Vial Filling Cleanroom Case Study
The bulk of the cost (capital & run-time) associated with the operations of a clean environment within the pharmaceutical and health-related industries is dictated by the desire to manufacture a high quality product and the need to satisfy the regulatory bodies such as the FDA. Mechanical ventilation design plays an extremely important role in determining the pass or fail criteria. At present the rules defining the best ventilation design practices are based on simplistic historical data that are often wrong. The leading corporations in these industries tend to have their own in-house mechanical expertise who scrutinize proposed designs, examine the final set up and verify original assumptions prior to final acceptance. Why? Because the performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts and any objects occupying the space. Consequently changes to any of these elements will affect the outcome and invalidate the built-in assumptions of the empirical configuration.
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