Mittelman M W, Jornitz M W, Meltzer T H
University of Toronto, Faculty of Medicine, Ontario, Canada.
PDA J Pharm Sci Technol. 1998 Jan-Feb;52(1):37-42.
There are two recognized mechanisms whereby organisms are retained by liquid filters; namely, sieve-retention and adsorption. The efficiency of each may be influenced by the organism, suspending milieu, and by the filtration conditions. Validations of sterilizing filtrations require the use of organism suspensions in product-specific media. However, where the product is bactericidal to the challenge organism(s), surrogate solutions may be required. The ideal surrogate solution would minimize adsorptive retention, ensuring that the sterilizing action of the filter under consideration is the consequence of sieve-retention. This review explores the impact that various physicochemical factors may have on bacterial cell size and cell surface characteristics. An understanding of interactions among challenge bacteria, suspending fluid, and filter medium is essential for the development of surrogate solutions that provide a "worst case" mileu for filter validation studies or a "placebo," non-inhibitory challenge solution.
有两种公认的机制可使微生物被液体过滤器截留，即筛网截留和吸附。每种机制的效率可能受微生物、悬浮环境以及过滤条件的影响。除菌过滤的验证需要使用特定产品介质中的微生物悬液。然而，如果产品对挑战微生物具有杀菌作用，则可能需要替代溶液。理想的替代溶液应使吸附截留最小化，确保所考虑的过滤器的杀菌作用是筛网截留的结果。本综述探讨了各种物理化学因素可能对细菌细胞大小和细胞表面特征产生的影响。了解挑战细菌、悬浮液和过滤介质之间的相互作用对于开发替代溶液至关重要，这些替代溶液可为过滤器验证研究提供“最坏情况”的环境或一种“安慰剂”、无抑制作用的挑战溶液。
