原料药生产车间防爆区净化系统施工关键技术

Key Technologies for Construction of Purification System in Explosion-Proof Zone of API Production Workshop

以江苏吉贝尔药业股份有限公司综合制剂车间一、二层净化及装饰装修和机电安装项目为例,阐述了无菌粉针剂原料药生产车间在空调系统安装和结构装修方面如何解决防爆区相对负压和生物安全问题。一方面对结构装修彩钢板安装的密闭性有更高的要求,另一方面对净化空调系统的排风做了更高的过滤和防泄漏等保护措施。采用袋进袋出新型技术在末端,高效过滤器的更换过程中有效地避免了操作人员对过滤器的直接接触,从而降低了人员被感染的风险。

Taking the purification,decoration,and mechanical and electrical installation projects on the first and second floors of the comprehensive preparation workshop of Jiangsu Jibeier Pharmaceutical Co.,Ltd.as an example,mainly elaborates on how to solve the relative negative pressure and biosafety problems in the air conditioning system installation and structural decoration of the sterile powder injection raw material production workshop in the explosion-proof area.On the one hand,there are higher requirements for the airtightness of the installation of structural decoration color steel plates,and on the other hand,higher filtering and leakage prevention measures have been taken for the exhaust of the purification air conditioning system.The use of a new technology of bag in bag out effectively avoids direct contact between operators and filters during the replacement process of high-efficiency filters at the end,thereby reducing the risk of infection for personnel.