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Cleaning Validation of Equipments for Producing rh TNFR: Fc and rhIL-11

Author: YinYongHong
Tutor: TangYanHui；HouSheng
School: East China University of Science and Technology
Course: Pharmaceutical Engineering
Keywords: TOC Verification Analytical methods Clean Residues
CLC: TQ464.4
Type: Master's thesis
Year: 2011
Downloads: 92
Quote: 0
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Abstract


Ⅱ injection of recombinant human tumor necrosis factor receptor - antibody fusion protein and injected with recombinant human interleukin-11 preparations verify the production of of Collinearity pharmaceutical equipment cleaning methods and effects , the establishment of a sterile preparation production equipment correct and scientific evaluation of the cleaning validation method . The total organic carbon law ( TOC Law ) is a way to check the total organic carbon in water and thus indirectly control the Determination of organic content . Thesis TOC method test method validation , verification including precision, linearity, limit of detection , limit of quantification , accuracy ( wipe recovery) and durability . The results show that the test method validation TOC method is suitable for injection of recombinant human II tumor necrosis factor receptor - antibody fusion detection of residues in the protein and injection of recombinant human interleukin-11 preparation equipment cleaning validation process . Verify representative parts of the object , such as dead ends , the inner surface is not smooth wipe sampling , and the final rinse water sampling equipment cleaning validation implementation . Detection include visual, drug residues of the active ingredient (TOC method ) , microbial limits , pH value , conductivity , and bacterial endotoxin . Each element of test results prove that the cleaning agent selected by the authentication object is correct, the cleaning method employed and procedures are effective . After cleaning , the cleaning effect is indeed sterile preparation production equipment to avoid cross-contamination and detergent residue contamination of drugs , practical and reliable way to ensure the quality of medicines , to ensure the safety of the patient 's medication , effective and reliable .

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