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Aseptic/Sterile
Aseptic/Sterile: Page 2
Sustainability
FDA Continues Support of Innovation in Medical Device Sterilization
U.S. Food and Drug Administration
A recent statement details the FDA’s efforts to find ways to reduce EtO emissions and concentrations used to sterilize devices without compromising safety and effectiveness.
August 16, 2022
Medical Device/Packaging
Fundamentals of Medical Device Packaging: In-Person Course Oct. 2022
The course, developed through IoPP’s Medical Device Packaging Technical Committee, takes place at McCormick Place at PACK EXPO International in Chicago (class dates: Oct 24-26) in three half-day sessions, totaling 13.5 hours.
July 22, 2022
Medical Device/Packaging
the[PACK]out: Inaugural Event Delivers Medical Device Packaging Innovation
The new conference in Austin, TX, (May 10-12, 2022) highlighted design, sustainability, and usability, developed for and by the medical packaging community.
June 21, 2022
Regulatory
FDA Issues Radiation Sterilization Update for PMA Holders
U.S. Food & Drug Administration
The agency is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.
June 13, 2022
Supplier News
Guardian Medical USA Raises Funds for Product Growth and Company Expansion
Guardian Medical USA
The company, which focuses on sterile barrier packaging for the orthopedics medical device market, has successfully secured more than $2 million in recent private financing.
June 1, 2022
Sustainability
Medical Device eIFUs: Hurdles to Overcome
Live from the[PACK]out: Regulations, regional acceptance, and validated packaging configurations all play a role. The challenges aren’t insurmountable but will require efforts from the packaging community.
May 12, 2022
Medical Device/Packaging
KiiP Tackles Wicked Problems in Package Material Stability
What began as a chat over coffee has led to work on a hypothesis and a white paper with far-reaching potential in saving time and resources in medical device packaging stability testing. Efforts were presented at the[PACK]out's inaugural event in Austin.
May 10, 2022
Medical Device/Packaging
Endoscope Processing in Healthcare Facilities Guidance Updated
The guidance explains the required steps in processing flexible and semi-flexible endoscopes and accessories to ensure they are safe for patient use.
March 8, 2022
Medical Device/Packaging
Kilmer Fund Accepting 2022 Grant and Scholarship Applications
The AAMI Foundation is accepting 2022 applications for the Kilmer Fund’s grant and academic scholarship programs.
February 9, 2022
Medical device packaging
Sharks: From Mortal Foes to Medical Inspiration
Ironically, the terror of the seas may prove to be instrumental in preventing/reducing infections, saving countless people from suffering and even death.
February 2, 2022
Take Five
Safety in Aseptic Filling
FDA provides insight into common pitfalls found during inspections along with possible solutions.
January 21, 2022
Medical Device/Packaging
Kilmer Innovations in Packaging Tackles 'Wicked Problems' in Med Device Sterility
KiiP is an industry initiative ‘solving wicked problems in healthcare packaging.’ They’re gathering passionate team members to tackle nebulous topics, ultimately improving patient safety.
January 19, 2022
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Supply Chain
IBM's Bill Green Says Sustainability Can and Should Be Everyone's Job
At the ISTA Forum's TransPack, Green said that beyond the business and moral case for reducing carbon impact, environmental regulations around the globe are increasing and getting more diverse, and companies must be ready.
PMMI News
Data and Analytics Management Varies Across Companies
Quick Hits
Melatonin Overdoses Among Children Prompt Calls for Packaging Changes
Recyclability
6 Healthcare Package Recycling Updates
Robotics/Automation
Practical Applications for the Future of Remote Services
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The SnapSlide cap features a first-of-its-kind design that allows single-handed opening for those with physical limitations while maintaining child safety and boosting sustainability.
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