Design and construction precautions for GMP clean room GMP is an autonomous management system that pays special attention to the implementation of product quality and health and safety in the production process. The dust-free workshop in the pharmaceutical industry needs special attention during the construction process to meet the GMP standards. GMP clean room construction precautions 1. According to the requirements of the GMP purification workshop, the purification workshop should be designed and installed to avoid the parts that are not easy to clean. When the project is cleaned and decorated, the doors and windows are installed and constructed, and the air conditioner, various pipelines and lighting fixtures are cleaned. The joint gap should be sealed. 2. All accessories, partitions, ceilings and hangers can only be connected to the main structure, and can not be mixed with equipment and pipeline brackets to prevent loosening of decorative materials and dust off due to micro-shock. 3. The architectural decoration and the gap between the doors and windows should be sealed on the front. 4. According to GMP certification inspection standards, indoor decoration must meet the following requirements. (1) Materials with good airtightness and small deformation under changes in temperature and humidity should be selected. (2) The surface of the wall and ceiling should be smooth, flat, ash-free, dust-free, corrosion-resistant, impact-resistant, easy to clean, reduce the uneven surface, fill the wall and the ground with a radius equal to 5 mm, wall color Be harmonious, elegant, and easy to identify contaminants. (3) The doors and windows and the inner wall should be straight, and the structure should fully consider the sealing of air and water vapor, so that the polluting particles are not easy to infiltrate from the outside, preventing condensation due to indoor and outdoor temperature difference, and indoors between different cleanliness rooms. The gaps, such as the inner window and the partition, must be sealed. 5. During the construction, the amount of dust generated during construction work should be controlled, especially the hidden space inside the ceiling and the wall, which must be cleaned at any time. 6. In the room where the high-efficiency filter is installed, it is not possible to carry out dusty decoration work. 7. Pay attention to the protection of the finished work surface, and it is not allowed to cause plate depression, cracking and surface decoration pollution due to impact, knocking, stepping on, and water-operating operations. Pharmaceutical production enterprises should have good production equipment, reasonable production process, perfect quality management and strict inspection system to ensure that the quality of products meets the requirements of laws and regulations. It is especially important to understand the maintenance and construction requirements of the above-mentioned clean room.
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