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Aseptic/Sterile: Page 5

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
Mdptc Thank You To Our Sponsors
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
the{PACK]out: Day 3 featured hands-on workshops to bring package design concepts to life. (Image courtesy: Cassie Ladd)
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
Fda Logo, Hi Res
Aseptic/Sterile
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
Guardian
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
Sustainability – No Longer Just a “Nice to Have”, Speakers from Left: Lindsay Smaron, Samantha Smith, and Kevin Kane with Moderator Jamie Pero-Parker, PhD at thePACKout.
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
At the[PACK]out, presenting 'Wicked Stability: Predicting the Aging Degradation of Materials' were speakers (from left): Dan Burgess, Henk Blom, and Rod Patch w/ Moderator Seema Momin.
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
Aami Logo
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
Logokiip
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
Shark Pic
Aseptic/Sterile
Safety in Aseptic Filling
FDA provides insight into common pitfalls found during inspections along with possible solutions.
January 21, 2022
Safety
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
The four areas of focus for the programs within KiiP are: The Last 100 Yards, Aseptic Handling, Speeding Things Up, and Sustainability.
Regulatory
Pitfalls to Avoid in FDA Aseptic Manufacturing Inspections
From personnel to facility design to process, FDA policy advisor provides an outline of what facilities can improve on.
January 5, 2022
Aseptic processing is one of the highest risk pharmaceutical operations, and thus requires a high level of control.
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Top Stories
Under the TIA/MWF petition, a single QR code could stand in for the printed compliance leaflets that ship with smartphones today, linking to a regulatory page manufacturers could update after products reach store shelves. For phones, the device itself provides an offline backup. OTC and pharma brands considering the same swap for package inserts have no such fallback.
Labeling/Printing
Telecom Asks FCC to Let On-pack 2D Codes Replace Printed Regs
Telecom groups want the FCC to let a QR code replace printed regulatory text on device cartons, an idea the agency shelved in 2017. The questions it raises, from code standards to the 1 in 11 U.S. adults without a smartphone, may inform or shape how OTC, pharma, and CPG brands move leaflets and on-pack text online.
Pharmaceutical Manufacturing Market forecast chart showing USD 603.7B market size in 2027 and projected growth to USD 945.2B by 2032 at 9.38% CAGR
Biopharmaceuticals
How Demand for Contract Manufacturing is Driving the Pharmaceutical Manufacturing Market Forecast
Eco-friendly personal care products with kraft labels, bamboo toothbrushes, glass bottles, and natural green leaves on beige background
Sustainability
Consumers Want Sustainable Health Packaging, but Not at the Expense of Quality
Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
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AI-enabled X-ray Inspection Software Platform
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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
Robotics/Automation
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Robotics/Automation
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Labeling/Printing
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Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
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