Blog

• Blog

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

• Blog

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

• PCL News

PRESS RELEASE: Don Kring Assumes Role as Chief Financial Officer at PCL

[Grand Rapids, March 13, 2024] — Packaging Compliance Labs (“PCL”), a sterile medical device packaging leader, is proud to announce […]

March 19, 2024

• Blog

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

• Blog

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

• Events

OMTEC 2024

Rosemont, IL
June 12 - 13, 2024
Booth #740

June 12, 2024

• Events

thePACKout Conference 2024

Coronado Bay, CA
May 14 - 16, 2024
Founding Exhibitor

May 14, 2024

• Events

MD&M West 2024

Feb 6 - 8, 2024
Anaheim, CA
Booth #1507 & #1175

February 6, 2024

• Blog

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