If the pharma industry wants to replace conventional batch processing with continuous manufacturing, it must also employ control procedures to ensure quality.
Jamie Clayton |
According to the FDA, continuous manufacturing has many advantages... greater consistency in product quality, reduced inventory, lower capital costs, a smaller ecological footprint, minimized manual handling, shorter process times through integrated processing, the ability to employ real-time release testing approaches... In essence, continuous manufacturing supports Quality by Design (QbD) initiatives by allowing quality to be directly built into a process – and the FDA is encouraging companies to consider continuous technologies (1).
However, working with a truly continuous system within a highly-regulated sector incurs challenges. Consistent outputs depend entirely upon the quality of feed materials, as well as a comprehensive understanding of how those materials behave within the process, and how changes in process conditions might affect that behavior. You must know exactly which material parameters are critical to your process – after all, there’s little benefit in generating multiple parameters if they have no relevance on what you’re trying to achieve.
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