การทดสอบคุณภาพรอยซีลด้วยเทคโนโลยี Airborne Ultrasound

การทดสอบคุณภาพรอยซีลด้วยเทคโนโลยี Airborne Ultrasound เป็นตามมาตรฐานการทดสอบ ASTM F3004-13 ซึ่งเป็นเทคโนโลยีการตรวจสอบรูรั่วและรอยซีลโดยไม่ทำให้บรรจุภัณฑ์เสียหายที่ได้รับการยอมรับ

การตรวจสอบรูรั่วและรอยซีลเหมาะกับการตรวจสอบผลิตภัณฑ์ที่ทำจากวัสดุดังนี้

อลูมิเนียม
โพลีโพรไพลีน
โพลีเอธิลีน
Tyvek

ASTM Test Method for Airborne Ultrasound

Technology is now FDA Consensus Standard Hawthorne, New York – April 15, 2020 – PTI is pleased to announce that the Center for Disease and Radiological Health (CDHR/FDA) named ASTM Test Method F3004-13 (Airborne Ultrasound Technology) as a consensus standard for the evaluation of seal quality.

This is another breakthrough in recognition of the performance and value of this non-destructive technology developed by PTI.

In determining the basis of the decision, CDRH considered that nondestructive airborne ultrasound has been in use to detect leaks in packaging for years. The international laboratory study (ILS) performed as part of this test method consisted of four labs, testing three different types of packaging, with six known defects and the testing consisted of a sample size of 45 samples of which 30 were defective samples. The results of the ILS concluded that there were no significant deviations observed. Therefore, complete recognition of this test method was determined to be appropriate in its ability to detect

leaks in the following packaging types:

• Aluminum/Aluminum
• Polypropylene/Polypropylene
• Polyethylene/Tyvek

About CDHR The CDRH Standards Program was Created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. ® a PTI technology a PTI technology TM Seal Quality Testing and Seal Analysis 100% Inline Seal Inspection.