Study On The Improvement Of The Air Purification System In Polypropylene Bottles(Bags) Workshop Of Infusion

As a special commodity,the quality of drug is closely related to the life of patients.With the progress of the society and gradually improvement of people’s living standards, the awareness of the risk of the drug quality is gradually improving.In this case,the primary task of pharmaceutical production enterprises is to strengthen the control of all aspects of production, reduce risk level, guarantee the quality of drug. Large volume injection in aseptic preparation belongs to high risk dosage form. Its production process is very complicated and its hardware, software, wetware have strict requirements.Heating ventilation and air conditioning system in the GMP in China is called air purification system. It’s a key system in the pharmaceutical factory. It has important effects on the pharmaceutical factory’s ability to achieve its goal of providing safe and effective products to patients. If the drug production environment can be properly designed, constructed, commissioned, operated and maintained, it will help to ensure product quality, improve product reliability, meanwhile reducing the initial investment costs and operating costs of the plant.With the implementation of the new version of GMP (2010 Edition), some of the early construction of the workshop due to the lack of hardware investment and some other reasons can not meet the requirements, It need to be transform. In this paper, we take the large volume injection PP bottle infusion workshop as an example. Under the premise of controlling investment costs through some of the transformation, it can meet the requirements of the new version of GMP, improve the working environment of workers and improve product quality.In this paper, renewal projects include the transformation of the high temperature region of high yield, the transformation of the exhaust air recycling, the transformation of the system of the coal dust removal system, and the transformation of the high humidity area.The relevant workshop which completing transformation has passed the new GMP certification.The problems mentioned in this paper are common in the production process of large volume injection. Hope that the future of the new project will be inspired, and for the existence of similar problems in the pharmaceutical industry to provide reference.