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Single-Use System Integrity (SUSI) Assurance

Built-in Integrity Control Strategy all along the SUS life cycle

Built-in Integrity Control Strategy with the fast growing implementation of single-use bags into commercial production and critical process steps, the industry and the regulatory agencies require a higher assurance of single-use system integrity (SUSI). The recent publication of the ASTM E3244 providing a QRM-based approach and test methods for integrity assurance for SUS allows to enforce a higher control on bag integrity in line with the requirement of the USP<1207> and the more recent Annex 1 from the GMP guidelines. In addition to the SUS manufacturing robustness, Sartorius implemented the most sensitive integrity test methods at both the supplier and the end-user for demonstrating the proof of single-use integrity along the SUS life cycle

Best-in-class Supplier Integrity Testing (SIT) with 2 µm sensitivity for patient and operator safety

The assurance of single-use system integrity (SUSI) is the result of QbD, process validation, process controls and integrity testing along the entire product life cycle. For critical process steps, a 100% integrity test with helium at 2 µm sensitivity demonstrates the integrity with a correlation to bacterial challenge test.

Point-of-Use Integrity Testing for Flexsafe® 2D and Flexboy® bags in a Safe, Fast, Easy and Reliable Way

A 100% point-of-use integrity test at a sensitivity of 10µm avoids the risk of losing high value product and enhances patient and operator safety by ensuring that no damage occurred during shipping, storage and handling of Flexsafe® or Flexboy® bags.

Point-of-Use Leak Test for Flexsafe® 3D bags for Storage and for Mixing

The well-established Sartocheck® 4 plus Bag tester technology provides a non-destructive and safe leak test for Flexsafe® 3D storage and mixing bags already installed in their Palletank. The unique patented porous spacers perfectly fit the Palletank shape and avoid any masking effect due to direct contact between the bag and its container, assuring the test reliability. Robust validation with a 6-sigma confidence level applied to ASTM F2095 pressure decay leak test allows to guarantee the absence of leak just prior filling and post-installation.

Single-Use System Integrity (SUSI) Assurance

Proven integrity of your process improves patient safety, regulatory compliance, production costs and drug availability

  • Enhances patient and operator safety
  • Prevents any risk of high value product loss at commercial phase
  • Meets cGMP regulatory expectations for SU system integrity
  • Speeds up drug product manufacturing capacity and market availability with SU proven process integrity  

 

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