Investigation of Influencing Factors and Risk Analysis of Sterilization Effect in Tunnel Oven
In order to comprehensively investigate the factors affecting the sterilization effect of the tunnel oven and strengthen the risk identification,this paper studied from the aspects of the microorganisms,temperature distribution,air flow,moisture residue,pressure gradient change,etc.The results showed that the microorganisms could still be detected in the cooling section of the tunnel oven by manual wiping.The high temperature environment in the sterilization section for a long time would increase the number of suspended particles,increase the stress in the bottle,and increase the risk of broken bottle and pollution.The change of air flow between washing bottles would bring fluctuations to the pressure difference balance of the equipment.The increases of residual moisture in the bottle and the height of the baffle above the bottle would decrease the value of the bactericidal thermal strength(FH).Placing multiple rows of probes for temperature verification could more fully identify sterilization cold points.In order to eliminate the risks and hidden dangers to the maximum extent to ensure drug safety,in actual production,it was recommended to increase the sterilization function in the cooling section of the tunnel oven,avoid the long-term stagnation of the bottle in the sterilization section,maintain the relatively stable air flow between the bottle washing room,check the smooth blowhole of the bottle washing machine and ensure its exhaust capacity,select the appropriate baffle height according to the height of the bottle in production,and arrange multiple rows of probes for temperature verification.
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