Note: This is the first article of a three-part series covering medical plastics packaging (1) trends, (2) material/process advances and (3) applications.
In terms of the future, experts say medical packaging will be dramatically different by the end of the next decade. Medical device and pharmaceutical packaging will become easier to use, less costly to produce and provide much better protection in the future.
These significant changes in medical packaging in the coming decade will strongly impact the materials used in medical packaging. Many forces in alternative drug delivery methods, advances in interactive medical packaging and possible future legislation to require drug packaging to carry tactile (Braille) information are already laying the groundwork for this transformation.
Additionally, the industry will be reaping benefits from the adoption of sustainable packaging practices. Beyond these changes it is only a matter of time before someone comes up with a concept that ends the struggle to open child-resistant containers.
To start with, the rapidly-changing healthcare industry is continually driving development of alternative drug-delivery systems including oral film, nasal spray and inhalation delivery. Such drug delivery systems significantly impact medical packaging material requirements as the packaging function is shifted from a passive to active one.
Factors driving these changes in medical delivery methods are pharmaceutical companies' needs to extend the commercial life of patented drugs, the need by physicians to improve patient treatment/compliance, and added benefits that accrue to patients by facilitating drug delivery. Drugs delivered by these alternative technologies — especially those that are biologic based — are typically sensitive to moisture, oxygen and light and thus require high barrier packaging.
A proliferation of inhaled drugs is expected to drive development of new inhaler concepts. One alternative method offering much promise is pulmonary drug delivery via pMDIs (pressurized metered dose inhalers).
For example, pMDIs provide diabetes patients with a convenient alternative to the needle injection form of insulin. Aspira, a breath-actuated inhaler commercialized by Medicom, includes an integrated dose-counter, which can record up to 300 individual doses, important for people who have difficulties tracking their medication and can help with patient compliance issues.
Next, in the coming decade, medical packaging will become more interactive, impacting the materials used in medical-packaging applications. Software is being employed for applications such as the data collection, storage and analysis required, supporting track-and-trace capability and pedigree records.
In the U.S., the Food and Drug Administration (FDA) is encouraging that each primary package produced should carry a radio frequency identification (RFID) tag with a unique code. Tags activate packaging line operations, such as labeling, provide data for pedigree records, and help track and trace product through the supply chain to prevent counterfeiting and diversion.
Intelligent shelves and storage cabinets will communicate with the tag, permitting automated inventory tracking in hospital and retail settings. This concept has been introduced to the home where tags will interact with smart medicine cabinets or other devices to increase patient compliance by providing visual or audible alerts regarding dosage times, refill reminders or other information.
In concert with printed electronics, nanotechnology and related nanomaterials, RFID tags will provide on-package tools to alert customers/consumers if a product is out-of-date, has been tampered with or encountered temperature abuse. Low-cost talking packages will also be able to communicate information about product side effects or interactions, as well as provide reminders about dosage times.
Continuing, the European Union has pioneered and required drug packaging to carry tactile information about product name, dosage and expiration date to aid sight-impaired consumers (EU 2001/83/EC). This legislation has spread beyond the EU globally.
While embossing can provide this information, a glue dot dispensing system can apply 0.5-millimeter characters on any substrate. One such system from Nordson Corporation, which consists of an adhesive melter, "e.dot" dispensing gun, and Braille code pattern controller, is capable of interpreting multiple languages into Braille.
The adhesive used for Braille dots is customized to the package substrate, (aluminum, glass, and paperboard), dispenses precisely and dries to a nontacky finish. The clear adhesive dots do not interfere with package graphics and do not deteriorate over time.
Let's now focus on the many new drugs coming onto the market that are based on chemistry previously thought to be too unstable for commercialization. Thanks to new formulation and packaging technologies, some of these molecules are being reintroduced into drug product formulations.
Medical packaging engineers increasingly need to work with formulation chemists to understand the specifics of the compounds they are packaging. A range of sorbents are increasingly used to avert chemical and/or physical degradation from occurring in the pharmaceutical package. These sorbents can be customized to eliminate oxygen from the packaged environment while managing free moisture and maintaining a specific equilibrium relative humidity, critically important to ensuring the integrity of certain new drug compositions.
For formulations used in new dry-powder inhaler systems a moisture-management system is needed to prevent the drug product from becoming hydrated and the particles agglomerating, or clustering together while also avoiding excessive drying that could promote static charge of particles and compromise the performance of the device.
Building further, terminally sterilized packaging harmonization is a technical market driver in medical plastics packaging. The International Organization for Standardization (ISO) has revised ISO11607 "Packaging for Terminally Sterilized Medical Devices," to harmonize it with the European Committee for Standardization (CEN) EN 868-1, "Packaging Materials and Systems for Medical Devices Which Are to be Sterilized."
The revised ISO 11607 is divided into two separate sections: "Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems," and "Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes." This latest revision takes into consideration the changes and advances in both technology and regulations in the medical device industry.
The Sterilization Packaging Manufacturers Council (SPMC), a section of the Flexible Packaging Association in the U.S., has condensed the complex requirements of the standard and associated guidance document into a two-article series with the first part exploring two critical areas: design inputs and the selection/evaluation of materials. Also analyzed is the design of the sterile barrier system and associated protective packaging, packaging process feasibility evaluation/optimization, and sterile barrier system design feasibility.
In the second article, system elements of package and process validation are explained under three subsections: validation of sterile barrier system manufacturing processes, final packaging system design validation, and revalidation.
Finally, RFID mandated legislation is advancing. The FDA, in recent anti-counterfeiting reports, once more promoted the adoption of RFID for the pharmaceutical supply chain globally. The agency encouraged all drug manufacturers to pilot RFID on their highest-risk or highest-volume product.
Institute of Packaging Professionals
Medical packaging security measures currently used or considered by respondents.
States are also continually advancing their efforts to protect the supply chain with electronic pedigree (ePedigree) laws for drugs. California's pharmaceutical product serialization and ePedigree law has been implemented right through to the drug wholesaler level.
The law requires pharmaceutical/biotechnology manufacturers to provide serialized identification on prescription drug products and to produce ePedigrees as part of electronic supply chain records. Each organization handling the drug at each stage of the supply chain must update the record. This ePedigree will track each drug at the smallest item level with a unique serial number and must be in an electronic format (e.g. RFID or variable bar codes) that is interoperable throughout the supply chain.
Drug pedigree requirements are already in place in Florida and other states. However, California's extensive requirements and status as the most populous state are expected to have a ripple effect throughout the pedigree movement.
The California law has impact far beyond California. Many manufacturers, for example, will not know which units will ultimately be shipped to California, as their drugs are shipped to regional distribution centers that in turn ship to customers in numerous states. In instances where the final destination is unknown, ePedigrees may be needed for all manufactured product shipped to that distribution center.
