Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Hallie Forcinio

Concerns about efficiency and sustainability are inspiring improvements to equipment for all parts of the packaging line. Many packaging innovations and portents of future trends were on display at the most recent Pack Expo International, which was held in Chicago, Illinois, in November 2008.  

Uhlmann Pac-Systeme, long known for its blister-packaging equipment, launched a fully integrated tablet-filling line at the show. The line is the company's first foray outside blister packaging equipment and its first product introduction outside Germany ("Integrated Bottle Center," Uhlmann Pac-Systeme, Laupheim, Germany). 

The turnkey, modular line integrates equipment from several suppliers to fill as many as 240 bottles/min. The line's hygienic design and automated changeover reduce downtime. Designed to comply with stringent European limits, the line generates noise levels of less than 74 dB, even at top speed. Bottles ranging in diameter from 35 to 76 mm and as tall as 193 mm pass through an unscrambler and receive a two-dimensional code, which is checked by a vision system for correctness and readability. Code data also are captured and stored to enable future tracking and tracing. When the bottle arrives at the desiccant dispenser, another camera checks the code. If it's not accurate, no desiccant is dispensed, and an integrated shift register ensures the bottle is not filled or capped.  

The next step is the filler, which maintains positive control of tablets. After filling, a metal detector checks for contamination before a rotary chuck capper applies the cap. The capped container than passes below an induction sealer. Just before the exit, another camera checks the bottle code once again. Three lanes at the exit transport good containers and shunt aside rejects and samples. Line operation and changeover is controlled from the operator interface. Changeover between bottle sizes requires no physical adjustments and takes only 20 min.  

Another turnkey line supports ePedigree serialization and track-and-trace initiatives. Incorporating equipment from several companies, the line consists of a pressure-sensitive labeler, shrink bundler, several vision systems, and a case packer and palletizer. The labeler applies serialized, two-dimensional barcodes or radio-frequency identification (RFID) labels. The vision system captures the serialized codes and makes the data available to ePedigree software through an Ethernet connection. Serialized containers are shrink bundled, and a print-and-apply labeler applies another label, which may be RFID-equipped. This label also is checked by a vision system. Shrink-bundled products are then loaded into cases, which are labeled by another unit. A third vision system checks these labels (Integrated packaging line for product serialization, NJM–CLI, Lebanon, NH).  

Innovations related to blister packs, a common pharmaceutical container, were also in evidence at the show. One line automates the assembly of a paperboard wallet pack with a dual sliding mechanism that keeps the medication and information leaflet together. Pulling the leaflet carrier causes the blister card to slide out the opposite side, thus providing access to the tablets. Prefolded patient information booklets can contain as many as 24 pages. The 17-m machine handles single or double blister formats at rates as high as 150 packs/min. A special feeding-wheel technology for fast pick-and-place operation, combined with a transverse product infeed chain, minimizes format changeover time ("Burgopak" wallet pack, Burgopak, London and Burgopak packaging line, Sigpack Systems, Beringen, Switzerland). 

A small unit for filling solid dosage forms into bottles counts pills at as many as 300 bottles/min. The machine reportedly provides better count accuracy than electronic counters or slat fillers and can be equipped with a color inspection system. Other features include integrated dust management and reject tracking. The machine can be disassembled in 20 min for cleaning and requires few change parts ("ACT9000" bottle filler, Aylward, New Bern, NC).  

Uhlmann's completely integrated, turnkey bottle-filling line. 

A new inserter cuts cotton coil with a guillotine blade, thus eliminating strands that could get caught in the capper, as well as fiber residue that complicates cleaning. The compact, portable unit can be configured with single or dual heads and offers speeds as high as 60 bottles/min. Its features include a programmable logic control, touch-screen operator interface, adjustable cutting head for lengths of 2–7 in., and stepper motor-driven rollers. A motorized height-adjustable stand enables the unit to be moved easily from line to line ("CF-1" automatic cotton inserter, ABOX Automation, Wharton, NJ). 

An upgraded dispenser slices desiccant or oxygen-absorber pouches from a roll and drops them into containers at rates as high as 300 bottles/min. An open exit chute reduces the chance of jams, and an angled feed ensures accurate pouch placement. A touch-screen operator interface and 1-min knife replacement expedite changeover. A remote access feature supports diagnostics to minimize service time and costs ("AZCO VIP-100 Sur-Pak" pouch dispenser, AZCO, Fairfield, NJ).  

Hapa on-line ultraviolet printer reduces waste and inventory by printing blister foil on demand. 

A polypropylene utensil, designed to be handled with one hand, breaks open along a score line to release a single dose of liquid or dry product. Available in spoon, fork, stirrer, and brush configurations, the package consists of an injection-molded shell and printed foil-laminate lidstock. A custom machine fills the utensil's reservoir with 4–20 mL of product and seals the lidstock in place ("Snapsil" utensil, Snapsil, Birtinya, Australia; "Optima Snapsil 400" fill–seal machine, Optima Group Consumer, Schwäbisch Hall, Germany). 

Another one-handed, single-dose dispensing design combines a scored semirigid bottom web with a flexible top web in a four-side-sealed construction. Folding the edges of the pouch together breaks the score and dispenses the liquid or semiliquid product. The proprietary bottom web consists of polystyrene–ethylene vinyl alcohol–polyethylene (PE) and flexes 90° (bottom barrier web for butterfly sachet, Alcan Packaging, Chicago, IL).  

Butterfly sachet with a proprietary semirigid bottom web folds to dispense a single dose of liquid or semiliquid product. 

A special vertical form–fill–seal machine combines top and bottom barrier webs and fills 150 packs/min. Four standard pack sizes hold 1–25 mL and measure 40 × 30, 40 × 80, 45 × 80, or 60 × 100 mm ("Easysnap3" vertical form–fill–seal machine, Easypack Solutions, Brantford, Ontario, Canada). The first machine is destined for Knowlton Development (Knowlton, Quebec, Canada), a large liquid personal-care contract packager. 

Suppliers of end-of-the-line equipment such as case packers and palletizers are building greater flexibility into their units. One new case packer handles vertical and horizontal pack patterns or a combination of both with the push of a button. The two-robot unit suits operations that pack multiple products or use multiple-pack orientations that otherwise would require more than one machine or complex changeovers. It also offers tape or hot-melt sealing. The first robot collates product in the proper pack pattern, and a second robot picks and places the collation in a case. Simultaneous case erecting, accumulation, loading, and sealing maximize throughput ("HVCP" case packer, Schneider Packaging Equipment, Brewerton, NY).  

Burgopak difficult-to-counterfeit design combines consumer convenience with tamper evidence. 

A new machine palletizes corrugated cases and loads cartons into plastic crates and palletizes them. Central to the design is a four-axis gripper–transfer mechanism. Features include a compact footprint, servo-driven action, and easy management of different case infeed heights ("P9" palletizer, Cermex, Norcross, GA). 

Doing more with less also is a popular theme with end-of-the line equipment. A collating system arranges containers in an alternating pattern to create a tight bundle. The arrangement fits more product into the same space. Potential benefits include material savings, waste reduction, and increased efficiency (single-lane in-double-lane discharge container-handling system, Morrison Container Handling Solutions, Glenwood, IL).  

Rollprint foil lamination for blowâfillâseal overwrap applications addresses demands for solvent-free structures. 

Two standouts among the many coding, printing, and labeling machines on display at Pack Expo included a syringe labeler and a flexo printer that prints blister foil on demand. The syringe labeler applies various pressure-sensitive label substrates to filled or unfilled syringes at a rate of 360/min. The machine loads syringes from an infeed star wheel onto a roller chain conveyor. A motion-controlled labeling head then applies the label, which is wrapped around the syringe as it passes under the independently driven wrap unit. Digital position indicators on all major adjustments expedite changeover from one syringe size to another. A vision inspection system is optional ("Harland Syringe Master," Harland America, Delran, NJ). 

On-demand printing of blister foil reduces inventory and obsolescence issues associated with preprinted rollstock, cuts waste, speeds changeover, and minimizes downtime. Capable of running on either intermittent or continuous-motion blister packaging machines, the ultraviolet flexo printer prints in one color, accepts any index length, and handles web widths as great as 260 mm. A cartridge-based ink system simplifies color changes by eliminating the need to remove the ink fountain, as well as purging and cleaning activities ("EasyFlex" printer, Hapa, Zurich, Switzerland).  

Snapsil's single-serving dispenser, available on the market in Australia, doubles as a utensil. 

A carton coder that prints either crash-lock cartons or blister cards applies batch or production codes, expiration or sell-by dates, logos, and barcodes at a rate of 262 ft/min. Servo drives help maintain precise registration and support operation in intermittent and continuous motion. In addition, the system is available with thermal-transfer or hot-foil printing technology, as well as multiple print heads. Changeover to a new carton size is performed without tools or changing parts and takes about 1 min. The machine stops when it senses a double feed, thereby minimizing chances that an unprinted or double-printed carton will be shipped. Options include barcode scanner–verifiers and vision inspection ("ACF-400" carton coder, Norwood Marking Systems–Allen Coding Systems, Downers Grove, IL).  

Toray's metallized polyethylene terephthalate offers a light, high-barrier alternative to foil laminations. 

Pack Expo International also featured several materials of interest to pharmaceutical packagers. A new family of high-barrier metallized polyethylene terephthalate (PET) films serves as a low-cost, lightweight alternative to foil laminations. A 36-gauge metallized PET can replace a 48-gauge foil lamination, which could be expensive and complex. The metallized film bolsters source-reduction efforts by eliminating the need for a sealant layer. Resistant to delamination and compatible with hard-to-hold products, the thin, multilayer films offer oxygen-transmission rates ranging from < 0.01 to 0.15 cm

/day and water-vapor transmission rates ranging from 0.03 to 0.15 g/100 in.

/day ("LumLife MK" PET film, Toray Plastics America, North Kingstown, RI).  

Another potential foil replacement is a clear film that offers a strong barrier to oxygen and moisture. The product combines an polychlorotrifluoroethylene (PCTFE) fluoropolymer layer and a polyvinylidene chloride (PVDC) coating. The four-layer polyvinyl chloride (PVC)–PVDC–PCTFE–PVC structure is designed for the most sensitive pharmaceuticals and nutraceuticals. Because PVC is the contact layer, the film does not require special tooling on form–fill–seal equipment. Also available in an opaque version, the film exhibits excellent lay-flat characteristics ("Pentapharm kpMax" films, Klöckner Pentaplast Group, Gordonsville, VA). 

A new solvent-free foil lamination designed especially for pharmaceutical overwrap applications is an extrusion-coated 48-gauge PET–low-density polyethylene–35-gauge foil–metallocene PE structure. Despite a significantly thinner sealant layer than competing materials, the metallocene PE forms stronger weld seals at speeds higher than 100 ft/min. Typical applications include secondary packaging for blow–fill–seal unit-dose containers for inhalation therapy or diagnostic kits. Reverse- or surface-printed white or natural foil structure can be supplied in rollstock form or as premade pouches or die-cut lids ("Triad" foil lamination, Rollprint Packaging Products, Addison, IL). 

's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, 

Articles

Integrated lines, flexible machines, and high-barrier materials enhance packaging options.

End-to-End Innovations

The new year is approaching fast, and it's not too early to think about goals for 2009. Although they differ from person to person and from job to job, three goals should be on every packaging team's list for 2009: improving the sustainability of its package or packaging line; identifying and implementing a container, material, machine, or practice that could improve its packaging process; and considering ways to make its packaging more consumer-friendly. 

No matter which goal a team pursues, taking time to plan strategies and tactics in advance will help ensure that it is achieved.  

It's important to periodically compare package designs with the reduce, reuse, recycle hierarchy that the Environmental Protection Agency advocates. For example, designers should ask whether the product's efficacy depends on the weight of the package. Even the smallest reduction in material thickness or weight can significantly decrease material costs, transportation costs, and greenhouse-gas emissions (see "Sustainability Surprises" in the September 2008 issue of 

Designers should also ask whether the package must be as large as it is. Shrinking the size of a primary package, even by a millimeter or two, not only reduces weight, but also decreases the size of secondary and tertiary packaging. This reduction allows more product to be stacked per pallet, potentially making a difference throughout the supply chain.    

Another criterion to evaluate is whether the package contains recycled content. If it does, perhaps more recycled content can be added. If recycled content is present, that fact should be noted on the package for consumers.  

Plastic-identification recycling codes help consumers increase recycling rates. PETE is polyethylene terephthalate, HDPE is high-density  polyethylene, V is vinyl, LDPE is low-density polyethylene, PP is polypropylene, and PS is polystyrene. (IMAGE IS COURTESY OF THE SOCIETY OF THE PLASTICS INDUSTRY.) 

Fiber-based materials such as corrugated shipping cases, paperboard folding cartons, and paper-based labels, lidstock, and inserts or outserts should be made from certified material. Third-party certifications to the standards of organizations such as the Forest Stewardship Council and Sustainable Forestry Initiative confirm that the pulp used in the packagingproduction process comes from responsibly managed forests.   

Packagers should seek to identify the biggest source of waste on the packaging line and discover how waste could be reduced. If preprinted material is the biggest source of waste, converting to a print-on-demand process might be cost-effective. Print-on-demand equipment is commonly available and includes various types of coders (e.g., laser, inkjet, and thermal-transfer) as well as label printers and applicators. Some units also can incorporate radiofrequency-identification-tag encoding modules to help drugmakers meet pedigree requirements.   

If the package is not commonly recycled, packagers should find ways to improve its recycling rate. When recycling, consumers tend to focus on packaging for foods and beverages and overlook containers for other products, which are equally acceptable in many collection programs. Perhaps consumers should be reminded about the container's recyclability through a message on the label or a recycling logo on the base of the package.   

The infrastructure supporting the collection of used packaging for recycling needs to be improved. Many trade associations are working to boost recycling rates. In addition, companies such as Estée Lauder's Aveda and TerraCycle have established creative programs to keep packaging material out of landfills.  

In cooperation with schools and its network of stores and salons, Aveda has organized a program to collect polypropylene closures from water, carbonated soft drink, detergent, and shampoo bottles. The program is designed to reduce litter, pollution, and the chance that birds, seals, turtles, and other wildlife might ingest the closures. The collected parts will be used to make new caps such as the 100% recycled-content dispensing closure Aveda began using in September 2008 for its new "Limited Edition Vintage Clove" shampoo.  

Supported by several brand owners, TerraCycle has organized a grassroots recycling network that collects empty drink pouches and cookie-package wrappers. TerraCycle cleans the material and uses it to make consumer products such as totes, pencil cases, umbrellas, and shower curtains.  

Reusing distribution packaging is another sustainable strategy. Coldchain Technology Services (Spring Branch, TX), a provider of logistics and consulting services for temperaturesensitive shipments, discovered that reusable insulated shippers quickly pay for themselves. Recyclable components also enhance the packaging system's sustainability profile ("Greenbox" insulated shipper, Entropy Solutions, Minneapolis, MN, see "Containers Insulate Companies from Product Loss" in the March 2008 issue of 

It is important for a sustainable package to identify itself. Consumers, retailers, distributors, wholesalers, pharmacists, and doctors want to know about the package and its environmental impact. Claims of sustainability should include supporting data. For example, a statement that a package is 20% lighter and reduces greenhouse- gas emissions by 16,000 tons per year is much more meaningful than a vague claim about an "improved," "more sustainable" or "new lightweight package." 

Improvements to packages and the packaging line

Packaging and packaging-line improvements begin with identifying the source of the greatest waste, inefficiency, or expense and looking for a better alternative. The alternative could be a simple, inexpensive fix such as arranging just-in-time delivery of packaging components, or it might require capital investment. 

Trade shows and conferences provide excellent opportunities to study design options and discover new ideas. Pharmaceutical packaging- related trade shows scheduled in 2009 include INTERPHEX (Mar. 17–19 at the Jacob K. Javits Convention Center in New York), the triennial NPE2009 (June 22–26 at McCormick Place in Chicago), and Pack Expo Las Vegas (Oct. 5–7 at the Las Vegas Convention Center in Las Vegas, NV).  

The pharmaceutical-industry trade show INTERPHEX, which is colocated with the Pharma MedDevice show, features numerous exhibitors dedicated to pharmaceutical packaging. In addition, a conference program offers information about productivity improvement, automation, isolator technology, counterfeit prevention, and pedigree solutions.  

An all-encompassing look at what's new in plastics will be presented at the NPE2009 International Plastics Showcase, organized by the Society of the Plastics Industry. With more than 2000 exhibits, it's a must-see event for anyone looking for innovations in plastic packaging, especially because it only occurs once every three years.  

Pack Expo Las Vegas is held in oddnumbered years and alternates with Pack Expo International. Pack Expo Las Vegas is a machinery-oriented show and will be the year's best opportunity to see packaging equipment in action. Despite the dominance of machines, containers and materials are well represented in their own pavilion and at the colocated Converting and Package Printing Expo. A concurrent conference at Pack Expo gives attendees the opportunity to hear experts discuss a host of subjects organized according to tracks such as sustainability, upgrading operations, and brand protection.  

In addition, several trade associations and educational organizations host conferences designed to help pharmaceutical packaging personnel improve pharmaceutical packages and packaging lines. These groups include the Institute of Validation Technology, the Parenteral Drug Association, Healthcare Compliance Packaging Council (HCPC), the International Society for Pharmaceutical Engineering, BIOTAQ, Compliance Online, and SWE Enterprises.  

Finally, a great deal of research can be done on the Internet. Google is always a good starting point or final double-check. However, packaging- or pharmaceutical-industry-oriented websites generally deliver searches with more targeted results. Packaging websites include those of events such as Pack Expo and publications such as 

Informative pharmaceutical websites include those of 

Pharmaceutical and Medical Packaging News.

Consumer-friendly design should always be near the top of the list of required features for pharmaceutical packaging. Today's rapidly growing population of people older than 60, the significant percentage of people with a limited ability to read English, and the high rate of noncompliance make it more important than ever to provide packages that open and reclose easily and help consumers take the proper dose at the proper time. In addition, packages must still provide child resistance to prevent accidental ingestion by toddlers and babies.  

Winners of HCPC's annual "Compliance Package of the Year" competition offered creative ideas. Several winners used a wallet-pack concept, including this year's top-prize winner: a lockable package for "Glipizide," a bloodglucose lowering drug from Watson Pharmaceuticals (Corona, CA). A removable key card unlocks and locks the package. The card can be left in place to simplify access in households without children ("Key.In" package, Nosco, Waukegan, IL). Another wallet pack, this one for Pfizer's (New York) "Champix Starting Therapy" smoking- cessation treatment, captured the first runner-up spot. Designed for the Mexican market, the four-panel wallet card neatly accommodates a patient leaflet and holds a two-week supply of the drug.  

The second runner-up in the HCPC competition, the "Effexor XR Flow Wrap" titration package from Wyeth (Madison, NJ), ensures that patients receive the Effexor antidepressant with a medication guide, as mandated by the US Food and Drug Administration. The packaging consists of blister-card and secondary-pouch packaging, plus a carton (contract packaging service, Sharp, Allentown, PA).  

A fourth prize, awarded in the "Innovative Design" category that recognizes packages that are not yet  commercial, honored a child-resistant bottle and closure. A mechanism in the push-and-turn closure dispenses one dose at a time and also lines up a dial to indicate dosage day and time ("NextBottle," One World Design and Manufacturing Group, Warren, NJ).  

Winners of the HCPC competition will be featured in the Showcase of Packaging Innovations at Pack Expo International on Nov. 9–13, 2008 at McCormick Place in Chicago. With more than 300 award-winning packages from around the world, the Showcase, which is sponsored by Dow Chemical (Midland, MI), provides the perfect opportunity to gather ideas for new pharmaceutical packages. 

 is Pharmaceutical Technology's Packaging Forum editor, 4708 morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, 

Planning ahead will ensure successful efforts to improve packaging and packaging operations.

To-Do List for 2009

Today, everyone wants sustainable packaging. Unfortunately, what's perceived as sustainable may not be the most environmentally friendly choice. Application and geographic location influence the environmental impact of the final package because of variability in the amount and combination of materials used, the availability of raw materials, postconsumer collection and recycling resources, and other factors.  

In addition to exerting minimal environmental impact, sustainable packaging also must be cost-competitive and functional, according to the Sustainable Packaging Coalition. 

It's no wonder that "packaging people are unsure what sustainable packaging is," says Patricia Enneking, director of global sustainability and environmental affairs at Klöckner Pentaplast Group (Gordonsville, VA). Klöckner makes polyvinyl chloride, polyester, and polylactide film and sheet, laminations, and barrier-coated structures used in packaging. "It's perception 

 reality," Enneking explains. People think that if a package is one of the following—recyclable, biodegradable or compostable, derived from a renewable source, or contains recycled content—it's sustainable, but focusing on a single feature may not necessarily result in the best package for the environment.  

What does consistently result in improved sustainability is weight reduction. Thus, a good rule of thumb is to maximize the product-to-package ratio. Reducing package weight conserves raw materials and energy and reduces discards and greenhouse gas (GHG) emissions. It also lowers freight costs throughout the supply chain. 

In fact, weight is such a significant environmental attribute that a lightweight package that isn't recycled may have an advantage over a heavier package with a high recycling rate. For example, the 2007 

 published by the ULS Report shows that coffee drinkers send more pounds of coffee cans than of coffee pouches to the landfill, even though steel coffee cans are recycled at a relatively high rate in the US and pouch packaging is virtually never recycled.  

Wal-Mart Stores is widely credited with jumpstarting the thinking on sustainable packaging when it set a goal to cut waste generation to zero by 2025. Its Packaging Scorecard, introduced in November 2006 and implemented in February 2008, requires suppliers to look at their packaging holistically by ranking it according to several criteria such as GHG or carbon-dioxide generation per ton of production, product–package ratio, cube utilization, recycled content, and recovery value. 

Table I: US recycling rates for common packaging materials. 

The Sustainable Packaging Coalition also advocates looking at the big picture. According to its definition, sustainable packaging has the following characteristics:  

Beneficial, safe, and healthy for individuals and communities throughout its life cycle 

Meets market criteria for performance and cost 

Sourced, manufactured, transported, and recycled using renewable energy 

Maximizes the use of renewable or recycled source materials 

Manufactured using clean production technologies and best practices 

Made from materials that are healthy in all probable end-of-life scenarios 

Physically designed to optimize materials and energy 

Effectively recovered and used in biological or industrial cradle-to-cradle cycles.

Is a recyclable package better than a nonrecyclable package? Maybe. As noted in the coffee-can example, extremely lightweight, nonrecyclable packaging may send less waste to the landfill. Drugmakers should consider a material's recycling rate and recycling infrastructure. If a recyclable package isn't actually collected and recycled, it will have just as much negative impact on the environment as a nonrecyclable package, perhaps more. 

Is it better to create packaging from renewable resources than from nonrenewable sources? Packaging derived from renewable resources such as trees and other plants slows the depletion of nonrenewable resources such as oil, steel, and aluminum. However, making packaging from food plants such as corn is not a sustainable practice if it reduces the food available for people or increases its cost. 

In addition, although the recycling infrastructure for fiber-based packaging such as paper and corrugated boxes is well established and those materials are recycled at a relatively high rate, recycling for biopolymers is virtually nonexistent. Even worse, the presence of biopolymers may contaminate the recycling stream of conventional polymers. Polylactide, for example, ruins recycled polyethylene terephthalate (RPET) at levels of less than one bottle per thousand, according to a study by PTI-Europe (Yverdon-les-Bains, Switzerland) for the Technical Committee of Petcore. 

However, it may be possible to obtain traditional polymers from renewable resources, which would be the best of both worlds. A joint venture is building a facility in Brazil to produce linear-low-density polyethylene from sugarcane-derived ethanol. The resulting resin, scheduled to be available in 2011, will be molecularly and functionally equivalent to traditional hydrocarbon-based linear-low-density polyethylene (Dow Chemical, Midland, MI, and Crystalsev, São Paulo, Brazil).  

Hybrid resins that combine petroleum content with renewable content also are appearing on the market. One polypropylene made of equal amounts of petroleum and starch injection molds, extrusion blowmolds, and thermoforms just like purely petroleum-based resin (Biopropylene, Cereplast, Hawthorne, CA). 

Are biodegradable materials better than nonbiodegradable materials? Not if they end up in a landfill. Modern landfills are designed to prevent decomposition. Thus, "biodegradable material in a landfill is of questionable value," says Enneking. Even worse, biomaterials that do degrade generate methane, a GHG with 23 times more heat-trapping power than carbon dioxide. According to the Environmental Paper Network, more than one-third of municipal solid waste is paper, and municipal landfills represent the largest source of human-related methane emissions. In fact, the US Environmental Protection Agency has identified the decomposition of paper as among the most significant sources of landfill methane. 

Are compostable materials better than biodegradable materials? Compostable materials are biodegradable, but not all biodegradable materials are compostable. Compostable materials decompose in commercial or home composting facilities in a matter of weeks without any negative impact. To ensure compostable packaging performs as expected, it should meet US or European standards for degradability in industrial composting settings (i.e., ASTM D6400 or EN 13432, respectively) or be certified by the Biodegradable Products Institute. Yet the extremely limited access to commercial or home composting facilities means that few compostable packages are actually being composted at present. 

Is packaging that contains recycled content better than that made of virgin material? Recycled content will significantly reduce costs and GHG emissions for packages made of aluminum, glass, and steel. In addition, these materials can be recycled repeatedly with no loss in properties. 

Infinite reuse of fiber- and polymer-based packaging may not be possible, however, because each generation tends to suffer a loss of properties. Still, technology continues to improve the properties of these recycled materials. As it does with aluminum, glass, and steel, recycled content in fiber-based and polymer packaging reduces energy consumption and GHG emissions. High percentages of recycled content are possible, too. Packaging with 100% recycled fiber content is commonplace and often marked with a special logo (100% Recycled Paperboard Alliance). Percentages of recycled polymers tend to be lower. But food-grade containers made of 100% RPET, a percentage once thought to be impossible, are on the market. 

Food-grade PET film with recycled content is available for use in thermoformed trays, clamshells, surface-sealed blisters, and other containers. Some films not only offer guaranteed levels of recycled content but also are produced with renewable energy ("SmartCycle" films, Klöckner Pentaplast). 

Recycling rates for most packaging materials are low in the US, compared with many other parts of the world. Rates range from about 20% for glass containers to 78% for corrugated boxes (see Table I). To raise recycling rates, collection rates must increase. Increasing collection rates would entail convincing business, government leaders, and consumers to view used packaging as a raw material rather than waste, improving the reach and efficiency of the collection infrastructure, and advancing sorting technology to increase the purity of sorted material streams. It's also necessary to address economic factors to ensure that collection programs generate income, or at least break even, rather than drain community resources. A particularly important goal should be to change consumer behavior to eliminate the reasons for not recycling such as laziness, inability or unwillingness to pay fees for curbside collection of recyclables, absence of curbside collection or convenient drop-off programs, and lack of collection points.  

Identifying the most sustainable packaging for a product is rarely a simple exercise.

Sustainability Surprises

In March 2008, when the California Board of Pharmacy postponed the deadline for compliance with the state's electronic pedigree (ePedigree) law from Jan. 1, 2009 to Jan. 1, 2011, members of the pharmaceutical supply chain breathed a huge sigh of relief. Few firms were prepared to comply. 

One company that could have met the 2009 deadline, privately held wholesale distributor H.D. Smith (Springfield, IL), began exploring pedigree options in 2005. Since then, it has conducted a series of pilot projects with select suppliers, customers, and vendors. "We are fully prepared to handle 100% serialization in Carson, California," reports Rob Kashmer, vice-president of information services at H.D. Smith, referring to the location of one of the company's distribution centers (DC).

At the moment, however, pedigree requirements involve extra handling and expense. For example, Florida ePedigree regulations require lot tracking. "This is not a normal process in our DCs, so it adds additional labor and complexity," says Kashmer. To meet Florida's requirements, H.D. Smith confirms each lot as it's received and assigns each lot number a specific location in the DC. This way, order fulfillment can be done by lot number. "There's also additional labor at order-verification stations," he notes, adding, "We do 100% outbound verification at all of our facilities to make sure the invoice and order match perfectly. In Florida, that means packers must look for the lot number on the product. [Currently,] very few are scannable."

SupplyScape software provides ePedigree records that list each stop a drug makes as it moves through the supply chain. 

To achieve the item-level serialization that would be necessary to meet California's ePedigree requirements, H.D. Smith has studied radio-frequency identification (RFID) and two-dimensional (2D) barcodes. Unfortunately, a "high percentage of product in the pharmaceutical supply chain has neither," says Kashmer.

In addition, H.D. Smith pilot projects have shown that both technologies currently involve additional labor and expense but don't contribute enough efficiency to the process for full-scale deployment. In fact, Kashmer believes that RFID, which doesn't require the line-of-sight scanning that barcodes do, has an advantage because it can automate receiving and order verification. However, only a small percentage of product currently needs a serialized code. For this reason, tagged and nontagged products must be handled separately; thus RFID also involves extra complexity, handling, and cost.

Nevertheless, technology that has no line-of-sight requirements offers many advantages. For retailers and hospitals, tagged product can not only automate receiving, but also confirm the correctness of prescriptions and locate misplaced product. At the consumer level, a smart medicine cabinet in the home could serve as a compliance aid by tracking when medication is removed from the shelf. The technology could potentially provide an alert when it's time to take a dose or a reminder if a dose is missed.

Of course, the prime reason for pedigree laws is product authentication to ensure that counterfeit product is not introduced to the supply chain. Pedigree information also can help identify cases of diversion.

The new product-authentication process did hit an early snag, though. H.D. Smith could not immediately authenticate the first order of "Viagra" it received with high-frequency 13.56-MHz tags. The order arrived in days, but Pfizer (New York) initially updated pedigree files once a week. Daily pedigree file updates now keep up with the fastest order-to-delivery cycle.

The RFID system at H.D. Smith required participation from numerous suppliers, including providers of hardware (e.g., conveyor portals, antennas, and readers) and software as well as a systems integrator (ePedigree software, SupplyScape, Woburn, MA), and systems-integration services (Franwell, Lakeland, FL). Not only must the components work together, they also must be easy to change. "We've probably changed hardware such as antennas and readers four or five times now as the system [and equipment] continues to evolve," reports Kashmer.

The wholesaler also wanted the system to integrate seamlessly with its warehouse-management system, which works in real time to accept orders and generate advance ship notices, order confirmations, and electronic invoices. As a result, H.D. Smith can send pedigree data to shipment recipients or allow customers to retrieve the data by interrogating its system.

As the industry prepares to meet the deferred California ePedigree deadline, numerous challenges remain, including the lack of federal requirements and the proliferation of different state requirements. "A lack of standardization is trouble," says Paul Baboian, senior RFID business-development manager at Zebra Technologies (Vernon Hills, IL), a supplier of RFID tags, printers, and services. Differing requirements mean exception handling, he explains, which reduces efficiency and increases costs.

To complicate matters for global companies, requirements in Europe are not uniform either. However, the European Federation of Pharmaceutical Industries and Associations (Brussels) recommends a unique serial number presented in the form of a 2D data-matrix code on each secondary packaging unit. The federation expects that the industry will eventually switch to RFID when the technology becomes practical and cost effective (1).

Also, consensus about basic questions has not been established. One of the questions is which type of data carrier should be used. Choices include linear and 2D barcodes, RFID, and manual data entry. RFID and 2D barcodes are the current favorites, and most observers predict that RFID will eventually dominate because it can be read without being in the scanner's line of sight. However, it also seems likely that 2D barcodes will continue to be used as a backup for the RFID tags.

Another unanswered question is whether a product's serialized code should include its National Drug Code (NDC), lot number, and expiration date. Including the product-identifying NDC raises privacy concerns and increases the potential for theft. On the other hand, encoding the NDC provides quick identification, potentially saves network traffic, and eliminates the need to refer to a database.

Whether serialization should be performed by the packaging converter or on the packaging line has yet to be determined. With RFID, tagging is more likely to occur on the packaging line, although a few converters currently offer source tagging. One technology under development applies an RFID antenna to an in-mold label during the injection-molding process (RFID in-mold label, Alcan Global Pharmaceutical Packaging, Kirkland, Canada). Barcodes are easily applied at the converting and packaging-line stages.

One drug plant in Ireland laser codes 300 serialized, 2D barcodes per minute on the bottom of plastic vials. The system consists of an ultraviolet laser, material-handling system, integrated vision system to verify code accuracy and traceability, and software to capture data and maintain ePedigree records (material-handling system, FP Developments, Williamstown, NJ; vision system, Cognex, Natick, MA; "ProTrack" software and systems integrator, Crest Solutions, Little Island, Ireland).

Another 2D barcode system integrates a carton-feeding system with an inkjet printer and vision system to apply and inspect serialized codes. The validated portable unit can be moved from line to line (serialized barcode system, Nutec Systems, Lawrenceville, NJ).

Members of the pharmaceutical supply chain also will need to find networks, servers, and computer systems with the necessary bandwidth to accommodate the huge amounts of data associated with item-level serialization. Trading partners will have to find ways to share data. Three standards established by GS1 EPCglobal (Lawrenceville, NJ) should help, including the programmable 96-bit electronic product code number known as the Global Trade Identification Number, the EPCglobal Information Services (which standardizes XML-based data exchange), and the GS1 EPCglobal Pedigree Messaging Standard.

The goal of pedigree efforts and laws is to ensure a safe supply chain free from counterfeit product. Some companies only seek compliance. Others view pedigree implementation strategically. Indeed, once product serialization and pedigree record-keeping are in place, previously unavailable supply-chain data can be used in many beneficial ways. For example, one manufacturer increased revenue by halting a parallel trading operation that was diverting product sold overseas into the United States.

Serialization also offers the potential for faster, more precise, and less costly recalls than are currently possible. Recalls tend to be a largely manual process. "You never know if you're done," says Peter Spellman, senior vice-president of products and services at SupplyScape. "A pedigree system can immediately tell you how much of an affected lot was on hand and where it was sent," he explains. "What normally takes days can be accomplished in 15 minutes," he concludes.

Other advantages of serialization include improved inventory management, particularly expiration-date management, expedited payment, and efficient processing of returns.

Although members of the pharmaceutical supply chain can assemble their own systems, some suppliers have collaborated to offer a turnkey solution. Products include the "California Express Solution," which consists of enterprise software from HP (Palo Alto, CA), preserialized packaging from Nosco (Waukegan, IL), ePedigree software from SupplyScape, a packaging-execution system from Systech International (Cranbury, NJ), the "PharmaTrack" serialized distribution solution from Acsis (Marlton, NJ), and serialization strategy and services from VeriSign (Mountain View, CA).

Solutions for electronically capturing pedigree data at various supply-chain points are being brought to the market. One system that supports linear barcodes, 2D barcodes, and RFID tags is available in tabletop, conveyor-mounted, and mobile-cart configurations. The system creates the initial ePedigree; aggregates items into cases, totes, pallets, orders, and shipments; verifies the ePedigree and completeness of incoming goods; updates the pedigree of items being shipped; and provides quarantine or special handling ("Blue Vector Serialization Station," Blue Vector Systems, Palo Alto, CA).

Decisions about suppliers must be made soon to ensure timely delivery and implementation. Waiting 8, 12, or 16 months to place an order could easily double or triple lead times because of order volume.

Although counterfeit prevention is the goal of pedigree requirements, it should be noted that serialization and tracking must be supplemented by physical authentication features because it is "inevitable that serial codes from legitimate product will be copied and used on counterfeit product. The capability to authenticate both the serial code and the physical item quickly, definitively, and in the field will be a critical component of a complete product surety initiative" (2).

1. "Identification and Coding of Pharmaceutical Products in Europe," position paper, European Federation of Pharmaceutical Industries and Associations, Brussels, June 2008.

2. J. Rittenburg, "Authentix Comments to the European Commission, Enterprise and Industry Directorate-General, Pharmaceuticals," European Commission, Brussels, May 7, 2008.

Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.

Saved by the Delay

Attendees and exhibitors seemed happy to return to Philadelphia for the annual INTERPHEX trade show Mar. 26–28, 2008, after a three-year run in New York City. Traffic in the aisles was steady, and exhibitors reported high-quality leads.  

Attendees looking for packaging innovations found something in every aisle. All facets of packaging were represented, from the beginning to the end of the line. Special emphasis was placed on sterile filling, barrier materials, quality control, and anticounterfeiting measures. Although the California e-pedigree deadline was postponed from Jan. 1, 2009, to Jan. 1, 2011 immediately before the show opened, pedigree solutions were also well represented and will be discussed in detail in August's Packaging Forum. 

Integrating closure treatment with an isolator-equipped filling system simplifies delivery of sterile stoppers to the sterile filling line. After stoppers are treated, an elevator lifts the closed vessel in place to dock it with the isolator. A rapid transfer port ensures a sterile connection. Programmable logic control and an identifying chip hard-wired in the vessel track stoppers to ensure they are ready for use and are correct for the product. The lift, which is constructed entirely of stainless steel and specially sealed, is cleanroom compatible and handles 30–300-L vessels (stopper processing, vessels, transfer station, and "Atec Lifting Device," 

Low energy electron-beam (e-beam) technology used in the food industry for surface decontamination also can sterilize the outside of syringe tubs before they enter an isolator. The e-beam system eliminates the use of hydrogen-peroxide vapor, links directly to the isolator, and handles as many as six tubs per minute. Three such systems have been installed, one each in Switzerland, Italy, and the United States ("E-Beam Tunnel," 

Operators working through glove ports can be the limiting factor on sterile filling lines. Sanofi-Aventis (Paris) has boosted line productivity 100% by installing a six-axis robot on a syringe-filling line at its vaccine plant in Le Trait, France. The robot also reduces operator exposure to toxic products and repetitive-motion injuries. The ISO Cleanroom Class 4 (Class 10 under US Federal Standard 209E) robot features a smooth surface coating, lip seals at joints, internal lines and connections, and a round, smooth base. It also withstands hydrogen-peroxide vapor sterilization ("Stericlean TX60" robot, 

The "Stericlean TX60" cleanroom robot from StÃ¤ubli withstands hydrogen-peroxide vapor sterilization. 

Because cleaning packaging lines is time-consuming and companies must protect operators from exposure to toxic chemicals, interest is growing in disposable product-contact parts. Commonly used on the processing side in the biotechnology industry, disposable product-contact parts on vial-, ampul-, and syringe-filling lines can eliminate hours of cleaning and validation work while increasing line flexibility and uptime. A single-use product path also cuts changeover time and utility and cleaning-agent consumption while minimizing wastewater generation, cross-contamination, and the capital investment in stainless steel parts. 

The first prevalidated, preassembled, and gamma-sterilized system consists of positive-displacement rolling diaphragm pumps, needles, and other product-contact parts. The system meets US Pharmacopeia standards. Accompanying documentation certifies sterility, extractables and leachables levels, and the shelf life of the product-contact parts, which come double-bagged and ready to install with sterile plug-and-use connections. Used parts are generally incinerated ("Prevas Disposable Dosing System," 

The "Prevas Disposable Dosing System" from Bosch Packaging Technology. 

Cyclo olefin polymer (COP), a material relatively new to pharmaceutical packaging, is capturing companies' interest because it it is less brittle and more moldable than a related resin, cyclic olefin copolymer, which is used to make syringes. COP can also be used to make vials, bottles, and push-through blister packaging. COP exhibits high transparency, low interaction from protein adsorption, low water-vapor transmission rate, and low residual-metals content. Diluent in COP containers is less likely to experience a pH shift than is diluent in glass and other materials. COP also is compatible with steam, ethylene oxide, and gamma sterilization ("Zeonex" COP, 

A four-ply laminate for cold-formed blister packaging combines the light and moisture barrier of foil with enhanced dent resistance and draw depth. The laminate contains 60 μm of polyvinyl chloride (PVC), 25 μm of nylon, 45 μm of foil, and 60 μm of PVC. Polyurethane laminating adhesive ensures that the layers resist delamination. To meet branding, tamper-evidence, and compliance needs, the outer layer of PVC can be reverse printed in as many as 10 colors on a rotogravure press ("Cold Form 4000" foil laminate, 

"Zeonex" cyclo olefin polymer resin from Zeon Chemicals is suitable for syringes and other types of pharmaceutical packaging. 

Another foil laminate makes chevron and four-side-seal pouches that peel cleanly yet provide maximum product protection ("Sure-Peel" pouch laminate, Reynolds).

Expanded capacity for polychlorotrifluoroethylene film helps meet growing demand from pharmaceutical packagers for barrier film. The clear film supports compliance initiatives because it shows whether a dose has been taken ("Aclar" film, 

 Films, Morristown, NJ). To help design optimum blister structures, enhanced analysis software helps compute the total cost of candidate materials. Software also can help fine tune designs and line speeds to minimize material consumption and maximize line output (thermoformed packaging analysis, Honeywell).  

Quality control begins with package design, and it can be difficult to manually track all the changes that occur between concept and printing. A web-based artwork-management system, used by Merck & Co. (Whitehouse Station, NJ) in Europe and Mylan Pharmaceuticals (Morgantown, WV), automates this process for generic pharmaceuticals. The system complies with 21 

 Part 11, provides a complete record of changes, and prevents errors. The software gives drugmakers control over the artwork at all times and provides access to authorized parties such as printers and contract packagers. Because sign-off occurs online, the system is particularly suitable for multisite operations and eliminates the expense and time involved in sending documents by courier ("GL-AMS Global Artwork Management System," 

Another full-range system combines software and vision technology to automate proofreading, prepress doublechecks, color matching and counterfeit detection. Applications include regulatory affairs, clinical-trial labeling, packaging development, document development and prepress, customer and vendor proofing, print-plate inspection, production-document inspection and incoming inspection. Text-verification software identifies deviations between combinations of electronic files and physical output, including proofs, bluelines, plates, inserts, and labels. The personal computer-based system locates, marks, ranks, and tabulates disparities greater than a specified size and contrast. Because the operator only has to check deviations instead of performing a complete visual inspection, efficiency increases nearly 100% ("Avia Proofreading," "Avia Prepress," "Avia Color Matching," and "Avia Private Eye" anticounterfeiting modules, 

The European Union requires Braille writing on pharmaceutical packaging, and quality-control companies are working on automated contact and noncontact methods to verify the presence and correctness of these codes. Because dot height is critical to legibility, the law requires dots to be 0.02 mm high. One system that uses a contact method to check dot presence, location, and accuracy relies on a pen-like micrometer to measure and verify dot height. The system complies with 21 

 Part 11 and includes a validation package that features installation-qualification, operational-qualification, and performance-qualification documentation ("Braille Suite," including "Digital-Page" with "Scan-TVS," "Docu-Proof," and "BraillePoint" modules, 

A nondestructive leak detector for empty or full vials and syringes reportedly exceeds the performance of the standard dye microbial-ingress test because it pinpoints multiple flaws smaller than 1 μm. To identify integrity problems, the vacuum-based system detects vapor or gas release at levels as low as 0.1 μL. The tester currently checks one syringe in a 10-s cycle, but a model that can handle multiple syringes is being built ("VeriPac 325/LV" leak tester, 

Counterfeit drugs are a continuing problem, and they are rampant in some parts of the world. As counterfeiters become more sophisticated, new measures are needed to stymie them. 

High-precision laser technology permanently marks foil with fine-line graphics, text, logos, or other microimages during the rolling process. Marked foil is virtually impossible to duplicate and can be made in almost any gauge or alloy. It also converts, lacquers, laminates, coats, prints, and slits like standard foil ("CPI Security Foil," 

Another high-tech solution creates a digital fingerprint of the packaging for later reference by capturing an image of a specific area at speeds as fast as 15 items/s. The digital image can be stored in a database, converted to a numerical code, and printed as a two-dimensional barcode to serve as the unique item-level identifier required for pedigree records. Authentication is possible at any point in the supply chain using a handheld reader–verifier ("Biometric Authentication," 

Cortegra's "Biometric Authentication" transforms information embedded in the structure of a package into a digital signature more distinctive than a fingerprint. 

Nanomolecular particles incorporated into paper, adhesive, ink, or other packaging material offer counterfeit protection at a cost of fractions of a cent. The tiny particles function as a synthetic DNA and can be detected and read by a proprietary scanner to authenticate products instantly ("Nano-molecular Forensic Marking System," 

 (Las Vegas, NV), a drug repackager that provides medication in 10- to 30-count packaging for dispensing in physicians' offices, recently began using packaging with invisible markers to prevent counterfeiting and fraud. "Authentication is very important for our industry, and this solution allows us to aggressively confront the issue of counterfeit products that risk innocent lives," says Sam Haddad, vice-president of operations at Med-Health Pharma. 

Low levels of tiny mineral markers can be added to virtually any packaging component or material. The markers can be incorporated into ink, toner, varnish, paper pulp, plastic, adhesives, and metals. Detection and authentication are accomplished with a special reader tuned to the mineral and particle level. The marker and reader can provide various levels of security, including basic pass–fail authentication, and can capture and verify a particle image ("Traceless System," Kodak Security Solutions, 

Security labels, tapes, bags, seals, and pallet-protection devices from a cargo-crime specialist protect unattended assets. Multiple technologies such as microprinting, special adhesives, and sequential numbering provide a layered solution. Security-tape options include silicone coating with a reverse-printed sequential number every 9 in. to prevent undetected removal and replacement of the tape. A numbered clip that crimps on at the intersection of two bands of pallet strapping incorporates a similar approach (tamper-evident labels and tapes, "Topp-Clip" pallet protection, 

Another company that advocates a layered approach to product security offers overt, covert, forensic, and track-and-trace technologies such as fine-line printing, color-shift coatings, holograms, infrared-and ultraviolet-detectable taggants, and fluorescence ("N'Crypt" overt and covert printed security features, other security features, 

A permeable, flexible, spunbonded polyolefin allows users to pack more desiccant in less space than is possible with the traditional rigid plastic desiccant canister. The flexible container is printed with the message "Do Not Eat" in several languages. The unit was created from a single web of material in a patent-pending form–fill–seal process. It maintains the same diameter as the rigid canister and handles the same way on high-speed dispensing equipment. Because the flexible canister is shorter, it occupies less space and represents a weight savings of about 50%. The cost of the form–fill–seal design is comparable with that of a rigid canister. The flexible design eliminates the dusting and lost caps that sometimes affect a rigid canister. Desiccant options include silica gel, clay, and a 50/50 silica gel–clay blend in 1–3-g sizes. All components are classified acceptable for food contact under 21 

A fifth-panel carton design involves applying the product insert to the inside of the panel during the carton-conversion process, thus eliminating the need to apply it on the packaging line. Once the carton is erected, the scored panel seals the insert in place. A die-cut window displays the barcode on the insert for quick identification ("Insert 2.0," 

New products for sterile filling, quality control, and anticounterfeiting measures gained notice.

Innovations at INTERPHEX: Part 2

The annual INTERPHEX trade show returned to the Pennsylvania Convention Center in Philadelphia, Pennsylvania, this year and presented its usual rich mix of processing and packaging innovations. Attendees interested in packaging found new ideas on the show floor during the event, which took place Mar. 26–28. 

Packagers looking for cold-chain management solutions, barrier materials, productivity-enhancing tools, reusable pallets, or contract packaging partners were well rewarded.  

New barrier materials included clear structures. A three-layer polyvinylidene chloride–polyvinyl chloride (PVdC–PVC) film provides an ultrahigh barrier to oxygen and water vapor. The high-crystallinity PVdC dispersion in the middle layer also delivers higher barrier properties. Compared with conventional PVdC-coated films, the symmetrical structure exhibits excellent mechanical stability. Blister packages that incorporate the film reportedly lay flat and are handled smoothly by cartoning equipment. Available in transparent clear and opaque colors, the multilayer film thermoforms in the same temperature range as monolayer PVC. The low coefficient of friction of the PVC outer layers prevents blocking in preheat plates and ensures a consistent material flow during thermoforming. The film is ultrasonically sealable to vinyl without coatings and heat-sealable to all standard vinyl-compatible lidstocks ("Pentapharm alfoil E S03," 

Barrier films optimized for medical-device applications combine rigid polyethylene terephthalate (PET) glycol with an Aclar laminate. The choice of Aclar laminate determines the level of barrier properties. Designed for applications that combine a medical device with a moisture-sensitive pharmaceutical such as a prefilled syringe or inhaler, these films seal to all standard polyester- and vinyl-compatible lidstocks. The products are compatible with gamma, e-beam, and ethylene oxide sterilization and available in high-gloss clear and transparent colors ("Pentamed Aclar PA 300/12," "PA 200/12," and "PA 190/12" rigid barrier films, Klöckner Pentaplast).  

Inksure's handheld reader authenticates items by scanning covert barcodes printed on packaging or documents. (COURTESY OF INKSURE) 

A competitor to Aclar structures provides a high barrier to water-vapor transmission. The PVdC-based films also offer a good barrier to oxygen. Options include PVdC–polyethylene (PE)–PVC, PVdC–PE–polypropylene, and PVdC–PE–PET structures. The films also can incorporate security elements ("Perlalux-Tristar Ultra" film, 

Data loggers are one way to monitor shipments and provide alerts to shippers if temperature-sensitive products are exposed to excess heat or cold. One data logger relies on a USB port for configuration and data output. The system monitors multiple trips during a 400-day period, captures 16,000 temperature data points between -35 and 70 °C, and supports compliance with 21 

 Part 11 requirements. An "X" or check mark in the corner of the screen instantly shows whether the product experienced acceptable conditions during the trip. An integral report generator presents the collected data as a PDF file and eliminates the need to install and qualify report software. Reports may be viewed, printed, e-mailed, or stored on a network ("PDF Datalogger," 

Drugmakers seeking contract packaging services had many exhibitors to visit. One new 30,000-ft

  facility offers aseptic vial filling and manufacturing that complies with current good manufacturing practices (CGMPs), plus a development area with multiple manufacturing and containment suites. The aseptic vial-filling line is designed to fill containment and high-potency products and will initially focus on filling small-molecule drugs. Designed for clinical supplies and niche commercial manufacturing, the operation includes a qualified, 60-ft

Easy-to-clean, multitrip aluminum pallets from LM Containers can be customized to user specifications. (COURTESY OF LM CONTAINERS.) 

A stainless-steel accumulator–single filer moves small vials at rates faster than 800 vials/min. The patented conveying system handles vials as small as 2 mL with virtually no back pressure ("Infinity Rx" accumulator–single filer, 

Life cycle management software manages each step of a label's lifespan, including design, review, approval, printing, updates, revisions, and obsolescence across multisite operations. Software is compatible with barcode and radio-frequency identification labels and provides the comprehensive security and audit logs required for compliance with 21 

 Part 11. An XML interface enables seamless integration with enterprise resource planning, product life cycle management and other enterprise systems ("ROBAR Enterprise Label Management System," 

Stainless-steel operator interface mountings improve efficiency, ease of use, and cleanability in sensitive pharmaceutical environments. Tightly integrated display and keyboard enclosures feature an industry-standard articulating arm for counterbalanced vertical adjustment and ergonomic flexibility. Durability and superior construction reduce data inaccuracies and unnecessary downtime ("MiniStations" operator interface mounting system, 

Statistical quality-control software for the packaging process integrates checkweighers, metal detectors, statistical balances, and other data-collection devices into a network. Test stations also can be established to measure and record product attributes such as cap torque, label placement, and lot numbers to unify all aspects of the quality process in one program. Extensive report and dashboard capabilities simplify the monitoring of important functions. An audit-trail module helps meet the requirements of 21 

 Part 11 for electronic signatures, data management, and traceability. The program also can be provided with a full set of validation protocols to ensure CGMP-compliant monitoring ("FreeWeigh.Net" software, 

"EQPac" software from Mettler-Toledo Hi-Speed expedites checkweigher qualification. (PHOTO: COURTESY OF METTLER-TOLEDO HI-SPEED.) 

Software also can help expedite the equipment-qualification process. A fully documented process for checkweighers, for example, adheres to good testing and good documentation practices to deliver accuracy and consistency ("EQPac" software, Mettler Toledo Hi-Speed).  

Tablets and capsules are printed in a programmable, noncontact process to provide a readily visible, pill-level method of product identification and differentiation. The 12-lane system relies on an inkjet printer and pharmaceutical-grade black ink. A vision system provides 100% inspection ("EAM Tablet/Capsule Printing Machine," 

, Long Island City, NY, "Industrial Print System," 

Machine-readable covert codes serve as a product-authentication tool and help prevent counterfeiting and diversion. Two-dimensional barcodes carry item or batch-level information and can be printed by existing equipment. Resulting codes are invisible to the naked eye and under ultraviolet light but are readily identified with an easy-to-use, handheld reader ("TrackSure" technology, 

Reusable steel or aluminum designs might be the answer for pharmaceutical manufacturers who want to eliminate wood pallets to comply with repair, cleaning, waste-disposal, or phytosanitary requirements put in place to eliminate the transport of woodborne pests. Metal pallets provide the highest strength-to-weight ratio, are fire-resistant, easy to clean, recyclable, and compatible with temperature extremes.  

Heavy-duty aluminum pallets do not rust, feature sturdy welded construction, are easy to clean and sanitize, withstand high-temperature steam, and are nonabsorbent, thus easy to dry. Standard sizes include 40 × 48 in., 42 × 48 in., and 48 × 48 in. and 800 × 1200 mm and 1000 × 1200 mm with two- or four-way forklift access (aluminum pallets, 

A lightweight, flame-retardant, 48 × 40 × 5.5-in. steel pallet reportedly ranks as first in meeting the capacity and compatibility standards of the Grocery Manufacturers Association. At 63 lb., the rust-resistant galvanized steel pallet weighs about 10 lb. less than a standard wood pallet. The product offers superior racking strength with more than 3500 lb of unsupported racking capacity and 40,000 lb of static load. Welded construction increases durability, reduces chances of damage, and helps maximize the number of trips the pallet can make before it is recycled. As a result, the steel pallet is said to cost less per trip than wood or plastic pallets ("Steelpac" pallet, 

Stoppers, dosage cups, and other products

A fluorinated polyester coating fused to ultraclean rubber provides an inert stopper material with minimal levels of extractables and leachables. Available in ready-for-sterilization and ready-for-use formats, the barrier-coated, silicone-free stopper runs freely through equipment and provides maximum seal integrity even after exposure to storage temperatures of -78 °C ("Omniflex3G" stopper, 

A stock dosage cup for general and pediatric markets features readily visible milliliter and teaspoon calibration lines printed in black with food-grade ink. Printed lines permit more accurate measurement than engraved or embossed lines on traditional translucent dosage cups. The units also may be printed with custom calibrations, instructions, and logos. Cups fit over child-resistant closures ranging in diameter from 22 to 24 mm ("AccuCup," 

A sanitary benchtop filler combines cleanroom design and touch-screen controls with servo-driven pump technology. Designed for developmental and short-run needs, the compact liquid-filling system can be equipped with piston, peristaltic, or lobe pumps to handle many viscosities. Fill sizes range from less than 0.05 mL to more than 1 L with ±0.5% accuracy (sanitary benchtop filler, 

Additional packaging news from the show floor can be found at 

. Meanwhile, it's not too early to begin thinking about participating in INTERPHEX 2009.  

The annual show provided one-stop shopping for packaging equipment and materials.