Material purification measures in GMP workshop

Material purification measures in GMP workshop

In order to reduce the contamination of the GMP workshop by the contaminants on the outer packaging of the materials, the incoming raw materials, packaging materials and other items should be cleaned in the material purification room or stripped of the outer packaging materials, and then passed through Pass cabinet or place on clean pallet to enter via airlock; Sterile...

Text label: GMP workshop purification, GMP workshop material purification GMP workshop design and installation

Material purification measures in GMP workshop

In order to reduce the contamination of the GMP pharmaceutical cleanroom by the contaminants on the outer packaging of the materials, the incoming raw materials, packaging materials and other items should be cleaned in the material purification room or stripped of the outer packaging materials, and then passed through Transfer cabinets or place them on clean pallets to enter through air locks; aseptic GMP workshops are production sites for aseptic operations, and the items that enter, including their outer packaging, should be in a sterile state. For items that can be thermally sterilized , double door steam or dry heat sterilizer is a suitable choice. In order to block the airflow between the GMP workshop and the material cleaning room or sterilization room and maintain the pressure difference, the material between them is transferred through the air lock or the transfer window. Do not open at the same time, so there is no need to set up an air lock.

The function of the transfer cabinet is the same as that of the air lock. The transfer doors on both sides of the transfer cabinet cannot be opened at the same time. In addition to the above requirements, in order to avoid the pollution of the sterile GMP workshop environment, the transfer cabinet is also connected to the sterile clean room. It is necessary to set up purification and disinfection devices, such as air supply devices with high-efficiency filters, ultraviolet disinfection lamps; since operators of different cleanliness levels enter and exit the same air lock, cross-contamination will occur, so unless the air lock adopts effective sterilization measures or limited personnel The flow direction, such as the one-way flow of personnel from the sterile clean area to the low-level area, should not be carried out in a room with an air lock for the material in and out of the sterile GMP workshop. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GM workshops and GMP workshops.

In the production process of the GMP pharmaceutical cleanroom, various wastes will be generated, such as waste glass residue, waste inner packaging materials, waste from intermediate quality inspection, waste liquid produced by biological fermentation or animal cell culture, tissue cells of waste gas, etc.; The production process and production scale, as well as the nature and quantity of waste materials, etc., determine whether a separate outlet needs to be set up. The waste must be sent out of the production area in time to avoid pollution to the production environment; some active waste generated in the production process of biological products In order to avoid safety accidents, corresponding inactivation facilities, such as steam sterilization cabinets, must be configured. For small-scale production with simple process and small amount of waste, the layout and the entrance of raw and auxiliary materials can be combined with the outgoing channel of waste. After the production is finished, it is passed out through the raw material inlet air lock or transfer cabinet.

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