Testing & Validation

Comprehensive testing and validation services ensuring the highest quality standards for single-use bioprocess components and assemblies.

What types of testing and validation do we offer?

We provide integrity testing for all SUT components. This primarily comprises of two tests: Pressure Decay Test and Pull Test. Most SUT components can be categorized into Flexible, semi-rigid and rigid components.

Pressure Decay tests primarily validate the structural integrity of an individual component as well as the seal integrity of container closures and of assemblies as a whole. Pull test primarily evaluates the integrity of the tubing connections.

Since leakage of the media is the ultimate failure of any SUT component or assembly, these two are used to assess the leak dynamics of the components.

Comprehensive Testing Portfolio

In addition to integrity testing, we provide:

  • Freeze-thaw testing - Components are subjected to extreme temperatures (up to -86°C). Post freeze-thaw integrity tests assess the effect of temperature stress.
  • Flow testing - Primary integrity test for filters and assemblies requiring specific output flowrates.
  • Extractables & Leachable (E&L) studies
  • Particulate testing
  • Sterility assurance & validation
  • Endotoxin/bioburden testing
  • Gamma irradiation compatibility
  • Accelerated aging/stability testing

Integrity Testing

Pressure Decay Test and Pull Test for structural and seal integrity validation

Freeze-Thaw Testing

Temperature stress testing up to -86°C with post-test integrity assessment

Flow Testing

Primary integrity test for filters and flowrate validation

E&L Studies

Extractables & Leachable studies for material safety validation

Industry Standards & Regulatory Compliance

We comply with all major industry standards and regulatory guidelines to ensure the highest quality and safety of our products.

USP <87>, <88>

Class-VI Testing

All our products have been tested and met the requirements.

USP <788>

Particulates Testing

Our sterile products are tested against USP <788>

ISO 11137

Gamma Sterilization Standard

Our sterile products are Gamma irradiated according to ANSI/AAMI/ISO 11137:2006

ISO 13485

Quality Management System Certification

Our facility Quality Management System is approved by an accredited registering body.

USP <85>

Bacterial Endotoxins Testing

Our sterile products are tested against USP <85>

Need Custom Testing Solutions?

Contact our testing experts to discuss your specific validation requirements and ensure your components meet the highest industry standards.

Get Testing Quote

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