Tim Sandle
Microbiology Department, Bio Products Laboratory Ltd., Dagger Lane, Elstree, Hertfordshire WD6 3BX, UK.
Madhu Raju Saghee

DOI:https://doi.org/10.5912/jcb488


Abstract:

This article, written from an industry perspective, examines the current trend towards the implementation of single-use disposable technologies in the biopharmaceutical and biotechnology sectors. Single-use technologies are generally sterile, plastic disposable items implemented to replace traditional pharmaceutical processing items that require recycling, cleaning and in-house sterilisation. The forces driving the technological change are a mix of process efficiencies (including cost reduction) and sterility assurance. This article examines the advantages of some single-use systems used for aseptic processing, although in doing so a cautionary approach is adopted, particularly with regard to the validation requirements and practical considerations when such technologies are implemented.

Keywords:single-use sterile disposable technology ,sterility assurance ,aseptic processing ,contamination control ,irradiation ,microbiology ,en ,