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Cleanroom technician wearing protective gown, mask, and gloves inspecting a sterile packaged surgical instrument, ensuring quality control and compliance in medical device manufacturing.
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November 11, 2025

A revision for ASTM F1886 has been released. So, what’s changed?

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What is Visual Inspection per ASTM F1886? 

ASTM F1886 , Standard Test Method for Determining Integrity of Primary Packaging by Visual Inspection, is a non-destructive visual evaluation of seals (peelable or non-peelable) and materials of packaging.  The test method can be used to test the visual integrity for multiple types of bags/pouches or trays. 

The latest revision divides the standards into two parts:  

Part 1: Inspection of seals  

Part 2: Inspection of materials surfaces  

Part 1 remains unchanged, while Part 2 has been newly introduced.  

How will PCL address the revision to ASTM F1886? 

Since no Interlaboratory Study has been conducted to date, individual laboratories are responsible for performing a Test Method Validation (TMV) to demonstrate proficiency.
At PCL, our team is actively validating the test method to confirm that our technicians can reliably detect defects.  

For any questions regarding your past or future testing, please call us at 616-227-4540 or contact us to meet with one of our packaging professionals! 

 

 

 

 

Source: ASTM F1886/F1886M – 25  

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