In any economy, Biopharmaceutical companies need to lower costs associated with manufacturing processes. 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.
The use of disposable kitting is a growing trend whose time has come. 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. For the purpose of discussion, Fluid Path Tubing Assemblies will be used as an example.
Recent developments in a variety of disposable tubing assemblies have created cost saving opportunities. 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. 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.
Progress in aseptic components and connectors is one promising development in the manufacture of disposable irradiation sterilized assemblies. Aseptic connectors attached to stainless tanks, bag systems or tubing assemblies allow sterile connections to be made in a non sterile environment. 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.. 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.
Silicon tubing has a long history in single use systems, but there are now many alternatives. Thermoplastic elastomer tubing alternatives are available, such as CFlex #8482, which has better physical characteristics, lower gas permeability, low particulate, and is good for use in peristaltic pump for manufacturing applications. 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. Silicon tubing can not be sealed or welded in this manner, which dramatically decreases manufacture flexibility.
Disposable valves are another cost saving option. Available from Millipore and Colder Connector (and other sources), disposable valves allow the replacement of stainless valves throughout the production facilities. The valves are available in SIP as well as steam trap configurations. Sanitary connectors typically in stainless can be replaced by plastic for one time use sterile products. Additionally, there are many OEM disposables manufacturers with the ability to develop just about any format of interest requested by the pharmaceutical manufacturing consumer for fluid movement within the facility.
Assembly Planning Can Save Money too. Purchasing disposable Irradiation sterile tubing set assemblies 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. 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. 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. Pre-planning production to use disposables such as pre-irradiated tubing assemblies can improve sterility assurances during connections in the fluid path.
Using contract manufacturers has both benefits and drawbacks. 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. 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. 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. 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. sterile processing technician salary