A sterile cleanroom must undergo inspection and acceptance after construction is completed to identify areas that do not meet requirements and carry out repairs or adjustments. Specifically, how should the inspection be conducted? What are the clothing requirements for personnel entering the cleanroom?
1. After the cleanroom construction is completed, inspection and acceptance must be carried out, divided into engineering inspection, functional inspection, and application inspection. Confirm that the technical parameters meet the design requirements, application needs, and relevant technical standards. Second, the engineering inspection is conducted by the construction unit, with participation from electrical contractors, design firms, and project supervisors.
3. Functional inspection should be conducted after the engineering inspection, performed by the construction unit and overseen by a certified third-party inspection agency. The design firm and construction company must coordinate.
4. Application inspection should be conducted after the functional inspection, performed by the construction unit, either by a certified third-party agency or jointly with the construction unit. The design firm and construction company must coordinate.
5. Cleanroom inspection and acceptance are divided into static air state, static data, and dynamic state. Engineering inspection should be conducted in a static air state; functional inspection should be conducted in a static air or static data state. The contractor, construction party, and construction unit should clearly agree, preferably conducting inspections in a static data state; application inspection should be conducted in a dynamic state.
What is the key point in cleanroom decoration?
What is the importance of cleanroom infrastructure construction? What is the key point in cleanroom inspection? Production rooms for packaged food and pharmaceuticals under supervision, sterile medical equipment production rooms, laboratories, GMP health product production rooms, cosmetics production rooms, animal testing rooms, GMP feed production rooms, and other cleanrooms typically require third-party inspection and adjustments after basic completion. Difficulties in GMP cleanroom inspection and acceptance.
