What are the materials and specific requirements for GMP laminar flow transfer windows?

As auxiliary equipment for GMP clean rooms, laminar flow transfer windows are mainly used in biological clean areas for the transfer of items. In the fields of laboratories, hospitals, biopharmaceuticals, etc., to prevent pollutants in the air from entering, keep the internal environment clean, and minimize pollution in the clean area, there are some special requirements for laminar flow transfer windows and their materials, as discussed below. Share it with everyone.

The laminar flow transfer window is a special equipment for clean rooms in biopharmaceuticals and large hospitals. In other complex research environments, some corrosive reagents such as strong acids and strong bases may be used, and high corrosion resistance is required. The following are the layers Specific material requirements for flow transfer windows:

1. Laminar flow transfer window boxes are made of SUS201, SUS304, SUS316, etc. Generally, 304 stainless steel is selected with a thickness of 0.8~1.5mm to ensure that it will not be affected by corrosion during long-term use.

2. The frame of the laminar flow transfer window is generally made of 304 stainless steel with a thickness of ≥1.2mm. The surface is polished and the surface finish should be no less than RA1.2.

3. The window material of the laminar flow transfer window needs to have high transparency. The visual window of the laminar flow transfer window is made of tempered glass. The thickness of the tempered glass is ≥8mm, which can observe the internal environment;

4. Rounded corners: Made of 304 stainless steel, thickness ≥1.2mm, the finish after surface polishing should be no less than RA1.2, which is more suitable for the clean room principle;

5. The high-efficiency filter frame is made of aluminum alloy, which provides better filtration effect and ensures the normal operation of the equipment;

6. The flow equalizing plate on the air outlet surface of the high-efficiency filter is made of 304 stainless steel mesh. The thickness of the plate is ≥1.0mm and there must be no burrs.

The laminar flow transfer window has specific requirements in GMP standards:

1. All sensors must be inspected by an inspection agency with legal qualifications, and inspection records and certificates must be provided.

2. After the equipment is installed, on-site testing is required for each laminar flow transfer window, including wind pressure, wind speed, noise, illumination, cleanliness, airflow pattern, etc., and relevant test reports are provided.

3. Provide verification documents that comply with GMP standards: functional description/design specification, SAT/IQ/OQ documents, and reports.

4. The surface of the equipment should be smooth, burr-free, dust-free, and clean. All gaps should be sealed with food-grade neutral sealants to maintain the isolation of the internal and external environments.

5. Equipment should have appropriate space for maintenance and inspection. Equipment should have a suitable working area to ensure smooth progress of maintenance and inspections.

6. All wires must not be exposed to prevent accidents and electric shock risks and protect the safety of operators.

7. All instruments and testing instruments should be calibrated by legal departments and traceable to ensure the accuracy and reliability of the instruments and effectively reduce misjudgments and inaccurate measurements caused by equipment errors.

The above are the materials and specific requirements for laminar flow transfer windows in GMP clean rooms. Choosing appropriate materials can ensure the effective operation of laminar flow transfer windows, thereby keeping the internal environment clean and safe.