Legal analysis: Class A: High-risk operation area
For example: filling area, area for placing stoppered drums, open-topped ampoules, open-topped vials of vials, and area for aseptic assembling or connecting operations. Laminar flow benches (hoods) are usually used to maintain the environmental status of the area. The laminar flow system must have a uniform air supply in its working area with an air velocity of 0.36-0.54 m/s (guideline value). Data shall be available to demonstrate the status of the laminar flow and shall be verified. Unidirectional flow or lower air velocities may be used in confined isolation operators or glove boxes.
Class B: The background area in which Class A zones for high-risk operations such as aseptic preparation and filling are located.
Classes C and D: Areas of cleaner operations of lesser importance in the production of aseptic drugs.
A, B is equivalent to a hundred clean area, the background environment of the A to be higher, more stringent requirements. class C is equivalent to 10,000 clean area, class D is equivalent to 100,000 clean area.
Legal basis: "medical device production quality management standard sterile medical device implementation rules (for trial implementation)"
Article XII of the production enterprise shall determine the production of products to avoid contamination, in the corresponding level of clean room (area) in the production process. Air cleanliness level of different clean rooms (areas) should be greater than 5 Pa static pressure difference between the clean room (area) and the outdoor atmospheric pressure should be greater than 10 Pa static pressure difference, and there should be an indication of the pressure difference of the device, the same level of the gradient of the pressure difference between the clean room should be reasonable. Sterile implantable medical device manufacturers should be set up in the working environment of the product quality does not adversely affect the principle.
Article XIII of the clean room (area) should be in accordance with the production process of medical devices and the required air cleanliness level for reasonable layout. The same clean room (area) or adjacent clean room (area) between the production operation shall not cross-contaminate each other.
Clean room (area) of the temperature and relative humidity should be compatible with the requirements of the production process. No special requirements, the temperature should be controlled at 18-28 relative humidity control in 45% -65%.
Article XIV of the production plant should be set up to prevent dust, insects and other animals from entering the facilities. Clean room (area) doors, windows and security doors should be closed. Clean room (area) of the inner surface should be easy to clean, can withstand cleaning and disinfection.
Article XV of the clean room (area) used in the compressed air and other process gas should be purified. Direct contact with the product surface of the gas, the degree of its impact on the product should be verified and controlled to adapt to the requirements of the products produced.
Article XVI of the production enterprises should develop a clean room (area) of the health management documents, in accordance with the provisions of the clean room (area) for cleaning, cleaning and disinfection, and make a record. The disinfectant or disinfection method used shall not cause contamination of equipment, process equipment, materials and products. Disinfectant varieties should be regularly replaced to prevent the emergence of resistant strains.
Article XVII of the production enterprises should be clean room (area) of dust particles, planktonic bacteria or settling bacteria, the number of air changes or air velocity, static pressure difference, temperature and relative humidity for regular inspection (monitoring), and the initial contamination of bacteria and particulate contamination of the product quality whether the impact of regular inspection (monitoring) and validation, inspection (monitoring) results should be documented and archived.