GMP‑compliant cleanrooms are designed to eliminate potential biological contaminants, particulate matter, and sources of contamination, thereby fundamentally preventing any factors that could compromise the production of high‑quality products. Consequently, such facilities must adhere to applicable design requirements to ensure that product quality meets regulatory standards.

I. Design of the Purification Structure for GMP Cleanrooms

1. Each production stage must be seamlessly integrated and facilitate hygienic control throughout the processing, thereby preventing cross-contamination.

2. In terms of layout, the sequence of the product’s processing steps must be followed, ensuring that processing progresses from non‑clean stages to clean stages, and prohibiting any cross‑contamination or backflow within the production line.

3. The GMP‑compliant cleanroom is equipped with a tool‑and‑equipment cleaning area and a disinfection room, featuring dedicated cleaning, disinfection, and rinsing tanks for shared tools and equipment. Where necessary, hot and cold water may also be provided; however, the temperature of the hot water must not fall below 82°C.

4. The cleanroom shall be equipped with effective dust‑removal and ventilation systems, and the airflow direction must ensure that it flows from the clean area to the non‑clean area.

5. Lighting fixtures in GMP cleanrooms must be equipped with protective guards.

II. Design of Personnel and Material Flow in GMP Cleanrooms

1. To prevent cross-contamination, operators and materials entering the cleanroom must not use the same entrance; separate air‑cleaning rooms should be provided for each, or appropriate air‑cleaning measures should be implemented.

2. In the GMP‑compliant cleanroom, only equipment directly related to production is permitted, thereby preventing food contamination.

3. Ensure that access to the cleanroom is direct from each production workstation and from storage areas for intermediate products or primary packaging materials, thereby effectively preventing cross-contamination between different product types caused by material handling and personnel movement.

4. Provided that the process flow and equipment layout are not adversely affected, when the air-conditioning system parameters are identical, adjacent cleanrooms in a GMP‑compliant cleanroom facility may be equipped with doors in the partition wall, pass-through windows, or conveyor belts for material transfer.

III. Installation and Design of the Air Conditioning System for GMP Cleanrooms

The selection of distinct designs for supply and return air systems in GMP cleanrooms is the decisive factor determining the facility’s various cleanliness classes.

1. Standard modular air-handling unit, air filtration system, cleanroom ventilation and insulation ductwork, HEPA‑rated supply diffusers, and a cleanroom return‑air ductwork system. This configuration continuously recirculates air while supplying fresh air to the cleanroom, thereby maintaining the cleanliness level required for the production environment.

2. In GMP‑compliant cleanrooms, ceiling‑mounted FFU industrial air purifiers deliver supply air directly into the cleanroom, complemented by a return‑air column system and ceiling‑mounted air conditioners for cooling. This configuration is typically employed in applications where stringent cleanliness requirements are not paramount and where costs are relatively lower.

A GMP‑compliant cleanroom is a complex, multidisciplinary undertaking that encompasses specialized knowledge spanning the production environment, process operations, manufacturing equipment, auxiliary systems, analytical testing methods, and personnel qualifications.