Cleaning Validation Of Equipments For Producing Rh TNFR: Fc And RhIL-11

This dissertation is aimed to establish an actural and justifiable assessment method on equipment cleaning validation for aseptic foumulation process through the study on cleaning methods and effect of the drug processing equipments,especially producing rhTNFR:Fc and rhIL-11.Total organic carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters by controlling the quantity of organism. The analytical method of TOC based on precision, linearity, detectation limit, quantitation limit, accuracy (swab recovery) and robustness, indicating that TOC is suitable for the residue analysis of the in the cleaning validation on the drug processing equipments for producing rhTNFR:Fc and rhIL-11.The sampling includes swab samples and the final rinsing water. The swab samples are supposed to be representive, for example the dead angles, the unsmoothness of the inner surface and so on. The analytical items includes visible residue, API [analytical by TOC],microbial limit, pH, conductivity and endotoxin. As demonstrated that the detergent is adaptable and the cleaning method and procedure is effective through the analysis result. The sterilization formulation equipments can effectively prevent the cross-contamination and the detergent residue. This cleaning method and procedure can assure that the drug production take is safe, effective and reliable.