During the integrity test, whether manually or using an integrity test instrument like the sartocheck 4 plus, potential false filter integrity test failures can occur. This guideline is considered a recommended industry standard procedure that can be utilized for testing the efficiency of hepa filtered equipment used in the control of hazardous materials. Performing filter integrity tests is a requirement by regulatory agencies fda, eu when a product is labeled sterile. The sartocheck 3 plus is not encumbered by the 21 cfr part 11 code as it is a paper based system and does not store test results electronically.
He is shown using a photometer to scan the hepa filter to the cold dop test method requirements of as1807. Auxiliary equipment, such as fans and ductwork, is not included. Personnel protection test and biological test of hepa filter. Prepacked sterile filters were also contaminated with b. If the filter is not installed correctly, water or air may bypass the filter membrane and give an incorrect test value. Filter integrity testing troubleshooting guidelines. A basic overview of installed hepa filter leakage testing for iso146443 compliance with a photometer. In addition to assessing the efficiency of hepa filters, they are also subject to leak testing. Equivalency of the alternative test method should be determined jointly by the buyer and seller. There is a major difference between filter leak testing and efficiency testing. Isolator integrity leaktesting four level classification system of hourly leak rate class hourly leak rate rh h1 pressure integrity test methods 1 high efficiency particulate air this type of air filter can remove at least 99. Bubble point test the most widely used nondestructive integrity test is the bubble point test see box. Today, manufacturers test each hepa filter according to methodologies as outlined in recommended practices rp as published by the institute of environmental sciences and technologies iest and filter test methods.
In situ aerosol filter testing is a black art to many, but the new isoen146443 test methods standard. The calculated number of times the total air volume of a defined space is replaced in a given unit of time. A prefilter is place in front of the hepa filter to capture large. Physical integrity testing of a process filter should be conducted before use where process conditions permit.
This sop shall be is applicable for hvac system, laminar air flow stations and air handlers of process equipment. Because potential leakage is not confined to the filter media, there is a requirement to perform an sn situ filter integrity test. Integrity tests on 969 hepa filters filtering air to and from rooms and laboratories have been done annually for years. Test procedures for hepa filters are discussed in 2016 ashrae. Manufacturers of highefficiency particulate air hepa filters for cleanrooms and controlled environments test their products for particle removal efficiency. Filter integrity testing fda guideline on sterile drug products. Either of the two test methods or an alternative method may be used for filter types c, d, e and f, if agreed upon between the buyer and seller. Filter integrity testing in the pharmaceutical process. In such setup, the first stage in the filtration process is made up of a pre filter which removes most of the larger dust, hair, pm10 and pollen particles from the air. The hepa filter used for the study was a type c eptfe filter, in accordance with iestrpcc001. The design airflow velocity is set prior to performing the filter installation leak test. The filter system is for a nuclear application and includes one test section and a pair of pressure sensors.
Doppao hepa intergrity testing of hepa filtered equipment. An efficiency test is a general test used to determine the rating of the filter. A filter integrity test is a critical unit operation commonly employed in the pharma industry. Viral penetration of high efficiency particulate air filter. These instruments can be used for scanning filters when using ultra low pao or microspheres as an aerosol challenge for filter integrity testing. The choice of which of the two methods is adopted in any specific case depends on whether the outcome requires an integrity test or a statutory efficiency accountancy test. Approved techniquesmethods for testing hepa vacuum cleaners.
Water intrusion integrity testing of hydrophobic membrane. Pdf filter integrity testing fda guideline on sterile. Hepa filter integrity testing for cleanrooms airepure australia pty. The probe should be held approximately 1 inch from the filter face during scanning. For some of the tests, several different methods and apparatus are recommended to accommodate different enduse considerations. For industries handling or processing radioactive or toxic materials giving rise to a risk of possible release, the main goal of the tests is to confirm that the filter. Water intrusion integrity testing of hydrophobic membrane filters. Brandys, infield test methods and reference standards for portable high efficiency particulate air filtration pheaf equipment.
Apr, 2017 basic demonstration of the hepa filter integrity test on a biological safety cabinet. Common standards require that a hepa air filter must removefrom the air that passes throughat least 99. Integrity testing sterilizing filters after a batch has been filtered can detect if the integrity of the filter has been compromised during the process. These solutions generate a gas type smoke and then generate gas. Oct 17, 2017 a filter integrity test is a critical unit operation commonly employed in the pharma industry. Figure 1 water intrusion test setup introduction cartridge installation prior to any integrity test procedure, the membrane cartridge filter must be sealed in the housing. Historically used for detecting failures in hepa and ulpa grade filters filter is challenged with 107cm2 0. Equally, once the unit is installed in the users production site, the test should be performed promptly to verify the integrity of the filter as well as the installation. Although these original test procedures are still practiced in the u. The hepa and prefilters are pictured below in figure 1. Highefficiency particulate air hepa and its significance. An intact hepa filter should be capable of retaining at least 99. The nebulizer was centered between side walls of the cabinet facing the front opening, above a metal cylinder penetrating the air curtain and representing a user. Disconnect the integrity testing apparatus from the filter housing.
Such filter tests are called integrity tests and are performed. In situ aerosol filter testing is a black art to many, but the new isoen146443 test methods standard incorporates two in situ test methods that are discussed here by neil stephenson of dop solutions. A typical fourstep integrity test procedure algorithm is figure 1. Today, manufacturers test each hepa filter according to methodologies as outlined in recommended practices rp as published by the institute of environmental sciences and technologies iest and filter test methods by the international organization for standardization iso.
The cost estimate assumes a factorybuilt, off the shelf modular design under typical operating conditions. Feb 27, 2019 manufacturers of highefficiency particulate air hepa filters for cleanrooms and controlled environments test their products for particle removal efficiency. A prefilter is place in front of the hepa filter to capture large particles and reduce the loading on the hepa filters. The dispersed oil particulate dop scan testing, also known as filter integrity testing, or leak testing, is one of the most quoted methods by. Flanders industrial grade filter label type a filter typical test results are entered on the label. Bubble point is based on the fact that liquid is held in the pores of the filter by surface tension and capillary forces. Introduction this booklet is designed to provide a basic understanding of methods for testing the integrity of millipore membrane. Integrity testing sterilizing filters is a fundamental requirement of critical process filtration applications in the pharmaceutical industry. There is a method for checking these filter element properties throughout the course of the processthe filter integrity test. The book deals with many aspects of testing and evaluation of air particulate cleaning systems, including specific references to hepa vacuum cleaners.
Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. Summary this paper compares the difference of hepaulpa filter test standards between america and europe from test procedures, aerosol types and its size, to air filter classification. Hepa and ulpa filters have been in use around the world for many years. Basic demonstration of the hepa filter integrity test on a biological safety cabinet. Prepacked sterile filters were also contaminated with. Mil std 282 authored to address hepa filter performance. This hepa unit is 24 x 24 x 12 in size and weighs 41 pounds. The test methods recommend test apparatus and test procedures for determining performance parameters.
Originally, hepa filter specifications called for a maximum pressure drop of 1 w. The capital cost for a hepa filter system is given below. Detecting a failed filter alerts operators to a problem immediately after batch processing, eliminating delay and allowing rapid reprocessing. Viral penetration of high efficiency particulate air. The personnel protection test was performed using a suspension. Filter manufacturer s testing instructions or recommendations may be used as a basis for a validated method. Class ii, type a2 biological safety cabinet hepa filter loading capacity percent increase in pressure drop average hepa filter life years 50% 3 years 100% 5 years 180% 7 years 250% 10 years percent increase testing based on nsfansi 49, annex a. A test method for determination of the overall integrity of hepa filter installations which are not terminally mounted is specified in as 1807. This standard sets out the method for determining the overall integrity of a terminally mounted hepa filter installation in a cleanroom, workstation, safety cabinet, or pharmaceutical isolator.
Sop for dop testing of hepa filters filter integrity testing. Because of the fragile nature of hepa filters, they may be damaged in transit or upon installation. Highefficiency particulate air hepa, also known as highefficiency particulate absorbing and highefficiency particulate arrestance, is an efficiency standard of air filter filters meeting the hepa standard must satisfy certain levels of efficiency. Integrity testing of hepa filters cleanroom technology. Incase a sterilizing grade filter which is used for filtration of nitrogen, compressed air carbon dioxide in vial filling room, fails in integrity test post, inform the production manager and quality assurance. Alternative test methodology for insitu testing of eptfe. Making provision for hepa filter testing filter integrity testing of installed hepa filters is required in virtually all applications. The iest is a recommended practice for all hepa and ulpa filters between customers and suppliers. Clean air was drawn through the loaded filters for 6 days at a constant rate face velocity of 0. The iest is a recommended practice for all hepa and. The first in situ hepa filter test method in the isoen146443 standard is the traditional aerosol photometer test method. A hepa filter can be used in conjunction with a pre filter usually carbonactivated to extend the usage life of the more expensive hepa filter.
The first hepa filter was developed in the late 1940s. Diffusive flow, pressure hold, and bubble point are acceptable physical integrity tests. Hepa and ulpa filter leak tests this recommended practice rp, iestrpcc034. Alternative methods for hepa filter leak detection ispe. Both standards are describing the feeding and uniform distribution of test aerosol into the. This booklet is designed to provide a basic understanding of methods. It is specified in as 86 cleanrooms and clean workstations and in other international cleanroom standards. The acceptance criterion is that filter penetration is less than 0. Challenging of a filter or an installed filter system by using a test aerosol. Standard operating procedure to test the integrity of hepa filters installed in hvac air handling system by hepa filter integrity testing using pao aerosols. Doppao testing is a very quick process that tests the integrity of the hepa high efficiency particulate air filter using dop or pao solutions in their operational conditions. The original procedures to test these filters were also developed around the same time.
Solid or liquid object, viable or nonviable, suspended in air. Summary this paper compares the difference of hepa ulpa filter test standards between america and europe from test procedures, aerosol types and its size, to air filter classification. Many industryspecific terms are defined in the glossary at the end of. Hepa filter integrity testing of negative air units, vacuums and any other hepa filtered equipment on abatement and remediation projects. This is commonly called the dop test after dioctyl phthallate, one of the first substances used as an aerosol challenge for this test. Dop testing procedure environmental abatement council of ontario. This is commonly known as the dop test and uses the aerosol photometer as the measuring device and an aerosol generator to produce an aerosol challenge. Filter integrity testing systems sartocheck 3 plus 319 description this unit supports all established integrity test methods and is characterized by its intuitive and easy handling. To lay down the procedure for dop testing integrity testing of hepa filter.
Iso 29463 a global standard for hepa and ulpa filters. Astm f1471 09 standard test method for air cleaning. Advance in filter integrity testing for ptfe media. The scanning rate should not exceed 2 inches per second. Pdf comparison of hepaulpa filter test standards between. Sterilizing grade filters require testing to assure the filters are integral and fulfill their purpose. Fda guidelines require integrity testing of filters used in the processing of sterile solutions such as large volume paren terals lvps and small volume parenterals svps.
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