PRODUCT C A T A L O G 2025 AFF INTERNATIONAL | a member of DAIKIN group ULPA Clean rooms & Laboratories
אודות החברה בע"מ משווקת ULPA Clean Rooms & Laboratories חברת ) מתוצרת FFU( ויחידות סינון עצמאיות HEPA בישראל מסנני , מהיצרניות המובילות בעולם AAF (American Air Filter) חברת בתחום סינון האוויר. HEPA (High Efficiency Particulate Air) מסנני ועד מסנני H-13 מספקים יעילות סינון גבוהה במיוחד מרמת סינון כולל מסננים לעבודה בטמפרטורה גבוהה U-17 ביעילות Ulpa ומיועדים לשימוש בחדרים נקיים, מעבדות ויחידות טיפול באוויר. ומפוח במארז HEPA משלבות מסנן FFU יחידות הסינון העצמאיות אחד, ומאפשרות התקנה קלה בתקרת החדר לשמירה על איכות אוויר מיטבית בסביבות מבוקרות.
Pharmaceutical Clean Air Solutions THE WORLD LEADER IN CLEAN AIR SOLUTIONS PARTICULATE AND GASEOUS FILTRATION
2 AAF Flanders has an in-depth understanding of the challenges and opportunities for pharmaceutical and medical device manufacturing processes. This understanding and technical ability makes AAF Flanders the preferred partner in optimizing process performance for protecting human health.
3 Optimizing Process Performance for Protecting Human Health Globalization, aging population, and economic shifts are transforming the pharmaceutical landscape. New medical needs and therapeutic areas are emerging that will put more pressure on innovation, productivity, and time-to-market. At the same time, sustainability has entered the playing field with a focus on energy efficiency, waste management, and emission reduction. All these developments shed a new perspective on the role for air filtration. The Importance of Clean Air Clean air is something nearly impossible to identify by our human senses. Most airborne particulates are so small that they cannot be perceived with the naked eye. In most cases, we do not know when something is wrong with the air quality until it is already too late and we see the damage that has occurred. Within the pharmaceutical industry, strict requirements on air purity levels are needed because of the direct effect airborne contamination has on the quality of the pharmaceutical products. Human health and safety depend on it. The Role for Air Filtration No clean air is possible without a carefully selected and reliably functioning air filtration system. The performance of installed air filters, whether terminal filters or prefilters, directly determines how effectively harmful contaminants are prevented from entering the airstream in process environments. As such, air filtration represents a vital link in the overall pharmaceutical process chain. This brochure provides insight into the most important aspects for realizing clean air conditions in pharmaceutical applications. The indispensable role for air filtration is explained through the lens of AAF Flanders’ in-depth expertise, state-of-the-art air filtration solutions, and value-added support concepts. Proven Expertise of AAF Flanders AAF Flanders offers the most comprehensive air filtration portfolio in the industry, including particulate and gas-phase filters, that provides a customized clean air solution. Each product is carefully designed, manufactured, and tested in full compliance with all applicable standards to meet the most challenging demands at the lowest energy consumption. AAF Flanders manufacturing takes place in ISO 9001 and ISO 14001 certified facilities. AAF Flanders HEPA (High Efficiency Particulate Air) filters are produced, tested, and packaged in a state-of-the-art ISO 7 or cleaner cleanroom environment for optimized filter performance and quality assurance. Many pharmaceutical applications today already benefit from AAF Flanders’ recognized expertise in air filtration. The combination of an extensive product portfolio with high level technical support capabilities has provided significantly improved results for many satisfied customers. Erik Geertsema Test Engineer, AAF Flanders We manufacture and individually test all our HEPA filters in a modern cleanroom environment. We believe that only then is product performance assured, through which the most stringent customer requirements can be met.
4 Controlling Contaminants The production of sterile products should be carried out under high levels of air cleanliness. Contamination of raw materials, finished goods, or personnel must be avoided at all times through the implementation of appropriate technical and organizational measures. The significance of such contamination risk may vary with the type of contaminant and the product that is being contaminated, but reliable airborne contamination control remains critical in all situations. Quality of Medicinal Products Everything that could come into direct contact with a pharmaceutical product is a potential risk toward contamination. Limiting exposure to airborne contaminants is critical, as it may result in health and safety issues. Preventive measures and quality management procedures are described in several industry guidelines: “CFR—Code of Federal Regulations Title 21”, “Guidance for Industry—Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice 2004”, and “European Union (EU) Guidelines to Good Manufacturing Practice (GMP) Medicinal Products for Human and Veterinary Use—Annex 1—Manufacture of Sterile Medicinal Products, 2008”. These guidelines are to ensure consistent production and control of pharmaceutical products for human use. Air filtration plays a critical role in making sure that these objectives are met and that the risk of any adverse effects on product quality is reduced. Mechanical Strength Reduces Contamination Risks Following the recognized US guidance for Sterile Drug Products Processing, HEPA filters should be tested twice a year for leaks, to demonstrate filter integrity. A critical leak is given when more than 0.01 percent of the upstream aerosol challenge penetrates a test spot. If a critical leak has been determined, it is customary to evaluate a possible impact on sterile processing. If a local defect is detected, this would require a filter repair or replacement, retesting, and finally the evaluation of possible effects on the production line in question. To avoid leaks, the extremely sensitive surface of traditional HEPA filters used to be protected by a grid on the filter surface. New HEPA filters with the latest generation of membrane media represent a better solution, due to considerably improved mechanical strength and reduced pressure difference, thus increasing the economy and quality of sterile production units. The higher costs of such new filters are justified, since the risk of damages will be considerably reduced. Dr. Lothar Gail GMP and cleanroom consultant VDI.
5 0.1 1 10 100 0.01 Particle size (μm) Human sneeze Spores Hydrocarbon aerosol Bacteria Viruses Suspended inorganic dust Coarse filters Medium/fine filters HEPA/ULPA filters Typical Size Range of Airborne Contaminants Filter Type Figure 1 Balancing High Level Protection With Total Cost of Ownership No clean air is possible without a carefully selected and reliably functioning air filtration system. The performance of installed air filters, whether terminal filters or prefilters, directly determines how effectively harmful contaminants are prevented from entering the airstream in process environments. However, if the Facility Managers selecting air filters do not also consider the lifetime operating costs of a given product, facilities could be exposed to unnecessary risks and expenses. Air in critical areas should always be supplied at the terminal stage by HEPA filtered unidirectional airflow, preceded by sequential prefiltration steps. Leak-free and high filtration efficiency performance of the HEPA filter is vital for ensuring that air purity is optimized, the pressure differentials between rooms are met, and healthy working conditions are achieved. TCO Diagnostic® A thorough air filter audit of your HVAC Systems is the first step in order to provide you with professional guidance and analysis for cost savings and risk reduction. By conducting this audit, AAF Flanders will be able to understand your current state and then utilize TCO Diagnostic,® an advanced analytical software tool, to identify how you can perform even better. The purpose of TCO Diagnostic is to assist you in selecting the best filters for your air handling systems and to understand their sensitivity to your operating conditions, in order for your system to operate in the most optimal and effective manner. TCO Diagnostic provides the insight to identify improvement opportunities, find the optimized options, and tailor to your specific needs for a comprehensive purchase perspective— improving air quality, energy savings, and operational flexibility while reducing Total Cost of Ownership. Typical Airborne Contaminants Airborne contaminants differ in size and impact in a pharmaceutical manufacturing process. Figure 1 shows a typical size range of airborne particles and microorganisms. Each particle size range requires a specific air filtration technique to obtain the required air quality levels.
6 The type of activities within a particular pharmaceutical processing environment will determine the level of cleanliness that is required. To ensure that stringent air quality levels for safely manufacturing medicinal products are met, a carefully designed air filtration system is vital. Based on their performance efficiency, air filters are classified according to two widely accepted standards, ASHRAE 52.2 and the Institute of Environmental Sciences and Technology (IEST) Recommended Practice (RP) IEST-RP-CC001. Internationally EN1822 and the ISO standard 29463 (High Efficiency Filters and Filter Media for Removing Particles in Air) is the accepted classification method (Table 1). ASHRAE 52.2 ASHRAE Standard 52.2 describes a method of laboratory testing to measure the performance of air filters as a function of particle size. The method of testing measures the performance of air filters in removing particles of specific sizes as the filters become loaded by standard loading dust. The dust is fed at intervals to simulate accumulation of particles during service life. The standard defines procedures for generating the aerosols required for conducting the test. The standard also provides a method for counting airborne particles of 0.3 micrometers to 10 micrometers upstream and downstream of the air filter in order to calculate removal efficiency by particle size. The overall reporting value of the air filter is expressed as Minimum Efficiency Reporting Value (MERV) (Table 2). AAF Flanders offers a broad range of ASHRAE 52.2 compliant and energy efficient air filters as prefiltration to final HEPA filters. The choice of prefiltration will determine the cleanliness of the air entering the final filter, and therefore its lifetime. Classifying Air Filters Standard 52.2 Minimum Efficiency Reporting Value (MERV) Complete Average Particle Size Efficiency, % in Size Range, µm Average Arrestance, %, Addendum B Range 1 0.30 - 1.0 Range 2 1.0 - 3.0 Range 3 3.0 - 10.0 1 n/a n/a E3 < 20 Aavg. < 65 2 n/a n/a E3 < 20 65 ≤ Aavg. < 70 3 n/a n/a E3 < 20 70 ≤ Aavg. < 75 4 n/a n/a E3 < 20 75 ≤ Aavg. 5 n/a n/a 20 ≤ E3 < 35 n/a 6 n/a n/a 35 ≤ E3 < 50 n/a 7 n/a n/a 50 ≤ E3 < 70 n/a 8 n/a n/a 70 ≤ E3 n/a 9 n/a E2 < 50 85 ≤ E3 n/a 10 n/a 50 ≤ E2 < 65 85 ≤ E3 n/a 11 n/a 65 ≤ E2 < 80 85 ≤ E3 n/a 12 n/a 80 ≤ E2 90 ≤ E3 n/a 13 E1 < 75 90 ≤ E2 90 ≤ E3 n/a 14 75 ≤ E1 < 85 90 ≤ E2 90 ≤ E3 n/a 15 85 ≤ E1 < 95 90 ≤ E2 90 ≤ E3 n/a 16 95 ≤ E1 95 ≤ E2 95 ≤ E3 n/a Table 1: ISO 29463 Filter Classes and Equivalents ISO Filter Class Efficiency IEST* EN 1822 ISO 15 E >95% – H 11 ISO 20 E >99% – ISO 25 E >99.5% – H 12 ISO 30 E >99.9% – ISO 35 H >99.95% – H 13 – >99.97% A,B,E,H,I – ISO 40 H >99.99% C,J(K) ISO 45 H >99.995% K H 14 ISO 50 U >99.999% D ISO 55 U >99.9995% F U 15 ISO 60 U >99.9999% G ISO 65 U >99.99995% G U 16 ISO 70 U >99.99999% G ISO 75 U >99.999995% G U 17 * IEST Types A, B, C, D, and E are classified per test results using photometers (Mil Std 282). Types F, G, H, I, J, and K are classified per test results using particle counters. IEST-RP-CC001 To ensure the highest levels of air purity, pharmaceutical processes need to rely on high efficiency particulate air filters as terminal filters. These air filters are subject to classification according to IEST-RP-CC001 (HEPA and ULPA filters). This recommended practice (RP) covers basic provisions for HEPA and ULPA filter units as a basis for agreement between customers and suppliers. Table 2: Air Filter Classification per ASHRAE 52.2.
7 Filters that meet the requirements of IEST-RP-CC001 are suitable for use in clean air devices and cleanrooms that fall within the scope of ISO 14644, and for use in supply air and contaminated exhaust systems that require extremely high filter efficiency (99.97% or higher) for submicrometer (µm) particles. IEST-RP-CC001 describes 11 levels of filter performance and six grades of filter construction. The level of performance and grade of construction required should be specified. The filter efficiency required should also be specified if it is not covered by the performance level specified in this RP (Table 3). Testing Capabilities of AAF Flanders All HEPA and ULPA filters produced by AAF Flanders are built in an ISO 7 cleanroom environment and tested in an ISO 4 cleanroom with full compliance to IEST standards. In a modern test rig, each air filter is individually tested by well-trained AAF Flanders personnel before shipment to the customer. HEPA and ULPA filters are leak tested using a challenge aerosol. The test results are documented in a test report for each individual HEPA or ULPA filter. This report gives full information about the tested air filter, test parameters (airflow, test method and aerosol), and the test results according to IEST-RPCC001, and are available for every filter when requested. Air filter labels include the identification of the air filter type, a serial number for full traceability, the test standard used, the filter class, and the nominal airflow rate at which the air filter has been classified. Strict quality procedures ensure that all HEPA and ULPA filters leaving the AAF Flanders factory are leak-free, perform according to applicable standards, and are consistent with the individual customer requirements. Air Filter Classification According to IEST-RP-CC001 Table 3: Recommended Test and Minimum Rating for Filters Types A Through K. Filter Penetration Test Last (Scan) Test1 Minimum Designated Type Efficiency Leak Method Aerosol Method Aerosol Comments Rating Penetration HEPA MIL-STD-282 Thermal DOP None None 99.97% n/a (type A) HEPA MIL-STD-282 Thermal DOP None None Two-flow 99.97% n/a (type B) leak test HEPA MIL-STD-282 Thermal DOP Photometer Polydisperse 99.99% 0.010% (type C)1 DOP/PAO HEPA MIL-STD-282 Thermal DOP Photometer Polydisperse 99.999% 0.0050% (type D)1 DOP/PAO HEPA MIL-STD-282 Thermal DOP None None Two-flow 99.97% n/a (type E)1 HEPA IEST-RP-CC007 Open Particle Open 99.9995% at 0.00250% (type F)1 Counter 0.1-0.2 or 0.2-0.3 µm HEPA IEST-RP-CC0072 Open Particle Open 99.9999% at 0.0010% (type G)1 Counter 0.1-0.2 or 0.2-0.3 µm HEPA IEST-RP-CC007 Open None None 99.97% at n/a (type H)1 0.1-0.2 or 0.2-0.3 µm HEPA IEST-RP-CC007 Open None Open Two-flow 99.97% at n/a (type I)1 leak test 0.1-0.2 or 0.2-0.3 µm HEPA IEST-RP-CC007 Open Particle Polydisperse 99.99% at 0.010% (type J)1 Counter or DOP/PAO 0.1-0.2 or Photometer 0.2-0.3 µm HEPA IEST-RP-CC007 Open Particle Polydisperse 99.995% at 0.0080% (type K)1 Counter DOP/PAO 0.1-0.2 or Photometer 0.2-0.3 µm 1 Either of the two scan test methods or an alternative method may be used for filter types C, D, F, and agreed. Designated leak details for these filter types are given in IEST-RP-CC034. 2 Filter medium tested at most-penetrating particle size (MPPS) prior to filter assembly. All filters are leak-tested but in some instances may not be tested for overall penetration. The MPPS for testing this filter type is determined from the media according to IEST-RP-CC021.
8 Particle size (µm) Airborne particle concentration (particles/m3) 100 0.1 0.2 0.3 0.5 1.0 5.0 109 108 107 106 105 104 103 102 101 ISO Class 9 ISO Class 8 ISO Class 7 ISO Class 6 ISO Class 5 ISO Class 4 ISO Class 3 ISO Class 2 ISO Class 1 Classifying Cleanrooms The production of sterile pharmaceuticals is subject to special requirements in order to minimize risks of particulate and microbial contamination. Manufacturing is carried out in clean areas within which the concentration of airborne particles needs to be controlled. The classification and monitoring of such clean areas follow the ISO 14644 standard and the EU GMP Directive 2003/94/EC. Classification Standards Pharmaceutical cleanrooms and clean air devices are classified according to ISO 14644-1. The level of airborne particulate cleanliness, applicable to a clean area, is expressed as an ISO class. The lower the classification number, the higher the level of cleanliness. The ISO class represents maximum allowable concentrations for considered particle sizes, ranging from 0.1 μm up to 5.0 μm. Figure 2 shows a graphic illustration of the nine ISO cleanroom classes with the concentration limits for the given particle sizes. Different room classes are typically necessary for the various pharmaceutical clean areas and production steps taking place. For the operational environmental monitoring of the production of sterile preparations, EU GMP distinguishes four alpha grades. Each grade is assigned maximum permitted airborne particle concentrations for sizes ≥ 0.5 μm and ≥ 5.0 μm ‘at-rest’ and ‘in operation’ state. Particles of 0.5 μm and larger can be considered as the most critical particle sizes that need to be effectively filtered out by HEPA filtration for obtaining the required aseptic process conditions. GMP grade A is the most stringent classification and equals ISO 5 according to ISO 14644-1. This type of area is expected to be almost completely free from particle sizes ≥ 5.0 μm, both ‘at-rest’ and ‘in operation’ condition. Figure 2: ISO 14644-1 Cleanroom Class Particulate Concentration Limits The graph shows the minimum and maximum particle size limits acceptable for each of the ISO classes shown. The classification lines do not represent actual particle size distributions found in cleanrooms and clean zones. Table 4: Typical Cleanroom Activities for Terminal Sterilization and Aseptic Preparation GMP Grade Examples of Typical Activities Terminal Sterilization Aseptic Preparation A Filling of products for sterilization (unusual risk profile) Handling of sterile starting materials and components Preparation of materials and products (non-sterile filtering) Handling and filling of aseptically prepared products B – Background area for grade A zones C Filling of products for sterilization (usual risk profile) Preparation of components (unusual risk profile) Preparation of materials and products (sterile filtering) D Preparation of components (usual risk profile) Handling of components after washing Sterile Manufacturing Activities The pharmaceutical industry is expected to take proactive steps in ensuring that products are safe and effective. EU GMP regulations require building a quality approach into the manufacturing process, to minimize or eliminate risk of cross-contamination and errors (Table 4).
9 Monitoring Microbial Contamination EU GMP Annex 1 Clean areas for the production of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate environmental cleanliness level for minimizing the risks of particulate and microbial contamination of the concerning starting material or product. EU GMP Annex 1 sets limits for microbial contamination for each of the four identified cleanroom grades (Table 5). The air in risk zone areas, particularly vulnerable to biocontamination, needs to be protected from viable particles, consisting of one or more live organisms. Methods for evaluation and control are provided by ISO 14698 (Biocontamination Control). The Role for Air Filtration Especially for aseptically prepared parenteral medicine (such as injectables and infusions), no contamination can be accepted, otherwise severe harm or life-threatening health risks to the patient can result. It is exactly in this area where air filtration comes in as the critical link in the overall chain. Air in critical areas should always be supplied at the terminal stage by HEPA filtered unidirectional airflow, preceded by sequential prefiltration steps. A leak-free and high filtration efficiency performance of the HEPA filter is vital for ensuring that air purity is optimized, the pressure differentials between rooms are met, and healthy working conditions are achieved. Table 5: Cleanroom Classification According to EU GMP Annex 1 Maximum Permitted Number of Particles /m3 Equal to or Greater than the Tabulated Size At-rest In Operation International Cleanroom Standard Comparison for “At-rest” Grade 0.5 µm 5.0 µm 0.5 µm 5.0 µm FED 209E FED 209D ISO 14644 A 3,520 20 3,520 20 M 3.5 Class 100 ISO 5 B 3,520 29 352,000 2,900 M 3.5 Class 100 ISO 5 C 352,000 2,900 3,520,000 29,000 M 5.5 Class 10,000 ISO 7 D 3,520,000 29,000 Not Defined Not Defined M 6.5 Class 100,000 ISO 8
10 User requirements specifications Performance Qualification (PQ) Functional specifications Operational Qualification (OQ) Design specifications Installation Qualification (IQ) Verification ‘In operation’ Cleanroom construction Verification ‘At-rest’ Verification ‘As-built’ Qualifying HEPA Filters Pharmaceutical cleanrooms require an extensive validation procedure before initiating pharmaceutical production. The process then has to be revalidated in predefined intervals. For HEPA terminal filtration, this means that there is initial qualification and periodic requalification of its performance characteristics. Qualification Procedure FDA cGMP Guidelines, including Section IV-Buildings and Facilities; Section IX-Validation of Aseptic Processes; and Section X-Laboratory Controls describe the principles of validation and qualification that are applicable to the production of medicinal products. This procedure typically follows a V-shaped model, consisting of three sequential steps (Figure 3). Each of these steps poses its own stringent demands on HVAC installations in general and HEPA filtration specifically. Selecting high quality manufactured HEPA filters will enhance the probability of success in this validation sequence. Installation Qualification (IQ): does the HEPA filter specification match what I had ordered and expected? Examples of HEPA filter requirements: • Individual test report according to IEST-RP-CC001 • Complete and accurate labeling, including serial number for traceability • Correct packaging and testing information Operational Qualification (OQ): does the HEPA filter perform according to functional specifications during ‘at-rest’ operation? Examples of HEPA filter requirements: • Absence of any visual damage to filter media, gasket, and frame • Successful in-situ test result with confirmed filter integrity • Actual initial resistance performance consistent with specification Performance Qualification (PQ): does the HEPA filter demonstrate reliable performance during full-scale operation? Examples of HEPA filter requirements: • Absence of leakage (e.g., media) and bypass (e.g., gasket seal) according to IEST-RP-CC034 • Consistent particulate collection efficiency over time • Absence of fiber shedding that could cause contamination Figure 3: Cleanroom Validation Procedure, Derived from ISO 14644-4
11 Installed HEPA Filter Integrity Testing The purpose of installed HEPA filter integrity testing, also called in-situ testing, is to confirm a flawless performance during normal operation. Filter integrity measurements encompass tests for installed filter leakage, such as in the media or sealant to frame, and bypass, such as in the frame, gasket, or grid system. As such, this testing differs from factory leak testing that focuses on measuring filter integrity under laboratory conditions. Both filter leakage and bypass can result in a penetration of contaminants that exceeds the expected value of downstream concentration. As these situations may seriously harm the sterility of critical parameters, and therefore the quality of medicinal products, periodic requalification of terminal HEPA filters is required. Subject to risk assessment of the cleanroom activity, this interval is typically set at six months for GMP grade A aseptic processes. The most commonly used methods for testing the integrity of installed HEPA filters are described in the ISO 14644-3 standard: Aerosol Photometer (AP) and Discrete Particle Counter (DPC). The AP method typically uses a high concentration 10-40 ug/liter of oil-based aerosol for scanning air filters for leakage. A low concentration aerosol challenge exposure is always recommended, as this testing leads to a less contaminated filtration system and therefore an optimized energy efficiency and improved HEPA filter lifetime expectancy. Dedicated Support From AAF Flanders With AAF Flanders’ patent-pending ePTFE Filtration Technology, filters can now be scan tested with the industry standard photometer at the standard aerosol concentrations set forward, as well as the low aerosol concentration DPC method. AAF Flanders engineers work with state-of-the-art test equipment and can provide a project team or supervisor on site for practical assistance. As AAF Flanders firmly believes that independency in testing is critical, its core policy is to educate staff and test agencies locally for transferring knowledge and sharing best practices. Please contact your local AAF Flanders affiliate office for more details on the in-situ testing support that AAF Flanders can provide to ensure that terminal filter performance is optimized for its purpose.
12 ePTFE Filtration Technology Resilient ePTFE Technology media at fold tip @ 10,000x magnification. Fractured ultrafine microglass media fibers at fold tip @ 10,000x magnification. Reduce Operational Risk The pharmaceutical industry estimates that 77% of production downtime can be attributed to failures of equipment and environmental problems.* Traditional HEPA filters typically fail due to some form of contact combined with the poor mechanical strength of the filter. Effectively managing the risks and costs associated with successful operation requires utilizing HEPA filters with dramatically higher tensile strength. Increase Uptime While FDA Testing Guidance requires critical room leak-testing certification twice a year, non-critical rooms require testing only once a year. With the extremely high tensile strength and durability of ePTFE pleated filter media, ISO 7 and 8 areas can be tested annually. Increasing time between certifications results in less PAO exposure to the gel seal (gel degradation), lower labor costs, and increased production time. Manufactured in ISO 7 Clean Facilities ePTFE media is manufactured by AAF Flanders. By doing so, we control the quality and consistency of the media. This media is produced in an ISO 7 cleanroom to ensure the purity and cleanliness of the product. The filter is then assembled, tested, and packaged in an ISO 7 clean manufacturing facility, resulting in unparalleled product performance and operational efficiency. *Source: Pharmaceutical Manufacturing Magazine (2004). AAF Flanders ePTFE Filtration Technology is designed specifically for the unique requirements and challenges of the pharmaceutical industry. Patent pending ePTFE media has the proven durability, polyalphaolefin (PAO) compatibility, high particulate filtration efficiency, and the lowest pressure drop to meet the demands of pharmaceutical manufacturing. Industry-Leading Durability Independent tests have shown that filters with ePTFE Filtration Technology have superior mechanical strength over filters with traditional ultrafine microglass media. This superior durability and tensile strength is 84 times the pleated strength of microglass.
13 HEPA and ULPA Filters HEPA filters are the most efficient air filters commercially available. They are used in pharmaceutical manufacturing and other applications requiring ultra-clean air—semiconductor, electronics, cleanroom, food processing, hospitals, and labs. AAF Flanders HEPA filters are individually tested before shipment to ensure they meet rated efficiency and resistance. AAF Flanders HEPA and ULPA filters are available in a variety of efficiencies—from 99.97% tested on .3 μm particles to 99.9995% and higher tested on .1 to .2 μm particles. All filters are available scan-tested. High Temperature HEPA Solutions To prevent endotoxin contamination in sterile conditions, containers and closure surfaces need to be depyrogenated. Endotoxins are removed by applying dry heat sterilization, where the air is cleaned by a reliable HEPA filtration system. AAF Flanders high temperature HEPA filters are designed to provide excellent protection of this critical depryogenation process. Particulate Filtration Solutions The HEPA/ULPA Filter line delivers: • Built according to IEST-RP-CC001.6 • Designed to meet the demanding requirements of the most critical applications • ePTFE Filtration Technology provides superior durability • Chemical-resistant capabilities for highly corrosive environments • High capacity, space saving designs • Filters designed specifically for high airflow applications requiring HEPA efficiency at an ultra low pressure drop High Temperature HEPA Filters feature: • High temperature resistance with a steel frame construction • Thorough heat-cycle tests confirm damage-free construction and consistent performance • Unique combination of high temperature operation and superior durability, optimizing process results and limiting unscheduled downtimes • The right solution for ensuring that strict air cleanliness conditions are met
14 High Efficiency Extended Surface Filters These rigid, high efficiency extended surface filters are ideal for use in all high efficiency applications. The supported pleat filters provide strength and integrity in high flow, turbulent, and variable airflow conditions. Disposable Ceiling Modules HEPA and ULPA filters are available are available in a variety of configurations to fit the highest efficiency filter requirements for new, existing, and retrofitted cleanroom applications. Particulate Filtration Solutions The High Efficiency Extended Surface Filter line provides: • MERV ratings from 11 to 16 • Strongest and longest-lasting MERV 8 pleated filter on the market • Lowest life cycle pressure drop and highest Dust Holding Capacity (DHC) reduces energy consumption and total operating costs • Most energy efficient 4″ filter available with longer life and the lowest initial resistance • Patented Impress® Technology delivers a higher DHC and a lower pressure drop for greater energy efficiency • Heavy duty construction and high performance in tough operating conditions Disposable Ceiling Modules feature: • Designed for pharmaceutical and biotech applications requiring an easily replaceable HEPA filter cartridge without risk of bypass leakage • Self-contained fan/HEPA filter modules for critical applications • Roomside replaceable HEPA/ULPA filter modules that are lightweight, low-profile ducted units
15 Cleanroom Components For guaranteeing an efficient installation and effective operation of terminal air filtration systems, AAF Flanders offers a broad range of matching cleanroom components. These components vary from ceiling grids to light fixtures. Please contact your local AAF Flanders affiliate office for tailored advice and a custom-made solution, designed by AAF Flanders cleanroom specialists. Gaseous Filtration Solutions AAF Flanders has assumed an industry leading position with the development of its innovative SAAF™ (pronounced as “SAFE”) product line designed to reduce or eliminate harmful gaseous contaminants. In combination with our expertise in airborne particulate filtration, SAAF products and solutions allow us to develop unique and effective total filtration solutions to protect people, processes, and equipment. No other company offers this combination of experience, expertise, innovation, and capability to combat airborne contaminants, particulate and/or gaseous, and deliver the best clean air solutions. The SAAF product line features: • Patent pending chemical media cassettes with superior sealing and energy savings. These cassettes also fit in most legacy units. The housings are designed for quiet operation and durability. • Complete chemical media line – adsorbents, oxidants, and blends configured by and produced under the supervision of our world-class global research and development teams. • Environmental Measurements related to the ISA Standard S71.04: “Environmental Conditions for Process Measurement and Control Systems. Airborne Contaminants to determine types of contaminants and their relative concentrations.” • RoHS compliant Corrosion Control (ASHRAE TC 9.9 Guideline). • Comprehensive, industry leading software – SAAF Tech Tools analyzes applications, develops solutions, configures equipment and media, and delivers a complete technical proposal.
9920 Corporate Campus Drive, Suite 2200, Louisville, KY 40223-5690 888.223.2003 Fax 888.223.6500 | aafintl.com AAF Flanders has a policy of continuous product research and improvement and reserves the right to change design and specifications without notice. ISO Certified Firm ©2017 AAF International and its affiliated companies. AAF-1-206A 01/17 Proven Expertise of AAF Flanders AAF Flanders offers the most comprehensive air filtration portfolio in the industry, including particulate and gas-phase filters, to provide a customized clean air solution. Each product is carefully designed, manufactured, and tested in full compliance with all applicable standards to meet the most challenging demands with the lowest Total Cost of Ownership. Contact your local AAF Flanders representative for a complete list of AAF Flanders Air Filtration Product Solutions. 888.223.2003 aafintl.com
MEGAcel®II eFRMHE Antibacterial high efficiency plate type efrm filter • Compared with the traditional glass fiber filter, the energy saving effect is obvious • It has strong corrosion resistance, is not easy to be damaged by acid, alkali and organic matter, and can adapt to harsh use environment • Chemical gas volatilization is low, which has little harm to production process and human health • The filter material has higher grade strength, and the filter is not easy to be damaged during transportation and installation • have a very low total cost of ownership (TCO) to help customers save money • It can meet the challenge of Pao test and has a long service life • It has the functions of antibacterial, anti mildew and anti-virus, creating a healthy and comfortable Environment Product Specification • Outer frame: aluminum frame • Filter media: megacelefrm filter paper • · antimicrobial agent: intersect Ⅲ • Filter separator: hot melt adhesive • Sealing gasket: injection molded seamless polyurethane PU gasket or ultra-low volatile EPDM concave convex gasket; • Filtration efficiency: EN1822 H13 ~ h14 • Continuous operation temperature: 70 ℃ • Recommended final initial resistance: 500pa Application Area • It is widely used in all kinds of clean rooms, especially the clean rooms and biosafety cabinets which need frequent disinfection and Pao detection in life science industry. Performance Data 1) The maximum deviation range of resistance is ± 15%; 2) Non standard size can be made according to customer requirements;
AmAir®/C AmAir®/C+SAAFOxi™ AmAir®/SAAFOxi™ AmAir®/CP Disposable Filters for Economical, Effective, Long-Lasting Gas-Phase and Particulate Filtration Better Air is Our Business®
AmAir®/C+SAAFOxi™ Multi-Purpose Blend AmAir/C+SAAFOxi 50/50 blend filters (granular activated carbon and potassium permanganate) are recommended for applications such as loading docks near air-handling equipment (air intake) and where sulfur, aldehydes, and VOC control is desired. Totally Unitized Construction Offers Superior Strength AmAir/C, AmAir/C+SAAFOxi, and AmAir/SAAFOxi filters are contained in a frame constructed of high wet strength, moisture resistant beverage board. Two mating die cut boxes are bonded together forming a double wall around the entire filter. The SAAFWebmedia is bonded to the inside of the frame on all four edges to prevent leakage and increase rigidity. A metal retainer is inserted to provide additional support on 2" thick panel filters. Each filter is individually sealed in a poly bag to prevent adsorption of random gaseous contaminants prior to installation. • Economical solution to many gaseous contaminant problems including odors • Available in pleats, panels, and pads • Activated carbon (AmAir/C and AmAir/CP filters), AAF's proprietary activated alumina impregnated with potassium permanganate (AmAir/SAAFOxi filter), and 50/50 blend (AmAir /C+SAAFOxi filter) • Effective on a wide variety of gaseous contaminants • Odor removal and corrosion control protection • Easy to install • Directly interchangeable with standard air filters • Disposable • UL 900 classified AmAir®/C AmAir®/C+SAAFOxi™ AmAir®/SAAFOxi™ AmAir®/CP Disposable Filters for Economical, Effective, Gas-Phase and Particulate Filtration 2 AmAir ®/C filters in 1", 2", and 4" depths A 50/50 blend of carbon and SAAFOxidant™is integrated into the AmAir ®/C+SAAFOxi ™filters. Odor Control with Particulate Filtration for Improved Indoor Air Quality The effectiveness of any gas-phase filter corresponds to the density (weight per square foot) of activated carbon contained in the product. AmAir/C, AmAir/C+SAAFOxi, and AmAir/SAAFOxi filters are more effective than other odor control filters, because they contain more chemical media, using AAF's SAAFWeb™technology. The AmAir/SAAFOxi and AmAir/C+SAAFOxi filters contain AAF's SAAFOxidant™, which is an exclusive formulation of activated alumina impregnated with potassium permanganate for the most effective gaseous contaminant chemisorption available. Greater gas-phase media density solves your odor problems by removing odor concentrations and providing protection over a longer period of time. The true test of a gas-phase filter is how long it will continue to remove objectionable odors and other gaseous contaminants. AmAir/C, AmAir/C+SAAFOxi, AmAir/SAAFOxi, and AmAir/CP filters deliver fresh air longer.
Chemical Media Density Model grams/ft.2 AmAir/C Pleat: (1") 100 (2") 200 (4") 300 AmAir/C-3 Panel (2") 300 AmAir/CP-3 Pad (1") 300 AmAir/C+SAAFOxi: Pleat (1" 50/50 Blend) 125 Pleat (2" 50/50 Blend) 250 Pleat (4" 50/50 Blend) 375 AmAir/SAAFOxi Pleat: (1") 150 (2") 300 (4") 450 More Chemical Media Than Other Gas-Phase Filters 3 Economical, Easy Odor Control No expensive housings or duct work modifications are necessary. No trays to refill or exchange. Simply install the filters as you would standard air filters and dispose of them when they are no longer effective. Pleated Filters AmAir/C pleated panel filters are made with activated carbon; AmAir/SAAFOxi filters with AAF's proprietary activated alumina impregnated with potassium permanganate, and AmAir/C+SAAFOxi filters with a 50/50 blend of each media. All models are available in 1", 2", and 4" depths, and are interchangeable with conventional particulate filters of the same size. They have a Minimum Efficiency Reporting Value (MERV) of 7 when tested in accordance with ASHRAE Test Standard 52.2 and are classified in accordance with UL Standard 900. Simply replace your prefilters with AmAir/C, AmAir/C+SAAFOxi, or AmAir/SAAFOxi pleated panel filters and enjoy gaseous contaminant control and odor removal plus particulate filtration in a single product. No modifications to your current frames or latches are necessary. Panel Filters AmAir/C-3 2" panel filters are directly interchangeable with standard 2" air filters. The AmAir/C-3 panel filter offers more carbon density per square foot than the 2" pleated model. Media Pads AmAir/CP-3 media pads consist of a 1" thick substrate impregnated with 300 grams of carbon per square foot contained in a fine mesh netting to prevent spilling. Use AmAir/CP-3 pads in combination with particulate filters to add odor removal capability to any filtration system. The carbon pads can be changed independently from other air filters to maximize the service life of each product. AmAir/C AmAir/C+ Applications Filters SAAFOxi Filters Nursing Homes • Loading Docks: • diesel odors Refuse: • trash, dumpsters Cooking Odors: • restaurants, cafeterias Ozone: • may be needed for urban areas during periods when ozone levels are elevated Chemical Odors: • cleaning chemicals and solvents Sewer Odors • Common Indoor Air Contaminants Associated • with Furnishings and Electronic Equipment: formaldehyde and volatile organic compounds (VOCs) Data Centers and Server Rooms, Corrosion Protection • of Electronic Equipment Roof Renovation Odors: • tar odor Construction and Renovation Odors: • sealants, paints, solvents, and adhesives Typical Odor Applications and Problems AmAir ®/C-3 carbon panel filter
Engineering Data — Standard Sizes AmAir®/C AmAir®/C+SAAFOxi™ AmAir®/SAAFOxi™ AmAir®/CP Performance Data (1) All performance data is based on the ASHRAE 52.2-1999 test method. Performance tolerances conform to Section 7.4 ARI Standard 850-93. (2) Carbon density is stated in grams per square foot of filter face area. Carbon Activity Rating: Minimum 60% on carbon tetrachloride (CCI4) at 25˚C. SAAFOxidant Potassium Permanganate Impregnation Rating: Minimum 8%. AmAir® is a registered trademark of AAF-McQuay Inc. in the U.S. Operating Temperature Limits: AmAir/C, AmAir/C+SAAFOxi, AmAir/SAAFOxi, and AmAir/CP filters and pads are designed for continuous operating temperatures up to 120˚F (49˚C). Temperatures above 120˚F have an adverse effect on adsorption. Underwriters Laboratories, Inc. Classification: AmAir/C, AmAir/C+SAAFOxi, AmAir/SAAFOxi, and AmAir/CP filters and pads are classified in accordance with UL Standard 900. AAF has a policy of continuous product research and improvement and reserves the right to change design and specifications without notice. 10300 Ormsby Park Place Suite 600 Louisville, Kentucky 40223-6169 www.aafintl.com Customer Service 888.AAF.2003 Fax 888.223.6500 ISO Certified Firm ©2010 AAF International The USGBC Member logo is a trademark owned by the U.S. Green Building Council and is used by permission. GPF-1-118A JUL '10 (1)Rated Initial Recommended (2)Media Model Resistance (in. w.g.) Efficiency Final Resistance Density Designation Size @300 FPM @500 FPM @500 FPM (in. w.g.) (gms./ft.2) AmAir/C, AmAir/C+SAAFOxi, and AmAir/SAAFOxi Pleated Panel Filters: C, C+SAAFOxi, and SAAFOxi 1" 0.21" 0.41" MERV 7 1.0" 100 C, C+SAAFOxi, and SAAFOxi 2" 0.20" 0.39" MERV 7 1.2" 200 C, C+SAAFOxi, and SAAFOxi 4" 0.15" 0.30" MERV 7 1.2" 300 AmAir/C Panel Filter: C-3 Panel 2" 0.31" 0.75" MERV 5 1.2" 300 AmAir/CP Media Pad: CP-3 Pad 1" 0.25" 0.54" --- 1.0" 300 Nominal Size Actual Size Pleated Panel Media Airflow Capacity CFM Filters/Pads (inches) (Inches) Filters Filters Pads @300 FPM @500 FPM Per Carton 12 x 24 x 1 113/ 8 x 233/ 8 x 7/ 8 • • 600 1000 12 16 x 20 x 1 153/ 8 x 193/ 8 x 7/ 8 • • 650 1100 12 16 x 25 x 1 153/ 8 x 243/ 8 x 7/ 8 • • 850 1400 12 18 x 24 x 1 173/ 8 x 233/ 8 x 7/ 8 • • 900 1500 12 20 x 20 x 1 193/ 8 x 193/ 8 x 7/ 8 • • 850 1400 12 20 x 24 x 1 193/ 8 x 233/ 8 x 7/ 8 • • 1000 1650 12 20 x 25 x 1 193/ 8 x 243/ 8 x 7/ 8 • • 1050 1750 12 24 x 24 x 1 233/ 8 x 233/ 8 x 7/ 8 • • 1200 2000 12 12 x 24 x 2 113/ 8 x 233/ 8 x 13/ 4 • • 600 1000 6 16 x 20 x 2 153/ 8 x 193/ 8 x 13/ 4 • • 650 1100 6 16 x 25 x 2 153/ 8 x 243/ 8 x 13/ 4 • • 850 1400 6 18 x 24 x 2 173/ 8 x 233/ 8 x 13/ 4 • • 900 1500 6 20 x 20 x 2 193/ 8 x 193/ 8 x 13/ 4 • • 850 1400 6 20 x 24 x 2 193/ 8 x 233/ 8 x 13/ 4 • • 1000 1650 6 20 x 25 x 2 193/ 8 x 243/ 8 x 13/ 4 • • 1050 1750 6 24 x 24 x 2 233/ 8 x 233/ 8 x 13/ 4 • • 1200 2000 6 12 x 24 x 4 113/ 8 x 233/ 8 x 33/ 4 • 600 1000 3 16 x 20 x 4 153/ 8 x 193/ 8 x 33/ 4 • 650 1100 3 16 x 25 x 4 153/ 8 x 243/ 8 x 33/ 4 • 850 1400 3 18 x 24 x 4 173/ 8 x 233/ 8 x 33/ 4 • 900 1500 3 20 x 20 x 4 193/ 8 x 193/ 8 x 33/ 4 • 850 1400 3 20 x 24 x 4 193/ 8 x 233/ 8 x 33/ 4 • 1000 1650 3 20 x 25 x 4 193/ 8 x 243/ 8 x 33/ 4 • 1050 1750 3 24 x 24 x 4 233/ 8 x 233/ 8 x 33/ 4 • 1200 2000 3
AmAir® 300X AmAir® HT 1″, 2″ and 4″ Extended Surface Pleated Panel Filters Business® Business® Better Air is Our Business® • Expanded metal pleat support grid (AmAir® 300X filter) • High loft media increases dust holding capacity • Excellent primary filter to prevent dust build-up on heating and cooling coils, fans, and ductwork • Excellent prefilter for higher efficiency filters • Directly interchangeable with disposable panel filters, media pads in metal frames, or permanent filters used in built-up filter banks and side access systems. No modifications are necessary to frames or latches. • 4" filters have pleat stabilizers to ensure uniform spacing and increase rigidity (AmAir® 300X filter) AmAir® 300X Filters AmAir 300X filters are constructed with AAF’s totally unitized, double wall, die-cut box, beverage board frame. The media pack is bonded inside the frame at all points of contact. AmAir 300X filters are built rugged for durability and reliability under tough service conditions. The AmAir 300X filter is a MERV 7 in accordance with ASHRAE Standard 52.2. Superior Strength AmAir 300X filters are extremely strong and durable, with all components rigidly bonded into a totally unitized construction. The filters will not rack or deteriorate under normal operating conditions, including high moisture applications. An expanded metal grid laminated to the air leaving side of the media creates more consistent pleat shape and maintains uniform pleat spacing. Expanded metal also increases the stability of the pleat pack, reducing media flutter during operation. The media pack support retainers, which are an integral part of the frame, are bonded to the pleats on both the air entering and the air leaving sides. This increases rigidity and also helps maintain proper spacing between pleats for maximum dust holding capacity while minimizing resistance. AmAir® 300X filters meet the performance requirements of the most demanding applications. AmAir® HT High Temperature Filters The AmAir HT filter is designed for applications with continuous operating temperatures up to 500˚F (260˚C). The frame is an aluminized steel U-channel, with the media pack bonded to the inside on all four edges. An expanded aluminized steel faceguard is spot welded inside the frame on the air-leaving side to retain the media pack at elevated temperatures. AmAir HT filters are made with micro-glass media, and is a MERV 8 in accordance with ASHRAE Standard 52.2.
AmAir® 300X AmAir® HT siness® AAF International Building 9920 Corporate Campus Dr., Suite 2200 Louisville, Kentucky 40223-5000 Customer Service 888.223.2003 Fax 888.223.6500 www.aafintl.com AFP-1-165W SEP ‘13 AAF has a policy of continuous product research and improvement and reserves the right to change design and specifications without notice. ISO Certified Firm ©2013 AAF International The USGBC Member logo and LEED® are trademarks owned by the U.S. Green Building Council and are used by permission. Product Information — (1)Standard Sizes Performance Data AmAir 300X AmAir HT (2, 3)Nominal Gross Gross Sizes (2, 3)Actual Sizes Rated Airflow Capacity Pleats Media Pleats Media (Inches) (Inches) (SCFM) Per Area Per Area (W x H x D) (W x H x D) 300 FPM 500 FPM 625 FPM Filter (sq. ft.) Filter (sq ft.) 10 x 10 x 1 9⅜ x 9⅜ x ⅞ 200 350 --- 11 1.5 --- --- 12 x 24 x 1 11⅜ x 23⅜ x ⅞ 600 1000 --- 14 4.6 --- --- 16 x 20 x 1 15⅜ x 19⅜ x ⅞ 650 1100 --- 20 5.5 --- --- 16 x 25 x 1 15⅜ x 24⅜ x ⅞ 850 1400 --- 20 6.8 --- --- 20 x 20 x 1 19⅜ x 19⅜ x ⅞ 850 1400 --- 24 6.6 --- --- 20 x 25 x 1 19⅜ x 24⅜ x ⅞ 1050 1750 --- 24 8.2 --- --- 24 x 24 x 1 23⅜ x 23⅜ x ⅞ 1200 2000 --- 28 9.3 --- --- 12 x 24 x 2 11⅜ x 23⅜ x 1¾ 600 1000 1250 15 9.4 13 7.4 16 x 20 x 2 15⅜ x 19⅜ x 1¾ 650 1100 1400 19 9.9 17 8.2 16 x 25 x 2 15⅜ x 24⅜ x 1¾ 850 1400 1750 19 12.4 17 10.1 18 x 24 x 2 17⅜ x 23⅜ x 1¾ 900 1500 1875 21 13.2 --- --- 20 x 20 x 2 19⅜ x 19⅜ x 1¾ 850 1400 1750 24 12.5 21 10.1 20 x 24 x 2 19⅜ x 23⅜ x 1¾ 1000 1650 2100 24 15.0 21 12.0 20 x 25 x 2 19⅜ x 24⅜ x 1¾ 1050 1750 2175 24 15.7 21 12.5 24 x 24 x 2 23⅜ x 23⅜ x 1¾ 1200 2000 2500 28 17.6 25 14.3 12 x 24 x 4 11⅜ x 23⅜ x 3¾ 600 1000 1250 11 12.8 11 14.0 16 x 20 x 4 15⅜ x 19⅜ x 3¾ 650 1100 1400 14 14.0 14 14.9 16 x 25 x 4 15⅜ x 24⅜ x 3¾ 850 1400 1750 14 17.5 14 18.5 18 x 24 x 4 17⅜ x 23⅜ x 3¾ 900 1500 1900 16 19.4 --- --- 20 x 20 x 4 19⅜ x 19⅜ x 3¾ 850 1400 1750 18 18.3 18 19.1 20 x 25 x 4 19⅜ x 24⅜ x 3¾ 1050 1750 2150 18 22.9 18 23.8 24 x 20 x 4 19⅜ x 23⅜ x 3¾ 1000 1650 2100 21 22.6 18 22.9 24 x 24 x 4 23⅜ x 23⅜ x 3¾ 1200 2000 2500 21 27.1 22 27.9 25 x 29 x 4 24⅜ x 28⅜ x 3¾ 1500 2500 3150 25 33.5 --- --- (1) Additional AmAir 300X sizes available: 10x20x1 14x20x1 15x20x1 18x24x1 25x25x1 15x20x2 16x24x2 25x25x2 12x12x1 14x25x1 16x16x1 18x25x1 12x20x2 16x16x2 18x25x2 24x20x4 (2) Other standard size and special size AmAir 300X filters are available in handmade construction assembled from four beverage board strips. The filters are stapled in each corner with the pleated media pack bonded to the inside of the frame. Special sizes are available in the same construction, or can be made from standard size filters which are cut down and “capped” with beverage board strips. (3) Width and height dimensions are interchangeable. All AmAir filters may be installed with the pleats either vertical or horizontal. Continuous Pleats Rated Initial Resistance Recommended Rated Average Operating Per (in. w.g.) Final Resistance ASHRAE 52.2 Arrestance Temperature Limits Filter Lineal Foot 300 FPM 500 FPM 625 FPM (in. w.g.) MERV (%) ˚F ˚C AmAir 300X 1″ 14.0 .20 .45 --- 1.0 7 90-92 200 93 2″ 14.0 .13 .28 .44 1.0 7 90-92 200 93 4″ 11.0 .12 .25 .36 1.0 7 90-92 200 93 AmAir HT 2″ 13.0 .20 .43 .60 1.2 8 95-97 500 260 4″ 11.0 .18 .40 .57 1.2 8 95-97 500 260 All performance data based on ASHRAE Standard 52.2. Performance tolerances conform to Section 7.4 of ARI Standard 850-93. Underwriters Laboratories Classification AmAir 300X and AmAir HT filters are UL Classified. Testing was performed according to UL Standard 900 and ULC-S111. AmAir® is a registered trademark of AAF International in the U.S.
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