New models and upgrades are increasing the flexibility of pharmaceutical blister packaging lines.
By Daphne Allen
Pharmaceutical manufacturers are experiencing unprecedented market conditions. Blockbuster drugs are facing generic product competition, many new drugs are often treating limited populations, marketing activities are coming under fire, and a struggling global economy may be affecting drug demand.n
|The Oystar IWK Blisterpac BP5 maintains a speed of 300 blisters per minute.
Reducing operating expenses, including those involving blister packaging processes, is a priority for many drug makers. Therefore, packaging production managers and engineers are looking for flexible lines that
can handle multiple campaigns with easy changeover, cleaning, and maintenance.
"There continues to be movement toward running multiple products on a single machine," notes Richard Bahr, president and CEO of MGS Machine Corp. (Maple Grove, MN). "Flexibility and ease of changeover are important. We haven’t seen firms move equipment on, then off line."
These products are "in smaller, quicker batches," says Ben Brower, vice president of sales and marketing for Micron PharmaWorks Inc.
(Odessa, FL). "We aren’t seeing a whole lot of new solid-dose drugs these days. Instead, we are seeing projects that are reformatting the packaging for already marketed drugs into smaller batches for different markets,"
he says. "Reformatting often consists of different counts and different
Drug companies also want to get the most from their machines, and that often entails a study of overall equipment effectiveness (OEE). "OEE is huge," says Dustin Hanson, sales engineer for Fargo Automation (Fargo, ND). "Really, OEE is a calculation that encompasses all aspects of the machinery. And it doesn’t stop at the blister machine."
Hanson adds that most drug companies are holding OEMs to a high OEE.
Lose the tools
The need for changeover is almost a matter of routine these days, so blister machinery manufacturers are constantly working on ways to ease change. "We see quick changeover requested in every proposal: five-, 10-, and 30-minute changeover times," says Hanson. "Many are requesting one-button changeover, where the machine walks the user through the changeover process. No one wants to use bolts or wrenches for changeover anymore."
Machinery is following suit. "As a manufacturer of packaging equipment, we have implemented many improvements to reduce the time for the changeover and the ramp-up time to zero," explains Dirk Corsten, managing director for Uhlmann (Towaco, NJ). "We have a number of highly flexible machines in our program, like the Blister Express Center (BEC) 300 and the BEC 500, which were designed for quick changeovers. All other machines have been upgraded to make the changeover easy and reproducible. So the physical changeover can be as quick as 10–15 minutes these days."
Pharma companies not only want to change tools quickly, but they also want to make adjustments easily. "There are a lot of gains to be made in the machine movement itself," says Brower. "Customers are looking for smart machines that make automatic adjustments."
Employing servos and lasers, Micron PharmaWorks has been able to get its blister machines "to start producing faster," he says. "Employing self diagnosis, the machines can handle smart adjustments, such as moving X number of millimeters on its own."
These automatic adjustments can help users overcome seal registration problems, says Brower. "When machines stop and start, such as during changeover or other line stops, the plastic web shrinks when it cools, or newly loaded webs need to be registered when you pull the material forward through the machine. Using lasers that sense the position of the web, we can employ active registration to sealing stations."
Drug companies also need machinery that helps them ease into automation, depending upon product demand. When drug companies begin using wallet packages for compliance, for instance, they may start by employing several operators to handle and place cards. But switching such an operation to an automatic one must be as seamless as possible.
MGS Machine’s Blister Card/Wallet machine can adapt to either production line. "It can fold and tack (or tab) heat-sealed wallets fed by operators," says Bahr. "Once the blister is sealed by heat into the card, it typically has multiple folds and then must be held closed by peelable glue or a wafer seal label."
The MGS unit can also create a complete wallet by feeding the blister, on or off line, sealing it with hot-melt glue, then performing the rest of the operations (folding, gluing, or labeling), says Bahr. "Glue walleting hasn’t traditionally been as popular as heat seal, but some of the issues of a child resistant–quality seal and aesthetics have improved dramatically since MGS built its first wallet machines in 1991," he continues. "A key advantage is that the cost of the materials is substantially less with a glue-sealed wallet. We are beginning to see some increase in glue-wallet projects." Bahr points to the latest CR glue wallet format from
Carton Service—Packaging Insights as a "pretty clever" design that deals well with the CR concerns of a glue wallet.
The UPS 5 is the successor of Uhlmann’s UPS 4. "One of the reasons for its success is the fact that it is modular in design and can be configured for almost all applications," says Corsten. "The machine consists of modules that can be added in order to add new functions, or extend the fill section or add special feeders. This makes it the most versatile blister machine in the marketplace."
The UPS 5 can be used for
solid-oral drugs as well as syringes, ampules, patches, and other products. "It can be used for multiple products because we can design the length and the components of the UPS 5 to accommodate the different requirements," Corsten adds.
Bahr says that MGS Machine can provide modules for its new high-speed blister card folder/wallet card machine for either on or offline configuration. "We are flexible, offering multiple solutions based on how the customer wants to run the operation. We have seen more offline schemes for walleting and all the compliance packaging formats, though. Operating the walleting machine off line from the blister thermoformer could improve the line’s OEE. If the packaging equipment goes down, there is no effect to the blister machine. Blister machines typically don’t like to go up and down."
Smaller could be better, in some instances. "One other step we recommend is production splitting," says Corsten. "This means you run your short batches on a small flexible machine with small changeover parts that require only a few parts to clean and put the larger batches on the faster and bigger machines."
Change over from one drug to another often requires stringent cleaning processes.
"One of the biggest challenges is still the time it takes to clean the machine, to get the paperwork signed, the line cleared, and the materials for the new batch on the line," explains Uhlmann’s Corsten. "In doing a lot of OEE assessments with our customers, these were the points that are still very time consuming."
At ACHEMA, MediSeal exhibited its new optimized dosing zone for the CP600 high-performance blister machine to help users reduce cleaning time between two product changes.
"On the new machine, cleaning takes half as long as usual. In addition, the entire design of the dosing zone has been revised to ensure that uniformly flat surfaces and rounded corners facilitate cleaning," explains Stephan Plewa, MediSeal’s CEO.
The previously open zone is now hermetically sealed off from all the other stations of the machine, so lidding foil can no longer become dusty or contaminated, reports Plewa. To ease access, the dust extraction system has been moved into the upper zone. Table-type construction and hermetic sealing of the zone allows damp surface cleaning when needed.
The Oystar IWK Blisterpac BP 5 from The Oystar USA Pharmaceutical Packaging Division offers features flexible and user-friendly work stations for enhanced productivity, the company reports.
The system’s feeding area features a modular design, allowing extensions for multiphase products. All product feeding drives can be integrated into one unit for a simple exchange of feeding systems. The Oystar IWK Blisterpac BP 5 is designed for an output speed of 300 blisters per minute and offers fast, toolless changeovers.
Economic conditions continue to influence nearly every business sector, and blister machinery makers are feeling the pinch, too. "The economy has an effect on all of us," says Corsten of Uhlmann.
"However, there is still a need for equipment, and we adjusted our business to offer more economical solutions, like preowned machines, refurbishing, and upgrading," he says.
Micron PharmaWorks sees people with a lot of assets looking to sell
equipment. "The worse it is, the better we like it," says Brower. "We rip it down to the frame and rebuild and completely modernize it. We are after the metal, if you will."
When it comes to new machinery purchases, Brower says that Micron
PharmaWorks has been selling twice as many of its small machines—the TF1—as its larger machines.
"Companies often cannot afford to run the big machines owing to tooling costs and setup time. In many cases, they are running hundreds of thousands
of units, not millions," he says. "Tooling is cheaper on smaller machines, too."
Any machine is still an investment, though. "Regardless of the machine size, you still need printers and cameras," says Brower.
Sustainability is also a consideration, says Hanson of Fargo, and it ties into smarter utility use. "Sustainability is breaking down into what blister machines can do. They’re typically very demanding in resources. Air used to be widely used, to the point of being over used. Now we are seeing specs asking machines to use little or no air. Air use is very inefficient in a plant, so facilities are turning to pure electronics." Fargo’s all-electric blister machines don’t use air in the traditional sense, employing electrical components instead of pneumatic ones.
Uhlmann sees a trend toward more potent drugs being packaged in blisters. "They require a higher level of operator and product protection," says Corsten. "This is being accomplished by different levels in housing of the fill section and implementing special HVAC units to control temperature, humidity, and particle count."
The other trend is still inhalable microdosed powder in blisters for a number of applications, he adds.
And drug companies are still seeking machines that cycle at faster rates. "They want higher production, higher run time, higher output," concludes Hanson. "We are tailoring our blister thermoformers to provide a one-stop shop. Additional equipment being purchased in conjunction with the machines are robotic
loaders, which tie assembly equipment directly into the machines, as well as automated off-loading and cartoning equipment, printers, vision systems, etc."
Editor’s Note: Anastasia Thrift contributed to this article.