The great majority of sterile products commercially available as well as prepared in compounding pharmacies are sterilized by sterile filtration during aseptic processing. This brief and basic review will highlight the nature, action, and use of sterilizing filters. Special emphasis is given to how filters are validated in producing a sterile filtrate while being compatible with the filtered solution, as well as how filters are integrity tested during aseptic processing.
市面上绝大多数的无菌产品以及在制剂药房制备的无菌产品都是在无菌操作过程中通过无菌过滤来灭菌的。这篇简要的基础综述将重点介绍灭菌过滤器的性质、作用和用途。特别强调了在生产无菌滤液的同时与被过滤溶液兼容的情况下如何对过滤器进行验证，以及在无菌操作过程中如何对过滤器进行完整性测试。
