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MedTech Outlook | Tuesday, May 17, 2022
It is not surprising that so much time and attention is spent on both the product and its packaging in an industry where comprehensive process control ensures compliance and patient safety.
Fremont, CA: The medical device sector is frequently recognized for its ongoing innovation and evolution. However, even the most revolutionary medical device technology is useless if its functionality and integrity are not safeguarded. In order to assure the safe distribution of medical items, the burgeoning medical packaging business is in stride with medical device innovation.
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Alternate methods for advanced medical packaging
With the rapid development of medical packaging, original equipment manufacturers (OEMs) are seeking creative solutions and remedies for current flaws. The packaging materials of the past are failing to satisfy modern demands, failing to meet the needs of the end-user, and failing to ensure patient safety. End users are increasingly aware of potentially hazardous substances, such as bisphenol A (BPA) and styrene, seeking alternatives that exclude them. Even original equipment manufacturers (OEMs) are aware that future legislation could restrict the use of particular materials, and some wish to anticipate these prospective legal changes.
Concerns about styrene continue to grow, particularly when it is utilized in medical packaging designed to house gadgets. Under the Environmentally Preferable Purchasing standards of numerous healthcare systems, styrene packaging has been flagged as a safety and sustainability risk. Concerns are increasing globally regarding the usage of polystyrene (PS) in the same types of applications. Due to the potential risk associated with particulate contamination, some are currently searching for alternate materials, particularly for implanted or fluid-path medical device applications. This is sufficient to convince some to consider alternative solutions.
Material providers are addressing these challenges by developing alternate solutions to supply alternatives. A specific copolyester, for instance, can be utilized as a styrene-free alternative to high-impact polystyrene (HIPS). It can be thermoformed and utilized to create opaque medical packaging, reducing the occurrence of particles and angel hair by a considerable amount. It is far less brittle than HIPS and can reduce package failure in the field while preserving the vital sterile barrier. Whether for vital cardiovascular devices, orthopedic implants, or the handling of biologics, the cost-effective material — manufactured without materials of concern such as BPA, orthophthalates, and polyvinyl chloride — can increase performance and reduce the total cost of ownership (TCO). This is a benefit over some of the brittle HIPS alternatives, which may shatter after sterilization due to a decline in performance.
In addition, sheets extruded from the copolyester can be thermoformed, trimmed, and sealed using the same machinery as HIPS. For example, the created copolyester takes less processing energy, which frequently results in greater throughput. This affords more chances for enhancing process efficiencies and developing more environmentally friendly packaging.
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