Process requirements for modern oral liquid preparations
- Clicks:1147 Release time:2011/3/17
In the "Guidelines for the Implementation of Quality Management Regulations for Pharmaceutical Production", it is clearly stated that the oral liquid has different levels of cleansing in the preparation process and production environment due to different drug properties. The cleanliness of the non-zui terminally sterilized oral liquid medicine is 100,000 grades, and the cleanliness of the exposure process of the Zui terminally sterilized oral liquid medicine is 300,000 grades. However, one of the technological differences between non-zui terminally sterilized oral liquid medicines and Zui terminally sterilized oral liquid medicines is the sterilization process after the filling process. Under the requirements of the oral liquid preparation process, the equipment configuration may include a bottle washing machine, a tunnel oven, a filling mill, an aluminum cover sterilizing cabinet, and a double sterilizing cabinet. Among them: for the bottle washing machine, the control of insoluble particles is mainly considered; for the tunnel oven, the heat distribution test and the tuyere filtering effect are mainly considered; for the filling mill, the filling precision and the capping effect are mainly considered. For the double sterilizer, the heat distribution and heat penetration test are mainly considered. However, the premise of the rational preparation of the oral liquid preparation production process and equipment is the production of non-sterile drugs, and its high cleanliness level is only 100,000. Usually used for exposure process cleanliness of 300,000. Only by using the previous question as a starting point can we combine equipment and technology reasonably and effectively.
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