Madsen Russell E, Meltzer Theodore H
The Williamsburg Group, LLC, 18907 Lindenhouse Road, Gaithersburg, MD, USA.
PDA J Pharm Sci Technol. 2009 May-Jun;63(3):240-4.
Sterilizing filtration process variables can cause unpredictable results and post-filtration integrity test values that are not representative of those obtained during validation of the filtration process. This paper discusses several points to consider in sterilizing filtration designed to assure the validated process is robust and consistently yields a sterile filtrate. These points include pore- and particle-size distributions, the use and choice of prefilters, pore configuration, and the use of redundant (serial) filtration.
除菌过滤工艺变量可能会导致不可预测的结果以及过滤后完整性测试值，这些值并不代表在过滤工艺验证期间获得的值。本文讨论了在除菌过滤设计中需要考虑的几个要点，以确保经过验证的工艺稳健且始终能产生无菌滤液。这些要点包括孔径和粒度分布、预过滤器的使用和选择、孔结构以及冗余（串联）过滤的使用。
