Conference Dates
October 18-21, 2015
Abstract
Assurance of the integrity of a single use system is important to ensure process fluids are contained and to limit the potential for a sterility breach. This discussion will describe an approach for the technical assessment of single use systems (SUS) for a specific biopharmaceutical process step. The presentation considers the key properties that need to be evaluated to ensure the integral components of a single use assembly are able to meet the performance attributes for the process step.
Understanding the polymer properties associated with the plastic materials used in single use system (SUS) ensures that the system will be integral during use. The properties include the physical, mechanical, chemical and regulatory requirements that the SUS must meet to be able to be used in the process.
Two attributes are particularly important in testing the performance of the single use system. One of the critical attributes of SUS is that it must not leak during use. To ensure leaks do not occur, robust testing must be performed to ensure that the assembly of key components can meet the system requirements. Within this presentation the criticality of engagement testing will be discussed where tubing to hose barb connections are qualified prior to use.
The polymer properties of the tubing and hose barb play an important role in being able to create a proper engagement. Tubing type, tubing hardness, tubing size contribute to the proper creation of the engagement with the hose barb. Hose barb design is also associated with providing a secure connection to the tubing. How these engagements are assembled and secured also play an important role in creating an integral engagement in the systems. The engagement testing parameters are critical to qualifying the engagements.
With proper engagement tests, leaks can be reduced, if not eliminated. Engagements that were found to leak were evaluated and changed to proper engagements for a SUS. These studies showed that robust engagement testing ensures that the SUS will not leak during process use.
Assurance of the integrity of a single use system is important to ensure process fluids are contained and to limit the potential for a sterility breach. This discussion willdescribe an approach for thetechnical assessment of single use systems (SUS) for a specific biopharmaceutical process step. The presentation considers thekey properties that need to be evaluated to ensure the integral components of a single use assembly are able to meet theperformance attributes for the process step.
Understanding the polymer properties associated with the plastic materials used in single use system (SUS) ensures that the system will be integral during use. The properties include the physical, mechanical, chemical and regulatory requirements that the SUS must meet to be able to be used in the process.
Two attributes are particularly important in testing the performance of the single use system. One of the critical attributes of SUS is that it must not leak during use. To ensure leaks do not occur, robust testing must be performed to ensure that the assembly of key components can meet the system requirements. Within this presentation the criticality of engagement testing will be discussed where tubing to hose barb connections are qualified prior to use.
The polymer properties of the tubing and hose barb play an important role in being able to create a proper engagement. Tubing type, tubing hardness, tubing size contribute to the proper creation of the engagement with the hose barb. Hose barb design is also associated with providing a secure connection to the tubing. How these engagements are assembled and secured also play an important role in creating an integral engagement in the systems. The engagement testing parameters are critical to qualifying the engagements.
With proper engagement tests, leaks can be reduced, if not eliminated. Engagements that were found to leak were evaluated and changed to proper engagements for a SUS. These studies showed that robust engagement testing ensures that the SUS will not leak during process use.
Recommended Citation
Trishna Ray-Chaudhuri, "Preventing Leaks in a Single Use System" in "Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications", Ekta Mahajan, Genentech, Inc., USA Gary Lye, University College London, UK Eds, ECI Symposium Series, (2015). https://dc.engconfintl.org/biopoly/16