Leak Detection in GMP Regulated Industries

In the manufacturing of biologics, preventing contaminants from entering bioreactors or other containers is of paramount importance. However, the new industry standard of single-use technology carries the risk of leakages. These can occur as a consequence of handling errors or material defects especially in gaskets and tubing. 

The industry is aware of the risk of leakages and has come up with technologies to minimize the risk, like pressure decay, helium leak detection and bubble testing. Also, thorough operator trainings are regarded as crucial to inimize the risk of leaks during operation. Unfortunatley, operator training cannot completely avoid the risk of leakage. Constant monitoring is required during operation.

Leaks that go unnoticed for several hours or days can  ruin entire batches of biopharmaceuticals and often lead to more follow up challenges including operator health risks, waste disposal, disruption of tough production schedules as well as enormous financial loss. 

On the other hand, for leaks that are discovered instantly, effective countermeasures are possible. 

To address this issue, DeepEyes technology has been developed and is a real innovation in this field. The video-based DeepEyes AI  Leak Detection technology provides 24/7/365 monitoring of single use bags and recognizes leaks in real-time, allowing for instant repairs and countermeasures to be taken. 

The DeepEyes video-based Leak Detection technology enables optimized control and reliability across the life of biopharmaceutical processes. The in-service leak detection recognizes anomalies in the form of drops, puddles and streams outside the container and issues real-time alerts  to personnel, e.g. via mobile devices, warning signals, desktops. Instant repairs make it probable that damages can be averted and batches can be safed.

The DeepEyes Leak Detection in a nutshell:

  • Starting liquid leaks
  • Spillage on surfaces
  • Liquid streams, drops, droplets
  • Real-time detection
  • On all surfaces, e.g. transparent plastic, stainless steel, tubes, connectors, floor

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