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Seal-Scan® Technology Featured in New ASTM Test Method F3004-13 “Evaluation of Seal Quality and Integrity Using Airborne Ultrasound Technology”

Tuckahoe, New York (August 27, 2013) – PTI announces the approval of ASTM Test Method F3004-13, a new non-destructive test method for “Evaluation of Seal Quality and Integrity using Airborne Ultrasound Technology.” Approval of this test method was based on PTI sponsored inter-laboratory research study utilizing PTI’s patented Seal-Scan® technology.* This test method may be applied to the inspection and evaluation of flexible package seals of all material types. The approval of ASTM F3004-13 marks a significant breakthrough in the field of seal integrity testing for the entire packaging industry.

Application Seal inspection and seal quality analysis
Packaging Materials & Combinations Tyvek®, Paper, Foil, Aluminum, Plastic & Laminated Materials
Test Results Qualitative Pass/Fail and Quantitative Data Analysis
Defects Wrinkle, Contamination/Inclusion, Channel Defects, Misaligned Seal, Delamination or Blister, Incomplete or Missing Seals
Target Industries Medical Device/Pharmaceutical/Food

The precision of this test method is based on an Interlaboratory study of F3004, New Standard Test Method for the Airborne Ultrasound Seal Inspection for Flexible Barrier Packaging Systems, conducted in 2012. Four laboratories participated in the study, testing three different types of packaging, modified with six different target defect modes. The study challenged the repeatability and reproducibility of the quantitative test method.

To order ASTM F3004-13:

Methods may be ordered online at the ASTM International website www.astm.org, or by phone at 610.832.9485. ASTM International provides standards that are accepted worldwide and serve as a basis for manufacturing, research and development, product testing and in procuring quality systems.

About PTI Inspection Systems:

PTI is a leading manufacturer of non-destructive inspection technologies for micro leak testing, container closure integrity testing and seal integrity testing of pharmaceutical packaging including vials (liquid filled & lyophilized), ampoules, blisters, empty and pre-filled syringes, pouches and flexible packaging, bottles and other rigid containers, BPC and API bulk containers. PTI manufactures technologies ranging from high voltage leak detection (HVLD), vacuum decay, to airborne ultrasound. Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM and regulatory standards. PTI Inspection systems provide repeatable, reliable results and can be incorporated into protocols at any point in the manufacturing process as they are non-destructive, non-invasive and require no sample preparation.


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