无菌灌装隔离器

发布:2023-09-27人气:198

无菌灌装隔离器


     无菌灌装隔离器针对无菌灌装工艺开发,采用舱体设计,配合灌装设备形成完全隔离的物理屏障规范人员操作,通过物理阻隔与VHP汽化过氧化氢高效灭菌创造持续的A级无菌洁净环境,降低外源性污染和交叉污染风险,符合中国GMP和中国药典以及EU GMP/FDA cGMP/USP-NF要求,可有效保障无菌生产环境,确保无菌产品不受污染。

Aiming at the development of aseptic filling process, the aseptic filling isolator adopts the design of multi-cabin body and works with filling equipment to form A completely isolated physical barrier, which is operated by qualified personnel. Through physical barrier and efficient sterilization of VHP vaporizing hydrogen peroxide, the continuous A-level aseptic clean environment can be created to reduce the risk of exogenous pollution and cross contamination. In accordance with the requirements of Chinese GMP, Chinese Pharmacopoeia and EU GMP/FDA cGMP/USP-NF, it can effectively guarantee the sterile production environment and ensure that sterile products are not contaminated.