The essentials of the design and planning of the 10,000-level dust-free workshop
The design and planning of the 10,000-level dust-free workshop, the main points of the moving line planning: to review and analyze the path of people and vehicles, piping systems, exhaust pipes, material handling and operation processes, etc., to minimize moving lines and avoid crossovers to prevent cross-contamination. Operators, chemicals, materials, and other moving lines should not be concentrated; a buffer zone should be set up around the clean room; the access of manufacturing equipment should not have a great impact on the operation.
1. Selection and layout of air filters with different levels of air cleanliness in dust-free workshops: For 300,000 air purification treatment, sub-high efficiency filters can be used instead of high-efficiency filters; air cleanliness of 100, 10,000 and 100,000 Air purification treatment should use primary, intermediate, and high-efficiency filters. Three-stage filters should be used. Medium-efficiency or high-efficiency air filters should be selected according to less than or equal to the rated air volume. Medium-efficiency air filters should be centralized in the positive pressure section of the purified air conditioning ; High-efficiency or sub-high-efficiency air filters should be placed at the end of the purified air-conditioning system.
2. The air of some air purification systems cannot be reused if cross-contamination cannot be avoided after treatment: solid material crushing, weighing, batching, mixing, material making, tabletting, coating, filling and other processes; Refining and drying process of raw material drugs refined with organic solvents; radiopharmaceutical production area; pathogen operating area; production process that produces a lot of harmful substances and volatile gases during the process; pellets of solid oral preparations.