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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
As commercial manufacturing considers single-use materials, a look shows how industry moved to the technology.
How did single-use technologies get their start in biopharmaceutical manufacturing? Pharmaceutical Technology asked Chris Smalley, member of the International Society for Pharmaceutical Engineering’s Disposables Community of Practice and an industry veteran with experience at Wyeth, Sanofi, Johnson & Johnson, and most recently retired from Merck, for a look back at how the single-use revolution began.
PharmTech: What were the first applications of single-use technology, and how has the technology changed in the past 40 years?
Smalley: Forty years ago, permanent filter housings with replaceable filter media were the norm. The filter housings were multiuse, inflexible in their use, time-consuming in their preparation, and frequently considered the ‘cold spot’ in the autoclave (i.e., the slowest to reach temperature). With the introduction of single-use filters, flexibility and responsiveness greatly increased, because the filter could be installed in a process stream and the entire system could be autoclaved or gamma-irradiated (providing a higher level of assurance by reducing post-sterilization manipulations) and stored prior to use. Single-use filters were easier to handle because they were lightweight, and they eliminated cleaning steps.
Forty years ago, the most prevalent container for intravenous (IV) sterile solutions was the colorless glass bottle that needed to be vented to allow the solution to drain, and most times the vent was not even being filtered. When a bottle was dropped by accident, it sounded like a shotgun blast, and of course there was broken glass everywhere. Slowly, single-use bags made from polyvinyl chloride (PVC) were accepted in hospitals across the country. They were robust and didn’t need to be vented with the non-sterile air in the hospital room. The eventual broad use of bags for IV sterile solutions paved the way for expanding the use of other single-use systems in biopharmaceutical manufacturing. More systems were developed that have helped to revolutionize the applications of single-use systems in the past five years. In collaboration with suppliers, the expertise has been developed that enabled single-use systems to expand their use in challenging conditions (e.g., high temperatures, solvents, unique chemistries), which has allowed their evaluation and implementation in different applications. Before, low-risk applications (i.e., media/buffer preparation) adapted single-use systems. Now, the use of single-use systems has expanded to drug substance and drug product applications.
Vol. 41, No. 7
When referring to this article, please cite it as J, Markarian, “Single-Use Storage Containers and Filters Paved the Way for Single-Use Systems,” Pharmaceutical Technology 41 (7) 2017.