Medicine is a special commodity. Its production, scientific research, testing and storage all need a clean environment. The application of clean technology in medicine industry is the combination of universality of clean technology and particularity of medicine industry. In the process of design, construction and operation of clean room in the pharmaceutical industry, the relevant standards of clean room and the requirements of medical production quality management specifications should be followed. The purpose of GMP standard practice is to effectively ensure the safety and quality of medicine. GMP is a complete concept, involving every link of medical production and controlling all factors affecting the quality in the production process. Air cleaning technology accounts for 10% of the components of GMP standards, and is also one of the hardware to implement GMP standards.

The quality control of clean room in pharmaceutical workshop is the guarantee of medical production. Therefore, in the design, operation and management control of pharmaceutical clean room and related environment should be integrated with various factors, selecting the appropriate, meeting the requirements of the production process, in line with the relevant national standards of clean room. So as to make the design, testing and operation of the clean room can fully meet the needs of medical production.

Clean room in pharmacy should be designed to meet the following factors:

1. Clean room floor should be smooth, no gap; wear resistance, corrosion resistance, impact resistance, not easy to accumulate static electricity; easy to dust removal and cleaning；

2. Clean room doors and windows modeling should be simple and smooth; not easy to collect dust, easy to clean with good sealing performance;

3. The surface of the wall and ceiling in the clean room should be without cracks, smooth, ash free, dust free, corrosion resistant, impact resistant and easy to clean;

4. All kinds of pipeline lamps, tuyere and other public facilities in the clean room, should be considered to avoid the parts difficult to clean in the design and installation;

5. Clean area indoor decoration should choose material has good air tightness;

6. The surface decoration of air supply duct and return duct should be adapted to the whole air supply and return system.

                 

Suzhou Pharma Machinery Co.,Ltd.

2023/05/15

Spencer