Cobo Fernando, Grela David, Concha Angel
Stem Cell Bank of Andalucía (Spanish Central Node), Hospital Universitario Virgen de las Nieves, Granada, Spain.
Biotechnol J. 2008 Jan;3(1):43-52. doi: 10.1002/biot.200700122.
Modern high-technology industrial practices like pharmaceutical and stem cell line production demand high-quality environmental conditions to avoid particle contamination in the final product. Particles are important because their presence can affect both the output and the productivity and because they can have repercussion on human health. In this kind of production practice it is necessary to implement optimal methods for particle management and to introduce an environmental monitoring program. This should also address the regional regulatory requirements and will depend on local conditions in each processing center. Each center must evaluate its specific needs and establish appropriate monitoring procedures.
制药和干细胞系生产等现代高科技产业实践需要高质量的环境条件,以避免最终产品受到颗粒污染。颗粒很重要,因为它们的存在会影响产量和生产率,还会对人类健康产生影响。在这种生产实践中,有必要实施优化的颗粒管理方法,并引入环境监测计划。这还应符合区域监管要求,并取决于每个加工中心的当地条件。每个中心都必须评估其特定需求并建立适当的监测程序。