Closed systems: Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substance

The control of the environment around biologics manufacturing has historically been a key consideration for the design and operation of bioprocessing facilities to ensure product quality and safety. Facility design and control considerations for commercial biopharmaceutical manufacturing processes include environmental controls (e.g., temperature, humidity, and pressure), air quality (e.g., particulate and microbiological), facility finishes, gowning and flow procedures, equipment containment, system integrity, and cleaning procedures.  This paper written in 2011 argues that advances in process technologies and analytics enables manufacturers to close, contain and monitor more of their process steps and operate effectively with closed systems.  This paper was the precursor to studies to prove the principles that ultimately lead to the gude 'Data driven equipment and facility design case study' that is available here

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