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Navigating Transit Testing Standards: Understanding ASTM D7386 and How It Compares to ISTA 3 Series and ASTM D4169

The FDA recognizes ISTA and ASTM standards for distribution testing for sterile medical device packaging validations. The mainstays of sterile […]

October 2, 2024

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Are You Performing Usability Evaluations for your Sterile Medical Device Packaging?

In 2019, Section 7 of ISO 11607-01 was added to include Usability Evaluations for Aseptic Presentation. In the 5 years […]

August 23, 2024

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PCL Team Members Recall Their Favorite Moments from the[PACK]out Conference 2024

the[PACK]out returned for its third installment May 14-16, 2024, with medical packaging professionals and experts gathering over 2.5 days to […]

June 6, 2024

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Understanding the Roles of Dye-Leak and Bubble-Leak Testing in SBS Validation

Ensuring the integrity of the sterile barrier is paramount when validating medical device packaging. ASTM F2096 (Bubble Leak Testing) and […]

April 2, 2024

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Navigating the De Novo Process versus a 510(k) Submission

In the ever-evolving landscape of medical technology, innovators are constantly pushing boundaries to bring novel solutions to the market. One […]

March 21, 2024

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Should I Combine Shelf-Life Testing with Performance Testing?

We are often asked about our recommendations for conducting performance testing (distribution testing) and stability testing (aging testing). The question […]

February 29, 2024

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ASTM D4169 – 2023 Revision is Here!

ASTM D4169 is a consensus standard practice that provides a basis for simulating, in a laboratory, the ability of medical […]

February 21, 2024

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Understanding Endotoxin Testing in the Medical Device Industry

Endotoxin testing, also known as Bacterial Endotoxin Testing (BET), plays a crucial role in ensuring the safety of medical devices. […]

January 16, 2024

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Navigating Packaging Performance Testing: Palletized vs Individual Boxes

In the world of medical device packaging, determining the worst-case scenario is a strategic process that balances risks and costs. […]

January 11, 2024