The Contaminations Control During Injection Production And Sterility Test

As to be the drag manufacturer, it will directly influence the biological quality control of sterility product that the contaminations control during injection production and sterility test. By exerting the knowledge grasped, combining quality control management lessons learned in SASS, researching the case according to pharmacopoeias, I'd like to practice in future work, to develop and innovate the skills.This paper analyze the safety problem of injection based on autoclave and tunnel validation, many limitations in sterility test, the key assurance of sterility and environmental control in sterility production process. And bring forward the countermeasure how to improve the injection sterility level.When choice antiseptic method, proposed simultaneously guarantees the product aseptic and the stable antiseptic craft choice flow chartIn the steam sterilizing validation, proposed through carries on the idling, the full load hot distribution experiment, the hot penetration test and the biological indicator challenge experiment to the sterilizer and so on, determines the antiseptic way the suitability and the validity.In the aseptic examination quantity's limited aspect, proposed uses in representation which the sterility test the sample should have, namely the sample should include approves in the product to pollute the risk biggest that partial products. In the sterility test method's limited aspect, proposed can expand the applicable scope and be advantageous the fungus culture medium nutrient content which and the pH value picks out in the aerobe; And suggested increases the grease and the ointment class drugs dissolution and the dilution method.In the sterility test method confirmation aspect, had pointed out includes the antibacterial ingredient aseptic injection not to use the direct inoculation, but should use the thin film filtration law; The microorganism which discovered in the production environment should take regularly uses in the sterility test method confirmation the challenge mold mushroom spawn; As well as performs the static test regularly the goal, is to indicate that tests the product culture medium to have ability which in the entire raise process the support microorganism grows.In the aseptic security's guarantee essential factor aspect, media fill validation and the validation defeat case analysis, proposed investigates the reason comprehensively the method, and suggested corresponding corrects an error the behavior.In the aseptic production the environment monitoring aspect, easy to cause pollution each aspect through the example detailed introduction aseptic production process, elaborated how to carry on the environment confirmation, as well as establishes the daily environment monitoring in the environment confirmation's foundation the method.According to author's working practice experience, so long as takes the above countermeasure and the suggestion a whole to perform to use systematically, has may raise the control level which and the sterility test level effectively in the aseptic injection production pollutes.