基于HACCP风险评估的制药洁净空调系统设计思路探讨
Discussion on pharmaceutical clean air conditioning system design based on HACCP risk assessment
摘要：
对标ISO 14644洁净室及相关受控环境系列标准,2021年我国洁净室行业的GB/T 25915系列标准也相应更新。本文对比分析了我国新旧版本GB/T 25915第1部分和第2部分关于洁净室及相关受控环境的标准变化,针对新标准中提出的风险评估要求,结合制药厂房洁净空调系统设计经验,将危害分析临界控制点(HACCP)的风险评估方法应用于制药洁净空调系统设计。根据风险评估结果总结了洁净空调系统的设计流程,重点以洁净空调系统设计风量为例,提出了在设计阶段预留基于粒子浓度的风量控制模块,在保证洁净室污染风险可控条件下为洁净空调系统节能设计提供一个新思路。
Abstract：
Corresponding to the ISO 14644 series standards for cleanrooms and associated controlled environments, the GB/T 25915 series standards of China’s cleanroom industry have also been updated accordingly in 2021. This paper reviews and compares the changes in cleanrooms and associated controlled environments based on the old and new versions of GB/T 25915, part 1 and part 2. According to the requirements of risk assessment in the new version, combined with the design experience of clean air conditioning systems in pharmaceutical factories, the risk assessment method of hazard analysis critical control point (HACCP) is applied to the design of pharmaceutical clean air conditioning system. Based on the results of risk assessment, the design process of clean air conditioning systems is summarized. Taking the air volume design of clean air conditioning systems as an example, it is proposed to reserve an air volume control module based on particulate matter concentration in the design stage to provide a new method for energy saving design of clean air conditioning systems under the condition of ensuring controllable risk of contamination in the cleanroom.
Keywords:risk assessment; hazard analysis critical control point (HACCP); pharmaceutical factory; clean air conditioning system; IOS 14644; GB/T 25915