Originally Published IVD Technology October 2003
Packaging and labeling materials and components
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| A full line of devices is available from Dry Pak Industries Inc. (Studio City, CA) for monitoring the temperature of products in storage and in transit. |
Imagine that the R&D department of a major diagnostics company has developed an extremely accurate and reliable IVD test for a profitable application. The engineering team has devised a cost-effective setup for high-throughput manufacturing. The quality assurance department can inspect 100% of output for guaranteed quality of the shipped product. Marketing has a brilliant strategy for market penetration and branding, and the sales team, already trained, is energetic and very excited about the new product.
And then the company has to postpone the product launch by six months because a label bearing important information keeps peeling off. Or worse, it is forced to recall the product because moisture protection is inadequate and the clinical trials are revealing false negative readings. Or perhaps the company receives news of consumer focus groups complaining about strange odors coming from the plastic tube used to package the diagnostic strips.
Such nightmares, of course, are unlikely to happen, because major IVD manufacturers also are staffed with teams of packaging engineers who are involved in product development from the infancy of the project, and who make sure that package components perform as required and are thoroughly tested. These specialists will have contributed to the scenario in the first paragraph by developing a package design that suits the product uniquely, and yet is cost-effective with regard to component costs and packaging-line speed. Like their colleagues in R&D, they are governed by an ISO- and FDA-compliant quality system.
Product packaging generally must serve four functional purposes: product protection, dosage dispensing, user safety, and information delivery. In IVD packaging, protection and safety are undoubtedly the most important considerations. However, most packaging components and package designs serve more than one function. Aspects of dispensing and information conveyance should not be neglected in package design; they are important for achieving goals in product differentiation, brand recognition, and overall consumer satisfaction.
Protection
IVD chemistry is becoming more and more complex. Consequently, IVD products are increasingly sensitive to environmental factors such as humidity, atmospheric chemicals, and microorganisms. Their requirement for mechanical stability is their need for protection against incursions of moisture, oxygen, chemicals, odors, particulate matter, microorganisms, heat, light, and ultraviolet (UV) radiation.
Sophisticated IVDs depend on moisture control because moisture can affect them in ways that limit shelf life and degrade quality tremendously. Desiccant products are called for here. Desiccants for IVD applications are available as packets, canisters, tablets, cap inserts, stoppers, and polymer blends. Two companies supply desiccant polymer blends that can be molded into virtually any shape and size. Caps of fertility or pregnancy test kits, or even complete IVD housings, can be molded from such materials in order to provide moisture protection.
The type of desiccant used, and the specific product, should be chosen carefully. The level of performance required, insertion processes, packaging preferences, and cost are all important considerations.
Oxygen is another quality-damaging and shelf-life-reducing agent IVD products may encounter. Oxidation reactions are common for IVD chemicals and substrates. Up to this time, oxidation damage has been minimized only by using expensive high-barrier packaging materials (to block oxygen) and modified-atmosphere packaging, or MAP. But suppliers are now working on developing oxygen absorbers that can be incorporated into IVD packaging as easily as moisture or odor absorbers. A critical factor in this quest is that an oxygen absorber for IVD applications must be efficacious at humidity levels as low as 0%, which is a problem for most products on the market now.
Other airborne substances can also negatively affect the reliability, shelf life, or consumer acceptance of an IVD product. These contaminants may come from the external atmosphere or may result from packaging component
outgassing. Components of the IVD product can themselves be a source. Barrier materials or absorbers specially designed to deal with a particular type and source of contaminant can be incorporated into packaging to overcome contamination problems. Available absorbers include activated carbon, special zeolites, and combination products called two-in-ones that battle moisture and odors at the same time.
Proper protection from the damaging effects of light and UV rays can be ensured when appropriate packaging materials are chosen. These include black rather than white polypropylene for tubes and housings, and grades of polymer that feature UV protection and stabilization. Protection from particulate contamination can be best achieved by developing airtight packaging solutions, by limiting product exposure to particles during packaging operations, and by testing all packaging components—especially absorber sachets—for excessive levels of particulate contamination before assembling them into a package.
Quite a few IVD products are heat sensitive and require storage within a certain temperature range to remain functional. To achieve this in most cases, explicit instructions for storage are included in the product labeling, while the package itself requires no special design treatment. IVDs that require cold-chain distribution are another story, however. For these, specialized packaging concepts are available that incorporate heat protection elements such as insulation, a cooling reservoir, and active cooling components.
Dispensing
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| For 25 years, Odessa Packaging (Clayton, DE) has manufactured machines for the in-house packaging of small items, liquids, powders, and granulars. |
Dispensing functionality is becoming increasingly important for some types of packaged IVD tests. A suitable dispensing system controls dosage of test units without cumbersome and time-consuming handling. A straightforward example is the monodosing of test strips from a tube such that the risks of losing strips and of contaminating them by touching more strips than are actually used at one time are eliminated. This dispensing technology also makes the use of instruments such as forceps or gloves for removal of strips unnecessary.
Dispensing features generally make IVD products more user-friendly and improve consumer appeal. From this standpoint, adding a dispensing feature to an IVD package can be regarded as a tool for marketing and product differentiation.
Safety
FDA requirements for IVD packaging are not as restrictive as those for pharmaceuticals because IVDs are not intended to be ingested. Also, there is virtually no risk that an improperly packaged IVD product would directly cause serious injury or death. However, even if they are not meant for ingestion and cannot directly harm consumers, some IVDs nevertheless could be misused by children who mistake them for food or candy. Thus, adding child resistance to the packaging of such products, and of those that contain toxic chemicals—as well as to alluring types of packaging such as tubes, bottles, and vials—can improve product safety and minimize liability.
Another safety consideration in designing IVD packaging is the use of tamper-evident technology. In times of terrorism and global insecurity, this feature of packaging becomes increasingly important for food and pharmaceuticals, of course, but also for some IVDs. It is not difficult to imagine the consequences of a panic caused by numerous false positive results for a life-threatening disease that were brought about through ill-intentioned manipulation of a standard test-kit batch. Fortunately, tamper evidence is a standard feature of most bottle and vial caps and some tube closures, and can thus easily be incorporated into an IVD package design.
New regulations designed to increase the safety of IVD products have been or will be adopted by the European Union (EU) and FDA. FDA currently is discussing a regulation concerning mandatory use of bar codes on IVD products. The EU has issued an update to its GMP requirements that mandates stricter rules for labeling, and validated labeling management for both manufacturers of final products and suppliers of IVD components.
Information
Packaging also usually is a medium for providing information to clinicians and consumers. Product identification labels are the most basic components that convey information, while printed tubes and housings are more sophisticated solutions—not to mention whole booklets incorporated into special labels. Printed information in association with the product is partly required by regulations and partly necessary to ensure proper use of the IVD product by the consumer. “Information” in the broadest sense of the term is also any branding and any printing or labeling whose purpose is product differentiation.
Multifunctionality
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| Süd-Chemie Performance Packaging (Belen, NM) offers a variety of protection options for diagnostic packaging, including tubes, desiccant stoppers, canisters, packets, and polymers, as well as custom dispensing and protection solutions. |
Products and components to fulfill all the packaging requirements just enumerated are available from various suppliers. This edition of the IVDT Buyers Guide lists more than 70 suppliers that serve the IVD industry. Packaging and labeling materials and components are organized into 11 convenient categories in the following grid: bottles and vials, clamshells and blisters, closures and lids, desiccants and sterilants, display packaging, films and foils, labels, pouches and bags, rollstock, shipping containers, and trays. Many listed companies are also identified as contract manufacturers or suppliers of stock items.
Just as all complete IVD packaging solutions fulfill several necessary packaging functions, so, too, do most packaging components.
Bottles, vials, tubes, ampules, and jars serve mainly to provide mechanical protection. However, at the same time they offer defense against particulate contamination, light, moisture, oxygen, chemicals, and other deleterious challenges. A packaging solution with properties appropriate for the sensitivity of the IVD chemistry can be based on any of a wide variety of containers. These components need to be complemented, of course, by the right cap, stopper, lid, or other closure. In addition to their protection function, containers and closures can also bring product safety and dispensing capabilities to the final package.
If less-rigid packaging is called for, flexible films and foils are the choice. Besides mechanical protection, these materials offer barriers to light, chemicals, moisture, and oxygen. Important considerations for manufacturing with films and foils are their sealing characteristics and adhesive properties. Clamshells and blisters have features similar to those of films and foils, but also allow for easy dispensing.
Desiccants, oxygen absorbers, odor absorbers, and sterilants clearly have a protective function. With display packaging, on the other hand, the information function is at least as important as the protection. Labels, as suggested before, are mainly informational in purpose, but they help to meet regulatory requirements as well, and thus can be regarded as a safety feature of packaging. As a standard matter, labels should incorporate chemically inert inks, coatings, and adhesives. Labels in close proximity to IVD chemistry additionally must exhibit low outgassing of volatiles and moisture.
Exciting new IVD devices with more and more sophisticated chemistry, and biochemistry, are being developed every day. To keep up with these developments, new packaging designs and components are being created at the same pace, and feature interesting new functionality.
A potential fifth function of packaging may be intelligence. The most widely accepted definition of intelligent packaging is packaging that facilitates the transfer and exchange of information between the IVD device and the consumer. Such a capability is useful for identifying the device and the patient, for verifying compliance with a treatment and testing plan implemented by a clinician, and for automatically transferring test data to a storage medium. Many new IVDs already incorporate microchips. In years to come, the world will surely see increasing numbers of IVD packaging solutions containing intelligent
features.
Stefan Dick, Süd-Chemie Performance Packaging (Belen, NM)
Copyright ©2003 IVD Technology
