What is a high efficiency filter? How does a high efficiency filter leak?
High-efficiency filter generally refers to filtration with a collection efficiency of 97.97% or more for particles larger than or equal to 0.3um.
A terminal filter for the clean room of a pharmaceutical company to provide clean air. Can the clean room
Achieving and maintaining the cleanliness of the design is somewhat related to the performance of the KLC air filter and its installation.
If the filter itself has small holes or the installation is not tight enough to form tiny cracks, it will not achieve the predetermined purification.
Effect, affecting product quality. Therefore, after the high-efficiency filter is installed or replaced, the filter and the installation must be connected.
Leak detection, through testing the leakage of high-efficiency filters, found the high-efficiency filter and its installation defects
In order to take remedial measures.
A common method for detecting leaks in high-efficiency filters is the dust particle counter scanning method (ie, using atmospheric dust as a dust source,
Particle counter with leak detection) and DOP method for leak detection (ie using DOP solvent as a dust source, with aerosol photometer)
Combined detection leaks). The dust particle counter reading scanning method has the advantages of low equipment cost and simple operation;
This method is a cumulative reading, which is not conducive to scanning, and the inspection speed is slow; in addition, on the windward side of the high efficiency filter to be tested,
The concentration of dust in the atmosphere is low, and it is difficult to find the leak. In the case where the upstream dust source does not meet the concentration requirement, the particle meter is used.
The scanner scans and is prone to missed detection. Relative dust particle counter reading scanning method, DOP method leak detection cost
Higher, the operation is more complicated; the advantage is that it can make up for the above-mentioned deficiencies of the particle counter method for leak detection, and the accuracy of leak detection
high. Therefore, the DOP method is widely used in foreign countries for leak detection;
Several issues that should be noted during the use of high efficiency filters:
1. For the integrity and qualification test data of the high-efficiency filter external contractor, the enterprise should establish
Written procedures to explain or describe the content of the review.
2. The differential pressure on both sides of the KLC high-efficiency filter should be regularly checked to set the upper and lower limits of the high-efficiency filter differential pressure, especially
The cleaning chamber goes to the HEPA filter between the heating zone and the cooling zone in the pyrogen tunnel.
3, go to the pyrogen tunnel and oven should do high-efficiency filter DOP method leak detection. In the case of a reasonable explanation
Other methods can be used to detect leaks in the high efficiency filters in the hot zones of these tunnels and ovens.
4. The leak of the high-efficiency filter media is allowed to be repaired, but the area of ​​the single leak should be specified.
(cannot be greater than 1% of the total area) and the area limit of all leaks (not greater than 5% of the total area), otherwise
Must be replaced. The SOP should also address how to track the total repaired area during the life of the HEPA filter.
More than the regulations.
5. For the aseptic operation room, the leak detection of the high-efficiency filter should be more than 2 times a year.
6, should understand the difference between high efficiency filter effectiveness detection and leak detection. KLC filter effectiveness test using hot
DOP (0.3 micron single size dispersed particle aerosol) to evaluate the filter media, the readings downstream of the tuyere represent
The average value of the filtered particles on the entire filter surface is not more than 0.03% of the upstream tuyere solubility, which is effective.
Sex is not the case of detecting leaks in the filter and is only detected at IQ. The leak detection uses a cold DOP (more
Species of dispersed size: 0.1-0.3 μm), scanned at a speed of no more than 5 cm/s downstream of the tuyere
The present solubility is more than 0.01% of the solubility of the upper vent, which is considered to be a leak.
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