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Microfluidics: Steam-Sterilizable Diaphragm Needle Valve
August 4, 2003
Microfluidics has introduced a proprietary steam-sterilizable high-pressure diaphragm needle valve that operates at pressures up to 40,000 psi. This allows the introduction of a "Level II" steam-in-place option that is designed to meet the most challenging regulatory requirements for eliminating microbiological contaminants for injectable pharmaceutical formulations in cGMP manufacturing environments. Level II is an addition to the existing "Basic" and "Level I" SIP options for the Microfluidizer high-shear fluid processor. It is designed with single point inlets and outlets in the welded manifold for clean-in-place fluids, steam and purge air. A Ruttan drainable valve is used at each inlet and outlet (six total) to enhance condensate drainage.