无级别受控环境理念与应用——生物洁净技术发展新趋势

Concept and application of controlled not classified environment—New development trend of biocleaning technology

探讨了洁净室技术对高科技工艺环境控制措施的沿革,发展了无级别受控环境的理念,扩展了其应用领域,赋予了“区域易清洁、进出受控且通风经过滤”三项控制措施新的内涵。无级别受控环境改变了传统的控制理念,强调控制措施、过程控制,淡化终点控制,不涉及洁净度级别或无菌指标,强调全过程控制措施,使得控制措施既有限定又具灵活性,更切合工艺实际需求,是生物洁净技术发展的新趋势。

Discusses the evolution of the cleanroom technology for the control measures of the high-tech process environment,develops the concept of controlled not classified environment,expands its application field,and gives the new connotation of the three principles of“the area is easy to be clean,the entrance and exit are controlled and the ventilation is filtered”.The concept of controlled not classified environment changes the traditional control concept,emphasizing the control measures and process control,diluting the target control and no cleanliness or aseptic indicators,and emphasizes the whole process control measures,which makes the control measures not only limited but also flexible,and more suitable for the actual demand of process technology,so it is a new development trend of the biocleaning technology.