Technical requirements for oral liquid

- Apr 28, 2018-

In the guidelines for the implementation of the standard for the quality management of drug production, it is clearly stated that the oral liquid is also different in the process of preparation and the cleanliness of the production environment because of the different drug performance. The cleanliness of exposure to non terminally sterilized oral liquid drugs is 100 thousand, and the exposure level of the final sterilization oral liquid medicine is 300 thousand. However, one of the differences between the non terminally sterilized oral liquid medicine and the final sterilized oral liquid medicine is the sterilization process after the rolling process. Under the requirements of the oral liquid preparation process, the equipment can be equipped with bottle washing machine, tunnel oven, irrigation mill, aluminum lid disinfection cabinet and double door sterilizing cabinet. For the bottle washing machine, the main consideration is the control of insoluble particles; for the tunnel oven, the heat distribution test and the tuyere filtration effect are mainly taken into consideration; the filling precision and the rolling cover effect are mainly considered for the shrub mill. The heat distribution and the heat penetration test are mainly considered for the double chamber sterilizer. However, the premise of the rational preparation of oral liquid preparation technology and equipment is the production of non sterile drugs, and the highest level of cleanliness is only 100 thousand. The cleanliness of the exposure process is usually 300 thousand. Only by taking this as the starting point can we combine the equipment with the technology reasonably and effectively.