Single-Use Bioprocess Bag Leak Testing
Single-use bioprocess bags demand rigorous integrity testing to ensure compliance with the highest manufacturing standards and to protect the products they hold. To achieve effective leak detection and prevent microbial ingression, manufacturers increasingly rely on helium leak detection — the most sensitive and reliable method available. In many cases, industry standards define the maximum allowable leak limit (MALL) as equivalent to a 2-micron hole size.
Ensuring Quality & Safety: Helium Leak Testing for Single-Use Systems
Since 2012, LACO has taken 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 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:
White paper: Enhancing Single-Use System Integrity with Helium Leak Testing
Discover proven strategies to ensure leak-free single-use systems—download our expert white paper today.
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:
Helium Hard Vacuum Systems
- Helium hard vacuum testing
- Stainless steel frame, aluminum door with O-ring groove machined in, and toggle clamps for closure
- Mechanically retractable drawer with 2 test ports inside for attaching equipment
- Designed for 2D-style bio-process bags from 50ml to 50L
Helium Hard Vacuum Systems
- Stainless steel construction
- Single-chamber configuration with roll-out access
- Helium tracer gas hard vacuum testing
- Helium mass spectrometer leak detector
- Designed for 3D-style bio-process bags from 50L to 1000L
- Detect leaks 3-5um hole equivalent or larger
Perform fast, safe, and easy automated testing with the Allen Bradley PLC & HMI and included controls:
- Master start button
- Clear error button
- Switch to select calibration mode, auto mode, or manual mode
- Abort cycle button
- Start cycle button
- Emergency shut off
Helium Hard Vacuum Systems
Standard Platform Systems
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
Configure Your Standard System
Single-chamber or Dual-chamber systems
Choose between a single-chamber or dual-chamber system to meet your throughput requirements.
Allen Bradley or Siemens PLC
Choose which controller will be the best for your application.
Choose Your Options & Accessories
- Integration to MES
- Data logging
- NRTL/UL/CE and other certifications
- Barcode scanner
- Adjustable test chamber height
- Single or dual chamber configuration