Proven Reliability With Exceptional Performance
  • MEGAcel® II is designed to increase cleanroom uptime and reduce the risks associated with pharmaceutical manufacturing
  • Pharmaceutical grade ePTFE Filtration Technology media is proven to be more durable than microglass. delivering superior performance
  • Industry's first and only ePTFE media to be Polyalphaolefin (PAO) compatible, with a higher PAO holding capacity compared to microglass media
  • Superior durability and tensile strength, 84 times the pleated strength of microgass
Unit of Measure

Specifications

Brands

N/A AAF Flanders® MEGAcel®

Average Pressure Drop for MEGAcel® II Filter

N/A 0.25 in·w.g.62 Pa

Average Pressure Drop for Ultrafine Microglass High Efficiency Particulate Air (HEPA) Filter

N/A 0.47 in·w.g.117 Pa

Airflow Rate

N/A 100 fpm0.5 m/s

Annual Energy Consumption for Expanded Polytetrafluoroethylene (ePTFE) Media

N/A 285 kW·h

Annual Energy Consumption for Ultrafine Microglass High Efficiency Particulate Air (HEPA)

N/A 535 kW·h

Annual Energy Consumption (Δ Savings)

N/A 250 kW·h

Minimum Efficiency at 99.99 Percent

N/A 0.3 µm

Industry Standards/Certifications

N/A ISO 7 (International Organization for Standardization)

MEGAcel® II Overview

MEGAcel® II Overview

N/A
  • Patent pending, polymer-based, dual-density, expanded polytetrafluoroethylene membranes - ePTFE
  • Completely Polyalphaolefin (PAO) compatible
  • Lowest pressure drop mini-pleat HEPA filter available
  • 50 mm pleated pack
  • Anodized extruded aluminum or stainless steel frame
  • Gel, gasket, or knife-edge seal available
  • Thermoplastic hot-melt separators

Industry-Leading Durability

Industry-Leading Durability

N/A Independent tests have shown that MEGAcel® II HEPA filters with ePTFE Filtration Technology have superior mechanical strength over filters with traditional ultrafine microglass media.
Superior mechanical strength is demonstrated by a high tensile strength, burst pressure, and abrasion resistance. ePTFE media retains its integrity with a high resistance to any potential damage, such as mishaps in handling or installation. This means that the risk of filter media failure is minimized and that fiber shedding, which could cause contamination when entering the airstream, is eliminated. As a result, there is a decreased risk of contaminants entering cleanroom environments. Protection of sterile products and cleanroom personnel is optimized. Improvement in quality risk management systems of critical applications ensures a consistent supply of quality products and a reduction of failure rates.

Reduce Operational Risk

Reduce Operational Risk

N/A The pharmaceutical industry estimates that 77 % of production downtime can be attributed to failures of equipment and environmental problems (Source: Pharmaceutical Manufacturing Magazine (2004)). This downtime can be caused by HEPA filters failing. Traditional HEPA filters typically fail due to some form of contact combined with the poor mechanical strength of the filter. The actions required when these failures occur include repairing or replacing the HEPA filter, certifying the repair or new installation, investigating potentially contaminated product, and generation of a risk assessment report. Effectively managing the risks and costs associated with successful operation requires utilizing HEPA filters with dramatically higher tensile strength that are highly resistant to chemical degradation, thereby eliminating premature leaking and failure.

Increase Uptime

Increase Uptime

N/A 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 the ePTFE pleated filter media, 84 times stronger than microglass, 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.

PAO Compliant Expanded Polytetrafluoroethylene (ePTFE) Media High Efficiency Particulate Air (HEPA) Filter

PAO Compliant Expanded Polytetrafluoroethylene (ePTFE) Media High Efficiency Particulate Air (HEPA) Filter

N/A The purpose of installed HEPA filter integrity testing, also called in-situ testing, is to confirm a flawless performance during normal operation. With AAF Flanders® new ePTFE Filtration Technology, MEGAcel® II filters can now be scan tested with the industry standard photometer at standard aerosol concentrations, as well as the low aerosol concentration Discrete Particle Counter (DPC) method.

The MEGAcel® II filter contains dual-layer ePTFE media specifically developed to retain equivalent amounts of PAO aerosol with the same or lower pressure drop increases as ultrafine microglass. The dual-layer ePTFE media allows for the in-depth capture of progressively smaller solid particles.
Independent laboratory studies have shown that MEGAcel® II filters with ePTFE media have superior PAO holding capacity over traditional ultrafine microglass HEPA media.

Enhanced Chemical Tolerance

Enhanced Chemical Tolerance

N/A High Corrosion Resistance
ePTFE media is proven to be resistant in highly corrosive environments and will withstand attacks from common decontamination chemicals. Both components of the ePTFE media, the membrane and non-woven layers, are stable against exposure at the prescribed time and concentration for the above disinfectant agents.

Superior Water Resistance
Based on AAF Flanders® test lab results, ePTFE Media provides superior water resistance in comparison with ultrafine microglass media, reducing damage risk.

Negligible Off-gassing
ePTFE media has extremely low Off-gassing of chemical components, resulting in the highest quality clean air available.

Lower Energy Consumption

Lower Energy Consumption

N/A Estimates show that up to 50 % of a facility's energy consumption is used for heating, cooling, and air handling. With increasing utility prices and peak power billing plans, lowering energy consumption is a key initiative.
MEGAcel® II filters with ePTFE media feature a lower pressure drop than traditional filters with ultrafine microglass media, up to 50 % lower depending on the exact conditions. At the same time, the overall filtration efficiency for MEGAcel® II filters has proven to be higher than for filters with ultrafine microglass media. The lower pressure drop and improved efficiency are achieved from an evenly distributed layer of fibers with very fine nanometer-scale diameters. Air molecules can efficiently pass through the fibers, and airborne particles can be captured more easily. The result: air quality is optimized and energy costs are substantially reduced.

Performance Data

Performance Data

N/A
MEGAcel® II with Expanded Polytetrafluoroethylene (ePTFE) Filtration Technology Mini-Pleat High Efficiency Particulate Air (HEPA) Filters - Initial Resistance vs. Filter Face Velocity

Manufactured in ISO 7 Clean Facilities

Manufactured in International Organization for Standardization (ISO 7) Clean Facilities

N/A Both the MEGAcel® II HEPA filter and ePTFE Media are manufactured by AAF Flanders®. By doing so, we can control the quality and consistency of the media. The 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.

Additional Information

Additional Information

N/A AAF Flanders® ePTFE Filtration Technology-Today's Alternative to Fragile Microglass HEPA Filters

Designed specifically for the unique requirements and challenges of the pharmaceutical industry, the MEGAcel® II mini-pleat HEPA filter has the proven durability, polyalphaolefin (PAO) compatibility, high particulate filtration efficiency, and the lowest pressure drop to meet the demands of pharmaceutical manufacturing. It is the best choice for the most demanding applications, saving both time and money, while reducing contamination risk and invasive unscheduled downtime. With the lowest Total Cost of Ownership of all mini-pleat HEPA filters, the MEGAcel® II will help protect your environment, reduce your business risk, and optimize your clean air related spending.

Less Downtime. Less Worry. Less Risk.
  • Chemical-resistant capabilities reduce media degradation in highly corrosive environments
  • Exceptional water resistance compared to ultrafine microglass
  • Extremely low Off-gassing of chemical components, resulting in the highest quality clean air available
  • Lowest pressure drop mini-pleat HEPA filter available. reducing energy consumption for significant savings
  • MEGAcel® II and ePTFE media are manufactured, tested, and packaged in ISO 7 clean facilities to ensure the highest purity, quality, and consistency

Note

Note

N/A AAF Flanders® has a policy of continuous product research and improvement and reserves the right to change design and specifications without notice.
MEGAcel® is a registered trademark of AAF International in the U.S. and other countries.

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