Image showing an empty medical IV bag

Ensuring Quality & Safety: Helium Leak Testing for Single-Use Systems

Single-use bioprocess bags demand rigorous integrity testing to guarantee compliance with the highest manufacturing standards to safeguard the products processed and shipped in these containers. For effective leak detection and prevention of microbial ingression, the industry has widely embraced helium leak detection as the most sensitive method. For many single-use products, the accepted industry standard sets a maximum allowable leak limit (MALL) of a 2-micron equivalent hole size.

In 2012, LACO took the lead in pioneering the development of integrity leak test protocols and methods specifically designed to reliably detect defects in single-use bags.

Our cutting-edge technology has been successfully deployed at numerous leading manufacturing facilities worldwide. We are committed to upholding the highest quality standards and providing reliable solutions.

Standard Platform Single-Use Bag Integrity Testing Solution

LACO’s unique standard platform single-use bag leak test systems include these key features:

  • Helium hard vacuum testing method
  • Test 2D bags from 50 ml to 50 L in a universal chamber
  • Detects 2um hole equivalent or larger (MALL)
  • Fast throughput speed of up to 1 bag per 90 seconds
  • Interchangeable, easy-to-use quick connectors
  • Clean Room compatible with stainless steel construction
  • Dry vacuum pumps

Learn more about our standard configurable systems:

Standard Systems
standard dual-chamber test system

Leader In Leak Testing Bioprocess Bags Since 2012

LACO has been creating state-of-the-art single-use systems for leading manufacturers since 2012. Contact LACO today to learn how we can help you protect your products and your business.

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Custom 3D bag test chamber

Custom System Options

Enjoy the freedom of our custom-designed systems. At LACO, our engineers excel at tailoring solutions to meet your unique requirements. We take pride in crafting systems that are perfectly matched to your specific needs.  Here are just a few examples of the custom options we have provided in the past:

  • 2D & 3D single-use bags up to 1000 L
  • Custom chamber designs
  • Dedicated bag port testing
  • Other component testing

Contact LACO to discuss your single-use leak test requirements:

Custom Quote