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Security, the environment, aging populations, the bio-boom, and cost control are just a few of the drivers that will influence pharmaceutical packaging for the remainder of this decade.
From now until the end of the decade and beyond, pharmaceutical packaging will be affected by seven trends: widespread counterfeiting and diversion, increased environmental consciousness, growth in biotechnology products, influential retailers, aging populations in developed countries, increased access to healthcare in developing economies, and the ever-present need for cost control to preserve margins and keep medication affordable.
To adapt successfully, packaging professionals in the pharmaceutical industry must be prepared to adopt technology to track and protect products moving through the supply chain, leave a smaller environmental footprint, improve stability-enhancing packaging, expedite the package-design process, enhance senior-friendly and compliance features, boost packaging-line flexibility, reduce costs, and increase efficiency.
Radio-frequency identification (RFID) tagging to simplify shipping, receiving, inventory location, and control has been mandated by the Department of Defense, Wal-Mart stores (Bentonville, AR, www.walmart.com), several other retailers, and various hospitals. Already in use on an escalating number of shipments, RFID tagging eventually will be required by nearly all retailers and many hospitals.
RFID will be impossible for packaging professionals in the pharmaceutical industry to avoid because it also can carry and collect the data needed to track and trace product through the supply chain, prevent counterfeiting and diversion, and meet pedigree requirements.
Technological developments should make it possible to install economical, multifrequency readers before the end of the decade. This will end the debate about which frequency is best for pharmaceutical applications and eliminate the need to standardize on either ultrahigh or high frequency industry-wide, thus allowing each company to adopt the frequency best suited to its operation.
RFID tags also can be coupled with sensors to monitor conditions during shipping and storage and provide alerts if parameters are exceeded. Dual-function tags that couple RFID with temperature sensing already are available and cost significantly less than traditional devices for temperature monitoring. One example integrates a sensor, microchip, battery, and antenna on a paper-thin label. It operates at 13.56 MHz ("TempSens" smart label, KSW-Microtec, Dresden, Germany, www.ksw-microtec.de).
Another application for RFID is to monitor patient compliance. Tagged blisters record when doses are taken ("Med-ic" electrical compliance monitor, Information Mediary Corp., Ottawa, ON, Canada, www.informationmediary.com). This type of smart sensor label–equipped blister package is being used by the National Institutes of Health (Bethesda, MD), for a multiyear study of chronic obstructive pulmonary disease that will involve nearly half a million individual doses of medication.
As the pendulum swings toward higher environmental consciousness, sustainability will be the theme song no one will be able to get out of his or her head. Sustainability embraces not only the recycling and waste-reduction imperatives of the last environmental era, but also the sourcing of renewable materials and minimizing greenhouse-gas generation, water use, and energy consumption.
Wal-Mart, one of the driving forces behind RFID implementation, also has embraced sustainability. President and CEO Lee Scott announced the company's "Sustainability 360" program in February 2007 during a keynote address at the "Business and the Environment Programme" hosted biennially in London by the Prince of Wales. Wal-Mart's initiative relies heavily on suppliers as well as customers, communities, and employees. "It is the responsibility of every corporation to be more sustainable," Scott said.
The all-encompassing Sustainability 360 program sets high expectations for suppliers, who are required to participate in the retailer's "Packaging Scorecard" rating system. The system compares packaging in each product segment according to greenhouse-gas generation per ton of production, product–package ratio, cube utilization, recycled content, recovery value, and design innovation. The ratings will help identify best practices, enable the sourcing of products with the most environmentally benign packaging, and achieve the retailer's goal of a 5% reduction in overall packaging by 2013. "The impact of this packaging effort will be equal to removing 213,000 trucks from the road and saving about 324,000 tons of coal and 67 million gallons of diesel fuel per year," said Scott. "This is great for the environment. But there's also a business advantage—and a pretty big one. We believe this effort could save the global supply chain nearly $11 billion. Our supply chain alone could save $3.4 billon."
The Sustainability 360 program also includes an ethical-sourcing initiative that calls on suppliers to reduce their own environmental footprint. The retailer already has dedicated 200 workers to monitoring ethical sourcing and has begun auditing suppliers' performances related to activities such as processing, recycling, and disposing of solid waste. The company makes recommendations for improvement and reviews progress.
Another new program, "Global Innovation Projects," will encourage suppliers to reduce their dependence on nonrenewable energy in making their products.
As the number of relatively delicate biotechnology-based products expands, the demand for barrier packaging, seal-integrity test equipment, insulated distribution packaging, and cold-chain monitoring tools will grow. With some products costing thousands of dollars per dose, companies have little room for error in packaging, transportation, and storage. Proper handling can be especially challenging in developing countries where refrigeration may not be readily available.
The need for senior-friendly packaging has been discussed for decades. Unfortunately, senior-friendly products often are not child-resistant, so some seniors ask younger neighbors to come over when they need to open a medicine bottle. Now that the over-85 age group is the most rapidly growing segment of the population in many developed countries, and members of the baby-boom generation are reaching their sixties (an age when many people begin taking multiple prescriptions each day to treat chronic conditions), it's time to bring new senior-friendly solutions to market. Companies also should design packaging with better compliance aids to help people take their medication correctly, especially when they are managing more than one prescription.
Improvements in senior-friendly and compliance packaging also will benefit all consumers.
Because cost control directly affects the bottom line, it is essential for any successful company. It is especially important for organizations that make substantial investments in research and development and are in highly regulated industries in which compliance consumes a significant number of resources.
Typical cost-control measures include careful specification and sourcing of packaging materials and may encompass strategies such as downgauging or lightweighting materials, standardizing sizes, and minimizing the number of variations.
When sourcing equipment for the packaging line, companies should carefully consider machine efficiency, labor requirements, and changeover time. In fact, attention to changeover can pay off quickly, because downtime costs easily can add up to thousands of dollars per hour. Major time savers include servo motors, drives, and controls that automate physical adjustments, toolless adjustments and part-changes, quick-connect–disconnect hardware, and clean-in-place equipment (although the latter may not be applicable for solid dosage forms).
Other strategies include standardizing changeover procedures, storing change parts in order of use on dedicated change-part carts, color-coding change parts, and equipping anything measurable with a scale so settings are repeatable. On higher-speed lines, it can be helpful to incorporate features such as redundant labeling heads to quickly replace an empty label roll. The unit simply switches to the second labeling head, and the empty head can be refilled while the line is running. An enlarged carton magazine provides a similar benefit by reducing the number of times the operator must refill it.
Robots (and robot-like devices) also increase flexibility of packaging equipment, thus reducing changeover to a push of a button to change the recipe. More-complex changeovers may necessitate the replacement of one end-effector with another, but it may be possible for the robot to perform this activity without any physical intervention from the operator. Even if the operator must assist, the tooling change is not likely to require more than a few minutes.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, email@example.com