Almost over the hill manual#
Almost over the hill full#

Stainless steel offers competitive advantages due to almost no volume design restrictions and to the ability to design a system according to a clientвЂ™s specifications and processing requirements.

In such cases, the benefits of conventional stainless steel systems prevail. While the single-use option for systems smaller than one cubic meter often can be considered as a feasible alternative option, the situation is different if the targeted scale exceeds a few cubic meters or dedicated manufacturing facilities are envisaged.

They are even substantially higher if manufacturers use tailor-made configurations rather than the suppliersвЂ™ standard ones. Sourcing costs for single-use components rise substantially during regular production in line with the number of batches to be manufactured. In contrast, other cost blocks typically arising with Capex projects (e.g., building, cleanroom, and floor and ceiling construction, HVAC and laboratory facilities) yielded lower or even negligible potential for savings. Similarly, fewer qualification and validation efforts are needed due to vendor-sterilized (gamma-radiated) bags and associated flowpaths. Savings in Capex are mainly based on absence of the need for complex piping systems required for CIP and SIP, including associated automation components. 36вЂ“52% reduction in instrumentation and automation.37вЂ“40% reduction for piping and equipment installation,.Potential cost savings on capital expenditure (Capex) have been estimated as follows:

Almost over the hill full#

Various design approaches have been evaluated with respect to partial or full replacement of conventional systems by single-use components. Influence of tube diameter on maximum flow volumes and transfer times A thinner wall thickness may facilitate handling due to higher plasticity but it also entails a disadvantage in that if the medium is drawn off from the container by means of a pump, this may cause the hose to contract, thus reducing the flow or even blocking the hose.

Almost over the hill manual#

The greater the hose diameter the more complicated the manual handling of the material becomes. More recently, however, a diameter of 1 inch has been introduced. For many years Вѕ inch was considered to be the maximum viable connector size.

The tube diameter is determined by the connectors sealed to the bags. Restrictions arising from the tube diameter that result in overly long transfer and filling times also play a role ( Table). Operators must be familiar with the specific skills required for working not only with bags, but also hoses, since numerous new hose connections need to be created for each batch. This is primarily due to constraints with respect to the stability of the bags and their handling. Limits for the deployment of single-use systems are currently set at one to two cubic meters for stirred systems and two to three cubic meters for storage tanks. Such systems are typically based on conventional stainless steel designs for fluid integrity and construction material handling reasons. Starting with mid-size installations, skids for generation and loops for distribution of clean utilities, namely WFI and clean steam, must also be designed, procured, and installed. Sourcing of basic process skids (bag support containers and control units) must be considered and is not negligible. Still, implementation time cannot be reduced at any level. Thus, preparation times are shortened, particularly for product changeovers, but also for batch-to-batch preparation during manufacturing. Single-use technology permits more cost-efficient design and swifter implementation compared to conventional stainless-steel components and allows bioprocessors to minimize technological and procedural cleaning efforts.