WOL planning and construction of sterile laboratory purification engineering design and decoration

The sterile testing laboratory is a professional place for conducting sterile validation of samples such as drugs, medical devices, and biological products. It needs to take into account the three core aspects of sterile environment protection, testing accuracy, and biosafety protection. Its layout and construction should follow the principles of "graded isolation, one-way closed-loop, and precise regulation".

1. Key pollution prevention and environmental control design

• Physical and differential pressure isolationEach area is fully partitioned with 50mm thick antibacterial airtight color steel plate (extending to 500mm above the ceiling), and independent airlocks are set up between the core sterile area and the positive control area; Establish a pressure gradient of "core sterile area (+15Pa), low clean area (+5Pa), auxiliary area (0Pa), positive control area (-5Pa)" to ensure that the airflow flows from the clean area to the contaminated/positive area.

• Material transfer controlThe test samples need to undergo outer packaging disinfection in a low cleanliness area and be transferred to the core sterile area through a double door sterilization transfer window (with VHP sterilization); Positive control strains need to be transported separately in a sealed negative pressure transfer box, with dedicated transfer windows isolated from other material channels; The experimental equipment needs to undergo high-pressure sterilization at 121 ℃/30min before being transferred to the sterile station.

• Environmental parameter regulationThe temperature of the core sterile area should be controlled at 22 ± 0.5 ℃ and the humidity should be 45% -60%. The cultivation observation room should be independently controlled at 30-35 ℃; The HVAC system is independently configured in different areas, and the air supply in the core area is filtered through three levels of "initial efficiency G4+medium efficiency F8+high efficiency H14". An online monitoring system is also installed to monitor real-time indicators such as particulate matter and settling bacteria, and automatic alarms are triggered when exceeding the standard.

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3. WOL planning and construction of sterile laboratory purification engineering design and decoration

4. WOL planning and construction of sterile laboratory purification engineering design and decoration