Aseptic half-adding stopper method

Abstract

The invention relates to a sterile partially stoppering method, which is characterized by the following steps: the outside of the rubber plug washing machine outlet is provided with a sterile separating screen; the rubber plug is intruded into the rubber plug washing machine for finishing processes of washing, sterilizing, siliconizing, drying and the like; a transferring barrel sterilized by a dry hot sterilizing cabinet is placed under the discharging outlet of the rubber plug washing machine in the sterile separating screen to intrude the rubber plug, then moved to one side of a lifting machine for docking and locking, and then driven by the lifting machine to be lifted to the height above a feeding hopper, and a sterilized connecting soft pipe is connected with an outlet and a connecting head on a stoppering machine; the valve gate of the transferring barrel outlet is opened, the rubber plug in the transferring barrel falls on the feeding hopper on a partially stoppering machine automatically by the connecting soft pipe, and the stoppering of medicine bottles is carried out in the feeding hopper. The sterile partially stoppering method has the advantages of guaranteeing the whole partially stoppering process under the sterile protection state, having high sterility and meeting requirements of cGMP of the international pharmaceuticals industry.

Description

technical field [0001] The invention relates to a method of aseptic semi-stoppering. The whole rubber stopper is cleaned, sterilized, silicified and dried from a rubber stopper machine and then discharged into a rubber stopper transfer barrel. The rubber stopper in the transfer barrel is in the entire aseptic process Under the control of the rubber stopper, it is transferred to the hopper of the filling machine to complete the aseptic transfer of the rubber stopper. It belongs to the technical field of pharmaceutical machinery. Background technique [0002] Vacuum freeze-drying (referred to as freeze-drying machine) is to freeze the lyophilized aqueous substance or solution in advance at a low temperature, and then dehydrate the substance in a vacuum environment to obtain a dried product. Generally speaking, the plugging of the lyophilized rubber stopper of the vial is completed inside the lyophilizer using the hydraulic device of the lyophilizer. Therefore, the vial must b...

AI Technical Summary

Problems solved by technology

[0004] Due to the large amount of manual intervention in the whole process, and many operating rubber plugs are in an open state, directly in contact with the external environment, the sterility is very poor, which may cause bacterial contamination of the rubber plug, and contamination in the process The high risk is not conducive to the requirements of high sterility in the production of pharmaceutical factories

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