, for example. A 0.9 ml thickness used to be the standard. Now it’s 2 ml. That reflects the shift to high-barrier materials.” Also, as a result, he says Tekni-Films is adding cold-formed foil to its product line. 

One of the newer child-resistant/ senior-friendly packages is the PharmaPak SHR from  Stora Enso Consumer Boards.

Alcoa Flexible Packaging (Richmond, VA) is another company investing in cold-formed foil. It recently introduced Alcoa Cold Form 3000 Laminate, a foil-based blister material designed for hygroscopic products. It reportedly provides improved formability and deeper depth of draw, and enhances equipment efficiencies. The product can be used with Alcoa’s Drug-Pak and Safety-Pak foil blister lidding for optimum barrier integrity. 

“The one thing with cold form is that it makes for larger packages and requires more materials,” says van den Berg. “It quickly becomes more expensive. The production line also tends to run slower.”

Larry Blake, director of marketing for MeadWestvaco (Mebane, NC), says his company is experiencing a similar dilemma. “The big trend is to moisture-sensitive drugs now, and as a result we’re using more cold-formed foil as a blister material. However, that can result in the carded blister package being much larger. Cost is definitely an issue,” he says. 

As a result, some are exploring other high-barrier film solutions. Klöckner Pentaplast of America Inc. (Gordonsville, VA) recently launched the ultrahigh barrier Pentapharm Aclar 400/02 film. Designed for products that are ultrasensitive to moisture, it offers a moisture barrier that’s more than 25% effective than other clear thermoformable films, according to Kent Sides, the company’s business manager, pharmaceutical films. He adds that it also offers excellent machinability on existing standard form-fill-seal packaging lines and tooling. Aclar is supplied by Honeywell (Morristown, NJ).

Sides also mentions the company’s Aclar G03 film, designed for smaller footprint packages that require less material and cost per package than cold-formed foil packages. The three-layer G03 includes ethylene vinyl alcohol copolymer for applications requiring medium to ultrahigh moisture and oxygen barrier properties.

Tekni-Films has a new series of high-barrier laminate films called MVO2. Designed to offer a high moisture-vapor barrier and high oxygen barrier in one structure, it allows manufacturers to get the benefits of a blister film along with high MVTR and high oxygen-barrier properties. The company also recently installed new equipment for the production of mono PVC. “Mono PVC is very cost-effective for blister packs,” says van den Berg.

Still, despite the costs of Aclar and cold-formed foil, these materials are in high demand. “Companies still need the highest barriers available,” says Roggenhofer of Hueck Foils. “There will always be that demand for these materials—no matter what the cost.”

Faster Turnaround Times Required

Along with the need for moisture-sensitive drug protection, pharmaceutical manufacturers are looking to get these products to market at an ever-faster pace. “Pharmaceutical companies are more interested than ever in accelerated product stability,” says Sides of Klöckner Pentaplast. “They want to get their drugs into the market as soon as possible. That means accelerating the testing process.”

This is contributing to the trend toward high-barrier blister packaging materials to help improve the chances of passing packaging stability tests. “When companies launch a new product, they’re not fully aware of the product’s stability,” adds van den Berg of Tekni-Films. “They then can downgrade, which is a growing trend. High-barrier thermoformed blisters can be easily downgraded.”

Thau of Sonic Packaging sees more customers asking for additional help in achieving quicker turnaround times. “We’re being asked to modify tooling and produce tooling in-house much more,” he says. “It’s all part of the faster turnaround these days.”

The Challenge of Security Packaging

While bar coding is the current packaging trend, future FDA packaging guidelines are predicted to be driven by the need for anticounterfeiting measures. The resulting regulations could lead to a bigger switch from bottles to blisters. “If that happens, you’ll see a huge push for blister packaging,” says Blake of MeadWestvaco. As that push becomes a reality, more and more developers will request a completely tamper-evident blister package.

The topic of anticounterfeiting— and radio frequency identification (RFID) in particular—is already on many blister packagers’ minds. “With the anticounterfeiting efforts, some companies are looking to differentiate blister packages to help aid against the copying of branded products,” adds Sandra Luciano, healthcare market development specialist for Honeywell.

“We’re already looking at ways to layer anticounterfeiting features like labels and color-shifting inks,” says Blake. “We need to find out our customers’ preferred methods before we really get involved in it, though.” Blake says RFID will be very important for secondary packagers such as MeadWestvaco. “It’s a leading issue, with a lot of questions around it right now.”

“There are so many developments going on with anticounterfeiting and security packaging,” adds Roggenhofer of Hueck Foils. “For example, using special labels on blister foils. Other technologies are picking up steam, too.”

Some companies are already well past the planning stage and into the product stage. Alcan, for example, recently launched N’Crypt, a line of market-ready overt and covert technologies for blister packaging. N’Crypt is applied as an addition to a normal blister foil design and doesn’t involve any changes within the packaging process, according to Alcan’s Denley. “That makes it an ideal antitampering technology to implement,” he says. The N’Crypt system incorporates a variety of high-security printing techniques for blister foils. A dedicated validation procedure is available for each N’Crypt security level. This is done with various methods depending on the security level and the location in the overall supply chain.

The CR-SF Dilemma 

In addition to these new developments informing packaging decisions, there is the ongoing challenge of designing CR-SF blister packages. “Meeting CR protocol in particular is a distinct challenge,” says Honeywell’s Luciano. “As blister demand keeps growing at this pace, the need to continue to understand CR regulations will grow as well.”

Ismo Saarinen, director of pharmaceutical solutions at Stora Enso Consumer Boards (Finland), is more blunt. “Current blister solutions such as peel off and push through are inconvenient because opening them requires good finger mobility and eye vision,” he says. His company just introduced the Stora Enso PharmaPak SHR, which offers a child-resistant, senior-friendly, and reclosable carton.

The package consists of an automatic cartoning machine and specially developed board material. “It is really ideal for unit-dose packages such as blister cards,” he says. “The carton is made from a board with high tear-resistance. It also has a unique opening system designed to deter children.”

He says the product’s packaging machine consists of a carton-manufacturing module that can be combined with a semi- or fully automatic blister infeed and carton-assembling module. In the carton-manufacturing module, flat, unglued carton blanks are converted into cartons via a specific forming and welding process. 

Sonic Packaging is another company involved with a new CR-SF design. They recently partnered with Keystone Folding Box Co. (Newark, NJ) to produce a new blister card that has achieved an F-1 rating. (In that rating, access to one unit signifies failure.).“It’s 100% child safe and 100% senior-friendly,” says Thau. “It’s also a very lightweight board, which is less costly to manufacture.”
Other Design Challenges

Sonic Packaging recently collaborated with Keystone Folding Box Co. on a new lightweight blister card.

In addition to the above challenges, some packagers are dealing with unique combination challenges. Howell Packaging (Elmira, NY), for example, recently came up with a carded blister patient starter compliance package for a major pharmaceutical client. “The challenge was to design a package that could house both a 10-mg and 20-mg blister of product along with a patient information brochure and insert,” says Joe Lally, director of sales at Howell Packaging. “The other challenge was to engineer a high-speed production line that would ensure initial segregation of the two product doses during assembly and final verification. The package and packaging operation ran for more than three years in two dedicated, adjacent contract-packaging suites. The result was that our client had a new package with minimal investment and a line that could be terminated at the end of the program with no internal operation disruption.”

Conclusion

Despite the innovations currently taking place in the industry, some point out that there will always be companies hesitant about blisters. “Bottles and jars are still being used in the United States in such huge volumes,” says Saarinen of Stora Enso. “I still see some major resistance to switching to blisters.”

“Cost will unfortunately always be an issue,” says Rick Sury, vice president of strategic partnerships for Alcan Packaging (Bethlehem, PA). “Even with all the new cost-effective developments going on, you might have a hard time convincing companies to change. It’s just a tough road.”

Still, there is little question that blister packaging will remain a key component of future industry growth. As long as new materials continue to hit the market and regulations cause companies to consider blisters, demand will only rise. 

Copyright ©2004 Pharmaceutical & Medical Packaging News