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Cip cycle development sep04

CIP Cycle Development This article demonstrates how the principles of ISPE's C Q Baseline Guide can be applied to a cycle development program at a modern biotech manufacturing facility Figure Overview of CD testing program and cleaning validation prerequisites Reprinted from PHARMACEUTICAL ENGINEERING The O ?cial Journal of ISPE September October Vol No Biotech CIP Cycle Development by Timothy Howard and Matt Wiencek Introduction CIP Cycle Development CD is a systematic approach of setting CIP systems to work in a manner that promotes rapid and successful execution of Cleaning Validation CV activities The Cycle Development program is an integral part of the overall commissioning of a facility and its processes It is not enough to merely con ?rm tubing valves pumps controllers and instrumentation are installed as designed functioning as speci ?ed and within acceptable tolerances The act of running a cleaning cycle and con ?rming the software and associated control elements respond as expected or functional testing does not constitute Cycle Development All of these activities are elements that must take place prior to Cycle Development but do not provide for development of a cleaning cycle Cycle Development employs CIP skids that have been commissioned and through a three step process optimizes the cycle parameters for each cleaning circuit in the plant A formal Cycle Development program will lead to robust CIP cleaning cycles which in turn minimizes cleaning validation deviations retests and lengthy investigations of failures The purpose of this article is to demonstrate how the principles of the ISPE Commissioning and Quali ?cation C Q Baseline Guide can be applied to a Cycle Development program at a modern biotech manufacturing facility Background Cycle Development CD typically occurs after CIP and support systems are mechanically complete and prior to Cleaning Validation CV execution CD is one subset of activities within the overall commissioning e ?ort The ISPE Baseline Guide on Commissioning and Quali ?cation C Q can be applied to plan and execute an organized and e ?cient CD program ?Copyright ISPE SEPTEMBER OCTOBER PHARMACEUTICAL ENGINEERING CCIP Cycle Development Equipment CIP Circuit Circuit Name L Bu ?er Prep Vessel L Bu ?er Prep Vessel Vessel identical to L Bu ?er Prep Vessel L Bu ?er Hold Vessel L Bu ?er Hold Vessel L Bu ?er Hold Vessel Vessel identical to L Bu ?er Hold Vessel Tank Inlet Line Outlet Line Tank Inlet Line Outlet Line Tank Inlet Line Outlet Line Tank Outlet Line Tank Outlet Line Tank Outlet Line Tank Outlet Line B-C B-C B-C B-C B-C B-C B-C B-C B-C B-C B-C B- C B-C B-C B-C B-C B-C Table A Functional test plan - bu ?er prep Unique Clone Unique Unique Unique Clone Clone Clone Unique Unique Unique Unique Unique Unique Unique Clone Clone Unique Unique This article will examine the planning of a CD program for a modern biotechnology manufacturing facility and present two case studies for execution of the plan The case studies will examine development of a process vessel cleaning circuit and a