ISPE：制药用水生物膜控制（中英文版）.pdf

MICROBIOLOGICAL CONCERNS 微生物问题 本文摘自 ISPE 博客，作者 Tim Sandle, Dr. Ph D Potable water from private water companies ormunicipalities is monitored to ensure that levels of chemical pollutants remainwithin established safety criteria, and screened for microorganisms includingEscherichia coli, enterococci, Pseudomonas aeruginosa, and fecal coliforms.4 In most locales the quality of the water supplied to thepharmaceutical facility is satisfactory. As a safeguard, however, manyfacilities elect to test the water for organisms like E. coli as a marker forfecal contamination. Onsite potable water is treated, softened, purified(according to the grade required), and distributed . 对私营水务公司或市政当局的饮用水进行监测，以确保化学污染物水平保持 在既定的安全标准范围内，并筛查微生物，包括大肠杆菌、肠球菌、铜绿假 单胞菌和粪便大肠菌群。在大多数地区，提供给制药工厂的水质都还是合格 的。然而，作为一项保护措施，许多设施选择检测大肠杆菌等生物体，作为 粪便污染的标志。现场饮用水经过处理、软化、纯化（根据要求等级）和分 配 。 While most well -designed water systems can be maintainedin a state of control, microbiological problems can develop. Microbialadherence is a consequence of the balance of attractive and repulsivephysicochemical interactions between bacteria the surface. The primary issue isbiofilm formation— slime- like microbiologicalcommunities that occur when microorganisms adhere to a surface (such aspipework with a poor flow rate). 虽然大多数设计良好的水系统可以保持在控制状态，但微生物问题可能会发 生。微生物附着是细菌表面吸附性和排斥性物理化学相互作用平衡的结果。 主要问题是生物膜的形成—— 当微生物粘附在表面时（如流速差的管道）， 就会发生粘液样的微生物群落 。 A biofilm develops because bacterial cells, onceattached, secrete a polysaccharide known as glycocalyx (hydrated polymericslimy matrices). The glycocalyx enables each bacterium to encapsulate itself onthe surface; biofilm forms as these organisms accumulate. The steps involved inbiofilm formation are (Figure 1): 生物膜的形成是因为细菌细胞，一旦附着，会分泌一种称为糖被膜的多糖 （水合聚合物粘稠基质）。糖被膜将每个细菌能够包裹；随着这些生物累 计，形成生物膜。生物膜形成所涉及的步骤是（ 图 1） ： 1. Individual cells populate thesurface (initial attachment) 单个细胞在表面附着（初始附着 ）