The usage environment of high-temperature filters is extremely harsh, especially in dry heat sterilization tunnels, where the temperature in the heating zone can reach up to 350 ℃~380 ℃, which puts forward high requirements for high-temperature filters. High temperature resistant filters need to face the following challenges:
🔷 Always maintain its integrity (without damage, cracking, or leakage) during frequent and significant temperature fluctuations;
🔷 Do not pollute the product due to dust generation, leakage, or insufficient filtration efficiency;
🔷 Always ensure a GMP A level clean environment for the dry heat sterilization section;
🔷 Reduce the time required for user heating and cooling programs, and improve production efficiency.
The main function of the sterilization and pyrogen removal tunnel is to maintain the positive pressure of the cavity and provide sufficient heat for the container to achieve the effect of removing pyrogens. To ensure that the tunnel equipment meets the design requirements, five functional confirmations related to filters need to be conducted before formal use.
1) Wind speed:
To maintain positive pressure in the tunnel and bring in heat to the container, the wind speed inside the tunnel is usually higher than the 0.45m/s required by the GMP A-level zone, and the actual surface wind speed is around 0.55-0.65m/s.
2) High efficiency filter leakage and efficiency testing:
After confirming that the wind speed is qualified, conduct a leak test on the high-efficiency filter to ensure that the filter efficiency meets the requirements.
3) Cleanliness confirmation:
Conduct cleanliness testing of the work area in accordance with the requirements of ISO14644-3 standard to ensure the cleanliness of the working environment.
4) Heat distribution/heat penetration:
It is necessary to confirm the tunnel no-load temperature distribution and full load temperature distribution to ensure uniform heat transfer.
5) Equivalent sterilization time Fh:
Calculate the equivalent sterilization time based on the recorded data, and ensure that the sterilization effect meets the domestic requirement of Fh ≥ 1365.
The SAF high-temperature resistant filter is competent in these functional tests, and with its excellent product performance, it provides reliable guarantee for the sterile production of many enterprises. Its application in sterilization and heat removal tunnels effectively maintains a clean environment and ensures product quality and safety.
