Issue link: https://www.e-digitaleditions.com/i/1135366
www.biopharminternational.com June 2019 BioPharm International eBook 19 Single-Use Systems Components customers to utilize single-use bioreac- tors in more production facilities. This development in single-use bioreactors has led to improvement in connector technology and sensor technology. BioPharm: What single-use compo- nents does WMFTG offer for biopro- cessing, and at what scale can these components be used (e.g., preclinical, clinical, commercial-scale)? Baldwin: Our components are used throughout the various stages of a biopharma product lifecycle and can scale up with the customer's pro- cess. Our single-use components are used when customers look to trans- fer fluids within their process. We offer True Bore sanitary connectors up to 1" inner diameter (ID) with a 1 ½" triclover, pump elements to utilize our range of peristaltic pump heads, and single-use pump heads for our Quantum pump. We also offer Triclover clamps up to 8" to allow connections to a wide range of products and processes, filling needles for our Flexicon aseptic liq- uid filling machines, and fluid path assemblies from upstream to final finish and fill. A LOOK AT GASKETS AND TUBING BioPharm: Where in the bioprocess setup are gaskets used, and what par- ticular advantage or benefit do single- use gaskets offer? Baldwin: Gaskets are used in areas where a sanitary fitting is used, either connecting a sterilizing filter into a process line or tangential flow fil- tration (TFF) system. They are also utilized to connect pre-packed res- ins into a chromatography process or just connect a piece of hardware to a process line. Gaskets are utilized throughout all areas in upstream and downstream processing, and, when single use, they give the end user confidence that no cross-contamina- tion can occur between batches and that there is always a secure leak-free connection for each process run. BioPharm: For single-use tubing, what characteristics or innovations optimize fluid-handling and flow control (e.g., braided tubing)? Baldwin: Choosing the correct tub- ing can greatly improve fluid han- dling in the process. There are a few basic factors that influence this choice: chemical compatibility, flow rate, performance in peristaltic pump applications, pressure, process cycle time, and connection technology. For chemical compatibility, plati- num-cured silicone and thermoplas- tic elastomer (TPE) tubings cover the majority of the chemicals used in the process. For the more complex chem- icals, the evolution of fuoropolymer tubing, for example StaPure, has given the end customer increased confidence within their applications. Larger ID tubings in silicone and TPE allow customers to empty and fill vessels in a shorter time, which allows greater flexibility and turn- around of production equipment. If a tube is going to be used in a peristaltic pump, then it is imperative that the correct wall thickness is cho- sen, as this has a massive impact on pump performance and the length of time the tube can be used in a pump. There are now specific silicone and TPE tubing offerings on the market to accommodate this. WMFTG offers a wide range of pump tubing and pump elements (optimized for use in WMFTG pumps) that can give the end user greater confidence for processes at higher than normal pressure—along with increased process life. Among other advancements, the ability to seal/weld TPE tubing has allowed technology to be developed that can make connections in a less classified environment, which again increases flexibility for the end user. Platinum-cured braid hoses give the advantage of security within higher pressure operations as well as for inline integrity testing of ster- ile barrier filters. Documentation and validation information has also been developed recently, giving the end user more confidence in choos- ing the correct fluid contact materi- als to utilize in a process. COMPONENTS FOR CLOSED-SYSTEM PROCESSING BioPharm: How do single-use compo- nents promote a closed system and can you give an example? Baldwin: Aseptic connector tech- nology along with TPE tube welders allow more flexibility for the end user to have a completely closed system. Being able to use a lower classifica- tion of cleanroom to make connec- tions and truly contain the fluid path reduces the risk of any cross-contam- ination damaging the valuable prod- uct being processed. It also provides a degree of safety to the operators. This can save valuable time and money for the end user and increase the func- tionality of working areas. BioPharm: With the biopharmaceu- tical industry continuing to adopt single-use systems for bioprocessing, are there still components that nec- essarily need to stay reusable (e.g., stainless-steel components) and why? Baldwin: It became apparent early in the single-use cycle that there needs to be a hybrid solution when working in single use. Holding vessels above a certain size must remain stainless steel. Skid systems used for chroma- tography and ultrafiltration/microfil- tration utilize a more hybrid solution with stainless and single-use com- ponents working in unison. These systems are size-dependent within bioprocessing. Single-use solutions are being utilized in larger systems; however, there is still an inbuilt con- fidence in stainless steel for specific processes at higher capacities. REFERENCE 1. R. Hernandez, "Innovations in Single-Use Bioprocessing Components," BioPharm International 2014 Secure Single-Use Systems eBook, Issue 4. BP