Blisters

Blister Machinery Solves Issues Market trends have been influencing the development of new blister machines, designed to solve arising issues.

In an effort to ensme that the lat­est blister packaging equipment incorporates the necessary tech­nology and functionality to fulfill customer needs, machinery man-

ufacturers are paying close attention to production trends.

"'lve are always listening to our cus­tomers' needs, and it drives our machinery development," says Ben Brower, vice president and sales director, Pharmaworks (Odessa, FL).

Keith Bailey, regional sales manager at Korber Medipak (Clearwater, FL), has spotted a continuing trend in the demand for smaller batches of blisters, shipping to a greater number of coun­tries from one factory. "NIore drug companies are merging, resulting in a consolidation of production facilities. At the same time, manufacturers are selling more globally. We're even see­ing smaller pharmaceutical companies going global with product launches," he says.

Smaller co untry-specific orders

A wallet-style blister, shown without printing and graphics, produced by Fargo Automation.

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Fargo Automation, in conjunction with Pharmaworks, developed an industry first: a high-speed WIP (Work in Process) machine called the Blister AccumulatorlSleever.

require each batch of blisters to be labeled differently, according to each country's specific requirements. "vVe used to see our customers run a large batch size for the United States or Europe, but now we're seeing pharma­ceutical companies run many different ' smaller batches for different countries, and each has different markings," says Bailey. "Due to this, flexibility in print­ing and packaging capabilities has become extremely important for sup­pliers," he adds.

Dirk Corsten, managing director, Uhlmann Packaging Systems (Towaco, TiD, says that the trend toward smaller batch production is also the result of "many medications being customized .. . to accommodate specific user-group needs."

Dustin Hanson, sales manager at

Fargo Automation (Fargo, ND), says that machine speed is also affecting the pharmaceutical and blister packaging industries. "The faster the line speed, the more critical it is to keep the blister machine running. If you're running at 400 per minute, every minute of downtime is 400 parts you're losing," he says.

H anson also says that secondary package design is also affecting the type of machinery being developed. "New designs for blister packaging, such as wallets, are requiring specialty equip­ment that may run at slower speeds," Hanson explains. The blister is embed­ded between two pieces of card stock to form a wallet. "Some pharmaceuti­cal companies use wallets because the blister can then stay somewhat generic, and the change in graphics is done on the card stock that makes up the wal­let," Hanson adds.

DESIGNED TO PREVENT DOWNTIME ,

As blister machines are being designed to produce packaging at fast­er rates, any issues that arise, caus­ing the machine to stop, will be more costly. To address this issue, Fargo Automation, in conjunction with Pharmaworks, developed an industry first-a high speed WIP (Work In Pro­cess) machine called the Blister Accu­mulator I Sleever. The supplier's first accumulatorlsleever was developed in 2007, but a few design changes led to the release of two of its latest models,

pmpnews.com • Pharmaceutical & Medical Packaging News September 2010

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Blisters

the most recent of which was launched last spring.

The accumulator/s leever unit is designed to be placed righ t behind a blister machine. The unit acts as a pro­cess control between a blister machine and the secondary packaging machine. "It will allow the blistering machine to stay running if the secondary equip­ment downstream has issues, and vice versa," says Hanson.

A PRINTING TECHNOLOGY TO FACILITATE SMALL BATCH PRODUCTION

R unning a large unmarked blister batch is a much more efficient produc­tion process that saves time and leads to a lower cost-per-unit. T he trend toward smaller batch sizes, and the need to Plii1t each batch with different cOlmtry-specific requirements, led Korber Medipak to develop new printing capabilities.

This new special ty unit also addresses critical issues regarding the production of new designs for blister packaging, which may require specialty equipment that runs at slower speeds.

"Customers are buying one fast blis­tering machine and possibly taking that fast production and splitting it up into two or three slower, more cus­tom secondary packaging machines," says Hanson. "Doing this requires a machine that could take 400 or more

A wallet made with plastic stock, and a sleeve from Fargo Automation 's WIP Accumulator/ Sleever.

"We've been working on devising the best strategy to deal with small batch sizes for the past 5 years or so, and our so lu tion, called Late Stage Customization, effectively decouples blister production from the cartoning process," says Bailey. "The fact that we developed the technology to automati­cally store, retrieve, align, and print on the back side of a sealed blister is the reason our system works," he says.

blisters per minute and put them into a VVIP system. Our accumulator/sleever unit will allow pallets of sleeves, each containing up to 200 blisters, to easily be carted- facilitat ing this process," he adds. The supplier began integrating this

ORDER WHAT You NEED

Two-sided eight-color blister push-though foil is now available from Control Group. The company introduced QuickFoil to meet customer demand for short to medium runs of printed foil with a quick turnaround.

Pharma companies that never explored two-sided printing or have complex graphics may find new design options with Quick­Foil. "We are seeing customers with rudimentary inline printing in one color. Now they have options for high-quality printing, more colors, and more product identification," says co-founder of Control Group, Bill Cheringal. "Our customers have increasingly become more creative with their graphics, so this has become a more common request. The recoated foil performs well for cus­tomers, presenting no quality or performance issues," he adds.

While Control Group has been printing foil on both sides for some time, if customers needed their graphics to show through a blister, the firm often had to print over the original heat-seal coat­ing, which deadened it, and then had to reapply the coating. The costs of two heat-seal coatings was too much to bear for custom­ers managing shorter and shorter runs for multiple SKUs, reports Jeff Levine, co-founder of Control Group. "We set out to address our customers' needs for smaller runs, quick turnaround, and most importantly, competitive cost."

The company decided to install a new gravure coating line to support increasing demand for coated foil. Having just completed a 60,000 sq ft expansion including validation of the new coater, Control Group can now convert uncoated foil and print and coat

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it, or it can-take a customer-sourced foil and print and coat (or recoat) as needed.

"There's a drive in pharma to reduce inventory, so this option allows our customers to avoid commissioning large print runs," adds John Chris, director of business development. "Traditional gravure foil printing requires much larger runs and lead times, but our option allows you to order what you need when you need it. "

Levine adds that its servo-driven presses use the metric scale, allowing its foil products to accurately match up to the metric­based tooling frequently used by European blister packaging machinery. "We feel this is unique among narrow web printers" adds Cheringal. In addition, given the company's forty year history as a cGMP pharmaceutical/healthcare printer, Control Group main­tains Drug Master Files with FDA and Canadian authorities.

Two-sided blister foil printing can be used to drive patient compli­ance, says Chris. "It could be used as an altemative to wallet cards."

Transition time and cost has often been an issue in delaying package improvements, but "our quick turnaround time could be a determining factor," says Levine. "We can now print and coat in days. For companies with 20, 30, 40 SKUs, they need short runs and they cannot wait for twelve weeks' turnaround time."

Levine adds that customers that utilize Quick Foil have included those producing "impulse and OTC products with two to four tablets per card, which must have decorative graphics to show through the PVC blister. These products do not have secondary packaging, so they have to market themselves. "- Daphne AI/en

pmpnews.com • Pharmaceutical & Medical Packaging News September 2010

Blisters

TEKNI-PLEX TURN AROUND HINGES ON PHARMA

PACKAGING PRODUCTS AND SERVICES

With finances back on a solid footing, the company plans investment in its pharma and medical device businesses.

Tekni -Plex Inc. (King of Prussia, PAl is focused on growing its pharmaceuti ­cal packaging and medical device busi­ness segments, after implementing broad reforms to restore corporate profitability.

Since a financial restructuring two years ago, the global manufacturer of packag­ing and tubing products has maintained investment in its core businesses, and is planning for continued growth, says Paul Young, CEO, Tekni-Plex.

"In the first 18 months, we cleared away a lot of the debris. Now, as a smaller but more profitable company, we are focus­ing heavily on profitable growth. We have invested over $40 million since 2008, with a great deal of that going to the health­care businesses," Young says. "We have improved earnings by over $30 million over the last two years, on about $200 million less in sales. [And] we expect that fiscal 2011 will be the best year in a long time in this company's history." Young adds.

Through a string of acquisitions since its founding in 1967, Tekni-Plex grew into an $800 million company with businesses in health care, foods, consumer products, and specialty markets.

Left vulnerable by increases in raw material costs, weak operating results, and high debt, the company completed a finan­cial restructuring in 2008. Oaktree Capital Management and Avenue Capital Corp. acquired a controlling interest in a debt­for-equity swap.

Young was hired soon thereafter from Graham Packaging Holdings Corp. as CEO to execute a turn around plan and run the business.

"The company was paying about $100 million in cash interest annually on $800 million of debt. All the available cash was going to service the debt," he says. In the restructuring, about $300 million of debt

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was converted to equity, reducing the annual interest payments by about $50 mil­lion. "Then the free cash became available for improving the business," Young says.

"There were three things we had to do: Solve the liquidity issue; put the domestic business on a solid footing and stop the bleeding operationally; and strengthen orga­nizational capabilities and talents," he says.

New upper management and business segment leaders were hired. Company­wide budgeting and forecasting was imple­mented. Unprofitable businesses were downsized or eliminated in a reorganization of manufacturing and product lines.

Most of the company's problems stemmed from non-packaging segments that had threatened to undermine the whole company. Burlington Specialty Res­ins, a manufacturer of non-pharma grade PVC that lost $27 million over seven years, was shut down. Three Dolco Packaging' Corp. plants were closed as the company exited the consumer PS plate segment.

New leaders were hired in four of Tekni­Plex's six business segments, with other top managers promoted. The company also hired a new CFO, and added functions that were missing in the old Tekni-Plex organization.

"Tekni was buying $300 million in rub­ber and polymers with no common pro­curement function . We brought in a new VP of procurement to bring cost discipline to purchasing; that has translated to an improved value proposition for our custom­ers," Young says.

Tekni businesses that performed well through the rough years of 2006-2008 inciud-

PMPNews .com Read the full story includ­ing Tekni-Plex's plans for

the closure liner, vinyl compound, and bl ister fi lm businesses, and for new product launches across the company, in this month's online edi­tion of PMP News. Visit www.pmpnews.com

ed the European division. Luc Vercruyssen, managing director of the Tekni-Plex wholly­owned European subsidiary T ekni-Plex Europe NV, reports to Young. "Our business in Europe has continued to flourish. Recent investment in state-of-the art pharma and medical films technology had driven growth in many differ­ent applications," he says.

New investment is planned in the $250 million healthcare businesses. Segments include pharmaceutical packaging, com­p,ounds and components, and liners and films for medical and drug-delivery device manufacturing and packaging.

"In the last six months, our focus has shifted from fixing the company and surviv­ing in a recession [to strategic growth]. We have strong market positions in these busi­nesses. Many businesses were siloed to a large extent [and] never grouped with a market focus. We are trying to unlock a lot of cross-selling opportunities," Young says.

Philip Bourgeois joined the com­pany from Rexam Plastics Packaging as the head of technology development and regulatory affairs. He is initially focused on development of all of the health care business-including the closure liner and seal business which includes the Blauvelt, NY-based Tri-Seal operations.

In pharmaceutical blister films, cus­tomers will benefit from a one-stop-shop approach.

John Zripko, vice president, pharma­Americas, oversees blister film manufac­turing operations in Canada, New Jersey, and South America.

Tekni -Plex plans to invest $6 million this year in the domestic film business, in projecting blister film market growth at 6 to 8%. "In addition, we are seeing excellent growth in our high-barrier film business in Latin America," says Young.-David Vaczek

pmpnews.com • Pharmaceuti ca l & Medica l Packagi ng News September 2010

printing method into their cartoners a couple of years ago, and was the first in the industry to do so, according to Bai­ley. Its printing method allows pharma­ceutical companies to produce blisters in large lot sizes coded with a 2-D Data Matrix code, but without any human­readable markings. The blisters are then automatically loaded in cardboard tubes and sent to inventory or a local secondary cartoning plant.

"As small orders come in, the man­ufacturer will pull the sealed blisters from inventory and then print the required information in the country­specific language on the back of the sealed blister as part of the cartoning process," says Bailey.

Traditionally, manufacturers print on the back of the blister foil when it's flat, before the backing is sealed onto the base film, according to Bailey. "Once a blister is heat-sealed, the height varia-

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Z KORBER MEDIPAK

Uhlmann's Blister Express Center 300 handles format changeovers quickly.

tions due to the cavities and the texture in the seal area makes printing on the back more complicated," he says. The company developed a cartoner that automatically unloads the blister from the storage tube. Then, it accurately registers the blister prior to applying print onto the blister. "The concept allows us to produce country-specific batches .with IO-minute changeovers.

This gives us and our customers a unique competitive edge," says Bailey.

LARGE FORMATS, DESIGNED FOR SPEED

Also taking into account issues sur­rounding small ba tch production, Pharmaworks has developed new machinery. "Both our new machines are tailored to facilitate quick and easy

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September 2010 Pharmaceutical & Medical Packaging News· pmpnews.com 37

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Blisters

BLISTER PRODUCT TRENDS

Blister packages designed to meet demand from pharmaceutical companies.

According to The Freedonia Group's latest Phannaceutical Packaging Study, the demand for ethical pharmaceutical blister packs is forecast to expand 1.8% annually to 3.9 billion units, valued at $1 billion, in 2012.

What types of blister packages are being developed? "New package design trends address customer demands, as well as child resistance regulations," says Dustin Hanson, sales manager, Fargo Automation. "The days of the carton are dwindling, while the use of wallets and pocket packs is increasing," he says. "Although they have been around a few years, they are a big trend now because they allow the blister and required patient informa­tion to be combined into one package."

Blister packaging designed to promote bet­ter patient compliance is key. "We see the need for better patient compliance, and put­ting blisters in a clearly marked wallet can help because it provides room for clear dos­age instructions," says Keith Bailey, regional manager, Midwest, Korber Medipak.

The new CPI Security Foil by Constantia Hueck Foils.

Ward Smith, director of marketing, Key­stone Folding Box Co., agrees. "Studies show the direct connection between well designed unit-dose packaging and improved patient compliance," he says. Smith often hears that creating cost-effective blister packaging that integrates both child resistance and senior friendly features is high on everyone's list.

Sustainability also continues to be a hot

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Keystone Folding Box Co.'s new KeyPak Plus, a fold-over, heat-seal blister card that slides into a lightweight outer carton.

topic. "Packaging solutions that are produced from sustainable resources are of great inter­est," says Smith.

These issues, as well as others, were addressed in the design of these new blister­packaging options below.

A Humidity-Resistant Blister Material Perfecseal launched a new aluminum­

based blister -forming web for moisture-sen­sitive unit -dose products, PerfecFonn C1200. Testing indicates it is suitable for high temper­ature and high humidity environments. ~ has been evaluated on blister-forming lines using deep-draw tooling, reports the supplier. "There is a great need in the Brazilian market and oth­er Zone 4 areas for high barrier fonning webs that can provide proper protection of complex unit-dose tablets," says Georgia Mohr, director of phannaceutical segment, Perfecseal.

A Protective, Senior-Friendly CR Blister Gard Keystone Folding Box Co.(Newark, NJ)

launched Key-Pak Plus earlier this year. Larger than the supplier's original Key-Pak, the new blister package has a slide-out feature.

The package consists of a fold-over, heat­seal blister card that slides into a lightweight outer carton. The card is secured to the car­ton, keeping the two components together

as single unit. The blister's sturdy protective sleeve accommodates light-sensitive com­pounds and drugs that can be physically damaged, and works well with gel caps and liquid-filled products.

The card consists of a polymer-coated SBS paperboard, made from chlorine-free bleached fiber. "A minimal amount of paper­board is used, making it more environmentally friendly that competing solutions," says Smith.

A Foil to Combat Counterfeits Constantia Hueck Foils (Wall, NJ) developed

a new product for pharmaceutical primary packaging, its patented CPI Security Foil. The product can be used in all blister lidding for­mats and pouch specijications.

CPI Security Foil allows for fine-line graph­ics, text, logos, and micro-features to be applied directly to the surface of the alumi­num during the rolling process. "Because the images are embedded in the foil, they cannot be removed. The high-precision laser technol­ogy used to create the foil cannot be imitated by counterfeiters," says Fred Lutz, director of sales and service. Since its physical properties are identical to standard foil in thickness and strength, no changes in the packaging pro­cess or specijications need to be made to use the product, according to the supplier.

pmpnews.com • Pha rmaceutica l & Medica l Packaging News September 2010

changeover of tooling, a necessary fea­ture when working with smaller batch­es," says Brower. Additionally, Brower says affordable tooling is essential.

Pharmaworks's two new machines are the TFI and TFle, which was com­pleted inJuly. A larger version, the TF3, will be introduced in the fourth quar­ter of 2010 . The TFI is a single-lane machine that was designed for quick production batches and can run blisters at a rate of 100 HUD blisters per min­ute. The new "e" version of this model is designed to handle larger format drug packaging, such as 30-day cholesterol­lowing regimens. The TFle can form and punch very large sizes.

The TFle has a small footprint, allowing it to be used in smaller spaces, which lowers operating costs. "Our first batch of machines has completely sold out-indicating a definite market need," says Brower.

The TF3 is a larger format machine, for jobs requiring an increased output. Like the TFle, it has quick-change tooling that easily loads through the front. It also has the ability to adjust to each station while the machine is in production. "Being able to tune the machine independent of other stations while the machine is running is an important feature," says Brower.

Both machines incorporate the lat­est in control technology. "The TF3, for example, incorporates the latest in seal registration capabilities. It uses laser feedback ensuring that blisters are sealed correctly, regardless of material shrinkage or other factors that traditionally cause seal registration problems," says Brower.

Uhlmann has developed a machine designed to address issues relating to small-batch production. "The indus­try's move toward small batch produc-

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tion has created the need for more flexible packaging lines and quicker format changeovers," says Corsten.

Uhlmann's Blister Express Center 300 is a compact integrated system designed for this purpose. "The machine features the largest format area and quickest for­mat changeovers in its category," he adds.

The machine can produce up to 300 blisters and 150 cartons per minute, and one person can complete change­overs in 20 minutes. A large format size of 95 x 145 mm accommodates a wide range of applications.

One major advantage of this machine is the zero ramp-up time, according to Corsten. "After placing the few format parts into their allocat­ed sppts, vvithout requiring the use of tools, the recipe for the next batch on the HMI can be called. The BEC sets evetything to the right parameters and you're ready to go," he explains .•

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September 2010 Pharmaceutica l & Medical Packaging News· pmpnews.com 39