The Biological Drugs Manufacture Enterprise Conforms To GMP Request CIP Systematic And The Clean Method Research

The present paper is for the purpose of to the biological drugs manufacture enterprise finishing after matting in the regular production working procedure provides one kind to be able the greatest degree to conform to GMP the request CIP systems engineering design and the clean confirmation method, thus guarantees the biological drugs manufacture enterprise to finish after the regular production can carries on to the production equipment and the system completely conforms to the GMP request completely automatic clean work.The present paper has discussed various countries' and organization's GMP to the equipment clean request, relates in detail the CIP system clean technology to develop first, from the CIP system clean principle and CIP system design manufacture request obtaining, elaborated this enterprise newest introduction and the design CIP system hardware architecture and the software system, how does design conforms to the GMP standard automatic control procedure, and according to the large-scale cell fermentation pot characteristic, from the most difficult clean spot and the sampling point confirmation, the method of sampling and the step, the sample returns-ratio experiment analyzes, the biggest permission residual type definite as well as the clean procedure confirmed and so on the aspects obtain determined conforms to the GMP standard clean confirmation method.