Allen Loyd V, Okeke Claudia C
International Journal of Pharmaceutical Compounding, Edmond, Oklahoma.
Int J Pharm Compd. 2008 May-Jun;12(3):252-7.
This article discusses the types of contamination that may occur when compounding personnel prepare, handle, or store sterile preparations, as discussed in United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations. Contamination may be microbial, physical, or chemical, and all these are possible when sterile preparations are made. Microbial contamination may be fungal or bacterial. The most frequently identified microbial organisms in sterile preparations are spores and endotoxins. Chemical and physical contamination includes foreign objects, chemicals, physical matter, nonsterile components or objects, and airborne particles, objects, or matter from environments with uncontrolled air quality. Thorough knowledge of the possible sources of contamination can help in implementing the steps and processes to avoid contamination. The purpose of this article is to review the contamination risk level categories as disussed in Chapter 797.
本文讨论了在调配人员制备、处理或储存无菌制剂时可能发生的污染类型，如《美国药典》第797章“药物调配 - 无菌制剂”中所述。污染可能是微生物、物理或化学污染，而在制备无菌制剂时所有这些污染都有可能发生。微生物污染可能是真菌或细菌污染。无菌制剂中最常发现的微生物是孢子和内毒素。化学和物理污染包括异物、化学物质、物理物质、非无菌成分或物品，以及来自空气质量未得到控制的环境中的空气传播颗粒、物品或物质。全面了解可能的污染源有助于实施避免污染的步骤和流程。本文的目的是回顾第797章中讨论的污染风险水平类别。
