新版GMP规范下卫生级脉动真空双扉灭菌柜URS

USR of Sanitary Pulsation Vacuum Double-doors Sterilizing Cabinet Complying with New GMP

URS是设备采购的重要技术资料,针对新版GMP规范要求,结合某企业灭菌柜工艺特点制定相关URS。

User Requirement Specification （URS） is important technical document. With respect to the requirements in new version GMP, and combined with the process characteristics for sterilizer used in one enterprise, the making process of URS was stated in this article.