Requirements for clean room workshops for the production of eye drops
Requirements for clean room workshops for the production of eye drops
The floor of the clean room for the production of eye drops must be able to withstand the production activities scheduled in the room. The bottom floor is generally ≥9.8MPa for the production pharmaceutical cleanroom, 7.8MPa for the laboratory, 2.9MPa for the office, and 14.7MPa for the three-dimensional warehouse; The ground material requires good integrity, flatness, no...
Text label: Eye drops production clean room, purification plant requirements, 10,000-level workshop
Clean room plant requirements for eye drops production
The floor of the clean room for the production of eye drops must be able to withstand the production activities scheduled in the room. The bottom floor is generally ≥9.8MPa for the production workshop, 7.8MPa for the laboratory, 2.9MPa for the office, and 14.7MPa for the three-dimensional warehouse; The ground material requires good integrity, smooth, seamless, impact-resistant, wear-resistant, and easy to clean. Commonly used materials are terrazzo, PVC, etc.; The floor height of the new workshop is generally 2.8-3.5m, the renovation project is 2.3-2.5m, and the net height of the technical interlayer is 1.2-2.2m; the surface of the inner wall and ceiling should be smooth, dust-free, smooth, corrosion-resistant and impact-resistant , Easy to clean, the concave and convex surface should be reduced, the junction between the wall and the ground should be arc-shaped or other measures should be taken to reduce dust accumulation and facilitate cleaning; the inner walls of doors and windows should be flat, try not to leave window sills The number of layers and the structure of doors and windows should fully consider the sealing of air and water vapor, so that the pollution particles are not easy to penetrate from the outside, and prevent the phenomenon of condensation caused by the temperature difference between indoor and outdoor; indoor doors, windows and partitions between rooms with different cleanliness indoors, etc. The gap needs to be sealed, the doors and windows should be simple in shape, not easy to accumulate dust, easy to clean, and there is no threshold for the door frame.
Various pipes, lamps and other facilities in the eye drop clean room should be designed and installed to avoid parts that are not easy to clean during use; the ceiling should be separated from the installation of air pipes, pipes, lamps, tuyere, etc. Open, smooth, seamless and easy to clean. The ceiling is divided into hard ceiling and soft ceiling. Soft ceiling is suspended ceiling. Commonly used are steel frame-steel mesh plastering ceiling and color steel plate ceiling. The commonly used methods for determining the concentration and particle size of suspended particles in the air are: light scattering method, filter microscope method and colorimetric method. Method, use filter paper to vacuum filter dust-laden air, capture dust particles on the surface of particles, measure the transmittance before and after filtration, and calculate the dust content according to the inverse ratio of transmittance and dust accumulation, which is often used in medium and high-efficiency filters. Leakage inspection; filter membrane microscope counting method, which uses microporous membrane to vacuum filter dust-laden air, captures dust particles on the surface of the microporous membrane membrane, and calculates the dust content according to the air sampling amount and the number of particles. This method can directly observe the dust. The shape, size, color and other physical properties of dust have high value for analyzing dust sources and pollution routes, but sampling and counting are cumbersome. The settling bacteria use the plate exposure method to collect the live microbial particles in the air, and propagate the visible colonies under suitable growth conditions through a special medium. This method is widely used, does not require special equipment, and is simple to operate. Poor representation because it cannot capture all the microorganisms per unit volume of air. For planktonic bacteria, an air sampler is used to collect live microbial particles suspended in the air, and through a special medium, the number of visible colonies is propagated under suitable growth conditions. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
Buffer facilities must be set up between the clean room and the non-clean room, and the flow of people and logistics should be reasonable; the number of personnel in the clean room should be strictly controlled, and the staff should be regularly trained in basic knowledge of hygiene and microbiology, cleaning operations, etc. During the assessment, temporary outsiders who enter the clean area should be guided and supervised; the transmission equipment used in the 10,000-level clean room should not pass through the lower-level area; the clean work clothes in the area of u200bu200b100,000 or above should be washed, dried, and granulated in the clean area. If necessary, it should be sterilized as required; the surface of the thermal insulation layer of the equipment should be flat, smooth, and free of particulate matter; The air purification system should be cleaned, repaired, maintained and recorded according to regulations; if the purified air of the clean room can be recycled, effective measures should be taken to avoid contamination and cross-contamination.
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