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The Biological Drugs Manufacture Enterprise Conforms to GMP Request CIP Systematic and the Clean Method Research

Author: XieGuoLiang
Tutor: ZhuangYingPing；HuHui
School: East China University of Science and Technology
Course: Pharmaceutical Engineering
Keywords: CIP system Cleaning methods Biopharmaceutical
CLC: X383
Type: Master's thesis
Year: 2012
Downloads: 64
Quote: 0
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Abstract


This paper aims to biopharmaceutical companies in the cleaning process after the end of the normal production process to provide a maximum degree of compliance with GMP requirements of CIP systems engineering design and cleaning validation method , so as to ensure a biopharmaceutical companies after the end of the normal production on the production equipment fully comply with the GMP requirements of the automatic cleaning system . This thesis explores the countries and organizations GMP clean equipment , detailed CIP cleaning system of the latest developments in technology , start from the principle of CIP system cleaning and CIP systems design and manufacturing requirements of the latest introduction and CIP system design structure of hardware and software systems , how to design a self-control program that meets the GMP standards , and in accordance with the characteristics of large cell fermentation tank , from the most difficult to clean the site and the confirmation of the sampling points , sampling methods and procedures , sampling recoveries experimental analysis , the maximum allowable residual determine and cleaning procedures to confirm aspects determine a meet the GMP standard cleaning methods , and the success of the the 2500L animal cells fermenter the three batches clean practice .

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CLC: > Environmental science, safety science > Administration of Environmental Protection > Environment and cleaner production ( clean technology ) > Clean technology (clean technology )
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