Westpak is certified to conduct product/package integrity testing to help guarantee successful delivery of products worldwide by any means of transportation.

Westpak is accredited to ISO/IEC 17025-2005, one of the most rigorous standards available for a mechanical testing laboratory.

Westpak is certified to the requirements of ISO 9001-2008 for quality management, and to ISO 14001-2004 for environmental management and sustainability efforts.

GROSS LEAK (BUBBLE) DETECTION - ASTM F2096

This test is conducted by submerging a lightly pressurized package under water to visually inspect for streams of bubbles that identify a leak or defect in both porous and non-porous packaging systems.

The bubbles here have been colored blue to show
how they help us detect a leak or defect in a sterile
medical device package.

Bubble testing is a widely used qualitative method of determining defects or gross leaks in sterile medical device packaging.

Primary packages or Sterile Barrier Systems are subjected to this test to determine if their ability to maintain a sterile barrier has been compromised by tears, holes, or improper seals. Properly applied in a package validation test plan (within guidelines of ANSI/AAMI/ISO 11607) this method has significant advantages to methods such as microbial challenge when determining if a Sterile Barrier System has been compromised. This is the most common method used to determine the ability of a package to maintain a sterile barrier since it tests the entire Sterile Barrier System and not only the seal.

Typical Procedures/Protocols
ASTM F2096
ASTM E515 
ISO 11607

Westpak Capabilities

Westpak continually upgrades and expands its equipment line-up. Therefore this list is a minimum of our capabilities:

(8) Bubble Leak tanks with state-of-the-art controls


Bubble Test Video