The GMP cleanroom requires enterprises to meet the national regulatory requirements for hygiene and quality in terms of raw materials, personnel, facilities, production processes, packaging, transportation, and quality control, establishing a set of operational guidelines to help improve the sanitation environment, promptly identify issues in the production process, and make improvements. In brief, GMP cleanroom standards necessitate that manufacturing facilities have good production equipment, a reasonable production process, comprehensive quality management, and stringent testing systems to ensure product quality (including food safety and hygiene) complies with legal requirements. Therefore, a GMP cleanroom refers to a facility that meets the requirements of the GMP quality and safety management system.
Structural materials for GMP cleanroom:
The materials for the cleanroom must meet GMP standards, being washable and sterilizable, free of cracks, with smooth and even surfaces, and having tight joints without any granular material shedding. Additionally, when selecting a material, it is not only necessary to ensure it meets GMP requirements but also to consider its lifespan, ease of installation, and pricing sources among other factors.
Cleanroom Floor of GMP Cleanroom for Purification Project
1. The floor of the purification workshop building requires to be flat, smooth, wear-resistant, impact-resistant, easy to clean, well-integrated, crack-free, with appropriate load-bearing capacity, and antistatic.
2. The clean room floor also requires moisture-proofing. Main moisture-proof measures: install a moisture-proof layer—set up a membrane isolation layer under the concrete subfloor of the ground, and use an elevated floor.
3. Purification Workshop Floor Materials: ① Non-elastic Surface Material - Polished Marble. ② Coating Surface Material - a. Thin Film: Acrylic, Epoxy, Polyurethane, etc.; b. Self-Leveling: Epoxy Self-Leveling. ③ Elastic Decorative Material - PVC Blocks or Sheets (PVC Plastic Flooring)
Cleanroom wall and partition for GMP purification engineering.
The walls and ceiling surfaces of the purification workshop should be smooth, non-dust-generating, flat, and easy to clean. Common interior wall materials include stone magnetic walls, special coatings, terrazzo, or colored steel plates. For areas that are particularly humid during production with lower cleanliness levels, ceramic tile walls can be used, but they must be laid flat with tight joints to prevent the growth of microorganisms. For rooms with high cleanliness requirements, paint coatings and colored steel plates are more ideal.
Cleanroom Doors and Windows Requirements for Purification Engineering GMP Cleanroom
Doors for cleanrooms should be flat, smooth, easy to clean, with simple designs, no thresholds, and open towards higher cleanliness levels. Automatic door closers and sealing strips are recommended to ensure air flow organization and room pressure difference control. Doors for cleanrooms should not be made of wood to avoid mold, mildew, or deformation.
Windows for cleanroom use should be airtight, simple in design, flat, non-porous, and easy to clean. They should be flush with the interior walls without window sills (if window sills are present, they should be slanted). Wooden materials should not be used. Double-glazed windows are required for walls separating air-conditioned and non-air-conditioned areas, with at least one fixed pane.
