1. Low Energy Cost and High Reliability Solution for Cleanroom
HVAC Systems John Clapham, Dr. Rahul Bharadwaj, and Gordon
Livingston
2. 2 Agenda 1. Introduction to PSC and BioTechnique 2. Facility
History 3. Study Hypothesis 4. HEPA Filter Medias 5. How HEPA
Filters Fail 6. AHU Energy Saving Strategy 7. How Cleanroom Air
Flow is Set Up 8. Our HEPA Filter Test Rig 9. Results of Our
Testing 10. Energy and Cost Savings 11. Conclusions 12. Future
Studies
3. 3 BioTechnique is a brand new facility purposefully built
for high potency and cytotoxic drug fill and finish capabilities.
Facility History 2008: Construction completed for Mentor Biologics.
2014: PSC acquired the facility and plans to operate as a CMO.
2015: BioTechnique customer ready.
4. 4 Facility
5. 5 The Model BioTechniques Big Idea: Use lower pressure-drop
PTFE HEPA filters in our ISO 5 and ISO 7 cleanrooms to reduce
energy costs and to increase reliability. What is a PFTE HEPA
filter? Why does it have a lower pressure drop? How can we
objectively test PTFEs against traditional microglass filters? What
is the actual pressure drop of a PTFE HEPA filter vs. a microglass
HEPA filter? Our Proposition
6. HEPA Filter Media Traditional Microglass 6 PTFE
(polytetrafluoroethylene) GLASS MEDIA Tensile Strength (Typical) MD
1.3 kN/m2 CD 0.7 kN/m2 Elongation (Typical) MD 1.3 % CD 1.7 % PTFE
MEDIA Tensile Strength (Typical) MD 5.5 kN/m2 CD 2.5 kN/m2
Elongation (Typical) MD 45 % CD 55 % PTFE Media is more reliable
and more energy efficient than traditional Microglass Medias used
in HEPA Filters.
7. How HEPA Filters Fail HEPA Filters typically fail due to
some form of contact combined with the poor mechanical strength of
the media Testing & Validation Removing/installing Scanning of
filters Cleaning Cleaning the screen High pressure water Unintended
Contact Moving equipment Repair/maintenance Handling
Transport/delivery Installing HEPA Filter Failure Modes 7
8. PTFE membrane at 5,000x magnification Traditional media at
5,000x magnification PTFE Technology Lowers Risk Traditional medias
failure rate of 3% to 5% during 6-month validation intervals will
be near 0% with ePTFE technology Traditional media fibers FRACTURE
when folded
9. What gives PTFE its unique properties? Fluorocarbon solid
strong bonding High molecular weight (at least 5,000,000) long
chain High Melting point (327oC) long chain Hydrophobic bonding
structure Third lowest coefficient of friction (0.05 to 0.10)
against any solid Slipperiness Inert to any chemical What is PTFE?
Chemically Polytetrafluoroethylene - ethylene 2 carbon (black)
atoms -tetra fluoro - 4 fluorine (green) atoms Poly - repeating
molecular structure Note that the fluorine atoms completely
surround the central polyethlyene chain
10. PTFE Facts Average membrane pore size 0.5 1 micron,
effective pore size much smaller. Traditional non-woven membranes
typically have a 20 micron pore size. 100 million pores per square
centimeter. Can fit about 1000-2000 pores across the tip of a ball
point pen. 2x Energy Savings 1.63x Longer Service Life PressureDrop
Time Vendor Advertised Dust Loading Capacities Energy Savings
Penalty for Running Longer The ModelPTFE Filtration Facts 9
11. Expanded PTFE Membrane (~ 100m depth) Nonwoven Layer (for
support) Human Hair (~ 60um diameter) PTFE Nodes (for structure)
PTFE Fibrils (for filtration) The reasons why PTFE has: High
Efficiency -many fibrils Low Pressure Drop -thin fibrils Excellent
Durability -nonwoven layer gives protection to membrane Ref: 100m
in SEM Scale ~1.5x Human Hair Diameter The ModelPTFE Composite
Construction Close-Up 10
12. Air Handler Units (AHUs) account for up to 65% of all
energy costs in biopharmaceutical buildings. Reducing the pressure
drop across HEPA filters directly reduces the operating cost of
AHUs. Industrial Facility Energy Usage Breakdown Source: U.S.
Department of Energy 11
13. 13 The ModelTypical Cleanroom
14. Our HEPA Filter Test Rig Setup Air flows from the cleanroom
through a balometer, which measures the air flow rate, and then
into the HEPA filter. 13
15. 15 The Model Test Rig to Compare Microglass vs. ePTFE
Filters (Front View) Test Rig
16. 16 The Model Schematic of the test Rig Schematic of the
test rig
17. 17 The Model Filter Loaded in the Test Rig Test Rig
18. 18 The Model Video of Test Rig Being Used Test Rig
Video
19. 19 The Model Side View of Test Rig Test Rig Side View
20. 18 Four different types of HEPA filters were tested. 100 mm
Microglass A (legacy filters in facility) 100 mm Microglass B (for
direct comparison) 50 mm PTFE (to demonstrate effectiveness 75 mm
PTFE even with less filter area) Three filters of each type were
tested. Each individual filter was tested three times, for a total
of thirty-six tests. Three trials on each filter ensures
statistical significance.
21. 19 Results Filter Model Measured Air Volumetric Flow Rate
(CFM) Measured Pressure Drop (IWG) Microglass A (100 mm) 507 0.313
Microglass B (100 mm) 504 0.261 PTFE (50mm) 506 0.221 PTFE (75mm)
507 0.201
22. 20 Results 30 % 36 %
23. 23 The Model What are the predicted energy savings from
using a lower pressure HEPA filter for BioTechnique? Total Annual
Projected Energy Savings for BioTechnique: 9,350 kWh Predicted
Energy Savings Using Simulation Model Filter Model Annual Base
Energy Consumption Microglass A (100mm) 232 kWh Microglass B
(100mm) 195 kWh PTFE (50mm) 165 kWh PTFE (75mm) 150 kWh
24. 24 The Model What are the other cost savings we hope to
realize besides energy savings at BioTechnique? Reduced Filter
Change out Periods Resulting in Lower Labor Costs and Disposal
Costs Additional PAO Studies Will Be Performed to Determine
Frequency Increased Recertification Period Resulting in Lower Labor
Costs Reduced Filter Failure and EM Excursions Rate Resulting in
Lower Production Loss and Labor Costs Other Cost Savings Besides
Energy
25. 25 The Model What did we learn from our study at
BioTechnique? PTFE is significantly stronger and more reliable than
traditional microglass media. PTFE has a significantly lower
pressure drop than traditional microglass media. PTFE has major
energy savings for Grade A and Grade B cleanrooms. Conclusions
26. 26 The Model Planned Studies for the Future (2015 &
2016): BioTechnique will perform a PAO loading study using the test
rig to determine the maximum loading capacity of PAO that can be
sprayed on traditional microglass media and PTFE media before
breakthrough. BioTechnique will perform an in-situ test of both
traditional microglass HEPA media vs. PTFE media, measuring energy
savings. The production filling and capping rooms at BioTechnique
will be used for the test. This will include approximately 70
microglass HEPAs and 40 PTFE HEPAs. Next Steps