Throwing it All Away

Disposable products still require validation, which vendors typically provide, for materials, sterility, leaching and extractables. Process designers also must specify interconnectivity among plastic components with disposable valves, connectors and tubing. All such products carry a measurable validation overhead, which, depending on the application, may be compounded by multiple-vendor sourcing. Connectivity is a basic, enabling technology for disposables so users must carefully specify connectors, ports and valves, especially under sterile conditions. Many firms offer kits and tools for creating almost any type of connection between throwaways and the rest of the process. Kleenpak filter capsules from Pall (East Hills, N.Y.) use proprietary mechanical connections; Wave Biotech sells a sterile tubing welder and a portable tube sealer; Millipore (Billerica, Mass.) has introduced preassembled, presterilized connectors. Many companies offer pinch valves for flexible tubing, among them Thomas Ladisch Associates (Gilbertsville, Pa.), which sells both manual and actuated versions. Collaboration + Integration = Innovation Joint ventures have thus far been the life-blood of disposable manufacturing innovation. All major container manufacturers have ongoing agreements that add functionality to their "biobags." For example, Stedim collaborates with Integrated Biosystems (Napa, Calif.) on freezing applications, with Sweden's Pharmadule on design of rigid-vessel equipment and disposable bags, and with yet another firm on sanitary ports. TC Tech (Maple Plain, Minn.) obtains disposable process vessels from Stericon (Broadview, Ill.) and supplies 200-liter bags for the disposable, magnetically-levitated mixing system of LevTech (Lexington, Ky.). Sartorius' involvement in disposability includes sterile and pre-filtration, membrane chromatography, storage/holding bags (through an alliance with TC Tech), fully assembled bag/filter devices, and crossflow micro- and ultra- filtration as single-use cassettes. The company is working in a two prong approach: fully disposable processing and fully integrated large-scale engineered processes. Sartorius has invested in process know-how and engineering talent, in addition to building a new facility for its Sartorius