Packaging & Product Protection Featured Articles
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Breeze Through Surprise Audits — Take These 5 Actions Now
6/8/2023
Summer is here! That means you might hear the dreaded words, “Surprise! We are coming to audit you!” Whether it’s a client, supplier, or regulatory agency calling for an audit, those words can strike fear in even the most organized companies. But not if you're prepared by taking these five action items now.
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Transformative Shifts In Medical Device Package Quality Testing
5/30/2023
While the medical device industry continues to evolve to accommodate lifesaving therapies, advancements in deterministic testing technologies ensure medical device packaging integrity and sterile delivery to the patient.
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Inspection Technologies For Tablets And Capsules Packaging
3/28/2023
Inspection technologies play a crucial role in ensuring the safety, quality, and reliability of tablet and capsule packaging. Explore package integrity testing methods proven to be accurate and efficient.
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Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
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Automated Inspection Of Pre-Filled Syringes And Biologics
3/8/2023
Container closure integrity (CCI) test methods aim to find manufacturing errors and mitigate risk to patient safety. Here, we delve deeper into the CCI testing of biologics and effective test methods.
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Stability Chambers: Testing, Equipment, And Uses
3/7/2023
Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
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Why Pharma Should Adopt Vacuum Decay Technologies For CCIT
3/2/2023
Most primary package applications require a controlled headspace, and this can be tested very practically using vacuum decay solutions. Learn about vacuum decay and the benefits of this technology.
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High Voltage Leak Detection For Parenteral Drug Container Closure Integrity
2/25/2023
Medical and pharmaceutical products are often packaged in fluid-filled containers. Learn about container closure integrity testing using high voltage leak detection (HVLD), how HVLD technology works, and more.
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Trends In FDA FY2022 Inspection-Based Warning Letters
2/21/2023
We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.
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The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
2/7/2023
With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.