How long is the replacement cycle of the HEPA filter? (pharmaceutical factory)

About the replacement cycle of high efficiency filter, many clean room users are very concerned about, after all, high efficiency air filter determines whether the cleanliness of the clean room can reach the standard, before we also sort out the relevant problems: replacement standard of high efficiency filter

In the pharmaceutical industry, HEPA filters are used as terminal filters for air treatment or filtration in production Spaces. They are mandatory in aseptic production, although they are sometimes used in the manufacture of solid or semi-solid dosage forms. In the HEPA filter or HEPA filter, the filtration grade is H13 to H14 (din1822), the latter has a retention rate of 99.995%. But how often do they need to be replaced? The latter has a retention rate of 99.995%. But how often do they need to be replaced? (HEPA filter manufacturer)

In the pharmaceutical industry, high efficiency filters (HEPA) are used to produce terminal filters for treating and filtering space air. Hepa filters are required in aseptic manufacturing and are sometimes used in solid and semi-solid dosage forms. H13 ~ H14 (DIN1822) are two efficient filters, and the interception rate of the latter is 99.995%. But how often do you need to replace them? (high efficiency filters manufacturer)

One can often find company internal guidelines, according to which filters should be replaced annually, regardless of monitoring results. Is that reasonable? An exact figure cannot be found in the relevant GMP guidelines for the maximum time HEPA filters can be used over a period of several months. Filters must be leak-free according to GMP requirements. According to ISO 14644-3, this is mandatory for aseptic facilities through qualification verification and regular leak testing. According to the technical explanation of Annex 1 (PIC/S PI 032-2), leak tests are conducted every 6 months in zone A/B and every 12 months in zone C/D. FDA sterility guidelines call for regular inspections. The requirements of Annex 1 can also be applied here. Leaks can be fixed; These repair areas may account for as little as 0.5% of the filter surface. (HEPA filter manufacturer)