Many people are unfamiliar with the definitions of GMP cleanrooms and purification workshops, and some even do not know what a GMP‑compliant dust‑free workshop is. In fact, the design requirements for GMP cleanrooms emphasize aesthetics and cleanliness to prevent product contamination and quality degradation. Consequently, the design of doors, windows, floors, walls, and ceilings in cleanroom interiors differs from that of ordinary factories. Below, we will take a closer look at the specifics of GMP cleanrooms:

GMP‑compliant cleanrooms are established in accordance with the regulations of the Food and Drug Administration across five major production sectors: sterile pharmaceuticals, active pharmaceutical ingredients, biological products, blood products, and traditional Chinese medicine preparations. Common GMP‑compliant cleanroom types in China include facilities for active pharmaceutical ingredient production, tablet manufacturing, solid dosage forms, injectable preparations, capsule formulations, and traditional Chinese medicine preparations.

A GMP‑compliant cleanroom refers not only to the air cleanliness of its production and auxiliary areas, but also to its critical role in controlling particulate contamination and maintaining a sterile, clean environment. Adhering to the design and construction principles of “safety, efficacy, and quality control,” GMP cleanrooms ensure the safety and quality of pharmaceutical manufacturing.

By design, GMP‑compliant cleanrooms prioritize aesthetic appeal and cleanliness while preventing product contamination and quality degradation; accordingly, they differ significantly from standard cleanrooms in the construction and maintenance of clean doors and windows, walls, ceilings, and floors.

In terms of building layout, GMP cleanrooms typically feature a circular sealed corridor outside the workshop, creating a buffer zone between the clean area and the exterior to prevent external contamination and conserve energy. The number of layers and structural configuration of exterior windows should carefully account for air- and water-tight sealing. Interior doors and windows are flush with the interior walls, with no protruding window frames.

To prevent condensation caused by temperature differences between indoor and outdoor environments, close the gaps around doors and windows in rooms with different cleanliness levels to maintain isolation. The door and window materials exhibit minimal natural deformation, resulting in small measurement errors, excellent sealing performance, and a simple, easy-to-clean design. Flooring should be seamless and uniform, with high wear resistance and corrosion resistance, and should minimize static electricity buildup.

Currently, the vast majority of epoxy self-leveling floors are made with epoxy resin. When the coating thickness exceeds 1 mm, their typical service life is more than six years. Wall surfaces should be smooth and free of loose dust. At the junctions between walls and floors, rounded edges with a radius of 50 mm should be provided to minimize dust accumulation and facilitate cleaning. In high‑traffic areas such as public corridor walls—where impacts are likely to occur—impact‑resistant posts should be installed to prevent vibrations in decorative materials and the loosening of dust.

To ensure proper cleaning of the GMP‑compliant cleanroom, all ductwork and lighting fixtures must be installed within the suspended ceiling. Ceiling panels are typically sealed with color‑steel composite panels, which offer lightweight construction, high overall compressive strength, thermal insulation, and resistance to contamination. Fire‑safety considerations must also be given due attention. GMP cleanrooms impose stringent requirements on electrical wiring; where feasible, steel conduit should be used to prevent cables from serving as pathways for fire propagation.