Rationale Design of Valves for Flexible Processing

The use of diaphragm valves is common throughout traditional pharmaceutical processes where, with good aseptic design, they deliver the best hygiene for processes with fixed, reusable installations. The same valve hardware with elastomeric diaphragm is used for multiple batches and routine cleaning, sanitization and diaphragm replacement controls the risk of cross-contamination and contamination. Nevertheless, they remain linked to the number one cause for bioprocessing contamination as well as requiring significant installation and maintenance time, leaving significant room for improvement. Herein we outline a rational design for a single-use direct replacement alternative to diaphragm valves that removes installation complexity, the need for cleaning between batches, and offers further process efficiency benefits by eliminating shear, cavitation and hold-up concerns. A comparative visualization between the traditional and the new alternative valve will be supported by computational flow modelling which will visually highlight these improvements in drug processing efficiency and quality.

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