What is Single-Use Technology for Biopharmaceutical Manufacturing?
The increased need for biopharmaceutical production with greater flexibility and reliability is driving the trend toward single-use technology. Through its use of specialty polymers, Solvay is revitalizing single-use technology by allowing for greater production flexibility, quicker production turnaround time and reduced capital investment. In addition, single-use technology simplifies the process of sterilization by eliminating the need for clean-in-place (CIP) and the risk of cross-contamination.
Until recently, the biopharma industry has relied heavily on stainless steel for the production of biopharmaceuticals. Stainless steel is a traditionally conservative market that produces on a larger scale for greater product volume, though many of today’s manufacturers are switching over to single-use technology for more flexible and reliable production. Single-use technology is made possible with the help of Solvay specialty polymers. Plastics like Solef® PVDF, a fluorinated semi-crystalline thermoplastic, offer excellent chemical and mechanical properties, tensile strength, chemical compatibility and scalability.
Solvay offers a broad portfolio of specialty polymers for single-use technology that is applied explicitly to filtration, peripherals and containment biopharmaceutical processes. For instance, Solef® PVDF, a fluorinated semi-crystalline thermoplastic, offers excellent chemical and mechanical properties, tensile strength, chemical compatibility and scalability. These polymers can be found in membranes, membrane additives and housings, connectors, tubing, sensor housing and bioreactors.
Single-use technology involves easier and more flexible production with less capital investment, as polymers are generally less expensive than stainless steel and have a wider range of applications. Operation costs are decreased by superior process flexibility, the elimination of cleaning-in-place (CIP) and sterilization-in-place (SIP), and quicker product-to-market turnover. Additionally, single-use technology consumes less energy, water, utilities and sterilization chemicals. All these advantages in addition to greater production sterility assurance, provide the biopharmaceutical industry with new, more beneficial alternatives to stainless steel.
One of the most pronounced differences between single-use systems and a traditional stainless steel manufacturing operation is the sanitation process. Whereas stainless steel manufacturing yields a higher risk of product cross-contamination and has the need for cleaning-in-place and sterilization-in-place, specialty polymers are sterilized with gamma-irradiation, a treatment proven to be more effective. Solvay’s specialty polymers offer gamma irradiation compatibility up to 50kGY. This compatibility provides single-use technology with easily-sterilized material for medical and bioprocessing equipment.
Leachables and Extractables
When selecting polymers for single-use technology, it is crucial to understand the presence of leachables and extractables, because of the risk of contamination and these impurities impose. To reassure the absence of these chemical impurities, testing should be performed and their results provided. Solvay specialty polymers are USP Class VI certified and evaluated for leachables and extractables under BPOG-BPSA test protocols for worst-case scenarios to assess the presence of these impurities.
Simplified production, easier sterilization and lower capital expenditures are all benefits of single-use technology. As a more flexible alternative material to traditional stainless steel, specialty polymers offer excellent chemical and mechanical properties with minimal to no risk of cross-contamination. Single-use technology eliminates the need for cleaning-in-place and sterilization-in-place. In addition to the cost savings, Solvay specialty polymers are gamma irradiation compatible and provide safe, reliable materials for single-use technology.