How long will be changing a hepa filter to use?

by:Booguan     2020-10-25
Filter equipment

in the biological pharmaceutical industry, high efficiency air filter products is used to production and processing workshop of terminal filter processing and filtering. Aseptic processing rules to force application of , and solid and semi-solid dosage form production and processing enterprises sometimes hepa filter will be applied. H13 to H14 is two kinds, and behind a withholding rate higher. How long the hepa filter used must be the conversion time?

we often see in internal documents, set each year changing a filtering device, and no matter how monitoring results, that this method is scientific and reasonable? Actually in relevant GMP manual and can't find the detailed values efficiently filter can be used within a time limit. According to GMP rules, filtration unit there shall be no leakage, it need to check and implement ISO14644 - on time Leakage detection in 3, purification workshop also need to do this. According to annex 1 ( PIC/SPI032- 2) Technology application interpretation, grade A/B every six months the leakage detection, C/D testing for A year. The FDA sterile manual regulation need to carry out inspection on a regular basis. Generally found leakage is the ability to repair, but the area of the repair can not be beyond a single air filtration product unit area 0. 5%.

of course, is not only the integrity testing this one thing, the load on the air filtration product unit and its upstream and downstream pressure difference is also key. If filter upstream and downstream pressure increase, then send the energy of the exhaust system requirements will need to improve, so that can keep necessary air changes. Such filter upstream and downstream pressure can increase the function of the ventilation system, in order to better maintain , will need to apply the front-end filtering device, usually is to use such as F7 and F9 fine filter. These filters must be moved around in time to maintain efficient filters to prevent blocking.

from the Angle of practice, everyone can say hepa filter is longer than the application deadline is depends on the pressure difference between upstream and downstream. Only in the upstream and downstream pressure difference more than the corresponding values and interfere with the function of the ventilation system, or the energy requirements beyond the filtration unit conversion cost, air filtration product unit conversion was more meaningful. However, filtering device must be able to pass leakage detection. In fact, many companies will not be a filtering device beyond 8 years. As the above said, and could not find such value policy rules and regulations, these are merely on the basis of experience.

the hepa filter if it needs changing, what are the problems to be pay attention to the conversion?

1, small capacity injection workshop air conditioning unit of the hepa filter should be moved around on time? If not moved around on a regular basis, only when the air conditioning test conversion air output falls below the room efficient filter and hepa filter rule falls below? Changing a hepa filter on the basis of air conditioning inspection when the exhaust air and the rule is a must, but at the same time also should draw up a detailed hepa filter is longer than the application deadline, therefore, need to have the concept of on a regular basis. At the same time must be on time to carry out the filtration unit integrity detection.

2, clean area class A leak detection can leak detection can be applied to dust particle counter scan, if can of words, then decide what is the standard without any leakage? High efficiency filter leak detection in non-critical areas usually able to apply the dust particle counter, but class A hepa filter clean areas do not recommend application of dust particle counter scan leak detection.

above all, how long to replace one , mainly depends on the equipment application situation, need to check the leakage of corresponding regularly, so you can play well the work efficiency, and at the same time, also cost for enterprises to reduce unnecessary spending.

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