Development of a Single-Use Filling Needle: Implementation in a Single-Use System for Aseptic Filling

摘要

Single-use components such as tubing, connectors, and filters have been widely used for many decades in bioprocess unit operations. Users have been able to identify and quantify the specific benefits of single-use over cleanable systems. In more recent years, many other process components have been designed for disposability such as bioreactors, mixers, and chromatography and ultrafiltration systems. Those and other advances have made it possible to incorporate multicomponent, presterilized manifoldsinto both existing and new processes, realizing benefits such as reduced cleaning, shortened set-up times, increased production throughput, and enhanced sterility assurance.Although such developments have raised the possibility of developing fully disposable multistage processes, some unit operations have not been easy to convert to single-use because of limitations on scalability, costs, performance, and/or the unavailability of single-use options. One operation in which single-use technology is becoming more widely adopted isformulation and final filling. The industry is becoming more comfortable with single-use technology and gaining understanding of critical aspects such as extractables and leachables. In a 2012 survey of the bioprocessing market for single-use solutions,biopharmaceutical companies were asked to list those operations they considered to be suitable for such applications (l). Over half (54%) of respondents listed fill-finish operations.