Akers Michael J
Int J Pharm Compd. 2015 Sep-Oct;19(5):393-401.
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.
绝大多数市售无菌产品以及在配制药房中制备的无菌产品都是在无菌加工过程中通过无菌过滤进行灭菌的。这篇简短的基础综述将重点介绍除菌过滤器的性质、作用和用途。特别强调的是,如何验证过滤器在产生无菌滤液的同时与被过滤溶液兼容,以及在无菌加工过程中如何对过滤器进行完整性测试。