company news about How long is the maintenance cycle of the HEPA Filter Box in the pharmaceutical factory generally?

In pharmaceutical factories, the maintenance cycle of HEPA Filter Box (high-efficiency air filter box) is usually determined according to the usage environment, the degree of pollution and the specific operation of the equipment. The following are suggestions regarding the maintenance cycle of the HEPA Filter Box:

Primary filter (G4)

Replacement cycle: It is generally recommended to replace it every three months.

Replacement standard: When the pressure difference reaches or exceeds 150 Pascals (Pa) or obvious contamination is found during visual inspection, replacement should be carried out.

Medium-efficiency filter (F8)

Replacement cycle: It is generally recommended to replace it every six months.

Replacement standard: When the pressure difference reaches or exceeds 250 Pascals (Pa) or the filtration efficiency drops significantly, replacement should be carried out.

High-efficiency filters (HEPA, such as H13 or H14)

Replacement cycle:

It is generally recommended to replace it every 1 to 2 years.

However, in a highly polluted environment, it may need to be shortened to every six months to one year.

Replacement standard:

When the pressure difference reaches or exceeds 450 PASCAL (Pa).

Or the leakage rate was found to exceed 0.03% through the DOP/PAO leak detection test.

Or in A sterile production area (Grade A/B), a leakage test should be conducted every six months in accordance with GMP requirements.

Other maintenance suggestions

Differential pressure monitoring: Regularly monitor the differential pressure of the HEPA filter, which is a key indicator for determining whether replacement is needed.

Leakage detection: For aseptic production areas (Grade A/B), a leakage test should be conducted once every six months; For non-sterile areas (Grade C/D), a leakage test should be conducted once a year.

Daily inspection: Conduct visual inspections of the HEPA Filter Box weekly or monthly to ensure that components such as sealing strips and frames are undamaged.

Cleaning and maintenance: Regularly clean the casing and installation frame of the HEPA Filter Box to prevent dust accumulation.