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Integrity Testing

"Sensitivity of Integrity Test Methods"

What is the minimal size of pinholes that can be detected with Vacuum Decay and Pressure Decay testing? Currently, I see methods detecting as small as 35 to 10 microns. Are there more sensitive methods?

Last Updated On April 18, 2011

During the development of the SPMC Webinar titled “Package Integrity, A Look at False Alarms,” a number of ASTM Integrity tests were reviewed for sensitivity of detection level. A number of these standards ran interlab studies using a specifically sized orifice or specifically sized implements for creating defects such as channels in seals. The reported sensitivity of these methods is based on the hole or channel size evaluated and reliably detected; in some cases, the actual sensitivity may be greater. The pressure decay, vacuum decay, and trace gas tests define sensitivity levels based on flow rates. In order to translate these units of measure (standard cubic centimeters/second) into an effective hole size, we contacted members of the subcommittee task groups involved in the development of the standards and the interlab studies. They were able to give us the additional details needed to work through an online orifice calculator. The ASTM F2391 Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas indicates the ability to test down to 0.1 micron.

The FDA Web site lists many of these methods as Recognized Consensus Standards, which may be acceptable for use to test packaging for medical device products in 510K applications. Package testing levels for integrity are continuing to be developed in ASTM to improve the sensitivity of detection. The choices span methods with very high detection sensitivities using highly precise equipment and those less sensitive that can be used quickly, inexpensively, and at a large scale. Whatever limits are to be set for a package, the criteria and method for detection should be agreed upon and appropriate for the packaged product use.