Are there any cleanliness requirements for the changing rooms in clean rooms/dust-free workshops?

The dressing room of the clean room is a room where the staff handles their personal conditions before entering the air shower room and clean room, including changing shoes, changing clothes, washing hands, etc. The setting of the dressing room can greatly reduce the pollution of the clean room by personnel, and at the same time standardize the entry and exit procedures of personnel.

As the front area of the clean room, the specific cleanliness level of the dressing room should be determined according to the production process requirements of the product and the air cleanliness level of the adjacent clean room. If the cleanliness of the clean room itself is not high, such as 300,000 or 100,000, the dressing room may not require cleanliness, or use a high-efficiency air filtration and air supply system, or introduce part of the purified air in the clean room into the dressing room. If the clean room level is higher, such as 100, the cleanliness level of the dressing room can be set, which is generally 1-2 levels lower than the adjacent clean room.

As pointed out in the “Quality Management Specifications for the Production of Sterile Medical Devices”, the air cleanliness level of the clean work clothes room (changing room) can be one level lower than the production area.

According to the “Pharmaceutical Industry Cleanroom Design Standard” GB50457-2019 and other relevant standards, the changing room must be built and operated in accordance with strict design specifications. The new version of GMP requires that the static level of the rear section of the changing area (the part close to the clean production area) should be consistent with its corresponding clean area. The cleanliness level should be set appropriately for the front section, and changing shoes and changing outer clothes can be set in the clean area.

For the changing room of the food clean room, according to the “Technical Specifications for the Construction of Clean Rooms in the Food Industry”, the undressing area and the clean clothing area in the changing room should be separated. The clean work clothes area should be designed as a Class III to IV clean room, and the sterile underwear and the area after it should be designed as a Class II to III clean room.