Gressett Gary, Vanhaecke Erwin, Moldenhauer Jeanne
Alcon Laboratories, 7501 S. Freeway, Fort Worth, TX, USA.
PDA J Pharm Sci Technol. 2008 Nov-Dec;62(6):429-44.
Newer and more accurate methods for microbiology have evolved in recent years. While implementation of these methods has been slow, microbiologists have been waiting for a method that could eliminate or substantially reduce the 14-day compendial sterility test method. The ScanRDI system is a viability-based technology that allows for microbiological results to be obtained within several hours, without having to grow the microorganisms. This paper describes, in case study format, the procedures used at one company to select a rapid microbiological method for use in sterility testing. It further describes the methods used to validate and implement the method at the company location. In the current world of pharmaceuticals, most companies are global businesses, and Alcon Laboratories is no exception. As such, while these methods are approved for use in the US, full replacement of all traditional sterility testing cannot be accomplished until all of the foreign regulatory agencies have approved use of this methodology. The implementation discussed in this paper covers the ability to use this method for sterile ophthalmic drug products marketed in the US.
近年来，更新、更准确的微生物学方法不断涌现。尽管这些方法的应用进展缓慢，但微生物学家们一直在期待一种能够消除或大幅缩短为期14天的药典无菌检测方法的技术。ScanRDI系统是一种基于活力的技术，能在数小时内得出微生物检测结果，而无需培养微生物。本文以案例研究的形式，介绍了一家公司为无菌检测选择快速微生物学方法所采用的程序。还进一步阐述了在公司场所验证和实施该方法所使用的方式。在当今的制药领域，大多数公司都是全球性企业，爱尔康实验室也不例外。因此，虽然这些方法已获美国批准使用，但在所有外国监管机构批准使用该方法之前，无法完全取代所有传统的无菌检测。本文所讨论的实施内容涵盖了将该方法用于在美国销售的无菌眼科药品的能力。
