Adoption of Single-Use Technologies

Single-use manufacturing is almost 30 years old, beginning in the early 1980s when filter manufacturers began to make small process-scale plastic filter capsules to replace "junior" size stainless-filter housing assemblies. Small laboratory syringe filters were already being supplied presterilized by gamma radiation, but originally, disposable filter capsules for pharmaceutical production were only available in nonsterile format for autoclaving by the user. Higher area filter capsules for even larger volumes did not become available until the late 1980s to early 1990s, eventually including the large scale 10-inch modular capsule filter assemblies available today. Around the same time, the smaller production-scale filter capsules presterilized by gamma irradiation began to be offered. Single-use manufacturing was further facilitated in the early 2000s by the introduction of large-scale tube welders and sterile connectors that enabled the connection of two sterilized fluid pathways/systems while maintaining the sterility of both. Availability of larger bio containers by the early 2000s brought with them the innovative development of the disposable rocking-bag bioreactor, and by the late 2000s, stirred tankliner bioreactors and mixers came to market, with the larger filter capsule formats enabling the development of membrane chromatography units for trace-contaminant polishing. During that time, the Bio-Process Systems Alliance (BPSA) was established. BPSA has been instrumental in promoting best practices for implementation of single-use technologies. The most recent developments in the 2010s have been sterile disconnectors and single-use tangential-flow filtration systems. Today, the term "single-use technology" encompasses a broad range of primarily plastic disposable technologies that are suitable for a wide variety of scales and applications, from upscale bioprocessing to final formulation and filling. They can be found in manufacturing processes for licensed drug and vaccine products around the world.