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Nov 22nd, 2022
Nov 22nd, 2022
Desmond Hunt, senior scientific liaison at United States Pharmacopoeia, has said the biomanufacturing industry is working towards standardised guidance to simplify the implementation of single-use systems.
Mr Hunt made his comments after a survey by Pharma IQ found that 60% of stakeholders saw validation as their biggest challenge with single-use systems.
“I like to think that we’re at the frontier for standards and guidance related to single-use systems,” writes Mr Hunt in the Disposable Solutions for Biomanufacturing 2014 Survey Results and Insight.
Over the past year, he said, there have been a lot of organisations forming with the goal of looking into guidance and best practices.
Mr Hunt added: “From a USP perspective we have been thinking about developing a standard on single-use systems for the last four or five years but one of the things we wanted to do is, we currently have plastic standards in the USP and we wanted to kind of revise those and change the focus before we started tackling our standards for single-use systems.”
“And the way our current standard is being proposed is we want well-characterised materials to be used – meaning you have to be able to identify the material, its biological reactivity, various physical chemical tests you have to test for, various additives and extractable metals, and once you determine that a material is well-characterised whether you use it for a packaging system or a medical device or even a single-use system becomes quite easy.”
Mr Hunt underscored his belief that using good starting materials always resulted in a “much better” final product.
“And one of the things that we will be doing in the next couple of months is bringing together an expert panel from individuals from the manufacturing sector, from the single-use sector, to try and get an idea of what are some of those common practices that are being used and hopefully that works its way out into compendial standard.”
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