2020/06/09 (Tue) Connectors typically in stainless

Silicon tubing has a long history in single use systems, but there are now many alternatives. Disposable valves are another cost saving option. In addition, while recent history has seen major growth in disposable bags being used for bioreactors, mixers, transport, transfer, and harvest, to name a few, it is only the beginning of the opportunities for the integration into disposables manufacturing utilizing Tubing, components and assemblies. And allows the technicians to stay focused on higher production turns 5. A well developed disposable will assure lower risk of contamination probability in manufacturing. The use of disposable kitting is a growing trend whose time has come. Available from Millipore and Colder Connector (and other sources), disposable valves allow the replacement of stainless valves throughout the production facilities. In any economy, Biopharmaceutical companies need to lower costs associated with manufacturing processes. Further adoption of tubing assemblies with aseptic connectors and including disposable capsule filters, disposable valves, and sanitary ends, allow the consumer (manufacturer) to develop the complete fluid path in a disposable format. Thermoplastic elastomer tubing alternatives are available, such as CFlex ", which has better physical characteristics, lower gas permeability, low particulate, and is good for use in peristaltic pump for manufacturing applications. Disposables can eliminate the cleaning process and cleaning validation associated with stainless vessels 2. Additionally thermoplastic elastomer tubing can be used in conjunction with tubing sealers to seal the tube, or tubing welders to fuse two sterile tubing paths. This is particularly problematic since many of the components such as disposable valves have been developed closed and the autoclave process cannot always kill the bacteria burden on disposable valves that are in that position. Most companies integrate some disposable components while continuing to assemble and autoclave others; careful planning must be performed to prevent co-mingling these Fluid Path tubing assemblies. Pre-planning production to use disposables such as pre-irradiated tubing assemblies can improve sterility assurances during connections in the fluid path. Additionally, there are many OEM disposables manufacturers with the ability to develop just about any format of interest requested by the pharma manufacturing consumer for fluid movement within the facility. The valves are available in SIP as well as steam trap configurations. Assembly Planning Can Save Money too. Aseptic connectors attached to stainless tanks, bag systems or tubing assemblies allow sterile connections to be made in a non sterile environment. Disposable designs offer "faster to production" build-outs. Newly developed disposable valves, sanitary ends and filtration available in a capsule format have enabled the replacement of most stainless applications for sterile fluid transfer by disposable components. It is always easier to adjust downward order requirements, than attempt to have one's manufacturer respond to extremely short deliveries that utilize long lead-time components. Silicon tubing can not be sealed or welded in this manner, which dramatically decreases manufacture flexibility. Utilizing a contract manufacturer to assemble single use assemblies, like fluid path tubing assemblies, is a huge labor and cost savings opportunity for the Pharmaceutical manufacturer, but it also creates additional requirements. Use of custom pre-irradiated fluid transfer Tubing Assemblies negates the need to carry internal overhead of production and sterilization 3. Recent developments in a variety of disposable tubing assemblies have created cost saving opportunities. In conclusion, several key reasons for using disposable Tubing Assemblies and components include: 1.. Progress in aseptic components and connectors is one promising development in the manufacture of disposable irradiation sterilized assemblies. An additional level of management for these purchased assemblies is required, as well as the development of a strong supply partner relationship with an OEM to ensure a continuous supply of long lead-time components used in the product design. Use of disposables reduces the total investment in facilities and tank and piping costs, resulting in lower capital outlay 4. Asanitary connectors typically in stainless can be replaced by plastic for one time use sterile products. Furthermore, well managed inventories are critical, and any pharmaceutical manufacturer considering the use of disposable components should consider yearly production needs placing blanket orders to assure product availability at the desired production moment. Typically associated with bag systems replacing tanks, there are many new products and capabilities that can be applied to manufacturing processes that will meet the needs of today's medical device manufacturer. However, in today's challenging economic conditions and super regulated atmosphere, it is especially important to do so using a repeatable methodology and regulatory compliant manufacturing systems to eliminate waste, as well as the possibility for self-induced contamination. Purchasing disposable Irradiation sterile tubing set sssemblies will allow the reduction of internal assembly of tubing assemblies and eliminate the need for cleaning stainless connections prior to manufacturing, but additional planning will be necessary. Using contract manufacturers has both benefits and drawbacks. For the purpose of discussion, Fluid Path Tubing Assemblies will be used as an example. The use of aseptic connectors allow for less need to hookup or transfer under a laminar flow hood or class 100 clean environment, as they allow you to make a sterile fluid path connection in a non sterile environment.