Improvement of disinfection progress and evaluation of disinfection effect for an oral liquid preparation
Objective To select the appropriate disinfection process based on the key quality met the requirement of an oral liquid,and to evaluate the disinfect effect.Methods The impact of adding the disinfection process on key quality attributes of the oral liquid was observed,and improvment measures were formulated.Using microbial quantitative method,the disinfection process and disinfection effect of the oral liquid were assessed.Results Through workshop cleaning,wet heat disinfection,and staff hand disinfection measures,the microbial limit test of the oral liquid was qualified,and the microbial test results showed that the improved disinfection process had been tracked and all test were qualified.Conclusion The disinfection process can significantly decrease the risk of microbial contamination, which ensure the microbial limit test of the product to be qualified.
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