一次性使用负压引流护创材料包的无菌保证与细菌内毒素质量风险评估

Sterility Assurance and Bacterial Endotoxin Quality Risk Assessment of Disposable Negative Pressure Drainage Wound Care Material Package

文章对一次性使用负压引流护创材料包(VSD)的无菌保证和细菌内毒素的质量风险进行评估分析,通过分析造成灭菌前产品初始污染菌/生物负载污染的风险因素,以及对风险因素的评价并采取一定降低风险的控制措施,来评估产品的实际风险控制水平。通过分析数据,制定合理的控制依据,使得风险控制在可接受范围内,证明产品的无菌保证和细菌内毒素质量风险是完全可以控制的。

This paper evaluates and analyzes the sterility assurance and the quality risk of bacterial endotoxin of the disposable negative pressure drainage wound care material package(VSD),and evaluates the actual risk control level of the product by analyzing the risk factors causing the initial bacterial/biological load pollution of the product before sterilization,evaluating the risk factors and taking certain risk reduction control measures.By analyzing the data and formulating reasonable control basis,the risk is controlled within an acceptable range,which proves that the sterility assurance of the product and the quality risk of bacterial endotoxin can be completely controlled.