Cobo Fernando, Stacey Glyn N, Cortés José Luis, Concha Angel
Stem Cell Bank of Andalucía (Spanish Central Node), Hospital Universitario Virgen de las Nieves, Avda Fuerzas Armadas 2, 18014, Granada, Spain.
Appl Microbiol Biotechnol. 2006 May;70(6):651-62. doi: 10.1007/s00253-006-0326-5. Epub 2006 Mar 10.
The processing of stem cell lines for application in human therapy requires a physical environment in which air quality (i.e., the number of airborne particles) is controlled to minimize risk of contamination. The processing facility should be constructed and operated to minimise the introduction, generation and retention of particles and microorganisms. A formal program of environmental monitoring should be maintained in each stem cell bank to specify and assess key factors and their influence on the microbiological quality of the process and product. This program should assure the manipulation of cells involved in the derivation of stem cell lines and their culture under established limits for airborne particles and for microbial contamination of the air and surfaces. Environmental monitoring should also address the regulatory requirements in the countries in which the cells will be used. The monitoring programme will depend on local conditions in each processing centre or cell bank. Each centre will need to evaluate its specific needs and establish appropriate monitoring procedures which should not become intrusive to the extent that they might compromise the quality of the cell banks or products.
用于人类治疗的干细胞系的处理需要一个空气质量（即空气中颗粒数量）得到控制的物理环境，以将污染风险降至最低。处理设施的建造和运营应尽量减少颗粒和微生物的引入、产生和留存。每个干细胞库都应维持一个正式的环境监测计划，以明确和评估关键因素及其对处理过程和产品微生物质量的影响。该计划应确保在既定的空气颗粒限度以及空气和表面微生物污染限度内对参与干细胞系衍生及其培养的细胞进行操作。环境监测还应符合细胞使用所在国家的监管要求。监测计划将取决于每个处理中心或细胞库的当地条件。每个中心都需要评估其特定需求并建立适当的监测程序，这些程序不应具有过度干扰性，以免损害细胞库或产品的质量。
