Note: This is the third article of a three-part series covering medical plastics packaging (1) trends, (2) material/process advances and (3) applications.

Within the broad expanse of medical package development there are several simultaneous medical packaging challenges that always need to be taken into account. The development of innovative packaging starts with a complete understanding of the device or pharmaceutical, the packaging material and end-user requirements.

Behind every life-enhancing, state-of-the-art medical device or pharmaceutical product is a packaging system that must perform as designed to maintain device sterility and/or drug quality throughout the distribution life cycle. As medical/pharmaceutical original equipment manufacturers (OEMs) advance the leading edge of technology, engineers responsible for the packaging of medical products are challenged to implement innovative packages.

Modifications to packaging systems are frequently based on improving the medical device or drug’s usability, product protection and delivery, and customer interaction. To guarantee packaging development success, OEMs must review user requirements and thoroughly examine the characteristics of the medical product to be packaged.

In the end, these studies will provide the satisfactory specification of the medical package and its materials.

Oliver-Tolas Healthcare Packaging
Variables impacting packaging requirements.

Let's start with the scope of medical packaging performance. Packaging design and development engineers often work under strict cost considerations and tight product launch timelines. These cost/time pressures, and resource limitations together with established specifications often lead to insufficient evaluation of alternate materials.

Product characteristics and packaging needs are overlooked, causing medical products to be inadequately packaged. Underengineered packaging systems can produce package validation test failures and field issues necessitating product withdrawals and customer perception concerns regarding quality, safety and product efficacy. Overengineered packaging systems are more difficult to recognize and tend to remain hidden or are neglected. However, it impacts the end-user in terms of product presentation, storage considerations and waste disposal.

Overengineered medical packaging also influences medical product OEMs, increasing material, processing and shipment costs. Such hidden costs can accumulate over the medical product life in the end impacting the profitability of both the medical product OEMs and medical care providers.

Next, let's look at materials for medical packaging application strategies by taking with Klöckner Pentaplast’s aggressive growth strategy as a good example. A world leader in rigid plastic films, Klöckner Pentaplast (KP) manufactures films for the packaging of pharmaceutical and medical devices, foods and other products, as well as for specialty applications.

With its high-quality films, superior technical expertise/support and its global manufacturing platform, KP has developed a strong international market position with strong performance. The company has an aggressive strategy for internal growth, expansion and acquisitions. It was founded in Montabaur, Germany in 1965 and now has European and American divisions with operations from 25 facilities in 13 countries, primarily Germany, the U.S., the Netherlands and Switzerland.

The KP Group has always believed in being close to its customers in order to fully understand their requirements and ensure the highest quality of product and services. Over the last decade, the group has expanded into new markets through internal growth and by seven strategic acquisitions, particularly in Asia and South America, achieved leadership in the PET market and strengthened the company’s position in polyvinyl chloride (PVC) in the European and North American markets.

It has also invested in new facilities in Thailand and Russia to take advantage of the growth potential of these markets and is now pursuing the growing demand for pharmaceutical and specialty films in India. A good example here that has worked out is the KP Group purchase of the Gwalior/Malanpur, India, PVC films and sheet production from Supreme Industries of India.

Klöckner Pentaplast
Klöckner Pentaplast pharmaceutical films.

Continuing, Oliver-Tolas Healthcare Packaging’s innovative sterile packaging materials strategy is noteworthy. Oliver-Tolas Medical is a leading medical packaging supplier concentrated on development of innovative sterile-grade packaging materials.

A fully commercialized Oliver-Tolas development is Ovantex, the first sterile grade alternative to Tyvek material available for medical packaging. Ovantex and Osurance (the name selected to rebrand an earlier zone coated lid product) were coined using an "O" word to reinforce the visual and verbal brand theme "Only Oliver" has "Inventive Products," which has been strategically displayed throughout Oliver's marketing efforts over the last two decades as follows:

  • Only Oliver is said to provide the unique family of inventive products, superior adhesive, flexible customer service, and expert support to medical device manufacturers globally.
  • Only Osurance zone coated lid product unites optimal zone coverage, Oliver’s select Xhale adhesive/sure-seal DotCoat technology, and dependable seal integrity.
  • Only Oliver roll stock creates consistent peelable seals (rigid and flexible substrates) with a wider sealing window (±20°C versus competitors' ±8°C).
  • Only Oliver supplies expert packaging engineering and validation support to its medical device manufacturing customers.
  • Only Oliver's proprietary Xhale adhesive features superior anchorage for difficult lidding. Lids coated with Xhale adhesive seal to silicone PETG (amorphous copolyester, or PolyEthylene Terephthalate, Glycol modified) trays, provide wider seal temperature ranges, and create a superior seal window, allowing validation.
  • Only Oliver preformed pouches/pouches on a roll are available in Ovantex, Tyvek, foil, film or paper for ethylene oxide (EtO), radiation and autoclave sterilization.

Oliver-Tolas quality policy.

It is said that medical packaging applications 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 over 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.

In conclusion, materials are definitely meeting new medical packaging challenges. No material is flawless, and all can profit from some sort of improvement. This notion is what keeps materials scientists busy in their labs. It is also what contributes to the flood of developments in medical packaging materials, many of which are plastics.

Offering packaging design flexibility, multiple useful properties and a wide range of processing operations, plastic materials often play the role of problem solver in medical packaging applications.

Recent obstacles that have challenged medical packaging and design engineers include sterilize barrier packaging demands, and the need for improved oxygen-barrier performance of thermoplastic elastomers. In each case, various types of plastic materials and compounds have risen to the occasion to provide the elusive answers.