Some considerations for the implementation of disposable technology and single-use systems in biopharmaceuticals
DOI:
https://doi.org/10.5912/jcb488Keywords:
single-use sterile disposable technology, sterility assurance, aseptic processing, contamination control, irradiation, microbiologyAbstract
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.
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