- 1 - Agenda Items. atmospheric dust the invisible cesspool. 1 micrometer = 1/25,400 of an inch. Fiber Size. Lab v Real life conditions

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Bernard Hall
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Count.01 -.02.02 -.05.05 -.1.1 -.22.22 -.46.46-1 1-2.15 2.15-4.64 4.64-10 10-21.54 21.

design Industry Trends, Issues & 'Hot Topics' in the Pharma industry Sustainability Adopting TCO/LCC 'Science Based Approach' Material Compatability Gel/Urethane failure,

Selection Reducing/Eliminating stages of filtration (must have science based data) Factory/Field Repairs Patchless' filters, No repairs in Grade A space, EMEA demands?

Key Account Management Demand for Global Supply Chain & Support in developing markets, BRIC etc 173,929,613 atmospheric dust the invisible cesspool 395,213,491 338,577,845

500,000,000 400,000,000 300,000,000 200,000,000 69,890,564 100,000,000 2,801,973 212,705 15,235 645 28 0 Particle Size in Micrometers 100 µm = 1/10 mm 50 µm = hair 10 µm =

3 µm = smoke Number 99 % < 1 µm Weight 30 % < 1 µm particle size Symbol:1micron =1mm 1 micrometer = 1/25,400 of an inch Pollen 7 to 15 microns Sugar or salt is 40 to 200

1 Count Agenda Items Industry Hot Topics TCO-LCC - the Science based approach Update on Industry Standards Common Products utilized globally Using Camfil software to optimize design Industry Trends, Issues & 'Hot Topics' in the Pharma industry Sustainability Adopting TCO/LCC 'Science Based Approach' Material Compatability Gel/Urethane failure, exposure of PAO, Decon/Cleaning agents A/C rate reduction Big Pharma' studies and implementation Field failure Bleedthru (old news) H14 or Type K selection NOT ULPA Filter Selection Reducing/Eliminating stages of filtration (must have science based data) Factory/Field Repairs Patchless' filters, No repairs in Grade A space, EMEA demands? When to change Hepa's Time, pressure drop, is there data available? Key Account Management Demand for Global Supply Chain & Support in developing markets, BRIC etc 173,929,613 atmospheric dust the invisible cesspool 395,213, ,577,845 Particles by Count Typical Atmospheric Air Sample 69 micrograms per Cubic Meter 906,959, ,288,728 1,000,000, ,000, ,000, ,000, ,000, ,000, ,000, ,000, ,000,000 69,890, ,000,000 2,801, ,705 15, Particle Size in Micrometers 100 µm = 1/10 mm 50 µm = hair 10 µm = visible 1 µm = 1/1000 mm 0.3 µm = smoke Number 99 % < 1 µm Weight 30 % < 1 µm particle size Symbol:1micron =1mm 1 micrometer = 1/25,400 of an inch Pollen 7 to 15 microns Sugar or salt is 40 to 200 microns Fiber Size Both media have same Test Report Efficiency: MERV 13, 80-85% DS, F7 Glass Fibers fine fibers many fibers/small diameter Synthetic Fibers coarse fibers fewer fibers/large diameter In Puerto Rico majority of installations are using wet laid glass (fine fiber) Lab v Real life conditions Efficiency at 0.4 um (%) Time (h) Compare apples to apples on Efficiency MERV 13/14 Glass media MERV 13/14 Synthetic media MERV 11 Glass media - 1 -

charges that may be either natural or imposed upon the media during manufacturing.

affect the efficiency of the filter but not as much as would be observed in actual service.

difference! Outdoor air Avg. particle size is 0.08 micron ASHRAE Dust Avg.

7 micron In-Situ Testing per ASHRAE Guideline 26-2008 Measurements Air Velocity

Repeatable Setup, eliminates questions Calibrated Met-One 237B 6 Channel laser counter 0.

0mm 2,000,000c/ft 3 coincidence Upstream Verification 10:1 Dilution system it needed Major

fine coarse DP (inwg) 0.15 0.20 0.4mm Eff.

2 ASHRAE says: electrostatic charge info Some fibrous media air filters have electrostatic charges that may be either natural or imposed upon the media during manufacturing. Such filter may demonstrate high efficiency when clean and a drop in efficiency during their actual use cycle. The initial conditioning step of the dust-loading procedure described in this standard may affect the efficiency of the filter but not as much as would be observed in actual service. Therefore, the minimum efficiency during test may be higher than that achieved during actual use. ASHRAE test dust and outside air bares no resemblance to real life conditions X 100 difference! Outdoor air Avg. particle size is 0.08 micron ASHRAE Dust Avg. particle size is 7.7 micron In-Situ Testing per ASHRAE Guideline Measurements Air Velocity Temperature/RH Resistance to Airflow Filter Efficiency Particle Counting Consistent Repeatable Setup, eliminates questions Calibrated Met-One 237B 6 Channel laser counter 0.3mm-3.0mm 2,000,000c/ft 3 coincidence Upstream Verification 10:1 Dilution system it needed Major Pharma 35 Filters (100% Outdoor air) Initial performance Final performance Field Study Data Global Pharma Co. MERV 14 Filters 16 Weeks Manufacturer Brand x Brand Y Type Durafil 95 Vari-Pak 95S Media fine coarse DP (inwg) mm Eff. (%) DP (inwg) mm Eff. (%) 72 25/19* * 16 week /52 week Tested AHU next to test AHU s common intake 12 months in use Brand X Fine Fiber Media Outside Air 1,500,000 Particles/ft 3 Brand Y Coarse Fiber Media MERV 14 Filter Penetration 420,000 Particles/ft 3 Major Pharma 1,125,000 Particles/ft 3 When to Change Filters Time Convenient & easier for SOP s Will use more filters Higher disposal costs Higher labor cost Resistance to Airflow (Pressure Drop) Logistics more difficult Maximize filter life Lower disposal costs (less changes) Lower labor cost Visual Inspection (Dirty filter) - 2 -

3 What is LCC? (Life-Cycle Cost) Correct Filter Selection = Best Value & Science based Method of analyzing the cost of a system over its entire life span Objective should be to choose the most cost effective system that yields the desired level of IAQ Selected system will not necessarily have the lowest first cost Components of Life-Cycle Cost LCC = Investment + PC energy + PC maintenance + PC cleaning + PC disposal Investment capital cost of filters, frames, installation PC energy present total cost of power PC maintenance present total cost of maintenance including replacement PC cleaning present cost of duct cleaning PC disposal present total cost for removal and disposal of the used filters Energy Equation for Life-Cycle Cost Energy Cost = current cost of energy: Energy (E) = [(Q * ΔP * T)/(ŋ * Co)] * Pc Q = Air flow, m 3 /s (cfm) ΔP = Average filter pressure loss, (in WG) T = Operation time, hr ŋ = Fan efficiency, % Pc = Cost of Power, $/kwh Co = Constant, 1000 in SI units, 8515 in IP units Fan efficiency Total Effciency Camfil has together with ECIS controlled over 760 fans in the west of Sweden. The fans were in all sizes and airflow from 0,1 m 3 /s to 6 m 3 /s and in different segments. The result is that the average was 33% efficiency. This is probably high compared to the rest of Europe =>20 20=>30 30=>40 40=>50 50=>60 Fan effciency (%) Number of fans Housing Industry Commercial State owned buildings Shipping Hospitals Totalt FA FF TA TF Total The fan efficiency influences the LCC Typical Distribution of Air Filtration Costs The norm for the Eurovent rating is 50% we recommend you measure the fan efficiency yoirself. You will see that their reality is much lower. $2,000 LCC = I + PC e + PC m + PC c + PC d Fan efficiency Energy cost ( ) Increase of energy cost Euro/Pa Total LCC Price filter ( ) Factor per year ( ) 50% 103 0,8 33 3, % % 1,0 33 3, % % 1,1 33 4, % % 1,3 33 5, ( N 2 3 m ) x1,0( m 1000x0,35 s) x4300( h) x0.9( ) 17 $1,500 $1,000 $500 $0 Investment PC-Energy PC-Maintenance PC-Cleaning PC-Disposal Energy costs typically represent anywhere from 50%-80% of life-cycle cost. Puerto Rico 80% MINIMUM! - 3 -

Filter construction The pressure drop of the filter is the sum of the media pressure drop and the construction pressure drop.

28 67% Bof Filter 0.37 0.33 0.7 47% Pocket Filter 0.45 0.2 0.65 30% V-Bank Filter 0.21 0.16 0.37 43% i.e. Even for a given material (good or bad) the product design will have a direct impact of the energy cost and the lifetime.

6 8515, units conversion factor 8515 $/kwh, cost per kwh ($) 0.200 HEPA 99.99 @ 0.3 E = q x dp x t = 4,629.48 kwh n x 8515 $ = E x $/kwh = $925.90 21 22 HEPA 99.99 @ 0.3 E, kwh q, volumetric flow rate (cfm) 2000 3400 3600 0.

4 Filter construction The pressure drop of the filter is the sum of the media pressure drop and the construction pressure drop. The construction pressure drop will differ enormously between a good and a bad construction: Dp m + Dp c = Dp filter Product Family Dpm Dpc Dpfilter % Construction Pleated Filter % Bof Filter % Pocket Filter % V-Bank Filter % i.e. Even for a given material (good or bad) the product design will have a direct impact of the energy cost and the lifetime E, kwh q, volumetric flow rate (cfm) dp, resistance to airflow (in. w.g.) 1.35 t, time (hours) 8760 n, fan efficiency , units conversion factor 8515 $/kwh, cost per kwh ($) HEPA 0.3 E = q x dp x t = 4, kwh n x 8515 $ = E x $/kwh = $ HEPA 0.3 E, kwh q, volumetric flow rate (cfm) dp, resistance to airflow (in. w.g.) 0.8 t, time (hours) 8760 n, fan efficiency , units conversion factor 8515 $/kwh, cost per kwh ($) E = q x dp x t = 2, kwh n x 8515 $ = E x $/kwh = $ E10 (95% DOP) E, kwh q, volumetric flow rate (cfm) dp, resistance to airflow (in. w.g.) 0.5 t, time (hours) 8760 n, fan efficiency , units conversion factor 8515 $/kwh, cost per kwh ($) E = q x dp x t = 1, kwh n x 8515 $ = E x $/kwh = $

MERV 14 (95%) E, kwh q, volumetric flow rate (cfm) 2000 3400 3600

31 t, time (hours) 8760 n, fan efficiency 0.

200 E = q x dp x t = 1,063.07 kwh n x 8515 $ = E x $/kwh = $212.

Savings $700+ + Unit cost Savings $300+ + Certification Savings

SOP/Reporting/Regulatory Savings $100+???? + Other?

5 MERV 14 (95%) E, kwh q, volumetric flow rate (cfm) dp, resistance to airflow (in. w.g.) 0.31 t, time (hours) 8760 n, fan efficiency , units conversion factor 8515 $/kwh, cost per kwh ($) E = q x dp x t = 1, kwh n x 8515 $ = E x $/kwh = $ If we did change from HEPA to MERV 14 Energy Savings $ Unit cost Savings $ Certification Savings $ Installation/Disposal Savings $50+ + SOP/Reporting/Regulatory Savings $100+???? + Other? Potential Total Savings PER FILTER $1,250.00! Risk..Testing, SOP, Change Control??...discuss! 29 Global Pharma Co. 2 year TCO Saving Calculation

Carbon Footprint Sources Carbon Dioxide Emissions from the Generation of Electric Power in the United States Department of Energy & EPA, July 2000

(lbs CO 2 /kwh) % Use USA % Use EU Coal 2.117 51 17 Petroleum 1.915 3 36 Gas 1.314 15 25 Other Fuels 1.

Wh Prefilters (Ring Panels, LC Pleats, etc.) 3 months Final Filters (Boxes, Bags, V-Beds, etc.

(Based on 600 gco 2 /kwh) ~ 818 Metric Tons Waste Reduction based of filter change schedules ~ 58 M Tons Filter class now also requires ME limit Table

synthetic dust of 0,4 µm particles of 0,4 µm particles Pa % % % Coarse G1 250 50 Am 65 - - Has to be G2 250 65 Am 80 - - reached G3 250 80 Sets filter

70 NOTE 1) The characteristics of atmospheric dust vary widely in comparison with those of the synthetic loading dust used in the 33 tests.

Loss of media charge or shedding of particles or fibres can also adversely affect efficiency.

6 Carbon Footprint Sources Carbon Dioxide Emissions from the Generation of Electric Power in the United States Department of Energy & EPA, July 2000 European Energy and Transport Trends to 2030 European Commission Directorate General for Energy and Transport, Update 2007 Fuel Source Output Rate (lbs CO 2 /kwh) % Use USA % Use EU Coal Petroleum Gas Other Fuels USA Average g CO 2 /kwh EU Average g CO 2 /kwh Carbon Footprint Example Major Pharma 15 Plants/Locations Previous system: 35,972 M Wh Prefilters (Ring Panels, LC Pleats, etc.) 3 months Final Filters (Boxes, Bags, V-Beds, etc.) 12 months Current Lowest LCC Filters: 22,813 M Wh 30/30 pleats Changing every 6-12 months Final Filters Changing every months CO 2 Reduction (Based on 600 gco 2 /kwh) ~ 818 Metric Tons Waste Reduction based of filter change schedules ~ 58 M Tons Filter class now also requires ME limit Table 1 Classification of air filters 1) Group Class Final test Average Average Minimum pressure arrestance (Am) efficiency (Em) Efficiency 2) drop of synthetic dust of 0,4 µm particles of 0,4 µm particles Pa % % % Coarse G Am Has to be G Am reached G Sets filter Am class for G Am - - F7, F8 and F9 Medium M Em 60 - M Em 80 - Fine F Em F Em F Em 70 NOTE 1) The characteristics of atmospheric dust vary widely in comparison with those of the synthetic loading dust used in the 33 tests. Because of this the test results do not provide a basis for predicting either operational performance or life. Loss of media charge or shedding of particles or fibres can also adversely affect efficiency. 2) Minimum efficiency is the lowest efficiency among the initial efficiency, discharged efficiency and the lowest efficiency throughout the loading procedure of the test. 34 It is now mandatory for all test reports to include a discharged (ME) value to be compliant All the information needed is available in the guidelines which is publicly available from Eurovent

7 % Penetration % Penetration Efficiency % Eurovent Certification Programme for Air Filters now includes new data IEST-RP-CC001 & EN1822 Comparison IEST-RP-CC001 EN1822 Classification Global Values Local/Leak Values Global Values Local/Leak Values Multiple of Particle Size for Collection Penetration Collection Penetration Multiple of Global Particle Size Collection Collection Global Filter Type Testing Efficiency % % Efficiency % % Efficiency % Filter Class for Testing Efficiency % Penetration % Efficiency % Penetration % Efficiency % E10 >85 < E11 >95 < Model Filter media Basic design Initial Depth/lenght, No. of bags Media Air flow mm or "V:s" velocity, m/s rate, m 3 pressure /h drop, Pa Product FamilyHi-Flo XL ME % Energy Energy Consump Filter class class kwh EN779: E12 >99.5 < A 0.3* >99.97 < H13 MPPS >99.95 <0.05 >99.75 < Two flow leak test B 0.3* >99.97 < Two flow leak test E 0.3* >99.97 < H or ** >99.97 < Two flow leak test I or ** >9.97 < Basic design nomenclature: e.g. One decimal Two decimals C 0.3* >99.99 <0.01 >99.99 < H14 MPPS > <0.005 > < J or ** >99.99 <0.01 >99.99 < K or ** > <0.005 > < D 0.3* > <0.001 >99.99 < F or ** > < > < U15 MPPS > < > < XLT 7 (HFGP- 592x592x ) Glass Bag filter , , F7 A G.1-.2 > < > < U16 MPPS > < > < U17 MPPS > < > < * Mass median diameter particles (or with a count median diameter typically smaller than 0.2 µm as noted above). 38 HEPA filters should be tested at the Most Penetrating Particle Size (MPPS) Example performance of a HEPA Filter Viruses Particle Size (µm) Droplet Nuclei Bacteria 0.12 micron 0.3 micron MPPS ( micron) Filter Efficiency and Integrity Testing: Efficiency: A measure of the filter s Overall Value performance designated as a percentage of 100. IEST-RP-CC001 IEST-RP-CC007 (ULPA) EN Integrity: A measure of a filter s (local leakage threshold value) leak free performance (within allowable specified limits). IEST-RP-CC001 IEST-RP-CC034 EN CAMFIL FARR penetration, at a fixed velocity, can vary significantly with particle size. max pen. at 90 FPM is ~0.008% at the MPPS (0.158 mm). typical pen. at 90 FPM is ~0.004% at the MPPS (0.158 mm). penetration vs. particle size Camfil Farr 53mm ( 2") Pleat HEPA 90 FPM Useable Face Velocity Performance Camfil Farr CETA Annual Meeting Vegas, 0.3 (April , 2002) Las Nevada Camfil - clean air solutions Particle Size (Microns) Typical % Penetration Maximum % Penetration PAO ( micron) DOP (0.185 micron) MPPS (0.158 micron) 41 increasing face velocity reduces MPPS. max pen. at 140 FPM is ~0.026% at the MPPS (0.144 mm). typical pen. at 140 FPM is ~0.013% at the MPPS (0.144 mm). penetration vs. particle size Camfil Farr 53mm ( 2") Pleat HEPA 140 FPM Useable Face Velocity Performance Typical % Penetration Maximum % Penetration PAO ( micron) DOP (0.185 micron) MPPS (0.144 micron) Camfil Farr CETA Annual Meeting Las Vegas, Nevada (April 29, 2002) Particle Size (Microns) Camfil - clean air solutions

8 Filter «BLEED-THROUGH» Over-Velocity HEPA/ULPA Panel Filter standard nominal front velocity = 0,45m/s Used velocity > 0,45m/s... 0,9 to 1 m/s => efficiency ISO (Passed formal ballot September 2011) Will be in the public domain in 2012 Parts 1 thru 5 Example H14 H13 These 5 parts of this standard deal with; Classification Aerosol Production Media Testing Filter Leak Testing Filter Efficiency Testing The foundation of this new standard is EN1822, primary differences are: Expanded filter classes Allows for photometer leak testing and the oil thread leak test (a visual test) 43 ISO Classification Global Values Local/Leak Values Multiple of Collection Collection Global Filter Class Particle Size for Testing Efficiency % Penetration % Efficiency % Penetration % Efficiency % (Group) ISO 15 E MPPS >95 < ISO 20 E MPPS >99 < ISO 25 E MPPS >99.5 < ISO 30 E MPPS >99.9 < ISO 35 E MPPS >99.95 <0.05 >99.75 < ISO 40 E MPPS >99.99 <0.01 >99.5 <0.5 5 ISO 45 E MPPS > <0.005 > < ISO TC 209 has been working on the revision of the basic airborne cleanliness classification standard for the last 4 years. The standard should be published towards the end of 2012, main changes the proposed standard address s are the following: Simplify the classification process and if possible remove the need to evaluate the 95% UCL for 2-9 sample locations Review the classification procedure and make it more applicable to rooms in operation. The contamination isn t expected to be evenly distributed an assumption the current statistical approach makes. ISO 50 E MPPS > <0.001 > < Generally update the standard to current thinking and industry requirements. ISO 55 E MPPS > < > < Avoid any radical changes to the principals of the current ISO cleanliness classes The classification would be based on the table below, with the well known formula used for the intermediate decimal classes. By using a look-up table as the basis for classification, it is easier to direct the reader to appropriate particle sizes for specific classes. The basic classification table proposed in ISO DIS :2010. The selection of number of sample locations is proposed to be based on a look-up table, intended to confirm with 95% confidence that 90% of the cleanroom will meet the intended classification. The table proposed for determining the number of sample locations in ISO DIS :2010. Area (m 2 ) Less than or equal to Minimum number of sample locations Area (m 2 ) Less than or equal to Minimum number of sample locations Area (m 2 ) Less than or equal to Minimum number of sample locations Table 1 Selected airborne particulate cleanliness classes ISO Classification Number (N) Maximum concentration limits (particles/m 3 ) 0.1 m 0.2 m 0.3 m 0.5 m 1.0 m 5.0 m ISO Class 1 10 ISO Class ISO Class ISO Class ISO Class ISO Class ISO Class ISO Class ISO Class

Situation Terminal Filter Housing by CF : many

Pharmaseal Camdistri And if we add Asia + USA CF

The situation by Camfil Farr might be a little bit

fast GMP in situ Leakage EMERY test Quick filter

adjustment command and indication PHARMASEAL Fully

pressure drop, airflow, velocity) Integrated Aerosol

centering guides Hinged grid Grid holding by magnets

: - Dp measurement - 100% sampling Hinged grid Quick

access from room side 100% sampling port Aerosol

Filter GMP controls All centralised on a ergonomic

1 single person can test Quick and airtight

(1) (2) PAO test really performed in compliance with

PAO IN HVAC DUCTING => Fire safety, increases filter

Pharmaseal : long term security No risks for leaks

Airtight Continuity with clean room ceiling with

housing Silicon gel (recommended) Immediate

9 Situation Terminal Filter Housing by CF : many possibilities Cleandistri Sofdistri TF FKOP Pharmaseal Camdistri And if we add Asia + USA CF offers Camseal + other local sourcing! The situation by Camfil Farr might be a little bit confusing for our customers Time Fully equipped for fast GMP in situ Leakage EMERY test Quick filter clamping by rotating auto-stop clamps Airflow adjustment command and indication PHARMASEAL Fully equipped for GMP in situ Controls (PAO test, pressure drop, airflow, velocity) Integrated Aerosol Dispersion Ring Only one person required Filter centering guides Hinged grid Grid holding by magnets Test aerosol injection port Upstream access port for : - Dp measurement - 100% sampling Hinged grid Quick closing with magnets/1/4 turn fastners Immediate access from room side 100% sampling port Aerosol injection port 52 PHARMASEAL Fully Equipped for Filter GMP controls All centralised on a ergonomic device => Injection + control from room side => Only 1 single person can test Quick and airtight connection => stainless steel quick disconnect ports (1) (2) PAO test really performed in compliance with ISO-IEST standards => aerosol dispersion ring (3) NO PAO IN HVAC DUCTING => Fire safety, increases filter life Aerosol Input (2) 100%(1) (2) Diffusion ring(3) Pharmaseal : long term security No risks for leaks Airtightness by construction Fully continuous welded Airtight Continuity with clean room ceiling with permanent trim standard design Universal knife edge housing Silicon gel (recommended) Immediate tightness without any mechanical strength Gel belongs to filter Expanded PU possible Expanded PU Gel Cleanroom False Ceiling

10 Horizontal Flow Pharmaseals installed! CamContain Ceil Why CamContain Ceil XS or XO? 56 Price Products for Bio Safety / Pharma BSL/Pharma/Nuclear WM BIBO Production Model Pharmatain CamContain CS BSL/Pharma BSL/Pharma/Nuclear G NI auto Scanning CamContain C CamBox CamSafe NI auto Scanning CamContain CL No test NI EFF/ NI man scanning NI EFF /NI man Scan BSL 1 BSL 2 BSL 2+3 BSL 3 BSL 3+ 4 Customer Value 57 Применение для таблеточного пресса Construction of HEPA Filters Anodized Aluminum Frame Microfiberglass HEPA media Polyurethane Sealant Fiberglass or Thermoplastic Separator with adhesive Panel-type HEPA Gasket or Gel Seal Box-type HEPA Galvaneal or Stainless Steel Frame Aluminum Separator

Camfil Farr Solution System CREO (Clean Room & Energy

developed in the early 1990 s Original Clean software,

sum up Make your air filter choices based on science and

Substantial savings possible, filters are generally low

. Follow International standards & industry norms: New CREO

products and consult the industry experts Read more about

11 Camfil Farr Solution System CREO (Clean Room & Energy Optimisation) software Famous LCC Green software, first developed in the early 1990 s Original Clean software, designed to assist consulting engineers & end users 62 To sum up Make your air filter choices based on science and technique. ALWAYS make your choice based on LCC. Substantial savings possible, filters are generally low hanging fruit.. Follow International standards & industry norms: New CREO software which essentially combines LCC & Clean Use proven products and consult the industry experts Read more about our sustainability work: Sean O Reilly Global Director Bio-Pharma Segment Camfil Farr oreillys@camfilfarr.com

THE WORLD LEADER IN CLEAN AIR SOLUTIONS. Pharmaceutical Clean Air Solutions PARTICULATE AND GASEOUS FILTRATION

THE WORLD LEADER IN CLEAN AIR SOLUTIONS Pharmaceutical Clean Air Solutions PARTICULATE AND GASEOUS FILTRATION AAF Flanders has an in-depth understanding of the challenges and opportunities for pharmaceutical