Injection pre-filling GMP workshop
Injection pre-filling GMP workshop
Injection pre-filling equipment is mainly composed of needle tube, rubber piston, push rod, cone head and needle cap. When the pre-filling line is sub-packaging sterile products, the filling machine needs to be placed in a room with a Class B environment , the unpacking machine and the filling machine are placed together in the B-level room, and the room where the packing is unpacked is sterile...
Text label: Injection pre-filling GMP workshop, clean pharmaceutical cleanroom design and construction, Zhongjing Global purification
Injection pre-filling GMP pharmaceutical cleanroom
Injection pre-filling equipment is mainly composed of needle tube, rubber piston, push rod, cone head and needle cap. When the pre-filling line is sub-packaging sterile products, the filling machine needs to be placed in a room with a Class B environment , the unpacking machine and the filling machine are placed together in the B-level room, and the aseptic level of the room where the bag is unpacked is C-level; if the packaging material is protected by two layers of sterile bags, the first layer of sterile bags can be removed in the D-level room. , and transfer the unpacked packaging material into the C-level room to remove the second sterile protective bag; the pre-filled injection after filling and plugging can be passed into the packaging pharmaceutical cleanroom, because the level of the packaging room is generally D/E In order to prevent the airflow from the packaging room from entering the packaging room, it is recommended to use a C-level environment buffer room to separate the two. The pressure in the buffer room is lower than that of the filling room and higher than that of the packaging room.
The function of the pre-filling and filling machine is to use the packaging material that is free of cleaning and sterilization. It does not need to re-clean and sterilize the packaging material, which can save the investment of equipment. It can be greatly reduced; it can be directly filled into the pre-filling seal, which can prevent cross or secondary contamination during injection; the name can be marked on the injection container, and clinical errors are not easy to occur. Before putting into use, it is necessary to carefully adjust and check whether the power supply voltage is consistent with the function of the equipment, whether the pipeline is leaking, whether the direction is correct, whether the fan rotates flexibly, etc.; It is not allowed to open the glass door of the isolator for operation during the production process; in the normal production process, the speed of the main engine, outsourced feeding, and plugging should be properly adjusted according to the operating conditions to keep the equipment running. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.
If the shutdown interval is long, the laminar flow fan can always be turned on to protect the unfilled bottles and liquid medicine. No matter what happens during the operation of the machine, hands or other tools are not allowed to work On the part, the power supply must be cut off when making adjustments; the protective cover must be installed correctly before operation to ensure that the operator's working ground is free of obstacles and stains; before leaving the working position, the operator should shut down the machine according to the relevant shutdown operation. Maintenance: replenish or replace the vacuum pump lubricating oil on time; check whether the sealing ring is worn and replace it in time; regularly add grease to the bearing; regularly check whether the timing belt is loose. The application of pre-filling and filling lines is mainly in the field of vaccines. In the future, more and more biological products and beauty products will also choose pre-filling packaging methods.
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