The Difference between GMP Cleanroom And Ordinary Workshop

In recent years, many pharmaceutical companies have actively taken measures to meet the needs of the international pharmaceutical market. The requirements for the design of GMP Cleanrooms are beautiful and clean to prevent product contamination and quality changes. Therefore, the design of doors, windows, floors, walls and ceilings in the interior decoration of cleanrooms is different from that of general factories. What are the specific differences? The following is a detailed description.

1. In the architectural layout of the GMP cleanroom, a circular sealed corridor is generally set up outside the factory. It creates a buffer zone between the clean area and the outside world. It can prevent external pollution and is relatively energy-saving. The doors and windows in the factory should be flat on the inner wall, and no windowsills should be set. The number of layers and structural forms of the external windows should fully consider the sealing of air moisture, so that pollutant particles are not easy to penetrate from the outside.

To prevent condensation due to temperature differences between indoors and outdoors, the gaps between doors and windows between rooms with different cleanliness levels should be sealed. The materials for Cleanroom Doors and Cleanroom Windows should be selected with good weather resistance, small natural deformation, small manufacturing error, good air tightness, simple shape, not easy to accumulate dust, easy to clean, and no threshold on the door frame.

The Clean Room Doors and windows of the GMP cleanroom should be made of metal or metal-coated plastic materials. Wooden doors and windows should not be used to avoid long-term moisture and bacterial growth. The windows on the exterior wall should be flush with the interior wall, with an angled window sill or no window sill, and double-layer fixed windows to reduce energy loss.

2. The ground should be flat, seamless, wear-resistant, corrosion-resistant, not easy to accumulate static electricity, and easy to clean. Cast-in-place terrazzo floor can be used in the design, and the diameter of the stone used should be between 6-15mm. The dividing strips must be separated by copper strips, and glass strips must not be used.

Nowadays, epoxy self-leveling floor is mostly used, which is a resin composite material floor. It is characterized by solvent-free, non-toxic and odorless, seamless, and self-leveling. It can achieve mirror decoration effect, seamless connection, oil resistance and acid, alkali, and salt chemical solvents. It has the characteristics of anti-static, low dust generation, wear resistance and impact resistance, but the cost is high.

Most of them are used in production workshops in the electronics, medicine, blood products and other industries that require high cleanliness, beautiful appearance, dust-free and sterile. The service life of epoxy self-leveling floor is generally more than 6 years with a thickness of more than 1mm. A moisture-proof layer should be laid under the cushion layer of the above floor, and the concrete compartment line should not pass through the clean area.

3.The wall surface should be smooth, flat, dust-free, corrosion-resistant, harmonious in color, and easy to identify pollutants. The interior wall paint must be anti-mildew, anti-static, glare-free, and resistant to cleaning and disinfection. The intersection of the wall and the ground should be made into an arc with a radius of 50 mm to reduce dust accumulation and facilitate cleaning. Anti-collision railings should be installed on the walls of transportation corridors and other places that are prone to collision to prevent dust from falling due to vibration of decoration materials.

4.  In order to ensure indoor cleanliness in GMP cleanrooms, all air supply pipes and lamps must be arranged in the technical mezzanine. Now most pharmaceutical companies use color steel sandwich panels to seal the ceiling. Color steel sandwich panels have the characteristics of light weight, high overall strength, good integrity, thermal insulation and low dust generation, and are more suitable for GMP production plants. However, the fixing of the ceiling must be connected to the main structure and cannot be mixed with equipment and pipeline brackets.

The ceiling and the wall should be connected smoothly. The ceiling and the return air duct should be reliably closed. After the ceiling is installed, a light inspection should be carried out to ensure that there are no gaps. According to the process requirements, an inspection walkway should generally be set up in the technical mezzanine to facilitate the inspection and replacement of pipelines and filters. The walls and ceilings of the technical mezzanine need to be painted.

In addition, strict requirements should be made for the pipe penetration of electrical lines. Steel pipes should be used as much as possible in places where conditions permit to ensure that electrical lines do not become a way for fire to spread.

In summary, GMP purification workshops have high requirements for air temperature, humidity and cleanliness. Designers should reasonably select building materials according to process requirements and production cleanliness levels, and consider fire resistance to meet GMP design requirements.