MEGAcel® II Filters 2 Results based on Test Standard DIN EN 29073-3. Results based on Test Standard DIN EN 13938-2. Results based on Test Standard DIN EN 12947-2. Tensile Strength Burst Pressure - Flat Abrasion Resistance - Flat ePTFE Media Technology Ultrafine Microglass Media Flat Folded Flat Folded 41.6 312.8 3.8 318.0 350.0 300.0 250.0 200.0 150.0 100.0 50.0 0.0 Tensile Strength (N) Flat: 8x Higher Folded: 84x Higher ePTFE Media Technology Ultrafine Microglass Media 0.0 6.4 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 Burst Pressure (kg/cm2) Endlessly Higher ePTFE Media Technology Ultrafine Microglass Media 20 20,000 20,000 16,000 12,000 8,000 4,000 0 Abrasion Resistance (# rubbing cycles) 1000x Higher Industry-Leading Durability Independent tests have shown that MEGAcel II HEPA filters with ePTFE Filtration Technology have superior mechanical strength over filters with traditional ultrafine microglass media. Resilient ePTFE Filtration Technology media at fold tip @ 10,000x magnification. Fractured ultrafine microglass media fibers at fold tip @ 10,000x magnification. 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 The pharmaceutical industry estimates that 77% of production downtime can be attributed to failures of equipment and environmental problems*. 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 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. *Source: Pharmaceutical Manufacturing Magazine (2004).
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