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ePTFE Technology Pharmaceutical and Isolator Applications

AAF ePTFE Technology - Latest Advancement in High-End Air FiltrationAAF ePTFE Technology is based on patent pending polymer based dual-density ePTFE membranes. ePTFE Technology provides significantly more durable filter media than ultrafine microglass media, resulting in greater performance reliability, comparable PAO testing compliance, and lower energy consumption. With unique performance characteristics, the AAF MEGAcel® II filter with ePTFE Technology is an excellent solution to the reliability and energy challenges seen in the pharmaceutical and biotech industries.

MEGAcel® II - First PAO Compliant ePTFE HEPA FilterThe purpose of installed HEPA filter integrity testing, also called in-situ testing, is to confirm a flawless performance during normal operation. With AAF’s new ePTFE Technology, MEGAcel II 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, Discrete Particle Counter (DPC) method.

The MEGAcel II filter contains dual-density ePTFE Technology media specifically developed to retain equivalent amounts of PAO aerosol and equivalent pressure drop increases as ultrafine microglass. The dual-density ePTFE layers allow for the in-depth capture of progressively smaller solid particles.

Independent laboratory studies have shown that MEGAcel II filters with ePTFE Technology have superior PAO holding capacity over traditional ultrafine microglass HEPA media as seen in the results below.

TECHNOTE

The MEGAcel® II filter with AAF’s ePTFE Technology represents the latest advancement in high-end air filtration for the pharmaceutical industry.

1st ePTFE Layer (Low Fibril Density)

2nd ePTFE Layer (High Fibril Density)

0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63Test Intervals

2 test Intervals is representative of 1 year in use

5 years10 years

Ultrafine Microglass ePTFE Technology

1.20 1.00 0.80 0.60 0.40 0.20 0.00 Di

ffere

ntia

l Pre

ssur

e ("H

2O)

1 Hour Test Intervals (@15µg/l) Time VS DPfor typical 50mm media packs

ePTFE Technology

2

Reduce Operational Risk

The pharmaceutical industry estimates that 77% of production downtime can be attributed to failures of equipment and enviromental 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/replacing the HEPA filter, certifying the repair or new installation, investigating potentially contaminated product, and generation of a risk assessment report.

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 TechnologyUltrafine Microglass Media

Flat Folded Flat Folded

41.6

312.8

3.8

318.0350.0

300.0

250.0

200.0

150.0

100.0

50.0

0.0Te

nsile

Stre

ngth

(N)

Flat: 8x Higher

Folded: 84x Higher

ePTFE TechnologyUltrafine Microglass Media

0.0

6.47.0

6.0

5.0

4.0

3.0

2.0

1.0

0.0

Burs

t Pre

ssur

e (k

g/cm

2)

Endlessly Higher

ePTFE TechnologyUltrafine Microglass Media

20

20,00020,000

16,000

12,000

8,000

4,000

0

Abra

sion

Res

ista

nce

(# ru

bbin

g cy

cles

)

1000x Higher

Improved Durability

Independent tests have shown that MEGAcel II HEPA filters with ePTFE Technology have superior mechanical strength over filters with traditional ultrafine microglass media.

The superior mechanical strength is demonstrated by a high tensile strength, burst pressure, and abrasion resistance. ePTFE Technology 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 probability 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.

Resilient ePTFE Technology media at fold tip @ 10,000x magnification.

Fractured ultrafine microglass media fibers at fold tip @ 10,000x magnification.

ePTFE Technology

3

Improved Chemical Properties

High Corrosion Resistance ePTFE Technology is proven to be resistant in highly corrosive environments and will withstand attacks from common sterilizing chemicals such as hydrogen peroxide, formaldehyde, and chlorine dioxide. Both components of the ePTFE Technology, 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’s test lab results, ePTFE Technology provides superior water resistance in comparison with ultrafine microglass and low boron microglass media.

Negligible Off-Gassing ePTFE Technology has near zero off-gassing of chemical components resulting in the highest quality clean air available.

ePTFE Technology Ultrafine Microglass Media

BEFORE

AFTERDamage after use of Hydrogen Peroxide (H2O2 ) for cleanroom sterilization.

SEM photos at 5,000x magnification.

ePTFE Technology

9920 Corporate Campus Drive, Suite 2200, Louisville, KY 40223-5690888.223.2003 Fax 888.223.6500 | www.aafintl.com

AAF has a policy of continuous product research andimprovement and reserves the right to change designand specifications without notice.

ISO Certified Firm

AFP-8-101A 02/15

©2015 AAF International

Lower Energy Consumption

Estimates show that up to 50% of a facilities energy consumption is used on 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 Technology 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

Initial Resistance vs. Filter Face Velocity

0.5

0.4

0.3

0.2

0.1

0

Initia

l Res

istan

ce (in

. w.g

.)

Filter Face Velocity (FPM)0 25 50 75 100 125

MEGAcel® II Ultrafine Microglass HEPA

99.99% HEPA Filter, 50mm Packs

Energy Savings

Energy Savings Calculation

Average Pressure Drop

MEGAcel II 0.25 in. w.g. (62 Pa)

Ultrafine Microglass HEPA 0.47 in. w.g. (117 Pa)

Airflow Rate 100 FPM – 0.5 m/sec

Annual Energy Consumption

ePTFE Technology 285 kWh

Ultrafine Microglass HEPA 535 kWh

∆Savings 250 kWh

Annual Savings

250 kWh = $20.00 / filter

Based on a national average of $0.08 kWh.