Process layout of purification workshop

Process layout of purification workshop

The process layout of the purification workshop should prevent cross-contamination between people and logistics. There should be separate entrances and exits for personnel and materials to enter and leave the production area. Special entrances and exits should be set for materials that are likely to cause pollution in the production process; personnel and materials should be set up separately. Purification before entering the purification workshop...

Text label: purification workshop engineering, purification workshop design, purification pharmaceutical cleanroom layout

Process layout of purification pharmaceutical cleanroom

The process layout of the purification workshop should prevent cross-contamination between people and logistics. There should be separate entrances and exits for personnel and materials to enter and leave the production area. Special entrances and exits should be set for materials that are likely to cause pollution in the production process; personnel and materials should be set up separately. The purification room and facilities before entering the purification workshop; the setting of indoor process equipment and facilities shall meet the requirements of production process and air cleanliness level, and the production and storage area shall not be used as a passage for non-workers in this area; conveying personnel and materials The elevators should be installed separately, and the elevators should not be installed in the clean room. When the process requires that a device for vertical conveying of materials must be installed in the purification workshop, measures should be taken to ensure that the air cleanliness level of the purification workshop is not affected, and to avoid cross-contamination.

On the premise of meeting the process conditions, the layout of various fixed technical facilities in the clean workshop of the pharmaceutical industry should be comprehensively coordinated according to the requirements of the purification air conditioning system; on the premise of meeting the production process and noise requirements, the air cleanliness level is high The purification workshop should be arranged close to the air-conditioning room, and the processes and purification workshops with the same air cleanliness level should be relatively concentrated; the personnel access and material transfer of different air cleanliness levels should be taken to prevent pollution; in the clean workshop, it should be close to In the production area, storage areas for raw materials, semi-finished products and products that are suitable for the production scale should be set up. The storage area should be set up as an area for inspection and qualified products. Measures can also be taken to control the pending inspection and qualified status of materials. Unqualified products should be stored in a special area. ; The sampling area for raw and auxiliary materials should be set up separately, the air cleanliness level of the sampling environment should be the same as the production environment of the sampled materials, the sampling of aseptic materials should meet the requirements of the aseptic production process, and corresponding materials and personnel purification should be set up. room. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for purification workshops and clean workshops.

The weighing room for raw and auxiliary materials should be specially designed. The weighing operation with large dust production should have dust control measures. The air cleanliness level of the weighing room should be the same as that of the production environment; the cleaning room should be set up separately. The air cleanliness level should not be lower than class D. Cleaning rooms should not be set up in purification workshops with air cleanliness levels A and B; online cleaning and online sterilization facilities should be set up for equipment that is inconvenient to move. The water and steam condensate from the online cleaning and online sterilization facilities must be discharged outside the area; the cleaned items should be stored in clean, dry and ventilated conditions, and the items used in the Class A and B purification workshops should be sterilized in time after cleaning. Storage after sterilization should ensure that its aseptic state is not destroyed; cleaning tools should be washed and stored in a separate room, and the air cleanliness level should not be lower than D level; laundry rooms should be set up separately to clean work clothes for washing and drying. and finishing room, the air cleanliness level should not be lower than D level; the work clothes used in purification workshops with different air cleanliness levels should be cleaned and sorted separately; the aseptic production purification workshop should determine the core according to the aseptic production process requirements Necessary protective measures should be set up in the production area to avoid contamination of the production process; the design of human flow and logistics must be reasonable to reduce unnecessary cross-influence; floor drains and water hoppers should not be installed in the sterile production purification workshop, and the water used should be sterilized For treatment, equipment and utensils should be removed from the area for cleaning after use, and entered after sterilization. Production equipment using online cleaning and online disinfection should be used. A sterilizing filter should be set up, and the water vapor generated by sterilization should be discharged from the sterile production workshop.

The sterility inspection experiment should be done in a class A one-way flow clean area in a class B background, or in an isolator in a class D background; the microbial limit inspection experiment should be done in a class B one-way flow in a class D background Each microbiology pharma machinery should set up corresponding personnel purification and material purification facilities according to their own air cleanliness requirements, and should effectively avoid mutual interference; positive control tests and antibiotic microbiological tests should be classified according to the degree of the treated objects and its biosafety requirements, it should be carried out in a biosafety pharma machinery of the corresponding level; the experimental animal room should be strictly separated from other areas, and should have independent air treatment facilities and animal-specific passages.

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