FEATURE
Joyce Laird
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Photo courtesy of MULTIVAC
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Evolving market demands are forcing medical packaging professionals to reconsider basic design issues. The home care industry, for example, is fuelling demand for patient-administered drug-delivery systems, which can prove challenging to package. In addition, the movement toward environmental accountability has reached the medical field, posing the question of whether “green” packaging materials can meet the stringent safety requirements inherent in health care.
Bringing devices and drugs together
When a medical device is bundled with a pharmaceutical, the whole package must meet drug-packaging requirements. Possible differences in the device’s and the pharmaceutical agent’s shelf lives also must be taken into account. In addition, the chosen packaging material must withstand sterilisation requirements without compromising the pharmaceutical’s potency. Other concerns include solvent loss, water-vapour absorption contamination and exposure to light and reactive gases such as oxygen. Regulatory requirements include stability studies of package design, selected materials and sterilisation methods.
With regard to drug-eluting or biomaterial-coated implantables, United States Food and Drug Administration (FDA) and European Union regulators specify quality-control requirements that often greatly exceed the rigours of standard package-integrity testing. One reason for this is that drugs and biological materials may be unstable under certain conditions. They also may have unique shelf-life and safety considerations. For example, packaging for drug-eluting or biomaterial-coated devices generally must be composed of materials providing photostability and a high level of moisture and thermal protection. In addition, this packaging cannot compromise the device’s biocompatibility.
To simplify the packaging of combination products, one strategy is to first package the drug and device separately, each with their own package and sterilisation format, and then place them in a kit for final packaging. The kit itself then will require hermetic sealing and sterilisation.
Another strategy is to sell and package the device and the pharmaceutical agent separately, but with detailed guidelines explaining how the two parts should be used. This has been the traditional method for insulin injection for diabetics, where syringes and vials are sold independently. Packaging specific amounts of drugs with an application device, however, is meant to address two issues. First, it keeps cost down on the packaging end. Second, it prevents misuse on the part of home users, because, if they only have the drug amount that is specified, the drug cannot be under- or overused.
Consider the big picture
To deal with the unique packaging considerations of combination products, drug-eluting devices and so forth, it can prove helpful to partner with a packaging company that can take a big-picture view of your requirements. As a service innovation consultancy, PDD Group Ltd, (London, UK) prides itself in considering the complete product experience, including designing the product itself, the primary packaging, the secondary packaging and the instructions for use, explains Alun Wilcox, Director of Medical at the company. “Having the ability to develop all of these elements with a single dedicated team ensures a unified, homogenous solution,” he adds.
“To be viable for the consumer to use correctly, the package design has to be simple to use and understand,” says Craig Wightman, Design Director of Kinneir Dufort (Bristol, UK) while addressing home care packaging. In this case, you don’t have the luxury of tapping into the training of a medical professional.” Kinneir Dufort is a design company that works closely with the initial manufacturer to bring new concepts and technology to the health care market.
Stressing sterilisation
Another important issue is sterilisation. Ronny Debaere, Global Marketing Manager at Vitalo Packaging (Meulebeke, Belgium) says all sterilisation methods have a positive and negative side for combination or biomedical device packaging.
Sterilisation requirements are a major concern with the development of packaging for combination products, says Don Handrow, Senior Design Team Leader at Prent Corp. (Janesville, Wisconsin, USA). The company is a certified global manufacturer of custom thermoformed rigid plastic packages, trays and components for the medical industry.
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The Model 830 heat sealer from Accu-Seal includes a control box, seal head and touch screen that enable precise placement of components while packaging.
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Sterilisation compatibility is always a critical consideration for determining medical or pharmaceutical packaging materials. “At times, there is a need to sterilise the product with the use of two sterilisation techniques,” Handrow explains. “In many cases, it may be necessary to find materials that can withstand two or more types of sterilisation without compromising the integrity of the commodity they are protecting. It is vital for device manufacturers to understand the effects that various sterilisation methods have on drugs and biomedicals and this often can help determine which packaging materials are acceptable.”
Although polyethylene terephthalate (PETG) and Tyvek are common materials for device packages, a combination package may need a high-barrier film such as polychlorotrifluoroethylene (PCTFE) and foil lidding. Another choice is to add special coatings to Tyvek to make it more compatible with combination packaging.
“There are certain materials that cannot be gamma sterilised because it breaks down the material,” says Joseph F. Scanlan, Vice President, Business Development of Surgical Technologies Inc. (St Paul, Minnesota, USA).“On the other hand, EtO sterilisation uses a lot of heat and ethylene oxide is a penetrating gas,” he says. “So, if you have a lot of little holes in the barrier, it can get trapped inside and that’s not good.” Whichever sterilisation method you select, you need to validate it, Scanlan adds. “Before you pick one, you have to make sure that all the materials you plan on using will be stable under that method. Generally, we look at barriers in materials with our engineers, our micro-biologist team and also with the support of the material suppliers.”
Going green
Many new packaging materials are being developed that are designed to be eco-friendly and still protect both the final product and the end user. Though most have limited application in the area of medical packaging, some are gaining wider use in basic consumer goods packaging.
“We continue to see the development of materials trying to break into the medical market,” Handrow says. “Historical data and validation costs slow the adoption of these materials in the market,” he adds.
Some alternatives for rigid packaging have existed for a while, and though not the major reason for their development, they are environmentally friendly. One example of this is the use of polyethylene terepthalate (PET) to replace poly(vinyl chloride) (PVC).
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Specialising in thermoforming, Vitalo Packaging develops packaging for a range of medical devices as well as surgical and pharmaceutical equipment.
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Although not yet able to withstand the sterilisation methods needed to replace rigid medical packaging materials, corn-based polylactic acid is being studied. Experiments have been conducted using this material in prototype packages for some pouch and blister applications. Rigid packaging needs even more integrity than this material can supply.
While waiting for chemists to develop the next breakthrough in rigid biodegradable materials, recycling may seem like a more obvious strategy to make medical packaging more friendly. Recycling materials such as PET, PETG, high impact polysytrene, PVC and recycled PET scrap and blending it back into new extruded material has obvious environmental advantage but most end users of medical packaging balk at using recycled material. Although some companies are allowing the use of recycled materials in blister packaging, recycling continues to be used the most often in nonmedical consumer packaging.
Scanlan says that he sees where recycling could be effective, if the quality of the recycled product was absolutely ensured. “Recycling Tyvek from a hospital environment can be tricky because there could be biocontamination,” he says. “You have to be extremely thorough in doing precleaning and sterilisation before ever reusing the product.” Of course, the more energy that goes into prepping materials for recycling, the less green and more costly it is.
“Zero default rate requirements and needed stability in the production process are among the major deciding factors to opt for virgin material,” Debaere adds. “Unfortunately, the source of recycled material isn’t traceable most of the time, if it’s sourced externally, and limited availability of uncontaminated recycled material is an issue.”
Another eco-trend is to simply reduce the amount of packaging material used for medical device applications. Handrow notes that the ability to decrease packaging depends on the product that is being packaged. “Often too much material reduction causes more problems and cost increases through packaging failures than creating the correct package in the first place.” While not closing the door to this trend, Scanlan notes that there are some inherent dangers when you start thinning down materials. “You can run into certification and validation issues,” he says. “It’s important to be sure that the packaging still is doing its job.” Package integrity is everything, he stresses. “You make the tray thinner, but then all it needs is one little push on a weak curve and the product dimples or cracks,” he warns. “Once the seal is broken, that product is not sterile anymore.”
Patient safety always must be the device manufacturer’s priority and the packaging is part of that. Scanlan notes that this is why there are so many highly complicated and expensive medical and surgical devices that are designed for a single use. “[Medical professionals] would rather use them once and throw them away regardless of cost, just to make sure it is safe,” he says.
Addressing ergonomics and safety
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Prent Corp. developed a thermoform package featuring a sterile pewter case with inner plastic presentation trays. The new design safely presents delicate radioactive products to the surgeon for
use in prostate-cancer radiation therapy.
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Though packages must maintain sterile integrity, they also need to be easy to open. This is particularly important for surgical applications where sterile packaging is critical; at the same time, getting to the device, which can often be small, needs to be easy because speed and accuracy are essential. One solution is to create custom container-packs that protect each individual product, but still provide for easy removal.
Consumer packaging ergonomics is another significant challenge, Wightman says. “More and more pharmaceutical products have child-resistant requirements.” He points out that a 70-year-old patient with severe arthritis may have poorer dexterity and motor skills than a four-year-old child. “As designers, we need to look for opening methods that rely partly on cognitive skills, based on knowledge and experience to achieve the appropriate balance of protection.” Wightman adds that, from the design end, a package can help with a multistep application where the consumer may have to follow several steps to complete the application.
The growing number of self-administered drug kits also results in a great need for patient friendly packaging that provides extremely detailed instructions. Whether a medical kit or single dose/unit packaging for accurate dispensing, manufacturers agree that delivering critical information to the patients is a priority.
Valeska Haux, Marketing Director of Multivac (Wolfertschwenden, Germany) believes that to find true solutions to patient safety, more information about the product should be on the package, preferably in multiple languages to serve global markets. “The packaging system has to provide sufficient flexibility for the fast-changing market requirements using prints, leaflets, folding boxes and so forth,” he says.
Consumer safety and product integrity go hand in hand. “To ensure safety when developing a package, it is important to take into consideration issues such as the closure of the product, tamper evidence, anticounterfeiting features, serialisation possibilities, child-proof aspects as well as recall prevention,” Haux says.
The equipment side
As the medical industry seeks improved, more-durable materials for packaging their products, they also are looking for packaging machines that offer extreme accuracy and secure operating parameters.
All of the changing materials and the different packaging designs must be put together properly, says Lesley Jensen, General Manager, Accu-Seal Corp. (San Marcos, California, USA). The company designs and manufactures heat- and vacuum-sealing machines for sealing flexible pouches for medical packaging. “The first question we ask is what is your pouch material?” Jensen says. Other important variables are the kind of product going inside it: “Is it a solid, liquid or a powder?” Jensen asks.
Luc van de Vel, Director, Business Unit Medical Consumer Industries at Multivac, notes that when products with biomedical coatings are packaged, their sensibility can lead to special requirements for temperature, radiation and mechanical impact of the packaging material. Multivac, services the global market with customised packaging equipment, systems and lines as well as services for packaging applications in life sciences. The company specialises in creating thermoforming as well as vacuum and modified atmosphere packaging.
The future
Innovations in packaging materials and techniques have served to make medical packaging safer, easier to use and potentially greener. Despite these advances, the main drives are the same. Medical packaging It has to meet the needs of the end customer, comply with regulatory requirements for the global market and still come in within a budget so that the initial manufacturer can show a profit and therefore, continue to advance technology.
