ASTM Test Method For Airborne Ultrasound Technology Is Now FDA Consensus Standard For Seal Integrity Evaluation

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.

April 1, 2020

Re: SR200003

Standard Designation Number: ASTM F3004-13

Standard Title: Standard Test Method for Evaluation of Seal Quality and Integrity

Using Airborne Ultrasound

The Federal Food, Drug, and Cosmetic Act (the Act), section 514(c), provides that any person may submit a request for recognition of all or part of an appropriate standard established by a nationally or internationally recognized standard organization. The Center for Devices and Radiological Health (CDRH) has reviewed your request for recognition with respect to the above standard established by a nationally or internationally recognized standard organization. CDRH has determined that the standard referenced above will be recognized. In accordance with Section 514(c)(1)(C)(ii)(II) of the Act, we set forth the basis for that determination as follows:

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. For more information, visit www.ptiusa.com.