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目的结合国际行业标准和新技术的发展趋势,对2010版照明设计进行探讨,以供参考。方法根据2010版GMP风险管理及洁净照明要求,探讨洁净区照明与药品质量及节能减排意义,制定不同药品生产的照明要求。结果 1998版GMP强调了生产的要求,是为了更好地增加工人的舒适度和安全度,减少错误率,并把照度根据工业标准照度级别将制药主要工作室做为精密操作,设定不小于300勒克斯。新版GMP要求没有规定照度,而是从产品质量角度考虑。结论药物在生产、贮存过程中不可避免地要受到光的影响,因此要提高药物的产品质量,需要设计合理的生产、贮存照明条件。现光源与药物的研究随着光学新技术的发展,国内外对LED新技术应用逐渐被认可。将新技术和新成果转化为适合我国药品特性的安全照明,不仅可以提高药品整体质量水平和临床用药的安全性,还可将减少药品企业不必要的投资和资源的浪费;同时也可以减少污染,节约能源。
Objective With the development of international industry standards and new technologies, the 2010 edition of lighting design is discussed for reference. Methods According to GMP risk management and clean lighting requirements in 2010, the author explores the significance of lighting and pharmaceutical quality in clean area and the significance of energy conservation and emission reduction, and formulates lighting requirements for different pharmaceutical products. Results The 1998 edition of GMP emphasized the requirements of production in order to better enhance workers’ comfort and safety, reduce the error rate, and set the illuminance as the precision operation according to the industry standard illuminance level to the major pharmacy laboratories, not less than 300 lux. The new version of GMP does not require illumination, but from the product quality point of view. Conclusion The drug is inevitably affected by light in the process of production and storage. Therefore, to improve the product quality of the drug, it is necessary to design a reasonable production and storage lighting conditions. Now the light source and drug research With the development of new optical technologies, the application of new LED technologies at home and abroad has gradually been recognized. Transforming new technologies and new achievements into safe lighting suitable for the characteristics of pharmaceuticals in our country not only improves the overall quality of medicines and the safety of clinical medication, but also reduces the unnecessary investment and waste of resources of pharmaceutical enterprises. At the same time, it can also reduce pollution ,Energy saving.