| To minimize the contamination risk of non-final sterilization sterile drug, we monitored the producing sections which could potentially introduce contaminations, such as production environment, personnel, stuff, injection water, compressed air, key operation zone of aseptic filling and key equipment, and analyzed the relevant data using statistical tools of Shewhart control chart and pie chart in the production process of recombinant lysostaphin powder. The maximal contamination risk ratio is for 100 grade personnel which is up to 38%. And the secondary maximal CRR is 36% and for WFI. The 10000 grade aseptic static settling microbe CRR is 22%. The CRR of key operation zone and equipment is 4%. However, the impact of 100 grade static settling microbe, filled drug solution after micro-filtration and compressed air is 0.According to the key production control points and manufacturing technology control chart of the recombinant lysostaphin powder, we assessed the risk factors of the picking process, stuff preparation phase, liquid preparation phase, filling phase, product disposal after manufacture, preparation for laboratory monitoring, environment monitoring for aseptic area and the devices on lyophilizer in the production process of recombinant lysostaphin powder, and also evaluated the current control steps, impact effects and risk grade for the key control points.We performed the risk analysis for the 28 key risk points of the manufacturing technology of recombinant lysostaphin powder using FMEA, carried out control steps on the risk project and then produced the fish-bone chart of manufacturing technology risk assessment for recombinant lysostaphin powder.Finally, we confirmed by media mimicking filling for the manufacturing technology of recombinant lysostaphin powder that the sterile operation regulation mainly of preventive measures can decrease the microbial contamination risks by using worst condition interference. |
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