| Summary: | 碩士 === 銘傳大學 === 國際企業學系碩士在職專班 === 107 === The BFS (Blow-Fill-Seal) process is an aseptic filling process that produces aseptic products. Process deviations, especially those related to sterility, are based on the concept of protecting the user. If the product quality cannot be ensured, the product will Being destroyed, if the user is hurt, the subsequent investigation and processing will consume huge resources, so how to reduce the process risk is a topic worth exploring.
This study used qualitative research (eg., focus groups, expert interviews)including professionals from appropriate sectors – quality departments, engineering, pharmaceutical regulatory affairs, production operations, design and development, and external consultants. The quality-oriented risk assessment system identifies the risks that may exist in the BFS process, analyzes the severity of various risks in the BFS production process, identifies the probability of possible risks, and then judges the risk level of each risk according to the Failure Mode Effects Analysis. The failure mode that is assessed as a critical risk must prioritize the introduction of risk management measures.
This study used risk management tools to assess the risks of the BFS process. The identified risks are through current control measures. Most of them are rated as serious and minor risk levels, and critical risk levels by adopting new controls to reduce the risk to a serious level. In addition, assessments are serious and minor risk, and new risk management measures can be considered to reduce risk.
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