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This part will include substantial new content on equipment and process systems plus
significant updates to existing sections of the standard. These changes include several new
sections with requirements for the design of bioreactors/fermentors, sterilizers/autoclaves,
CIP distribution systems, and process gas distribution systems. The entire CIP Systems and
Design section has been revised to meet current industry practices. Requirements have
been expanded for CIP skid design, CIP flow rates, process vessel cleaning, CIP supply and
return headers, and CIP spray devices. It has also been updated with enhanced content on
the design of hygienic pumps, ball valves, O-ring connections, top-entering mixers, and
steaming for bioburden control. |
