Engineering Design Of Aseptic Packaging Plant Of Protein Injections

Blood products are purified from the raw material of the plasma, which are many kinds of special functional protein and contain hundreds of proteins. In plasma, most of them are albumin and immunoglobulin, the rest of them are trace protein. GMP is the abbreviation of Good Manufacturing Practices for Drugs. The drug GMP has timeliness. It is a kind of continuous improvement standard. This specification is a part of the quality management system. GMP is the basic requirement of drug production management and quality control to minimize pollution, cross contamination and confusion. Which is also to ensure the production meeting the drug’s registration requirements and intended use. As the issue of GMP in our country, the pharmaceuticals company begin enter a special period about the implementation of new edition GMP.This paper focus on the injection protein aseptic workshop engineering design at the background of new version of the GMP. In the study, we transformed the air-conditioning, the system of aseptic filling and capping. We also remoulded the channel of people and the laundry room and the hole plant design. By the transformation, in the grade B workshop set up an independent into and out room, capping and filling, sterilization room change in grade C areas, wash clothing underwear material after high pressure directly to the workshop of grade B, so as to prevent cross contamination better. After verification and risk assessment medium simulation filling test, confirming that the workshop to transform the protein injection asepsis conforms to the requirements of GMP. Through the joint efforts, the blood products production workshop of the company has been accredited by the country in March2013and got the GMP certificate in July2013.This paper is divided into five parts:Chapter1was the introduction of blood products industry background, the GMP development course in our country and risk assessment methods. Combining with the characteristics of the company, we utilized the concept of risk management in the plant transformation.Chapter2,3,4were the transformation of air-purification system, filling and rolling cover system, flow channel and the laundry room, repectively. The fishbone diagram and failure mode effect (FMEA) were adopted to conduct the risk assessment of each link. The plant was modified base on retrofit scheme. The risk during production was minimized and the whole plant modification eventually passed2010version of the GMP certification.Chapter5was the results of medium simulation filling test results. We take the same conditions and operational methods with actual production process. We have confirmed the reliability of the process and made sure the environment, process control and operation conditions can prevent microbial contamination and meet the aseptic requirements.This study focus on the application of risk assessment in transforming the aseptic filling workshop about blood products. The new factory could meet the requirements of new GMP, optimize the process flow and technological conditions. With controllable risk, high quality products flow into society.