Preventing Leaks in a Single Use System

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

Collaborative progress toward standardization of user requirements for single-use bioprocess technology

Over the past decade, the application of single-use technology in the production of biopharmaceuticals has gained popularity because of the advantages it offers for improved versatility and efficiency with certain unit operations. However, the technology lacks the standardization of stainless streel and glass technologies that have had a lengthier history in the industry. There has been inconsistent messaging about how to manage single-use systems among end-user, suppliers, and throughout the supply chain. The drawbacks to the lack of standardization include: difficulties with implementation of single-use technologies, insufficient data packages for the systems, slower responses from suppliers with respect to implementing continuous improvement initiatives and advances in technology innovation, as well as regulatory uncertainty. A partnership has been established between a consortium of end-users and suppliers led by the BioPhorum Operations Group (BPOG) and Bio-Process Systems Alliance (BPSA) to work toward advancing the knowledge level and application of single-use technology to equivalent or better than that of stainless steel. One area of focus is on standardization. A cross-functional team of end-users and suppliers have been tasked with developing an approach to standardizing single-use user requirements (SUUR). This poster will provide an overview of the SUUR team’s approach to standardization of single-use requirements. This includes the development of a universal template for user requirements (URS) and a supporting document that provides a structure for suppliers to give additional details of how they will demonstrate conformance to the user requirements. This will help to facilitate more informed decisions regarding single-use technology and serve to address gaps in understanding between end-users and suppliers