医药工程设计
醫藥工程設計
의약공정설계
PHARMACEUTICAL ENGINEERING DESIGN
2014年
2期
30-33
,共4页
精制车间%设计%无菌%主要设备选择
精製車間%設計%無菌%主要設備選擇
정제차간%설계%무균%주요설비선택
reifning plant%design%sterilization%selection of main equipment
2010版GMP大幅提高了对无菌药品生产的控制要求，无菌原料药的生产复杂，除了环境的洁净要求外，对设备及管道的清洗和灭菌设计，物料、工器具及内包材转运均有不同于制剂生产的要求。根据无菌原料药精制车间的设计经验，归纳设计要点及主要经验供参考。
2010版GMP大幅提高瞭對無菌藥品生產的控製要求，無菌原料藥的生產複雜，除瞭環境的潔淨要求外，對設備及管道的清洗和滅菌設計，物料、工器具及內包材轉運均有不同于製劑生產的要求。根據無菌原料藥精製車間的設計經驗，歸納設計要點及主要經驗供參攷。
2010판GMP대폭제고료대무균약품생산적공제요구，무균원료약적생산복잡，제료배경적길정요구외，대설비급관도적청세화멸균설계，물료、공기구급내포재전운균유불동우제제생산적요구。근거무균원료약정제차간적설계경험，귀납설계요점급주요경험공삼고。
In 2010 version GMP, the control requirements for the production of sterile drugs have been raised greatly. The production process of sterile drugs is complicated. Besides clean environment is required in the production, there are many other requirements in the design of cleaning and sterilization of equipment and piping, raw materials, tools and inner packing materials. Experienced with the design of sterile reifning workshop, the key points in design were summarized, which can be used as reference later.
