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Medical Plastics Packaging Trends Keep Expanding

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.

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.

For example, pMDIs (pressurized metered dose inhalers) 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.

In the U.S., the Food and Drug Administ-ration (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.

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.

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.

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