Digital healthcare, the opioid crisis and updates to ISO standards for medical packaging headlined our pharmaceutical and medical coverage in 2019. Based on page views, here are the top three articles of the year related to pharmaceutical and medical device packaging:
In 2020, the EU Medical Device Regulation will go into effect. Here in the U.S., ISO 11607 and ISO TS 16775 standards for packaging of terminally sterilized medical devices are being updated.
Notable changes include:
• A provision that directs packagers to complete a documented usability evaluation for aseptic presentation in either a real or simulated-use environment.
• The stipulation that designs allow for easy and safe handling and…prevent microbial contamination, and that the integrity of that packaging is clearly evident to the final user.
• Formal inclusion of risk management.
• A new annex on ways to differentiate a sterile barrier system from protective packaging.
• A new section on visual inspection.
• A section on design changes and validation.
• A revised section on process validation that includes the new concept of a process specification.
• A new annex on environmental aspects according to ISO and CEN guidance.
The U.S. Food and Drug Administration (FDA) is seeking packaging solutions—such as fixed-quantity, unit-of-use blister packs—to help prevent opioid abuse as allowed by the new Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities regulation, which is better known as the SUPPORT Act.
One of the last articles published in 2018 presented three new examples in this area.
The best-read healthcare packaging related article of 2019 on PackagingDigest.com looks at how the trend of digital devices in healthcare will impact the packaging requirements. Two pharmacists on the Faculty of Pharmacy at Clermont-Ferrand in France thoroughly explain the market drivers, then focus on primary and secondary packaging that can enhance distribution safety, improve compliance and perhaps offer an alternative for drug manufacturing.
Other popular articles from co-author Dr. Pascale Gauthier, who is known for her impeccably researched and detailed reports, include:
“5 advances and packaging trends in the beauty universe” published in May 2017.
“The Asian influence and digital mutation in cosmetics packaging” published in July 2018.