Putting Blister Packaging to the Test
Companies are looking at new design options for blisters and for production lines
By David Vaczek, Senior Editor
By David Vaczek, Senior Editor
Blister packaging, at its simplest, presents a complex set of issues for companies packaging pharmaceuticals. Among the challenges that packagers must surmount are those of finding the appropriate equipment and setting it up to run the packaging materials chosen and tested for use with the product. Blister users then have to anticipate the demand for their product and select and configure primary and secondary packaging machines accordingly. Blister packaging and carding and cartoning machinery might be highly integrated to run large lots at top speed with little or no hands-on intervention. Or, production lines might provide flexibility to accommodate smaller lot sizes arising to produce a variety of formats.
Pharmaceutical companies are also trying out new films, including higher-barrier films and foils. They are looking for packaging that stands out, besides providing compliance features. Also, companies are exploring computer-aided design for tooling of blister cavities.
THE ISSUE OF LOT SIZE
Smaller lot sizes have fueled demand for blister packing and carding machines that allow quick job changeovers. Small runs and a proliferation of package formats have inspired alternative production approaches. Late-Stage Customizing (LSC) is one such concept, where companies minimize downtime on primary packaging machines so they can run at full tilt, while secondary packaging and customization might occur separately at a later stage. Packagers are also showing increasing interest in flexible or modular machinery.
Dividella has recently launched the latest-generation NeoWallet line, which offers a scalable solution to meet a range of flexibility and throughput requirements. The NeoWallet 800 is designed to operate in a high-mix environment, handling an array of wallet sizes along with multiple blisters, inserts, and fold-over panels. “With this machine, companies can be confident they can buy some tooling down the road and run almost anything the market can throw at them,” says Mike DeCollibus, vice president, sales and marketing, Körber Medipak (Clearwater, FL), the sales, marketing, and service division of The Körber Group, the parent company of Dividella (Grabs, Switzerland). Modular and configurable, the NeoWallet platform serves a broad range of production needs. For low-mix, high-volume applications, Dividella offers its NeoWallet 300 line, which operates at speeds of 300 wallets per minute.
The trend of smaller lot sizes has led MGS Machine Corp. (Maple Grove, MN) to emphasize modular designs and quick adjustments for its blister carding and cartoning machines. “We have redirected our design process to ensure that we focus on minimum changeover time. Changeovers have to be simple, quick, reliable, and repeatable. To this end, we have embraced a toolless changeover philosophy. We take extra care in combining the use of adjustment points, quick-change tool sets, and use of the recipe-recall capability within our control systems for electronic adjustments. This is done without compromises on machine speed,” says Dave Schuh, vice president, sales and marketing, MGS Machine Corp.
Features of MGS blister card machinery include multiple-panel-card capacity and toolless size changeovers for folding heat-sealed cards or gluing and folding cards. Other features include 300-card-per-minute maximum speed ranges and four-blister feeding configurations.
“We are designing our products in modules so that we can mix and match our design platform for a particular customer’s application requirements, operating mode, and throughput rates. We can offer shorter delivery lead times while we minimize the amount of customer engineering work on a project. The customer gets the product faster, and the project risk is greatly reduced versus a customized-design build-to-order operating mode,” says Schuh.
MGS also supplies validation support tools for machinery function and factory acceptance testing. “They allow customers to quickly gather information on our equipment to support their development and finalization of the validation documentation and testing protocols for MGS machinery,” Schuh says.
Many contract packagers are employing machines geared for both large and small jobs to meet order requirements that vary from year to year. “The majority of our lots are of standard commercial size, of approximately 300,000–400,000 blisters per order, on a rolling annual forecast,” says Rick Sury, vice president, sales, Alcan Packaging, Contract Packaging and Specialty Cartons (Bethlehem, PA). For these and higher-volume runs, Klöckner and Uhlmann UPS 4s machines provide the needed capacity and speed. Alcan employs machines including Klöckner’s EAS and Noack machines for smaller lots, stability tests, and clinical packaging. “We have not seen a great increase in smaller commercial lot sizes; however, there appears to be more requests for information regarding costs. Since this business is so cyclical, it is hard to predict the next trend. However, as a contract packager, we need to stay flexible in order to meet these trends,” says Sury.
|The Hapa 730 digital UV printer from Romaco is helping American Health Packaging print RSS codes on blisters.|
Uhlmann Packaging Systems LP (Towaco, NJ) offers a wide range of form-fill-seal blister machines. On the low-volume end, its Blister Express Center thermoformer, cartoner, and stretch-band unit is featured for producing batches of a few thousand packs. For addressing large-volume needs, Uhlmann has launched the B-1880 high-speed thermoformer, which can turn out 1300 blisters per minute. It includes better safety features in the sealing, embossing, and punching functions; enhanced distribution of air pressure using air cushions; and reduced heat loss through control of heat transfer.
New materials and innovative design features also support “easily accessible operator controls and simplified handling. The tool position in the servo-driven embossing and perforating stations, and in the self-cleaning punch, is accurately monitored,” says Markus Haid, director, customer support and services, Uhlmann.
“The air cushion used in the sealing station of the B-1880 is new technology for this application, providing extremely uniform sealing pressure for platen sealing stations. In addition, the machine features a patented sandwich tool design that allows maintaining uniform temperature throughout the entire sealing tool,” Haid says.
American Health Packaging (Columbus, OH) specializes in short-run orders using equipment from Uhlmann Packaging Systems, particularly its B-1240s. “They are geared for shorter runs and quick changeovers,” says Mike Rathburn, vice president of manufacturing.
Also, the company uses the CeraPak HP12 automatic in-line sealer from Sencorp Inc. (Hyannis, MA) to produce a 30-count portable compliance package for Taro Pharmaceuticals’ blood-thinner drug, Warfarin, called the Track Pack. Among its features, the HP12 reads the bar codes on the cards and the blister packages to ensure that they match up. “The HP12 can change over to another product in about 30 minutes. We could go from a 30-count card for institutional use to a 14-day prescription dosage,” says Jim Tedesco, vice president of sales and marketing, Sencorp. Anderson Packaging uses Sencorp’s CeraPak JA936 heat sealers that feature vision system inspection to ensure that product is intact and in the package, says Tedesco.
American Health started printing Reduced Space Symbology (RSS) last year using Hapa printers from Romaco (Pompton Plains, NJ). “Printing is becoming a very important issue. The pharmaceutical companies are looking for this, and hospitals want to scan at the bedside to ensure that people are getting the right medications,” says Rathburn.
American Health Packaging converted from the digital printing technology it was using to the Hapa 730 digital UV printers. The Hapa 730 printers utilize UV inks, explains Steve DiAngelis, Romaco’s director of sales. “UV inks at 600 dpi provide superior edge quality, which is critical to successful bar code printing. The ink cures to the material instantly when exposed to UV light, and it is available in any color in the PMS color range and has excellent adhesion qualities.”
Because highly accurate stepper motors drive all motion, the machine’s ease of setup and print-to-print accuracy is excellent, DiAngelis says. “All of these benefits are coupled with the elimination of print mats and the low running costs for mid- to low-volume batch operations to suit the Hapa 730 for in-line printing of tiny unit-dose bar codes and intricate tiny text.
SPEED AND FLEXIBILITY
“Many of our customers are seeking a balance between speed and flexibility to preserve their capital investment over time. The justification to automate is often compelling. Our technology provides exceptional efficiency and minimal labor,” DeCollibus says.
Körber Medipak’s carding, walleting, and cartoning machines can be used to support an LSC approach to blister package production that the company is advocating.
Companies with global reach must produce packages in a variety of formats and languages to meet local requirements. Using LSC, a company devotes its primary packaging lines to producing blister packs with “little or no printing.” Lines can run at full capacity without downtime. Körber Medipak features a BIB-BOB module (blister-in-box, blister-out-of-box) that can be rolled up to and linked to the blister machine. A transport system, BIB-BOB sleeves the blisters for storage and transport to secondary-packaging sites, which might be across the shop, across town, or offshore. For formats in which printing is required on lidding material, dedicated printing technology prints on the lidding stock of the individuated blisters before the cartoning.
“BIB-BOB might feed blisters into our P1600 cartoning machine or our NeoWallet machine. On the P1600, the printing would be on the blister lidding material. There has to be excellent control of the blister throughout the printing process to get a clear readable print, and you need the right ink and curing method,” says DeCollibus.
LSC could have wider applications, but it works best with blisters using Körber Medipak’s technology because the blisters stack nicely in the sleeves. Computer simulation has shown a 30% increase in production efficiency when using the BIB-BOB, compared with running small lots on high-speed dedicated lines, DeCollibus says.
“LSC goes hand-in-hand with the widespread industry trend away from high-speed production to smaller lot sizes for more stock-keeping units (SKUs) requiring different packaging presentations,” he says. “This is where we see the future. Maximize production of blister machines and do everything else at the point of sale. We have been blown away by the interest.”
Machine flexibility is an asset for converters as well as for packagers. For smaller-sized lidding stock printing jobs, Hueck Foils LLC (Wall, NJ) uses a plant in Germany that is set up to handle small runs, says Angela Roggenhofer, healthcare marketing manager for the Americas.
“We need flexibility in our printing. If a customer wants 10 lb of printed foil, we recommend the firm use our parent company’s plant in Germany that is set up to handle small runs. It can print 50 lb of foil within a couple of hours, if necessary,” she says.
The prevalence of quick-dissolve drugs and drugs in powder form that are sensitive to moisture is driving demand for higher-barrier materials.
SEEKING HIGHER BARRIERS
“Everyone is looking for new materials. But companies face a lengthy process in getting new packaging qualified by FDA. It is not easy to get a customer to change packaging materials, or to switch suppliers. There needs to be a compelling performance or cost advantage,” says Roggenhofer.
“There is a lot more interest in cost reduction, but perhaps even a higher level of interest in performance enhancements,” says Ralph Klein, marketing manager, International Converter Inc. (Caldwell, OH).
The company’s products include lightweight lidding materials for push-through blister-pack configurations. It has adopted thinner-gauge substrates and lower-cost heat-seal coatings. The company will soon employ a new triplex laminator/coater that can run thinner film, foil, and paper at higher speeds. “We can take thinner and wider film, and run it faster,” says Klein.
“Many of the newer molecular entities being approved tend to have very high hygroscopic characteristics, and foil is being used as the ultimate barrier,” says Shawn Reilley, vice president, sales and marketing, Anderson Packaging. One-third of Anderson Pack-aging’s blister business this year, or 250 million blisters, were cold-formed blisters, he says.
American Health Packaging has ordered forming and sealing tools and dedicated feed modules to launch cold-forming capability in response to demand, says Rathburn. Hueck has experienced rising demand for its triple-laminate cold-formable product. It situates a 45-µm aluminum foil between a 25-µm layer of OPA, and, usually, a 60-µm layer of PVC, for drugs needing protection from moisture, oxygen, and light, Roggenhofer says.
Alcan Packaging has introduced Guardlid, a new child-resistant lidding material for peel, peel-push, and tear-open formats. It is designed to meet new European child-resistant standards (EN 14375), and it conforms to potential new regulations within the European Union, says Scott Denley, marketing manager for pharmaceutical flexibles, Alcan Packaging (Shelbyville, KY). “Guardlid uses multiple materials, including papers, protective lacquers, foils, adhesives, and films, optimally integrated with each other, to enhance the safety of each of the Guardlid structures,” Denley says.
Blispak (Whippany, NJ) adopted Honeywell Inc.’s newest Aclar film, Aclar 20 E, in an 81¼2 × 51¼8-in. carded compliance pack for a pharmaceutical. INEOS Films Inc. (Delaware City, DE; formerly EVC Films) provided the Aclar laminate.
“Aclar films have tended to curl on our machinery. We found that the Aclar 20 E product runs as smooth as PVC,” says Jim Horan at Blispak, a contract packager in Sonic Packaging Industries Inc.’s (Westwood, NJ) contract packager network. “Our customers are willing to pay for the higher-barrier materials. They just want to get their product through stability. It is not always a cost issue with them,” Horan says.
Market acceptance for cycloolefin copolymer (COC) has grown as companies have tested it under stability. “We have upgraded our multilayer polyolefin coextrusion lines to run a good commercial-grade product. COC is really gaining a foothold in solid-dose blister packaging and some OTC applications. We have several major launches in the works for OTCs, personal care, and diagnostics,” says Michael Franklin, vice president and general manager of Tekni-Plex Inc.’s Tekni-Films division (Somerville, NJ).
Produced in a laminate or coextruded, COC’s advantages include inherent barrier properties and high clarity. “Its machineability and bond strength have been very good. And it doesn’t contain any fluorines or chlorines, which is an environmental plus. For some companies, that particular feature is very important,” says Denley.
COC’s barrier properties are comparable to PVdC and Aclar, depending on the thickness, says Sandra Luciano, director of marketing, Sharp Corp. (Conshohocken. PA).
Blister packaging inherently promotes compliance, as it helps patients keep track of the drugs they have consumed. Patient compliance may also help drug companies sell more drugs, and marketers can use card or wallet wraps and convenient delivery systems to differentiate products.
“Compliance packaging is growing significantly in the pharmaceutical industry. There is growing use of heat-sealable cards providing child-resistance features to the package as well as ample space for marketing and compliance messages,” says Reilley.
While innovative blister packaging helps patients comply with drug regimens, it can also help manufacturers comply with labeling requirements.
Sharp Corp. is promoting its Flow Wrap packaging system for physician samples and trade packages to companies faced with new labeling requirements, such as makers of antidepressant and antiinflammatory drugs. The blister unit, packaging insert, and patient Medication Guides or patient package inserts are overwrapped in clear or opaque film, allowing the information to stay with the sample throughout distribution. Packages are delivered to physicians in a compact dispenser. The outer-carton packaging is eliminated, reducing storage space in doctors’ offices.
“We call this ‘compliance packaging.’ Manufacturers are very interested in ensuring that this labeling gets to the patient,” says Luciano.
Sharp has set up a new package design department centered at its facilities in Conshochoken and Allentown, PA. Designers use CAD/CAM to create mockups of proposed designs for pharmaceutical marketers to review. The newest facility in Allentown features 29 state-of-the-art packaging suites. “We have initiated a new mission statement and value proposition. Companies are focusing on blister packages as a way to extend the life of their drugs and to differentiate their products using packaging and novel delivery systems. We want our customers to use blisters for their samples and trade packaging, so when the patients go to the pharmacy they receive the identical packaging they got at the doctor’s office,” she said.
Finite element analysis (FEA) is attracting the interest of pharmaceutical manufacturers. Merck, for example, is reportedly using the software in new product development.
Tekni-Films has introduced its Compass predictive blister modeling software, which it offers at no charge to qualifying customers, says Franklin. Compass is a user-friendly version of FEA software, he says. Users generate a 3-D map of a blister pocket showing blister-package wall thickness and moisture-vapor transmission rate (MVTR) distribution. FEA allows engineers to more precisely preselect barrier film alternatives and predict MVTR and thermoformability of a blister pack to optimize tool design for maximum MVTR performance. They can predict how much moisture a product will be exposed to in stability testing or on the shelf. Material thinning and stretched corners can reduce barrier values by 40%, he says.
“You are designing the correct draft angles and corners to arrive at the optimal blister design and form in order to achieve the highest barrier levels available to you with that package and film. This leads to the smart design of the tool,” says Franklin.
Manufacturers have the tools to predict the dispersion of film across a blister form, if they choose to use them. They are using blister and packaging machines that provide faster changeovers.
What they can’t easily control are marketplace forces. These include heightened scrutiny of drug safety profiles and a robust generic drug industry that is quick to challenge patents and capture market share when drugs lose their exclusivity status.
Flexibility in machinery is one solution for adapting to unpredictable change. For companies anticipating high-volume sales for a drug over a prolonged period of years and devoting capital and resources to set up highly integrated lines with fast throughput to meet that projected demand, risk assessment has become more critical than ever.