IEST RP CC034.2 PDF

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The performance of any cleanroom and its ability to achieve and maintain the designed cc034.2 class are critically dependent on the performance of the air filters used in its construction.

IEST-RP-CC034.2: HEPA- and ULPA-filter leak tests

Good practice dictates testing the performance of all filters for their overall efficiency, integrity, or absence of leaks. The article mentioned that filters are typically tested both as manufactured c034.2 after installation. In addition, many cleanrooms in regulated industries such as the pharmaceutical or nuclear facilities require these filters to be certified periodically as installed to ensure acceptable performance during their service life. This recommended practice RP provides guidance for filter integrity testing, both with automated test equipment at the manufacturing facility and for manual testing as installed, thereby ensuring that the filters meet design specifications.

Leak-testing is relevant to individual idst as well as to installations such as cleanrooms, biosafety cabinets, and lab benches. Recommended procedures for leak-testing were traditionally part of various IEST RPs dealing with filters or their use. These RPs were revised at different times, resulting in different recommended methods for leak-testing filters.

In an attempt to eliminate confusion arising from differing recommended eist practices, one leak-testing practice common to all relevant RPs was published in the mids. Although the procedures in the RP may be independently followed, the intention is for them to be used as a complement to other IEST RPs dealing with filters and filter applications.

Expanded guidance on the cc034.22 of leak-test methods, based on filter performance and application, is provided.

IEST-RP-CC034 2 Hepa Ulpa Leak-Test

The RP includes suggested choice of photometers or discrete particle counters for idst tests. See Table 1 for guideline information. The count mean diameter CMD is the average particle size of the number distribution of the aerosol. The mass mean diameter MMD of the aerosol is the average particle size of the mass distribution of the aerosol.

Typically, since the mass of a particle varies with the cube of its diameter, most of the mass of an aerosol tends to be in the larger sizes, resulting in the mass mean being larger than its count or number mean.

Understanding the difference is significant, since filter efficiency is very size-dependent. Leak-testing requires a uniform distribution of the challenge aerosol to ensure that local variations do not adversely affect the determination of a leak in the filter.

Calculation of the spatial and temporal uniformity is addressed in the RP with illustrations. Example calculations are also provided to help in estimating uniformity.

The nominal acceptable criteria for the uniformity are as follows:. Dead-air spaces areas of no airflow pose a significant concern in leak-testing filters and their surrounding support structure. This subject is addressed in some detail in the RP. The testing of these areas is necessary to detect air bypass or leaks in the filter frame, ccc034.2, or seals, and the filter support structure.

The problem arises due to the lack of HEPA-filtered dilution air in the dead-air space. A small leak will expand throughout the dead-air space and, over time, the aerosol concentration will appear to be much greater than its actual percentage dp penetration. This buildup will prevent the tester from isolating the actual source of the leak unless additional actions are taken.

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One action is to redirect HEPA-filtered air into the dead-air spaces using clipboards, metal plates, laminated sheets, and so forth. The HEPA-filtered air will wash out the aerosol buildup and allow the tester to find the leak source.

In recent years, there have been an increasing number of cases of originally tested and certified HEPA filters that fail during routine leak-testing and recertification in the field. In some cases, the photometer used in field leak-testing results in a continuous high reading, indicating failure.

This phenomenon is referred to as bleed-through, or excessive widespread nonsite-specific penetration in leak-testing. Leak-testing by scanning the filter measures the local performance of the filter at the current position of the scanning head. Cx034.2 typical HEPA filter with a face area of 4 ft. In comparison, the cross section of a scan head is about 0.

Thus, when you scan the filter, the local performance as well as the performance over a defect is measured. Because the penetration of any filter media used in HEPA filters varies within allowable limits, scanning the face of the filter will measure this variability in the media. In contrast, the overall efficiency of the filter measures the average or nominal penetration of the media or the filter.

Bleed-through is typically believed to occur when filters are scanned for leakage with kest criteria of a leak set too close to the overall performance of the filter or tested at the same mean particle size, or both. This is the allowable variability in the media, which results in the filter exceeding the leak criteria at numerous locations during scanning and, consequently, in the perceived bleed-through or excessive widespread nonsite-specific penetration.

That filter has a ieet efficiency of Its leak criteria is also Currently, filter manufacturers, because of market and business reasons, supply filters that will not strictly meet the Type C requirements. These filters are usually tested and classified to different test standards or use test practices modified from those originally included when earlier versions of IEST RPs were established.

Further, currently available devices for generating aerosols with larger particle sizes-typically Laskin Nozzle generators-produce aerosols in amounts sufficient for testing only small cleanrooms or biosafety cabinets.

For larger cleanrooms, it is a common field-testing practice to use the vapor condensation thermally-generated aerosols with the mean size of particles closer to the MPPS of filters. These two current practices often result dc034.2 filters tested for efficiency at particle sizes that are close to those used for leak-testing in the field. This leads to a leak criteria almost identical to that of the nominal filter efficiency and results in bleed-through. If a traditional Type C filter is not available, or if sufficient amounts of large particles cannot be generated, the occurrence of bleed-through may be minimized by increasing the local performance of the media-that is, the noise from the allowable local variability in the media is reduced, allowing only genuine defects in the cc0344.2 to be detected.

This can be achieved by choosing a filter with a higher nominal efficiency such that, even at the limits of the allowable variability, the local performance of the media is well within the leak criteria and, therefore, not detected as bleed-through. Since leak-testing is a key subject to many in the contamination-control industry, IEST welcomes input and suggestions on handling this vexing problem.

Without the input, the urgency, and the lively debate among the members of the Working Group, neither the timeliness nor the quality dc034.2 this RP would be possible.

As chair of the WG, I thank them all for their support. Vijayakumar holds a Ph. He has held senior technical and marketing positions in leading filter, filter media, and particle instrument companies, where he has assisted customers worldwide with their filtration and filter-testing problems. He also held the position of Chair of Standards and Practices from to He can be reached at vijay tsi.

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Easily iesr a comment below using your Linkedin, Twitter, Google or Facebook account. Comments won’t automatically be posted to your social media accounts unless you select to share. Your email address will not be published. Save my name, email, and website in this browser for the next time I comment. Keysight Technologies’ popular page Parametric Measurement Handbook is an invaluable reference tool for anyone performing device or process characterization.

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IEST-RP-CC 2 Hepa Ulpa Leak-Test – PDF Free Download

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Come for the Tech, Stay for the Analysts. History Leak-testing is relevant to individual filters as well as to installations such as cleanrooms, biosafety cabinets, and lab benches. The nominal acceptable criteria for the uniformity are cc034. follows: Relative standard deviation less than 20 percent. Maximum relative deviation of any single point 50 percent. Ratio of concentration at the representative upstream sample port to average concentration between 0. Leave a Reply Cancel reply Your email address will not be published.

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