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Current location: Air filter > News Center >How long should the high efficiency filter be replaced?

How long should the high efficiency filter be replaced?

In the relevant GMP guidelines, there is no specific value for the service life of HEPA filters.

According to GMP requirements, High efficiency filter There must be no leakage, which requires confirmation and regular execution of the leak test in ISO 1464-3, which is positive for the aseptic workshop.

12 months for technical level (A-32 / D) according to appendix.

FDA sterility guidelines require regular inspection. The requirements of Appendix 1 also apply here.

The leakage can be repaired, but the repair area should not exceed 0.5% of the area of a single filter.

 High efficiency filter

From a practical point of view, we can say that the service life directly depends on the pressure difference between upstream and downstream. Only when the upstream and downstream pressure difference reaches a fixed value, which affects the performance of the ventilation system, or the energy demand exceeds the replacement cost of the filter, can the filter replacement be meaningful.

However, the filter must be able to pass the leak test. In fact, many companies don't use a filter for more than eight years.

As mentioned above, there is no regulation for such a value, which is only based on experience.

The replacement of high-efficiency filter is based on the air volume and leakage detection during air-conditioning verification. However, the specific service life of the high-efficiency filter should also be worked out, so the concept of regular period should be established. At the same time, the filter integrity test must be carried out regularly.

High efficiency particle filter can be used in non clean area.

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