Do you know anything about clean doors in pharmaceutical laboratories

Pharmaceutical clean room as an important place for drug production, its environmental factors effectively affect the quality and safety of drugs, as well as the production efficiency and level of enterprises. Requirements for environmental factors include cleanliness, temperature and humidity, airflow speed, indoor pressure, air filtration and personnel operation process. In order to ensure the quality of the drug and prevent the potential pollution threat of the production environment to the product, the production area must strictly follow the established environmental parameter standards.

As an important passage in and out of the clean room, the design and management of clean doors and Windows are equally critical. Therefore, in the overall design of pharmaceutical clean room, the characteristics of clean doors and Windows need to be deeply considered to create a safe, efficient and high-quality environment for subsequent drug production.

The new edition of the "Drug GMP Guide" (2nd edition) "Plant Facilities and equipment" branch put forward specific and detailed requirements for the construction of clean workshop, which involves many aspects from the material, size, location design of clean room doors and Windows, to the direction of the switch, tilt Angle and even color.

The color of the clean room should be light and soft. The light reflection coefficient of the ceiling and the wall should be 0.60~0.80, and the light reflection coefficient of the ground should be 0.15~0.35.

The doors and Windows, walls, ceiling, ground structure and construction gaps of the clean room should be sealed.

Clean workshop should not be equipped with external Windows. When it must be set, the double-layer insulating glass should be fixed in the window, and should have good air tightness to prevent air leakage and moisture condensation; Window sill should not be set on one side of the window near the clean room. If there is a window sill, it should be angled to prevent ash accumulation and facilitate cleaning.

The size of the door should meet the requirements of normal operation transportation, equipment installation and maintenance, and personnel evacuation. Doors and their sandwich materials shall be made of non-combustible materials.

The airtight door of the clean room should be opened towards the room with high air cleanliness, and the room with high relative pressure difference should be opened when the cleanliness level is the same. Windows should be installed on the airtight door of the windowless clean room. Windows should be double-glazed, and the glass surface should be flush with the door.

The door of the clean room should be installed, the connection between the frame and the wall should be firm, the elastic material should be filled in the gap, and the surface should be evenly sealed by sealant. When there is a seal strip on the threshold sealing surface, the seal strip should be compressed after the door is closed. Door handles such as highlighting the facade, should not have sharp edges, sharp corners, should be smooth transition.

Clean room window installation, the window surface should be flush with the surface of its installation site, when not even, the windowsill slope, arc slope, edge, Angle should be arc transition. The window glass should be fixed and tightly sealed with sealant. The inner surface and interlayer space should be thoroughly wiped before installing the glass. The single-side coated glass of the double-layer window should be located in the outermost layer of the double-layer window, and the coated glass of the double-layer or single-layer window should face the interior. Curtains or louvers must not be installed indoors. Observation Windows that produce harmful aerosols such as chemical, radiation and microorganisms or flammable and explosive occasions should be made of materials that are not easily broken.