READY-TO-FILL? 無菌充填キットの無菌性保証と展望

摘要

Purchasing, validating, maintaining and operating container/closure cleaning and sterilization/depyrogenation equipment for periodic use in aseptic filling demands human, financial, and floor space resources an organization can better allocate elsewhere in small-scale drug development. In this paper, the authors describe how the innovative pre-packaged Ready-to-Fill? sterile components are cGMP-prepared suitable for aseptic filling and indicate the various benefits to pharmaceutical companies and medical institutions of all sizes.