制药企业压缩空气系统及压缩空气质量控制方法的探讨

Discussion on Compressed Air System and Compressed Air Quality Control Methods in Pharmaceutical Enterprises

文章简要阐述了压缩空气的定义以及特点,详细介绍了制药企业压缩空气系统的质量要求、系统构成以及运行原理。在药品的生产当中,由于压缩空气会与药品直接或间接接触,与药品直接接触的压缩空气的品质则直接影响了产品质量的好坏,因此文章对《药品生产质量管理规范》(GMP)要求下的制药企业压缩空气质量控制方法进行了进一步的探讨,并对其包括含油量、露点、悬浮粒子和浮游菌等方面的质量控制方法进行了实施,确保经过严格净化措施后出来的压缩空气质量得到可靠的保证,证明压缩空气质量符合GMP要求。

This paper briefly expounds the definition and characteristics of compressed air,and introduces the quality requirements,system composition and operation principle of compressed air system in pharmaceutical enterprises in detail.In the production of drugs,the quality of compressed air in direct or indirect contact with drugs directly affects the quality of products.Therefore,this paper further discusses the quality control methods of compressed air in pharmaceutical enterprises under GMP requirements,and implements the quality control methods including oil content,dew point,suspended particles and planktonic bacteria to ensure that the quality of compressed air produced after strict purification measures is reliably guaranteed,proving that the quality of compressed air meets the requirements ofGMP.