For the past decade, the development and approval of biological drugs has increased rapidly. This increase highlights the significance of aseptic processing because biologics commonly cannot be heat sterilized. Because aseptic processing receives greater regulatory scrutiny than heat sterilization does, the industry developed, in addition to risk-management and risk-analysis activities, new processing equipment and technologies to overcome potential weaknesses (1). These technologies' main purpose was the avoidance of human intervention, which is one of the most substantial risks in aseptic processing. The technologies included environmental-containment solutions such as isolators and restricted-access barrier systems, and new filling strategies such as blow–fill–seal. Disposable solutions have changed, and their applications have broadened, during the past several years.
The most far-reaching changes in the technology's early days affected processing equipment, which gradually was converted into single-use equipment (2). The benefits of single-use equipment not only enable a potentially higher sterility-assurance level within process steps than was possible before, but also enable production-utilization enhancements, cost savings, and end-user protection. Single-use equipment does not require setup times of 8–10 h or copious amounts of water for cleaning purposes (3). Furthermore, it protects end users from contact with potentially hazardous fluids. This article will focus on recent advances in single-use technologies.
The development of single-use equipment
Single-use bags are used most often in an assembly format, either with or without a filter, as part of a multibag system. The entire assembly is gamma irradiated in the packaging and is ready to use.
Single-use systems, though, are not restricted to bags and filters. Various equipment components are available that can be combined into a single-use system or process step. Such equipment components include the following: