对PTU、PRX、TNX三种原料药产品共线生产的风险评估

Risk Assessment for Production of Three API-Propylthiouracil, Piroxicam and Tenoxicam with One Shared Line

运用风险评估的方式,利用风险分析工具——失效模式影响分析(FMEA),评估多功能生产车间多个品种共线生产的可行性。通过对共线产品的特性、工艺、预定用途,共线车间的厂房设施、公用工程系统、共用生产设备适用性、共用设备清洗评估以及共线生产品种的生产过程评估,可以确认,多功能车间现有多个品种共线生产是可行的。现阶段采取的防止污染和交叉污染,防止混淆与差错的措施适用于多功能车间日常生产操作。

By using risk assessment method and the tool"Failure Mode Effect Analysis"(FMEA),the feasibility that one producing line is shared for multi products was appraised,which included the features,productive process and applications of the products from the shared line,facilities in workshop,utilities,the applicability and cleaning of the shared equipment.it can be determined that currently in multi-functioning workshop multi products are produced from the shared line is feasible,the measures of protecting contamination,and protecting errors has been proved to be proper in daily production.