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Replacement intervals for high-efficiency filters for air conditioning in pharmaceutical plants
Replacement intervals for high-efficiency filters for air conditioning in pharmaceutical plantsAir conditioning high-efficiency filter replacement cycle is a lot of cleanroom users are concerned about the issue, then the pharmaceutical plant is using which high-efficiency filter?Pharmaceutical plants generally have high requirements, generally, choose high-efficiency filters without partitions and high temperature resistant high-efficiency filters, and then require high cleanliness to choose sub-high efficiency filters. In the pharmaceutical industry, air conditioning high-efficiency filters are used for the treatment and filtration of air in the production space medium efficiency filters, aseptic production mandates the use of high-efficiency filters, while the production of solid and semi-solid dosage forms advantage will also be used, H13 and H14 are two types of high-efficiency filters filter efficiency, the latter retention rate of 99.995%. So how often does a pharmaceutical plant's high-efficiency filter need to be replaced? Air conditioning high-efficiency filters generally need to be replaced every 1-2 years to ensure the purification effect, some require annual replacement of high-efficiency filters, regardless of the test results, is this reasonable? According to the relevant GMP guidelines, there is no specific data on the duration of use of HEPA filters. According to GMP requirements, HEPA filters must not have leaks, which are to be confirmed, and leak detection tests performed regularly, which is a must for aseptic plants. Of course, there is not only one thing about the integrity of high-efficiency filters. The load on the filter and the differential pressure upstream and downstream are also important. If the pressure differential between the top and bottom of the filter increases, the energy requirements of the air supply and exhaust system will increase to maintain the necessary number of air changes. To protect the high-efficiency filters, the pre-filters are usually fine filters such as F7 and F9 medium filters.The pre-filters need to be changed regularly to protect the HEPA filters from clogging. |
