美国药典 USP36微生物限度检查.pdfVIP

USP36 1117 优良微生物检测规范（中英文 1/ 2 ） 2013-08-09 15:30:46| 分类：USP|举报|字号订阅 1117 MICROBIOLOGICAL BEST LABORATORY PRACTICES 优良微生物检测规范 INTRODUCTION 介绍 Good laboratory practices in a microbiology laboratory consist of activities that depend on several principles: aseptic technique, control of media, control of test strains, operation and control of equipment, diligent recording and evaluation of data, and training of the laboratory staff. Because of the inherent risk of variability in microbiology data, reliability and reproducibility are dependent on the use of accepted methods and adherence to good laboratory practices. 优良微生物检测规范由一些活动组成，这些活动依赖于几个基本要素：无菌技术、培养 基控制、检测用菌株控制、设备操作和控制、完善的记录和数据评估、化验室员工的培 训。由于微生物数据具有天生的不确定性，数据的可靠性和重复性取决于是否使用被接 受的方法，以及是否严格遵守化验室规范。 MEDIA PREPARATION AND QUALITY CONTROL 培养基制备和质量控制 Media Preparation 培养基制备 Culture media are the basis for most microbiological tests. Safeguarding the quality of the media is therefore critical to the success of the microbiology laboratory. Media preparation, proper storage, and quality control testing can ensure a consistent supply of high-quality media. 培养基是大多数微生物测试的基础。保证培养基的质量因而成为微生物实验室成功的关 键。培养基的制备、合适的存贮和质量控制检测可以保证持续高质量培养基供应。 It is important to choose the correct media or components in making media based on the use of accepted sources or references for formulas. The manufacturers formula and instructions for preparation routinely accompany dehydrated media and ready-made media. Because different media types may have different preparation requirements (e.g., heating, additives, and pH adjustment), it is important to follow these instructions to ensure preparation of acceptable media quality. A certificate of analysis describing expiration dating and recommended storage conditions accompanies ready-made media, as well as the quality control organisms used in growth-promotion and selectivity testing of that media. 在制备培养基过程中使用已接受的来源或配方标准，选择正确的培养基或成份是非常重 要的。一般生产商在供应培养基干粉和配制好的培养基时，其配方和配制指示都会随