Disposables: Single-use systems bag assembly leakage and defect toolkit

Improper handling of bags is a significant contributor to leaks in single-use systems (SUS). It regularly causes significant, often unreported, failure modes (e.g. tearing and punctures) that cause product, supply, product variability and end-user operability problems. The cost per leak – including investigations, lost time and product losses – ranges from thousands to many millions of dollars. Unfortunately, formal training methods and practices vary and are influenced by the bag supplier and the design integrity of single-use (SU) assemblies. Also, there is no standard for handling and deploying SUS, and there are different definitions of defects and failure modes

The  BioPhorum SUS bag assembly leakage and defect toolkit, gives users a set of tools to respond to problems and materials to include in their communications and operator training. The toolkit will help reduce product losses, investigations, manufacturing disruptions and the number of leaks. It equips industry with tools to help standardize the vocabulary around SUS anatomy and processes and expand its understanding of SUS abnormalities.

The package of toolkit deliverables includes:

• SUS bag assembly anatomy – provides SU components with commonly used names and descriptions
• SUS visual observation library – clearly defined and aligned SU terminology to help investigation communication, accuracy of information and trending of defects
• SU event response checklist – to ensure key information is consistently recorded and communicated internally and with suppliers
• SU leak root cause analysis guidance – a list of questions specific to the use and handling of SU materials that provide guidance for investigations
• Guidance for developing effective bag handling training – training on SUS handling/deployment for manufacturing operators to minimize ‘user error’.

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• Create Date 23rd October 2020
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