FDA Issues Guidances for Medical Device Transition Plans

05 Apr 2023
Aditya Panwar

The FDA’s Center for Devices and Radiological Health (CDRH) has issued two final guidance documents to assist with transition plans for medical devices that were issued emergency use authorizations (EUAs) or fall within certain enforcement policies issued to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic.

ISO 11607-2:Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

04 Apr 2023
Komal Sharma

Packaging for terminally sterilized medical devices should be designed and manufactured to ensure that the medical device can be sterilized and remain sterile under-documented storage and transport conditions until the sterile barrier system is damaged or opened.

ISO 11607-1:Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

04 Apr 2023
Komal Sharma

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain the sterility of terminally sterilized medical devices until the point of use.

It applies to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

Amcor wins Packaging Excellence Award for environmental performance and shelf appeal

03 Apr 2023
Press Packagin…

Amcor (NYSE:AMCR, ASX:AMC), a global leader in developing and producing responsible packaging solutions, today announced that it has earned a Flexible Packaging Association (FPA) Silver Achievement Award for its AmPrima™ PE Plus recycle-ready pouch for Lahli™ Morning Protein Bites.

The honor was announced at the FPA’s Annual Flexible Packaging Achievement Awards Competition in Amelia Island, Fla.

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Amcor launches enhanced heat seal coating healthcare packaging solution

31 Mar 2023
Komal Sharma

 

ACT2100™ will provide enhanced performance; available worldwide to offer enhanced business continuity and shorter supply chains.

Amcor introduced ACT2100™ heat seal coating for medical grade DuPont™ Tyvek®2 and paper packaging applications. This next generation coating technology delivers enhanced performance features for healthcare applications and will be produced in multiple locations worldwide to offer customers increased flexibility to be supplied from the most suitable location for the manufacturing and packaging of their devices.

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One year of digital print folders: hubergroup Print Solutions takes stock

30 Mar 2023
Press Packagin…

About a year ago, ink manufacturer hubergroup Print Solutions launched the digital print folder for its offset portfolio, which is intended to enable customers to benefit from faster and more efficient production, among other things. Now the international ink specialist is taking stock: according to hubergroup, the reaction of customers to the digital solution was consistently positive, and they were impressed by the high colour accuracy that is possible thanks to the integration in the company's own colour management system HDCC.

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