The Validation Of Heat Sterilization Equipment For GMP Certification

Along with the trends of fortieth reform and opening up policy,our society has stridden onto a rapidly developing stage.With the development of science and technology,the contradiction between the human and the natural environment has gradually emerged,as President xi jinping said: "fighting against natural disasters is the eternal theme of human survival and development.However,in the invisible battlefield of human beings and nature,we never stop.Whether the outbreak of "SARS" or "bird flu",whether influenza A or the beginning of this year's outbreak of pandemic influenza B virus,which threaten human beings' health and safety.The variation and evolution of microbes heighten the impact on the civilization of human society.From the discovery of microbes by Leeuwenhoek in 1673 to the establishment of Microbiology in nineteenth Century to the establishment of modern medicine,all of which have verified the rapid development and progress of humans in the field of microorganisms.In recent years,governments and international and domestic health organizations who have invested much human resources,materials and capital formulating more reasonable sterilization's norms and standards and constantly optimize and improve them in order to evaluate the effect of sterilization and validate the sterilization processes,which are the keys to ensuring that mankind wins this white war.Our company is a biological technology enterprise which specializes in research and development,production and sale of biological products,and issued the "Drug GMP certificate" by State Drug Administration.According to GMP standards,enterprises are required to meet the standards of hygienic quality which contains raw materials,personnel,equipment and facilities,production process,packaging and transportation,quality control,etc.and have a set of executable operational specifications.Enterprises can improve the hygienic conditions according to relevant operating standards,and find out the potential health and safety risk in the production process and solve them in time.The thermal sterilization equipment belongs to the equipment classification in the five factors of GMP "people,machine,material,statute and environment".Thermal sterilization equipment plays a crucial role in the vaccine production process.It can be used for disinfection,sterilization and depyrogenation for glass containers,production appliances,clothes,etc..Sterilizing equipment is mainly used to kill the number of bacteria that have been sterilized in order to keep aseptic.The << Good Manufacture Practice of Medical Products>>(GMP2010 Edition)has made explicit demands for the sterilization process and sterilization equipment in the production process of sterile drug.The scientific,effective and reasonable verification of the thermal sterilization equipment,which made the sterilization and depyrogenation achieve the desired effect and also is the basic guarantee.The verification method used in sterilization equipment to sterilization effect plays a vital role.In this paper,we carried out a comprehensive study to the verification of the thermal sterilization equipment in the GMP system.