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Heavy news/GMP industry new standards announced

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Heavy, the new version of GB/T 51466-2025 "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry" has been released and will come into effect on September 1st! On May 21st, the National Housing and Urban Rural Development Administration officially released GB/T 51466-2025 "Construction and Acceptance Standards for Cleanrooms in the Pharmaceutical Industry" to strengthen the management of construction and acceptance of clean rooms in the pharmaceutical industry, ensure project quality, and provide document basis for installation confirmation, operation confirmation, and performance confirmation of pharmaceutical engineering. This document covers various aspects of the construction and decoration of pharmaceutical cleanrooms, purification air conditioning systems, process piping systems, water supply and drainage systems, equipment installation, fire and safety facilities, electrical facilities, instruments and communication, and acceptance. As follows: Content analysis: 1 The architectural decoration of pharmaceutical clean rooms: specifies the decoration materials and construction requirements for the floor, ceiling, interior walls, doors and windows of the clean area. Emphasize the smoothness, corrosion resistance, ease of cleaning, and airtightness of materials. 2. Purification air conditioning system: Detailed instructions have been provided on the production and installation requirements of air ducts and components. Emphasis was placed on the debugging and testing requirements of the system. 3. Process pipeline system: Installation requirements for sanitary grade pipelines and accessories. Specific requirements are proposed for the construction processes of welding, acid pickling, passivation, and cleaning of pipelines. 4. Water supply and drainage pipeline system: specifies the installation requirements for water supply and drainage pipelines, especially the regulations for installing floor drains in clean areas. 5. Equipment: including installation requirements for medical clean area equipment, such as handling, dismantling, and protection after installation. 6. Fire and safety facilities: Detailed installation requirements for fire water supply, electrical facilities, fire extinguishing equipment, etc. are introduced. 7. Electrical facilities: Regulations have been established for the installation of electrical circuits, equipment and devices, lighting, lightning protection, and grounding. 8. Instrumentation and communication: involves the installation of temperature, humidity, pressure and other sensors, as well as the installation requirements of communication systems. 9. Acceptance: including specific requirements for clean area testing, cleanliness grading, microbial contamination level testing, and construction acceptance.

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