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Machinery & Materials
Logistics & Cold Chain
Regulatory: Page 2
FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula
In the coming months, the FDA will be able to greatly increase the supply of formula, including Abbott EleCare, available to U.S. consumers through international and domestic manufacturing facilities.
May 26, 2022
FDA Releases White Paper on Quality Management Maturity
The new white paper discusses developing a framework to evaluate the QMM of pharmaceutical manufacturing sites and the benefits of a rating system.
May 23, 2022
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
FDA Permits Marketing for Test to Improve Diagnosis of Alzheimer’s Disease
The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid.
May 6, 2022
the[PACK]out: Supply Chain - Navigating Disruptions
EXPERIENCE the[PACK]out: Created for industry professionals, by industry professionals.
April 26, 2022
FDA Issues New Guidance to Increase Racial and Ethnic Diversity in Clinical Trials
The agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s Cancer Moonshot goal of addressing inequities and beyond.
April 22, 2022
Cybersecurity in Medical Devices: FDA Announces New Draft Guidance
The new guidance deals with quality system considerations and the content of premarket submissions for members of the medical device industry, as well as Food and Drug Administration staff.
April 15, 2022
10 Temperature Monitor Qualification Considerations
From the 2022 ISTA Forum TempPack: Panelists discussed the latest on temperature recording device (TRD) qualification, including dry ice and LCD screens, probes that disconnect, and what to consider before selecting a shipper integrated with a TRD.
April 15, 2022
FDA Recommends Use of Duodenoscopes With Innovative Designs to Enhance Safety
The agency is providing new information supporting the transition to fully disposable duodenoscopes and those with disposable components, as well as new information on completed post-market surveillance studies.
April 8, 2022
Solution for Expiry Labels, DtP, and Study Timelines Due to EU 536/2014 Clinical Trials Regulation
The new regulation improves many aspects of clinical preparation and activation but brings certain new challenges for sponsors.
March 18, 2022
Full Vial Inspection: Simply Complete!
Unit carries out optical and radiometric inspection and volumetric determination of O2 content in the headspace
March 15, 2022
Future for Pharmaceutical Manufacturers Includes More Digitized Data Collection
While automation is driving physical changes to pharmaceutical production and packaging processes, another significant shift is occurring in the accumulation and use of data.
March 14, 2022
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DSCSA: Labels Practically as Important as the Medicine Itself
In becoming compliant with interoperable data exchange requirements under DSCSA, don’t overlook the pharmaceutical label itself. Missing case labels or faded inks can pose threats.
Newcorn Takes the Presidential Reins at PMMI Media Group
Reuse is on the Rise, but ‘Much More Needs to be Done’
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Robotic Filling Machines
Steriline robotics and isolators guarantee safer processes and minimize sterility breaks for nest and bulk filling applications.
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Triumphs and Challenges in Sustainability
Healthcare Packaging News Roundup: Sustainability
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Healthcare's Sustainability Approach: Waste Reduction
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