for biopharmaceuticals are made completely out of stainless steel or exist as hybrid and as single-use types. Hybrid production facilities contain single-use systems combined with reusable systems from glass or stainless steel. They are the state-of-the-art.
Single-use production facilities in general are production facilities in which the substance conversion, transport and storage of feedstock material, intermediate and final products take place mainly or completely in single-use systems. Such single-use production facilities can be divided into single-use production facilities of the closed type or single-use production facilities operating in stations.
In single-use production facilities of the closed type, the individual single-use systems are pre-fabricated and coupled in the order of processing steps. The raw material, intermediate and final products are transported from one single-use system to the next by free flow or pressure. Such production facilities are currently limited to simple technologies and small volumes.
In single-use production facilities operating in stations, the raw material, intermediate and final products are transported from one processing step to the next in single-use systems. This requires single-use process platforms, transportable, single-use containers (container systems), the logistics to identify and operate the systems, the sterile coupling of the systems with each other and with other single-use systems, as well as the technology to maintain the mixing state and the reaction conditions in the containers.
There is a current trend for production facilities where the USP is completely performed in single-use systems (e.g. the 2000-L system from Shire in Lexington, Massachusetts). These production facilities allow a station operation where raw material, intermediate and final products are transported from one processing step to the next via mobile containers. Single-use production facilities, like the one produced by Wuxi PharmaTech in Shanghai that exclusively work with single-use systems, are still rare (10 %). See ballroom concept.