Life Sciences Industry Insights
Clean air solutions
Sean O’Reilly, Camfil Farr’s Global Director, Bio-Pharma Segment, reflects on the industry events and changes during the last decade.
Welcome to Life Sciences Industry Insights — We have some very interesting articles from some top class contributors. Gordon Farquharson, a respected technical expert in cleanroom design and standards has written an excellent piece on contamination control practices in the Life Sciences industry. Don Thornburg, Camfil Farr’s HVAC expert in North America, reviews the history and present state of the ASHRAE standards. Jan Anderson, Deputy Managing Director and Head of Marketing for Camfil Farr in the Nordic Countries, updates us on the European EN779 norms. Tomm Frungillo, Camfil Farr APC VP of Focus Markets & Latin America Sales, reviews the rapid success our Dust Collection business unit has enjoyed in the Pharmaceutical sector. Finally, I will add some comments from recent discussions with industry experts on the use of HEPA filters and energy saving trends related to air filtration in the Life Sciences field.
Contents A Message from Our CEO.....................................................................................
3
Industry Insights.................................................................................................. 4-6 Contamination Control Practice in the Life Sciences.............................................
7-9
Filter Pharma Focus.............................................................................................
10-12
Camfil Farr Air Pollution Control...........................................................................
13-14
HVAC Air Filter Testing.........................................................................................
15-19
EN779:2011 A Step in the Right Direction............................................................ 20-21
A Message from our CEO
This year marks the tenth year since my appointment as Chairman & CEO of Camfil Group, and our first Pharma AirMail special. The Bio-Pharma industry remains one of our key businesses which helps drives our own product development and feeds other business units from the application challenges the industry demands.
Alan O’Connell Chairman and Chief Executive Officer Camfil Farr
Our philosophy has remained the same — we continue to develop and provide products with added value that protect the people, processes and environment. The world we operated in ten years ago though in comparison to today’s somewhat turbulent economic times has certainly changed. We have expanded our global reach to support our customers as they venture into specifically the BRIC & EEMEA regions. At the same time, we have bolstered our support in our traditional North American, European and Asian markets. Our leadership position remains solid. Our brand of products and application know-how worldwide is second to none. Our customers expect us to deliver a consistent product from Mumbai to Mexico City and Shanghai to San Juan Puerto Rico, they expect the same level of technical knowledge and support no matter where they manufacture. We are the only air filtration company who is positioned to do this and we benefit greatly from the industry continuing to choose us for their air filtration needs.
“Clean air is our contribution to society.” - Alan O’Connell
Sustainability is a word that was not on most users radar ten years ago. Today, reducing carbon footprint is not a choice it’s necessary, in fact like clean air, it’s a human right. Our goal is to continue to develop products that deliver the lowest Total Cost of Ownership (TCO) while still protecting the environment. To remain the market leader over the next decade and beyond, we will lead by example again, by practicing what we preach both internally and externally, delivering the best products on time, and reinforce the partnerships we have enjoyed for many years. To sum up, I will say, this leadership position does not come easy and involves many internal leaders within our own organization from the production floor to our cutting edge R&D teams who support our technical sales team on a global basis, without them we could not be where we are today. We look forward to enjoying continued growth in this key segment and remain the industry’s vendor of choice.
Camfil Farr
3
Industry Insights Sean O’Reilly
In 2001 Camfil Farr published a special edition of AirMail, a news magazine entitled Fantastic Pharma. The issue focused on the history of the industry and how the need for “clean air” had become a vital part of the manufacturing process since the industry’s beginning - traced back to the first pharmacies in France established in the 1100’s. In the United States, the Pharma industry began at the same time as the American Revolution in 1770’s. This industry revolution began with the arrival of sulpha drugs in the 1930’s, followed by penicillin in the 1940’s and then antibiotics in the mid-20th century. The latter has been hailed as one of the most important social revolutions in history as the advancement has nearly eliminated infectious diseases. In the 2001 edition of Fantastic Pharma, there was a technical paper on air filtration for anthrax, the average price of oil was $25 per barrel, and strong patents were yielding blockbuster drugs and large profits for “Big Pharma”. The
biotech, generic and CMO industry could not have predicted what was in store over the next ten years. At the beginning of the millennium, Camfil Farr appointed Alan O’Connell as President & CEO. His Irish roots and air filtration application experience within the Pharmaceutical sector helped foster the focus necessary to expand presence and activity globally. In 2000, Camfil acquired Farr Company, virtually doubling their size and giving them the footprint needed to support the industry in North America — especially for the expanding HVAC business. Camfil had long been recognized as the market leader in Europe supporting “Big Pharma” and associated industries. It was not long after Camfil Farr established a foothold in the North American market. As the industry invested in emerging markets – specifically BRIC – Camfil Farr either followed, or in some cases was ahead of the game, already established and ready to support the investments being made.
Most of those focused in the Life Sciences field know there have been some significant changes in the ten years since the 2001 publication of Fantastic Pharma. Consolidation, mergers and the dreaded patent cliff are some ‘highlights’ of the last ten years. The growth of the generic, CMO & biotech segments has also changed the industry landscape. Migration of the manufacturing base to the BRIC countries as well as government pressure on pricing has added to the challenges. Despite these obstacles, the market outlook remains strong. Yes, there might be fewer players and some aggressive new entries, but the industry continues to re-invent itself to adapt to these changes. Camfil Farr, not only viewed as a key supplier, but now more often as a partner, has also had to adapt to support this business segment on a global basis. Pfizer remains # 1 and passes the $50 billion mark for the first time
Credit: Pharmaceutical Engineering
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Industry Insights continued...
in 2010 fueled by the acquisition of Wyeth, Novartis jumps past Sanofi to # 2, while Merck makes a move from 7th to 4th helped by the Schering Plough purchase. Other notable moves were Abbott’s acquisition of Solvay & India’s Pirimal. The largest bump in revenue in percentage terms came from Ireland’s Warner Chilcott with the purchase of P&G’s pharma business including the billion-dollar blockbuster Actonel. Sanofi’s acquisition of Genzyme will again change the ranking and relegate Novartis to # 3 by year-end; Teva just continues its spending spree with the 2010 aquisition of Germany’s Ratipharm, not long after the Barr Labs puchase. The latest addition to the Teva family is the 2011 $6.8 billion acquisition of Cephalon, further consolidating Teva’s position in the top ten. Israel’s Teva now fills 20% of all prescription drugs in the USA. Ten years ago Camfil Farr launched our LCC (Life Cycle Cost) software in the USA — one clear example of what a difference a decade can
make. For many years, Camfil Farr has been educating and preaching to the market in multiple segments about the use of filters with low pressure drop, long life, low energy consumption and disposal implications. In other words, Camfil Farr was “green” before it was trendy to be green!
The F2000 or Sofilair Green offers longer life, fewer changeouts and significantly reduced energy costs.
The surge in energy costs over the last decade has almost forced the industry to adopt products and services that are much more sustainable. The industry, while historically slow to react, now has multiple energy saving projects in the pipeline. Filter energy saving initiatives are low hanging fruit, and relatively easy to implement with minimal capital investment. There are still possible change control and SOP challenges, although with some effort, not impossible to overcome. If there is one thing I’m sure of, the next ten years will see a 180-degree turn around and the industry will demand, expect and quite frankly, need sustainable products to maintain and increase profitability.
LCC Green software demonstrates how products such as the Hi-Flo ES can eliminate the need for prefilters.
The Durafil/Opakfil offers up to 200 square feet of media resulting in the lowest Total Cost of Ownership (TCO).
CREO software for air handler unit filter optimization and LCC
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Industry Insights continued...
In 2010 Camfil Farr upgraded the renowned LCC software to add features such as carbon footprint reduction calculations, direct comparisons with competitive products and a true comparison of a Total Cost of Ownership (TCO) calculation. For the first time, customers can make informed and educated decisions in a scientific way of when and how to optimize their air filter change frequency. In addition to the newly named LCC Green, Camfil Farr has historically offered software that allows simulation of cleanroom conditions when entering room dimensions, airflow, air change rates, occupancy levels, etc. In use since the mid 1990’s, this software had a successful introduction into the North American market, and has been used by consulting engineers to design Bio-Pharma facilities since the beginning of the millennium.
Clean room design software simplifies clean room design and air filter selection using industry standards and design criteria.
In another industry first, at the beginning of 2011 Camfil Farr launched CREO (Cleanroom Design & Energy Optimization) which is essentially a combination of Clean Room Design software & LCC Green. The software helps optimize TCO, filtration selection for supply and exhaust air, as well as simulating the target cleanroom classification from a sustainability point of view. This exciting, new software is a game changer and with continued valuable feedback from customers, expect continued development upgrades in the years to come. Version 2.0 is already in development with significant improvements planned. It will be formally launched at our North American Sales Meeting in April of 2012.
CREO Software
We have some very interesting technical articles to follow in this publication. Camfil Farr is well positioned to maintain our global leadership in the market segment for years to come.
In summary, I would like to thank all who contributed. Camfil Farr appreciates all of our customer support and partnerships over the last decade.
Camfil Farr
6
Contamination Control Practice in the Life Sciences – Clean Room and Bio-Containment Applications
In preparing this article, I looked back to see how our regulations have evolved and changed over the last ten years in the context of air filtration. I was very surprised to see that pharmaceutical GMPs (Good Manufacturing Practice) and bio-safety regulations and guidance haven’t materially changed at all. Indeed, if you look closely at the latest version of the EU GMP Annex1, you will see the same lack of specificity about the use of terminal HEPA filters……but, the regulatory expectations have certainly moved; they have become more demanding. It is important that we understand why this happens and track trends and developments to keep ahead of the game. In the cleanroom arena, we are awaiting the revision of ISO 14644-1:1999. This will have an influence on the classification of all cleanrooms. The final major consideration I want to address is our responsibility for energy saving and sustainability, and in particular aspects of energy saving in HVAC systems.
GMP Requirements GMP is a combination of documented regulations that set goals and objectives, and application of best practice which are often undocumented industry norms accepted as good practice to achieve those objectives. In the context of pharmaceutical cleanroom technology we are fortunate to find much best practice documented in the recently published ISPE HVAC good practice guide (GPG), and the second edition ISPE Baseline™ Guide for sterile products manufacturing facilities. When thinking about how to keep upto-date with GMP expectations, it is very important to understand that our GMPs are always going to be five to ten years behind the latest technology. In fact, because our GMP’s only set out to define the objectives, it is our responsibility to keep our finger on the pulse of developments. The phrase I like to use is “GMP requires that we take advantage of available technology, with the objective achieving the highest level of product quality assurance.” Within the field of air filtration and distribution, we have seen some significant developments in our understanding of the technology. In particular, our understanding of air mixing and distribution in non-unidirectional airflow clean has now improved to the point when we can predict much more effectively mixing effectiveness. This enables us not only to comply with the recovery time requirements of the EU, PIC/S, WHO and Chinese GMP, but
perhaps more importantly to enable us to develop much more efficient cleanrooms. The technology of terminal filter housings has also evolved and developed to allow us much more convenient in situ leak testing, as well as more reliable filter seal techniques. The use of proven and effective products from the marketplace helps us to meet the GMP performance with a high level of confidence. I was reviewing some recent trends in air filtration application for life science cleanrooms over the last two to three years, and found the following interesting themes. Many firms are trying to be more effective and efficient in the routine testing and certification of filtration installations. One key area seems to be a desire to extend the interval between subsequent in situ
Gordon Farquharson B.Sc.(Hons); C.Eng. UK Expert ISO TC209 Principal, Critical Systems Ltd Guildford, Surrey, GU1 2SY, UK. e-mail gjf@critical-systems.co.uk +44 (0)7785 265 909
leak tests of terminal filters, or make the testing process less invasive. The same time we have seen a number of somewhat surprising demands from regulators looking for hard evidence to justify test frequencies, provide a substantiated rationale for extending test intervals, and in a couple of cases a demand that a lifetime limit be placed on filters. It is not clear whether this last expectation has emerged from, since it is always being quite acceptable for firms to track the results of their routine leak testing in order to reach a conclusion that influence of installation continues to be robust acceptable, or needs improvement through filter replacement or other media works.
Table 1: The basic classification table proposed in ISO DIS 14644-1:2010. ISO Classification Number (N)
Maximum concentration limits (particles/m) 0.1 μm
0.2 μm
0.3 μm
24
10
0.5 μm
1.0 μm
ISO Class 1
10
ISO Class 2
100
ISO Class 3
1,000
237
102
35
ISO Class 4
10,000
2,370
1,020
352
83
ISO Class 5
100,000
23,700
10,200
3,520
832
ISO Class 6
1,000,000
237,000
102,000
5.0 μm
35,200
8,320
298
ISO Class 7
352,000
83,200
2,930
ISO Class 8
3,520,000
832,000
29,300
ISO Class 9
35,200,000
8,320,000
293,000
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Contamination Control Practice in the Life Sciences continued...
Be prepared, the ISO cleanroom standards are being revised. ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification standard ISO 14644-1:1999 for the last four years (Table 2). It is expected that the revised standard will be published towards the end of 2012. The ISO community voted for a revision to update and improve the standard specifically to address the following:
Table 2: Proposed table for determining the number of sample locations in ISO DIS 14644-1:2010 Area (m2) Less than or equal to
Minimum number of sample locations
Area (m2) Less than or equal to
Minimum number of sample locations
Area (m2) Less than or equal to
Minimum number of sample locations
2
1
36
9
108
17
4
2
52
10
116
18
6
3
56
11
148
19
8
4
64
12
156
20
10
5
68
13
192
21
24
6
72
14
232
22
28
7
76
15
276
23
32
8
104
16
352
24
436
25
500
26
• 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. In this situation, the contamination isn’t expected to be evenly distributed, an assumption the current statistical approach makes. • Generally update the standard as required to current thinking and industry requirements. • Avoid any radical change to the principles of the current ISO cleanliness classes 1-9. So, this was the challenge, and the DIS (Draft International Standard) was
published for public comment and national vote in December 2010. The proposed revised standard has some important new and revised requirements. These are summarized below: • The classification would be based on the Table 2, 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 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. • A semi-random sampling technique is proposed based on a “hyper geometric” distribution, which is the statistical model for sampling without replacement. This is a significant change from current practice, and means that each time a zone is classified, the sample locations may be different. If a firm has determined through a risk assessment, that certain locations need to be examined specifically, then these should be designated in addition to the
Megalam Green is the next generation of HEPA filters launched by Camfil Farr utilizing a plastic frame and replacing traditional anodized aluminium; another industry first.
randomly selected locations.Recognizing that the ≥5.0 micron class limit for ISO 5 has been removed in the revised standard, parties wishing to use the standard for classifying the environments EU GMP Grade A, and B “at rest” will have to use the macroparticle descriptor that is retained in the standard. Sustainability and Green Culture (choosing the right supplier partner) I don’t think I can ever remember a time when a subject in the life sciences industry has been discussed and written about so much. I was trying to think what the trigger was for the huge number of initiatives within individual firms and industry bodies that has stimulated so much discussion, seminars, and now publications concerning in particular energy efficiency and green chemistry. I reviewed the green credentials on a number of multinational pharmaceutical company websites, and found it clear that the firms were painting a picture of social responsibility and care for the environment (greenhouse gases mainly). However, each time I have been involved in the project, where sustainable design is being considered, then
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Contamination Control Practice in the Life Sciences continued...
in virtually every case, it has the essential to evaluate life-cycle costs and prove a return on investment in the range of three to seven years. It is recognized that within a biopharma facility, about 80% of the energy is consumed by the moving and associated refrigeration and chilling systems. So this is clearly an area should be targeted by designers and operators of new and established facilities. For HVAC systems, we can divide the energy saving opportunities into two areas. The first is to select system configurations that are energy efficient, and the second is to use low pressure drop components and fully life-cycle optimize system components. It is this second group that can often be applied to existing systems. Air filter selection is a key area where a holistic assessment of filter efficiency, pressure drop, filter life, disposal and purchase costs should be taken into account. Doing a good job needs an effective partnership between suppliers and industry professionals. As a designer and specifier, I use Camfil Farr’s energy saving software to help make the optimum selections. In critical aseptic processing and research applications, these predictive tools are also essential to ensure air filtration life between replacement is long enough to avoid system disruption during critical operations.
Containment housings have certainly advanced in the last ten years. More compact housings with integrated bubble-tight damper, auto scanning, aerosol injection, multiple measurement and decon devices are readily available.
Proposed ISO 29463 classification scheduled for release in 2012 Global Values Filter Class (Group)
Particle Size for Testing
Collection Efficiency (%)
Local/Leak Values
Penetration (%)
Collection Efficiency (%)
Penetration (%)
Multiple of Global Efficiency (%) -
ISO 15 E
MPPS
≥95
≤5
-
-
ISO 20 E
MPPS
≥99
≤1
-
-
-
ISO 25 E
MPPS
≥99.5
≤0.5
-
-
-
ISO 30 E
MPPS
≥99.9
≤0.1
-
-
-
ISO 35 E
MPPS
≥99.95
≤0.05
≥99.75
≤0.25
5
ISO 40 E
MPPS
≥99.99
≤0.01
≥99.5
≤0.5
5
ISO 45 E
MPPS
≥99.995
≤0.005
≥99.975
≤0.025
5
ISO 50 E
MPPS
≥99.999
≤0.001
≥99.995
≤0.005
5
ISO 55 E
MPPS
≥99.9995
≤0.0005
≥99.9975
≤0.0025
5
ISO 60 E
MPPS
≥99.9999
≤0.0001
≥99.9995
≤0.0005
5
ISO 65 E
MPPS
≥99.99995
≤0.00005
≥99.99975
≤0.00025
5
ISO 70 E
MPPS
≥99.99999
≤0.00001
≥99.9999
≤0.0001
10
ISO 75 E
MPPS
≥≤99.999995
≤0.000005
≥99.9999
≤0.0001
20
Bio-Safety Applications Finally, I thought I would look at some bio-safety air filtration issues. Rather like the Pharma GMPs, bio-safety regulations around the world set clear performance objectives, not engineering solutions. The engineering and supply side of the industry continues to develop added value solutions that slowly become good practice. Some of the current air filtration issues are questioning the real value of bag-in/ bag-out, determining the effectiveness of bio-decontamination processes (formaldehyde and hydrogen peroxide gassing), and the old chestnut of insitu leak testing (face scan or average volumetric test).
Pharmaseal — a fully welded terminal housing with integrated VCD, aerosol injection and measurement controls, with options of different diffusers is the industry’s standard.
Best engineering practice for state of the art bio-containment facilities at CL3 or CL4 facilities should include the following attributes: HEPA filter systems configured for manual or automated full face scan of filters to allow routine and on replacement filter testing. The ability to safely and effectively bio-decontaminate filters and housings to a defined level of performance using the reference spore forming indicator organism indicated by the gas or vapour used. To achieve this requires ultra-low leakage housings, tight shut-off dampers, and systems to circulate the fumigant through the filtration network. Airflow controls are essential to maintain negative pressurization of containment areas as filters foul. In conclusion, air filtration maintains a high profile as a critical component for safety and environmental control in the life sciences. The technology continues to evolve and develop to be more technically effective, cost effective, and sustainable. Success requires a real partnership between all stakeholders in the business, and we need to think of filtration solutions, not just filter elements as products.
Camfil Farr
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Filter Pharma Focus
– Quality, Productivity and Energy Reduction
Sean O’Reilly summarizes the feedback from end users on the use and importance of filters in the operations within the Pharmaceutical industry.
Why Air Filters in Pharma? Reliable and robust HVAC systems are paramount to the operation of cleanrooms for pharmaceutical production. HEPA filters play a key role when designing production facilities that comply with GMP requirements, ensure productivity and prevent excess energy consumption while not requiring excess capital investment or maintenance cost. With the choice of traditional glass fiber media, improved quality, high productivity and energy efficiency go hand in hand with the lowest cost of ownership when the correct filter at a slight premium is selected. Traditionally energy has not been a major concern in the pharmaceutical industry. With the HVAC system taking the lion’s share of the energy consumption in pharmaceutical production it is beneficial to reassess some traditional ways of thinking. Fairly simple measures can both “green” and “lean” the production. HEPA Filter Choice and Quality
panies stated: “While filter leaks are not always serious GMP deficiencies, we do prefer to have low numbers of them to reduce the non-conformity process and be able to show inspectors good re-qualification results”. For the pre-filters the situation is similar — lower airflow for a given filter increases filtering efficiency, lifetime and decreases pressure drop thereby reducing energy costs. HEPA Filters and Productivity An inherent part of running pharmaceutical cleanroom production is the recurring tests. Pharmaceutical companies have to demonstrate compliance with GMP requirements and for HVAC performance this requires tests such as room pressure differential, smoke studies, air change rate and filter leak tests. Apart from smoke studies, which are not performed that often, HEPA/ULPA filter leak tests are the most time-consuming tests. No production takes place in the rooms where tests are performed, and often the entire cleanroom suite is not productive during the HEPA certification. Nobody should argue: “we want fewer HEPA filters to reduce test time”, but no, in fact, it can be a lot faster to test more filters. An experienced certification
team can scan a filter in 5-10 minutes. That said, it can be very time consuming to change or repair filters if a leak is found, re-certification of the repaired or replaced filter adds significant time to the testing as filters need to be tested one at a time. Repairs There have been some recent discussions within the industry about what repairs are acceptable from the supplier in the factory and what repairs, if any, are allowed in the field. There is an IEST recommended practice which most filter manufacturers and end users have historically followed. The Recommended Practice IEST-RP-CC034.1 (Sect. 6.2): •
State size limits.
•
Factory repair: up to 1% of face area.No single repair larger than 2 square inches.
•
Field repair: up to an additional 3% of the face area. No single repair wider than 1.5 square inches.
An increasing number of end users will not allow ANY repairs in a Grade A space.
Quality seen as “low leak rate” and “no bleed through” is ensured through choice of quality filter media, filter to Table 3 notes the IEST Filter Classificahousing seal and correct installation and tion commonly used in the USA. It is certification. Bleed through is a phenomenon often quoted for excessive filter failure normally linked Table 3: IEST-RP-CC001 to aerosol challenge type, filter Global Values Local Leak Values efficiency selected and higher than Filter Particle Size Collection Collection Multiple of Global Penetration Penetration Type for Testing expected velocity. However, having Efficiency Efficiency Efficiency (%) (%) (%) (%) (%) all of these aspects in control there is still one other issue to consider: A 0.3a ≥ 99.97 ≤ 0.03 the volume of air flowing through B 0.3a ≥ 99.97 ≤ 0.03 Two-Flo Leak Test each filter. A standard 24” by 24” ≥ 99.97 ≤ 0.03 Two-Flo Leak Test E 0.3a (600mm by 600mm) HEPA filter H 0.1-0.2 or 0.2-0.3b ≥ 99.97 ≤ 0.03 might have a nominal flow of 90 I 0.1-0.2 or 0.2-0.3b ≥ 99.97 ≤ 0.03 Two-Flo Leak Test feet per minute (0.45 m/s) and will ≥ 99.99 ≤ 0.01 ≥ 99.99 ≤ 0.01 1 C 0.3a serve its purpose at this flow; howJ 0.1-0.2 or 0.2-0.3b ≥ 99.99 ≤ 0.01 ≥ 99.99 ≤ 0.01 1 ever by adding or choosing larger b filters, they will perform even betK 0.1-0.2 or 0.2-0.3 ≥ 99.995 ≤ 0.005 ≥ 99.992 ≤ 0.008 1.6 ter because the filtering efficiency D 0.3a ≥ 99.999 ≤ 0.001 ≥ 99.99 ≤ 0.005 5 increases as the airflow decreases. F 0.1-0.2 or 0.2-0.3b ≥ 99.9995 ≤ 0.0005 ≥ 99.995 ≤ 0.0025 5 The filters will present less leaks G 0.1-0.2 ≥ 99.9999 ≤ 0.0001 ≥ 99.999 ≤ 0.001 10 and the risk of bleed through from a Mass median diameter particles (or with a count median diameter typically smaller than 0.2 μm as noted above). a velocity point of view is reduced. b Use the particle size range that yields the lowest efficiency. One of the leading Pharma com-
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Filter Pharma Focus continued...
important to note the addition of the ‘Type K’ filter that can help address the bleed through issue and follow the H14 EN-1822 classification used in Europe (Table 4). How Long Does a HEPA Filter Last? How long is a piece of string? Most manufacturers change their HEPA filters based on pressure drop. Some users set a time frame on change frequency, especially in the most critical space (Grade A). A period of three to five years is not uncommon. There have been limited long-term studies on the HEPA lifetime, many factors influence life, inadequate pre-filtration, outside air, velocity/airflow (too high) cleanroom conditions & good housekeeping (or not) excessive loading of PAO has been quoted as reducing filter life with no real hard data. A Lawrence Livermore Labs study quoted ten years as a fair estimation of the life for a HEPA filter. In reality it can take years, in theory decades for HEPA filters to reach their final pressure drop (twice the initial is the historic rule of thumb assuming ‘normal’ design airflow). Don’t forget, we are generally recirculating clean air. There are full fresh air applications and they will obviously load sooner if the HEPA’s do not have good pre-filter protection, (i.e. MERV 14/F8 glass fiber pre-filters), then HEPA life is significantly increased. Cleaning, decon or wash-down during routine maintenance can cause more damage to a HEPA filters life than actual loading over a long period. Camfil Farr has performed studies on the common cleaning and decon agents such as Vaprox, SporeKlenz, VHP, Chlorine Dioxide, H2O2 noting no detrimental effects to the critical components used in HEPA filters such as media, urethane and gel. It is critical that the end user insists on studies and support documentation of material compatibility tests from their supplier before purchasing filters. When reducing the airflow
through a filter we not only reduce the initial pressure drop over the filter, the pressure development curve stays flat longer. Engineers know that more filters for a given volume of air will maintain a lower pressure drop over the filter’s lifetime, further decreasing the need for costly change outs. Increased life and fewer replacements have the added benefit of reducing man-hours and spare parts, but again the most costly impact is production downtime and should be minimized at all costs where possible.
to repel water/liquids). The challenge is exposure to the desired concentration of PAO (ISO states between 10-90 ug/l). Tests have shown an immediate increase in the loading of the media with a substantial impact in pressure drop when following the minimum requirement of upstream concentration. Reduction of the upstream concentration may help loading if accepted by the industry’s regulatory bodies.
The lower the pressure drop the less energy consumed by the fan. As stated by a leading Pharma company: “In our company we have set maximum pressure drop limits over all standard components for new installations — cooling and heating surfaces, ducts and air filters.” For filters, these pressure drops are listed in Table 1.
Testing with DPC typically increases setup time and specific equipment such as a dilution system, which is not readily available by industry certifiers, is required. The Total Cost of Ownership (TCO) could be interesting assuming a ‘fair’ premium for these style filters over traditional fiberglass is applied. We keep an open mind but today the availability, cost and questionable site testing requirements limits applications for this media today.
HEPA Media
Conclusion….Filter Choice
Camfil Farr has traditionally utilized glass fiber media when supplying our customers globally in Pharmaceutical air filtration applications. Media historically utilized in the microelectronics industry has some recent visibility in Pharma. PTFE (teflon) has some interesting characteristics such as lower initial pressure drop (no real proven lifetime data in Pharma), excellent mechanical strength and its hydrophobic (ability
It was reported, the way to ensure productivity, good GMP performance, low energy and maintenance cost in the Pharma world where the HEPA and ULPA filters are subject to frequent testing is to use filters with fiberglass media, large filter media area for the necessary air volume and to use a higher number of filters with large surface area.
Energy Costs
Table 1: ASHRAE 52.2 & EN779 Values Filter Value ASHRAE Standard 52.2 (Eurovent EN779)
Maximum Initial Pressure Drop (inches w.g./ Pa)
Recommended pressure drop at filter change (inches w.g./ Pa)
MERV 8 (G4)
0.10 / 25
0.20 / 50
MERV 11 (M6)
0.32 / 80
0.65 / 160
MERV 13 (F7)
0.40 / 100
0.80 / 200
MERV 15 (F9)
0.50 / 125
1.0 / 250
Inline HEPA filters
0.60 / 150
1.2 / 300
Terminal HEPA/ULPA filters
0.50 / 125
1.0 / 250
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Filter Pharma Focus continued...
Further Energy Savings Initiatives The HVAC design is very important to reduce energy consumption. Some of the design features to avoid are: Double fan recirculation, AHUs where a damper in the center controls the exhaust / fresh air volume; the dampers potentially “tax” the main flow with a pressure drop which can range from 0.02” - 2.8” w.g. (6 – 700 Pa) leading to excess fan electrical and cooling compressor energy consumption. Recirculating systems with fresh air directly into the flow. In the winter it works great, cool fresh air is mixed with heated recirculated air and if a little extra heating or cooling is needed this is done without too much energy. However in humid summer conditions all of the recirculated air has to be cooled in order to extract the additional humidity supplied by the fresh air, therefore all of the air has to be reheated afterwards. Having ensured low pressure drops over all components, filters, coils and ducts, and avoided the most inefficient designs it is time to look at the real need and smarter ways of fulfilling the needs. Real Need High air change rates are one of the means to achieve certain cleanliness levels, but it is only one of these means, others are: cleaning of the area, material sanitization and gowning. The rules
of thumb for air change rates in classified areas were made at a time when the energy costs were low. It is time to challenge the old rules of thumb and look at the other ways of achieving the cleanliness required, gowning and human behavior being the parameters with highest impact. Smarter Ways Humans contaminate the aseptic environment. Reducing the number of personnel inside the classified areas or improving their gowning behavior will lead to reduced need for high air change rates. Having realized the impact of humans it is easy to see, that when there are no humans the air change rates can be reduced dramatically. Even in a 24/7 production facility, the principle of “ventilation on demand” can be used. It was also stated : ”In a newly constructed facility we have seen this principle applied to the gowning rooms, the ventilation speeds up when personnel presence is sensed and reduced again some minutes after they have disappeared. In this manner the user can get the best of both worlds, very high cleanliness in a vulnerable area and low energy consumption”. Dedicated Units (FFU’s) The air supplied to a Pharma cleanroom serves three purposes: 1. Cleaning the air
2. Establishing a pressure cascade 3. Air conditioning Items 2 and 3 can be achieved with approximately five air changes an hour, which is a much lower air change rate than what is commonly used in higher grade production areas of the pharmaceutical plant. IItems 2 and 3 can be achieved by passing outside air through pre-filters, before heating and cooling coils and long duct runs. The pressure drop for this part of the system design is seldom below 1000 Pa total. On the contrary it is possible to clean the air in a local dedicated unit without coils and with only MERV 15 (F9) and ULPA/ HEPA filters. Delivering the air from different units according to need makes a very flexible system prepared for “ventilation on demand” and/ or “nighttime setback.” Summary I would like to thank those who contributed to this article. There are multiple initiatives supporting the industry’s demands to reduce energy costs. Reducing air change rates, smarter fan and motor selection, ‘mini-environments’ or isolator technology, along with optimizing filter selection are just some of the more common ways to realize these savings. To request a site filtration audit please contact your nearest Camfil Farr sales office.
Table 4: EN1822 Classifications Filter Class
Particle Size for Testing
Penetration (%)
E10
≥ 85
≤ 15
E11
≥ 95
≤5
E12
a
Global Values Collection Efficiency (%)
≥ 99.5
≤ 0.5
≥ 99.95
≤ 0.05
Local Leak Values Collection Efficiency (%)
Penetration (%)
Multiple of Global Efficiency (%)
≥ 99.75
≤ 0.25
5
H13
MPPSa
H14
MPPS
≥ 99.995
≤ 0.005
≥ 99.975
U15
MPPSa
≥ 99.9995
≤ 0.0005
≥ 99.9975
≤ 0.0025
U16
MPPSa
≥ 99.99995
≤ 0.00005
≥ 99.99975
≤ 0.00025
5
U17
MPPSa
≥ 99.999995
≤ 0.000005
≥ 99.9999
≤ 0.0001
20
a
≤ 0.025
5 5
MPPS - Most Penetrating Particle Size
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Camfil Farr Air Pollution Control (APC)
The History of CF APC in the Pharmaceutical Market
Dust Collector Requirements in the Market Utilized primarily in the Oral Solid Dosage (OSD) facilities where tablets are made and dust (sometimes hazardous) is created. Common dust collector uses within the OSD facilities include tablet presses, tablet coaters, fluid bed driers, filling and packaging areas and general housekeeping. Our History in the Market APC’s active focus in the Pharmaceutical industry really started one day in 2005 during a conversation between our corporate executives, our Director of Engineering, and our sales team. It began with a “strong suggestion” from our CEO that CF APC become more involved in the pharmaceutical industry. It was clearly stated, “Camfil Farr HVAC has a strong presence in Europe, North America and throughout the world within the pharmaceutical industry and there was no reason why APC should not be a part of that presence”.
Tomm Frungillo, Camfil Farr APC VP of Focus Markets & Latin America Sales
With that direction, the APC division set out to find what needed to get done to penetrate this market for dust collection. The best place to start was with the world’s largest manufacturer, Corporate Engineering and EH&S at Wyeth’s (now Pfizer) office in Collegeville, PA. The APC “pharmaceutical collector” at that time was basically a standard Gold Series unit with a large CF GB (Gasket Seal) Housing BIBO door attached. As Camfil Farr APC often does, we put a unit on a trailer and took it from the USA manufacturing center in Jonesboro AR to Collegeville PA. Technical discussions with senior global engineering & EHS staff ensued with many initial thoughts and ideas dismissed and then revisited time and time again. Listening to the end users needs and concerns was a valuable learning experience for our technical and production teams. The Camfil Farr APC Gold Cone and vertical cartridge technology grabbed the industry’s attention. With additional product development to the collector itself Camfil Farr APC had virtually
CF APC Containment Dust Collector complete w/Deflagration Suppression System
re-designed and re-built a new concept never seen before which addressed the common challenges the industry had faced but not solved in the past. It is truly an “industry designed” dust collector. What does CF APC and the Gold Series bring to the Market? Four main strengths that have allowed Camfil Farr APC to gain market share are: 1.
The Total Cost of Ownership (TCO) concept where, like Canfil Farr, we take a logical approach to comparing HemiPleat™ cartridges to competitor’s cartridges and estimate ownership costs and savings. This tool allows us to compare Energy Consumption including CO2 Footprint, Consumables including cartridge unit, shipping and inventory costs, and Maintenance including Labor, Disposal and Downtime.
2.
Independent Surrogate OEL Test Data illustrating the potential capability of particulate containment (below 1 mg/m³). The Gold Series Camtain™ dust collection system has been surrogate tested for validated performance verification. The ISPE GPG “Assessing the Particulate Containment Performance of Pharmaceutical Equipment” surrogate testing protocol was used as a guideline with an independently contracted, AIHA accredited laboratory (Bureau Veritas) performing the testing. Using 100% milled lactose as the surrogate; we collected over 48 personal, area and surface samples for both the BIBO cartridge filter change and continuous liner discharge operations. The GS Camtain™ can contain highly potent, toxic or allergenic compounds with an OEL ≥ 0.4 mcg/m³ for a time weighted average (TWA). Full test report data is available upon request.
3.
Vertical Cartridge Technology – Not a new concept but one that works.
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Camfil Farr Air Pollution Control (APC) continued...
Vertical cartridge design utilizes gravity to help shed dust into the collection hopper and more efficiently utilize compressed air cleaning from the top down, allowing for lower pressure drop and longer cartridge life. 4.
Technical Superiority especially regarding NFPA and ATEX requirements – Deflagrations are a major concern for dust collectors and their surrounding environments. NFPA and OSHA along with CE/ATEX provide specific direction in this area. Control measures such as explosion venting, chemical suppression and isolation systems may be required depending on the physical characteristics of the dust relating to Kst, MIE and the location of the collector. When explosion vents are required, they must be vented to the outside by either placing the collector outdoors or ducting the vent exhaust a specified distance through the building structure. CF APC recommends an independent authority specifies what explosion protection is required for a given material as it relates to standards in NFPA, ATEX and the major insurance carriers.
Camfil Farr APC has enjoyed very successful years in the Pharmaceutical industry. Gold Series units on pharmaceutical applications are now throughout the world including North America, Europe, South America, Asia and India. The APC division works closely with its HVAC colleagues and taps into the global sales network Pfizer continues to be a strong supporter and APC has been able to penetrate multiple end users including Eli Lilly, Novartis, BMS, BI, Cephalon, Sandoz, Covidien, GSK, Merck, Amgen and OEMs including Thomas Engineering, GEA Niro, Vector, O’Hara, Oyster Manasty. The world’s leading pharmaceutical A&E firms such as Jacobs, Fluor, CRB, IPS, CE&IC regularly consult our technical sales team for the most demanding applications. Website link: www.camfilfarrapc.com/ pharma
Tablet coating Gold Series dust collectors operating at a major pharmaceutical company.
AIR POLLUTION CONTROL Life Cycle Comparison Report for your 4 Cartridge Gold Series Dust Collector Energy Category Electrical Savings in Comparison (2080 Hours)
Using Standard Efficiency Motor
$587.01
Using Premium Efficiency Motor
$697.08
Using Premium Efficiency Motor with VFD
$2,091.23
Return on Investment for VFD
3,879 hrs. $46.53
Compressed Air Savings in Comparison (2080 Hours)
CO2 Emissions Savings to the Environment
10.05 tons
Total Energy Savings (with a VFD controller):
$2,137.76
Consumables Category Cartridge Only Replacement Savings (50% Longer)
$100.00
Transportation Savings
$10.00
Inventory Savings
$4.50
Total Consumable Savings
$114.50
Labor Savings
$58.33
Maintenance and Disposal Category
Disposal Savings
$5.00
Downtime Savings
$58.33
Total Maintenance and Disposal Savings
$121.67
Total Cost of Ownership Savings (2080 Hours)
$2,373.93
The Total Cost of Ownership Spreadsheet allows customers to simply input their existing collector information and make a quick comparison to the HemiPleat™ as to the TOTAL COST of owning cartridges and the potential money and time savings they could experience with HemiPleats™”.
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Don Thornburg Director of R&D, Camfil Farr Don has chaired numerous committees, including 52.2 promoting improved air filtration for industry users.
The History of HVAC Air Filter Testing
In the filtration industry it is common to use laboratory testing to evaluate air filter performance. However, the laboratory is not where the filter is used and thus “real life” performance is much more important. In addition, there is a big difference between Cleanroom or HEPA filter testing and HVAC (Heating Ventilation and Air Conditioning) filter testing. All true HEPA filters are individually tested as part of the manufacturing process. If the filter does not meet the minimum requirements, the filter can sometimes be repaired or it is scrapped. HVAC filters are not individually tested and are assumed to meet the performance level shown in the published literature. For Camfil Farr, HVAC filter testing is continuous throughout the life of the product in one of our many R&D facilities around the world. However, there are companies who never test their products and simply copy the literature performance of Camfil Farr or other manufacturers, and then sell the product. Most filtration users do not realize these issues are in this industry and assume the literature result and actual result will be the same. Expecting to get the same filtration performance of an HVAC product in a laboratory test would be like actually getting the 35mpg that was on the sticker when you bought that last car – remember “actual mileage may vary”. With cars or with air filters, some products do deliver the promised performance, but some are not even close. In this discussion, we will look at why these differences exist by examining the current air filtration standards, where they came from, where they are going, and what needs to be fixed along the way.
Why Air Filters The first question to ask is why do you use an air filter? Is it to save energy, to fill a hole in the air handler unit (AHU), or is it to remove particulate from the air? The first two items are attributes of an air filter; the last one is a requirement. This is a very important distinction and must be understood by the filter user. If saving energy is the only goal, take the filters out and call it a day. The cost of moving air through an AHU is directly related to the resistance to airflow of the items and components in that AHU. If you re-
move the air filters, the resistance will go down and the cost of the energy to move the air will go down in most systems. However, the particulate and contaminants in the airstream will remain and/or settle in places the owner does not want – on the equipment or worse yet, contaminating the product. Obviously, this is of major concern in the Pharmaceutical industry. HVAC Air Filter Standards The filtration industry is inundated with multiple filtration standards to classify, identify, and evaluate various performance characteristics of an air
Air Filters Testing Standards Comparison ASHRAE Standard 52.2-2007B Minimum Efficiency Reporting Value MERV
ASHRAE 52.1-1992
Composite Average Particle Size Efficiency, % in Size Range, microns
EN 779 2002
Average Arrestance
Average Dust Spot Efficiency
Average Efficiency at 0.4 micron %
Range 1
Range 2
Range 3
0.30 - 1.0
1.0 - 3.0
3.0 - 10.0
%
%
1
n/a
n/a
E3 < 20
Aavg ≥ 65
< 20
G1 A<65
2
n/a
n/a
E3 < 20
Aavg ≥ 65
< 20
G2 65< A ≤80
3
n/a
n/a
E3 < 20
Aavg ≥ 70
< 20
4
n/a
n/a
E3 < 20
Aavg ≥ 75
< 20
5
n/a
n/a
E3 ≥ 20
80
20
6
n/a
n/a
E3 ≥ 35
85
20-25
7
n/a
n/a
E3 ≥ 50
90
25-30
8
n/a
n/a
E3 ≥ 70
92
30-35
G3 80< A ≤90
9
n/a
n/a
E3 ≥ 85
95
40-45
10
n/a
E2 ≥ 50
E3 ≥ 85
96
50-55
11
n/a
E2 ≥ 65
E3 ≥ 85
97
60-65
12
n/a
E2 ≥ 80
E3 ≥ 90
98
70-75
G4 90< A F5 40< E ≤60 F6 60< E ≤80
13
n/a
E2 ≥ 90
E3 ≥ 90
98
80-85
F7 80< E ≤90
14
E1 ≥ 75
E2 ≥ 90
E3 ≥ 90
99
90-95
F8 90< E ≤95
15
E1 ≥ 85
E2 ≥ 90
E3 ≥ 90
99
95
F9 95< E
16
E1 ≥ 95
E2 ≥ 95
E3 ≥ 95
100
99
H10
Note: The final MERV value is the highest MERV where the filter data meets all requirements of that MERV.
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The History of HVAC Air Filter Testing continued...
filter. In the USA, the organization known as ASHRAE (American Society of Heating, Refrigerating, and Air-Conditioning Engineers) was founded in 1894 and is currently an international organization of 50,000 persons. As a service to their membership, ASHRAE develops standards for both its members and others professionally concerned with the design and maintenance of indoor environments. ASHRAE has published a laboratory filtration performance standard for testing air filters since 1968 and all have been accredited by the American National Standards Institute (ANSI) to define minimum values or acceptable performance. In Europe, the history of the filtration standards mimics the ASHRAE standard path. The European Committee for Standardization (CEN) formalized their filtration standard in 1993 with the publication of EN-779:1993. This document was very similar to ASHRAE 52.1-1992 and with only minor differences, used the same equipment and test method of the ASHRAE standard. In 2002 CEN followed the ASHRAE lead by revising EN-779 into a particle removal efficiency standard similar to ASHRE 52.2. However, this new document EN-779:2002 had some striking differences, both good and bad. The chronological history of these filtration standards is listed below: •
ASHRAE Standard 52-68 – Methods of Testing Air-Cleaning Devices Used In General Ventilation For Removing Particulate Matter
•
ASHRAE Standard 52-76 – Revision to 52-68
•
ASHRAE Standard 52.1-1992 – Revision to 52-76
•
EN-779:1993 – Particulate Air Filters For General Ventilation. Determination Of The Filtration Performance
•
ASHRAE Standard 52.2-1999 – Method of Testing General Ventilation Air-Clean-
H14 Type K
Typical air filtration design for a Pharmaceutical manufacturing facility ing Devices for Removal Efficiency by Particle Size •
EN-779:2002 – Revision to EN-779:1993
•
ASHRAE Standard 52.2-2007B – Revision to 52.2-1999
The 1968, 1976, and 1992 versions of Standard 52/52.1 and the EN779:1993 standard were very similar since all of these documents evaluated filters for the following and all used ASHRAE dust as shown as follows:
efficiency measurements taken after various stages of loading the filter with synthetic ASHRAE test dust. Unfortunately, this synthetic test dust has little resemblance to the dust a filter will experience in an operating AHU. Thus, the average efficiency has little to no value to a user in evaluating how the filter will perform in an actual environment. his value is commonly called “Dust Spot” or simply “DS” and filters were usually marketed with a range such as 60-65% DS. (This method was developed in the 1940’s before the advent of particle counters.)
Average Dust Weight Arrestance - This is the mass of ASHRAE test dust captured by the filter divided by the mass of ASHRAE test dust fed to the filter. Commonly called “Arrestance”, it is a value used to evaluate low end filtration devices such as residential air filters. It should only be expressed in whole numbers and generally in increments of 5% points since the accuracy is very low.
Dust Holding Capacity - This is the weight of ASHRAE test dust the test filter can retain up to a given final resistance to airflow. Commonly called “Dust Capacity” or “DHC” it should only be reported in whole numbers, i.e. 122g DHC. This value is intended to give a comparative “life” value for an air filtration device, i.e. the higher the DHC, the longer the life.
Atmospheric Average Dust Spot Efficiency This is a filter efficiency value based on the difference of the light transmission between two white media samples, one from the upstream and one from the downstream side of the test filter. It is an Average efficiency based on the clean filter efficiency and subsequent
Resistance to Airflow - This is the measurement of the differential pressure loss resulting from moving air through an air filter. It is measured at 4 different air flow rates. Commonly call “Pressure Drop” or “Initial” resistance. The 1999 release of ASHRAE Standard 52.2
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The History of HVAC Air Filter Testing continued...
included the same Resistance to Airflow as the 52/52.1 series, but introduced the following new items: PSE or Particle Size Efficiency - This is the particle removal efficiency of an air filtration device for a specific particle size range. There are 12 ranges defined from 0.3μm to 10.0μm and the PSE is reported in each of these ranges. MERV – Minimum Efficiency Reporting Value - The filter is loaded with ASHRAE dust and PSE measurements are taken at various loading stages and also reported. The minimum PSE for each of the 12 ranges is used to find the MERV for the filtration device based on Table 12-1 from the standard and shown in Figure 1. The MERV, as it is commonly referred to, replaced the Average Dust Spot Efficiency values used for the last 24 years.
In 2002 CEN released the 2002 version of the European EN-779 standard. As with the 1999 revision to the ASHRAE document, this new procedure converted from Dust Spot efficiency to a particle removal test method. The actual test method and equipment used is different between the two standards in a number of ways with the most important variations listed below: Particle size range measured – Since 99% of all the particulate found in atmospheric air is below 1.0 micron it is important to know the filtration performance below that point. ASHRAE went with a higher upper limit to be able to provide particle removal efficiency for lower end pre-filters. •
ASHRAE 52.2 – 0.3 micron to 10.0 microns
•
EN-779 – 0.2 micron-3.0 microns
•
Test Aerosol – The selection of aerosol goes with the size range. DEHS is easier to work with, but cannot be produced above 3.0 microns. KCl covers the full size range, but has to be neutralized.
•
ASHRAE 52.2 challenges the filter with a solid phase KCl aerosol (Potassium Chloride)
•
EN-779 challenges the filter with a liquid phase DEHS aerosol (Di-2-ethylhexyl sebacate)
•
Minimum Efficiency vs. Average Efficiency – ASHRAE made a bold move in getting away from the artificially inflated average efficiency values produced by loading a filter with ASHRAE dust. EN779 continued the historical trend of using the inflated averages.
•
ASHRAE 52.2 uses the minimum efficiency curve at all 12 particle size ranges from each of the loading steps. In almost EVERY filter tested, the minimum value is always the initial or clean filter value.
•
EN-779 uses the average efficiency at 0.4 microns, but this value is still based on loading with ASHRAE dust.
•
Conditioning vs. Discharging – Filters made with a media that has an electrostatic charge can show results, when tested per either standard, that are higher than how that filter will perform in an AHU.
•
ASHRAE 52.2-1999 did not address this within the test method.
•
EN-779:2002 took a very positive approach in requiring the use of Annex A. This Annex required the media from the filter be subjected to a discharging method such as an Isopropanol (IPA) dip and then tested for particle removal efficiency. This data would show the user if the media was charged and if
so, how far it might drop in efficiency when installed in service.
Major Encompassing Changes in 2008
The 52.2 standard is under an ASHRAE program of continuous maintenance where the Standards Committee meets at least twice a year to discuss and propose changes that would be beneficial to users of the standard. Most quality air filtration manufacturers attend and participate within this committee. Those who simply sell on price or “print their own values” have no need for an industry standard and do not participate. In 2007, ASHRAE re-published 52.2 with only minor error corrections. However, in 2008, a major revision took place with the publication of ASHRAE 52.2-2007B. This revision added the same DHC and Arrestance values from 52.1 into 52.2 which allowed ASHRAE to eliminate 52.1 as a Standard. In addition, ASHRAE 52.2-2007B introduced Appendix J which was developed from an ASHRAE funded research project studying the loss of efficiency in some air filtration
A technician views air filter testing results from one of the test ducts at Camfil Farr’s air filter technology center in Sweden.
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The History of HVAC Air Filter Testing continued...
devices. The result and recommendation of that research was to replace existing 30g loading of ASHRAE dust as a filter conditioning step. The Appendix J procedure replaces this with a challenge using fine aerosol of KCl (potassium chloride) to condition the filter with an aerosol that closely mimics the aerosol size particle distribution that air filters will experience in an AHU. This procedure provides air filter users an additional value so they can further ensure the filter’s performance for the intended application. The Appendix was developed because filter users and committee members recognized that with certain types of filters being sold, the resulting MERV from the 52.2-1999 test procedure was not the same level of particle removal efficiency that users were experiencing in the field. This was even mentioned in the forward of the 52.2-1999 Standard:
this electrostatic charge to achieve the published filter efficiency (MERV value). As atmospheric air passes through the filter with 99% of the particulate less than 1.0μm in size, this very fine particulate will dissipate/ mask/neutralize the charge affect and the filter quickly loses efficiency. This performance drop will be evident to users if the procedure in Appendix J is used. Filters that use fine fiber media operate on mechanical principles of particle removal, including impingement and diffusion. They do not lose efficiency over time and typically, their rated MERV will be the same MERV obtained when testing using the optional method in Appendix J. The user may take comfort that the published efficiency of the filter will be consistent throughout the life of the filter.
Why is Appendix J Non-Mandatory? To most reasonable adults this procedure should be a required part of the Standard. However, a good industry standard is one that everyone may not like, but they can live with it. The Standards Committees are made up of people from many different companies with many different agendas, such as media manufacturers, filter manufacturers, testing firms, research firms, filtration users to name a few. The 52.2 Committee had been trying to get this new procedure into the standard for over five years with no results. In 2007, a compromise of making it a Specifiable item, but a non-mandatory item was finally reached, which allowed the committee members to reach a consensus. 52.22007B fits the definition since the Committee “does not like it, but they can live with it”.
“Some fibrous media air filters have electrostatic charges that may either be natural or imposed upon the media during manufacturing. Such filter may demonstrate high efficiency when clean and 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.” In other words – “your actual mileage may vary”. The optional KCl conditioning step is the outcome of multiple ASHRAE funded research projects and industry input. These studies have shown that coarse fiber media enhanced with an electrostatic charge perform differently in real-life applications. Coarse fiber media depends on
Camfil Farr provides all data prescribed in the ASHRAE Standard to allow the user to select the appropriate filter based upon maintained efficiency and lowest Total Cost of Ownership (TCO).
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The History of HVAC Air Filter Testing continued...
So, why do you use an Air Filter? In the Pharmaceutical industry, the importance of quality air filtration is at an all-time high. Issues from product contamination, equipment protection, employee health concerns, and energy are but a few of the topics affected by air filtration. All of these issues have one common thread – without particulate removal there is no point in installing an air filter. If the filter being installed is going to drop in particle removal efficiency, how does the owner/user know what level of protection is being delivered from the air filtration system? This is the reason it is very important that users and specification writers incorporate the Appendix J testing requirement into their documentation. A filter that meets the minimum required level of particle removal efficiency after being subjected to Appendix J will, in all likelihood, maintain that same level of particle removal efficiency in “real life’ conditions. Where is the Industry Headed? We have covered the current industry standards in the USA and in Europe. In Europe, there is another revision underway to EN-779:2011 that is due to be published very soon. This set of changes will bring CEN and ASHRAE a little closer together in that this version of EN-779 will switch to a minimum efficiency standard and finally drop the inflated average efficiency values. One topic remains on both continents; the treatment of enhanced media and filter performance that does not sustain in service (electrostatic charge). This remains the biggest area of concern and causes the biggest heated discussions. In order to bring filtration standards into a global community, Camfil Farr spearheaded the formation of an International Standards Organization
(ISO) technical committee on air and gas filtration. The group was started with one working group on particulate filtration, and over the last six years has grown into twelve working groups covering every aspect of air and gas filtration. This committee will begin publishing new filtration test methods beginning in 2011 with the new ISO HEPA filtration standards. The new ISO filtration standards for the HVAC filters are well underway and will begin publication in 2012. The new global test procedure (ISO #16890) should be out in 2014 and will include a new classification system, test procedure, discharging procedure, and a gravimetric test method (Arrestance and DHC type procedures). In addition, the ISO particulate filtration working group is working on standards for calculation of the Life Cycle Cost (LCC) for operating an air filtration device, an energy rating system for air filters, definitions of test dusts to be used in evaluating air filters, and an In-Situ test procedure for field testing of air filtration devices. This field test method should be published in 2012 and will define a method of test to evaluate filtration performance where it is most important – in the users system and while operating under the actual field conditions. ASHRAE has a guideline for this procedure called Guideline 26-2008, but the ISO document is going forward as a Standard. The purpose of these ISO documents is to unite the various national test methods and rating methods, and allow global companies to specify and evaluate air filtration using the same criteria and expect the same performance results in China, Germany, or in the USA.
Appendix J test report. •
A complete report will include test on two filters, one with Appendix J conditioning and one with normal 52.2 conditioning.
•
Look for both the MERV and the MERVA values as you are comparing filters to confirm you are getting a filter that will provide its rated efficiency during its entire time in use.
•
If time permits, run a side by side comparison of air filter in separate but similar AHU’s and use ASHRAE Guideline 26-2008 testing to evaluate the actual filtration performance in your system. After all, the only place efficiency matters is in your system, not in an ASHRAE test lab.
•
Choose air filters that use a fine fiber media that is not dependent upon an electrostatic charge. These filters maintain their efficiency over time as opposed to filters that use coarse fibers that are dependent upon an electrostatic charge, which dissipates and loses efficiency over time.
•
Always consider the Total Cost of Ownership (TCO). Evaluation should include product cost, filter life, energy cost over the life of the filter, labor to install and remove filters, and disposal expense.
Last and most important, always remember “Your Mileage May Vary”! Filter manufacturers will tell you what they want you to hear and leave out the important information. It is up to the customer to ask the questions and MAKE them prove their filter actually does what they claim. With that approach the customer will always win. References The Long-Term Performance of Electrically Charged Filters in a Ventilation System, Peter C. Raynor and Soo Jae Chae, Division of Environmental Health Sciences, University of Minnesota, Minneapolis, Minnesota. Air Filtration in the 21st Century, Jan Gustavsson, University of Stockholm. Impact Of Air-Filter Condition On HVAC Equipment, J. Jung, Oak Ridge National Laboratory. ASHRAE is a registered trademark of the American Society of Heating, Refrigeration and Air-Conditioning Engineers.
What to do in the Mean Time? •
When specifying air filters, require the manufacturer to provide a complete
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EN779:2011
Jan Andersson is Deputy Managing Director and Head of Marketing for Camfil Farr in the Nordic countries. He is also Product Manager for the company’s Comfort Air Filters in Europe and Chairman of Product Group 4B “Air Filters” (PG4B) within Eurovent.
A Step in the Right Direction
The air filter market is expanding in Europe. It is expected to grow even more when all new buildings have to meet “zero-energy” requirements by 2020/21 (2018/2019 for public buildings). A zero-energy (ZEB) building is a popular term to describe buildings with zero net energy consumption and zero carbon emissions annually. A ZEB is basically a residential or commercial building with greatly reduced energy needs through efficiency gains. These “ZEBs” will need effective ventilation supplying high indoor air quality (IAQ), which in turn will require the use of high-quality air filters. Evolution of Filter Classes Over the years, our industry has seen the basic purpose of air filtration shift. Air filters used to be selected to protect ventilation equipment – today, their main function is to improve the indoor climate and protect the health of people. Today’s polluted air in urban environments may cause headaches, cardiovascular and respiratory problems. Clean filtered air, on the other hand, leads to improved work performance, reduced absenteeism due to illness and enhanced well-being. Over the years, filter classes have also progressed from low filter levels, such as G4 and F5, to today’s high filtration classes, F7 and F9, with F7 being the most common and minimum class for guaranteeing acceptable IAQ. Unfortunately, there is a paradoxical relationship between filter classes and energy savings because the better the filter, the higher the energy consumption since a filter’s resis-
tance to air flow and pressure drop often increase. Due to their resistance to the air flow, air filters account for at least 30 percent of a ventilation system’s energy consumption today. With energy costs spiralling, the cost of cleaning, supplying and exhausting air in buildings has consequently become a major concern today and the choice of the right filters can help. Improving the energy efficiency of HVAC systems is another way to make buildings greener and combat climate change. Filters with the lowest pressure drop development, such as those manufactured and marketed by Camfil Farr, help customers reduce energy costs. Simply put, less energy is required to “push” air through the filters, which also maintain their efficiency longer, compared to low-cost products with poorly functioning filter media and/or insufficient filtration area. In Eurovent’s Product Group 4B “Air Filters” (PG4B), we have discussed pressure drop considerably and the energy classification of filters. The Table 1: Classification of Air Filters Group
Coarse
Class
Final Test Pressure Drop (Pa)
50 ≤ Arr < 65 65 ≤ Arr < 80
G4 Medium
on
The new European standard for air filters (EN779:2011) is coming into force this autumn. Its purpose is to classify air filters based on their minimum filtration efficiency (ME) on 0.4μm particles. Camfil Farr, in its position as a leading air filter manufacturer, welcomes the new standard and considers it a step towards improving IAQ. The industry has now voted for tougher Average Efficiency (Em) of 0.4 micron Size Particles (%)
Minimum Efficiency2 of 0.4 micron Size Particles (%)
80 ≤ Arr < 90 90 ≤ Am
M5
40 ≤ Em < 60
M6
60 ≤ Em < 80
F7 Fine
comment
A Welcomed Initiative
Average Arrestance (Am) of Synthetic Dust (%)
G2
250
Let me now EN779:2011.
1
G1 G3
Eurovent Guideline 4/11 – “Energy Efficiency Classification of air filters for general ventilation purposes” – is ready and published on Eurovent’s website. Starting in January 2012, Eurovent Certification will certify all fine filters that will be assigned an energy efficiency class (A to G) tested according to EN779:2011. They will also be labelled according to their annual energy consumption, initial efficiency and minimum efficiency (ME).
80 ≤ Em < 90
35
F8
90 ≤ Em < 95
55
F9
95 ≤ Em
70
450
Notes 1 The characteristics of atmospheric dust vary widely in comparison with those of synthetic dust used in the 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 fibers can also adversely affect efficiency. 2 Minimum efficiency is the lowest efficiency among the initial efficiencies, discharged efficiency and the lowest efficiency throughout the test procedure.
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EN779:2011 continued...
requirements for air filters. National versions will be available, after which the former standard will no longer apply. In Camfil Farr’s view, the new standard will help eradicate a number of problems related to filter performance. One of these problems is associated with electrostatic-charged synthetic filters. These filters usually demonstrate good initial filtration efficiency while they keep their charge, but tend to discharge extremely rapidly, often after just a few weeks of operation. F7 performance in the lab for an electrostatically charged filter can therefore decrease to F5 in real operating conditions, and sometimes even more. Their cleaning ability deteriorates considerably as a result. Unfortunately, far too many European buildings are now using electrostatically charged F7 filters that have medium efficiency (ME) values between 5 and 10 percent. As a consequence, as much as 90 to 95 percent of the contaminants in outdoor air find their way into buildings and pollute the indoor environment. By basing classification on an ME of at least 35 percent for F7, the new EN779:2011 standard will force these filters out of the market. At the same time, it will contribute to the development of synthetic filter materials offering considerably higher particle separation. Not All Filters Are the Same – Even in the Same Class
there is a possibility that “good” filters will be made “worse”. Although energy savings can be achieved by having the lowest possible pressure drop, such development could be retrograde. For example, on 0.4μm particles, Camfil Farr’s Hi-Flo XLT7 (class F7) filter has an ME value of 56 percent. However, to be classified as an F7 filter, the standard requires no more than 35 percent. Camfil Farr’s position on this is clear: we will not lower the efficiency of our Hi-Flo filters. Air quality would deteriorate approximately 40 percent if we did. However, there is a risk that other manufacturers will not think like us. They may see the standard as an opportunity to reduce pressure drop and, thereby, energy consumption. This could unfortunately result in poorer air quality. At Camfil Farr, we have always put every effort into improving IAQ. Thus, no one is more pleased than us that the new EN779:2011 air filter standard imposes tougher requirements even if the requirements are not as tough as we would have liked and do not meet the quality standards set for our own air filters.
Available from www.camfilfarr.com.
We welcome further debate and discussion on this. For further information download our brochure, “New filter standard EN 779:2011”, available in PDF format on our website www.camfilfarr.com.
Regrettably, the price for this will include higher pressure drops and increased energy consumption. Camfil Farr has one concern about the new classification: while the “worst” filters will vanish from the market,
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Setting the Standard for Air Quality and Filter Technology
Camfil Farr Road Show The Camfil Farr Road Show, based in Europe, allows visitors to review the latest air quality and air filter technology. In-place testing equipment demonstrates air filter perfomance under local air quality conditions. Promoted to local politicians, manufacturers and customers, it advocates clean air as a human right.
Worldâ&#x20AC;&#x2122;s Most Advanced Testing Laboratory Camfil Farrâ&#x20AC;&#x2122;s corporate laboratory in Trosa, Sweden offers air filter evaluation beyond any level presented anywhere including universities and other filter manufacturers. Long a leader in particulate filter evaluation for commercial and HEPA grade filters, Camfil Farr has added the most extensive gaseous testing laboratory in the world.
Mobile Filter Testing Laboratories Our mobile lab has been used at multiple pharmaceutical facilities in the USA & Europe to validate our LCC/TCO projections. The mobile lab measures filter efficiency, pressure drop, temperature, humidity and filter related energy consumption all through cell phone technology and without disrupting the site facilities, and most importantly giving a true representation of how Camfil Farr (and competitorâ&#x20AC;&#x2122;s filters) perform in your environment!
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Camfil Farr’s Global Bio-Pharma Team at a meeting in our German manufacturing facility in March of 2011. Over 50 people from 19 countries and regions were represented. Product development, sharing best practices, key account management, global filtration standards and sustainability were some of the topics focused on during our 3-day meeting.
Camfil Farr has direct sales locations, manufacturing facilities, agents, authorized distributors and representatives throughout the world. Manufacturing
Agents
Direct Sales Offices
For a list of these locations and additional local Distributors and Representatives please consult your country’s page on www.camfilfarr.com.
Camfil Farr www.camfilfarr.com
Camfil Farr
© 2011 Camfil Farr
Locations Worldwide to Serve You
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Camfil Farr â&#x20AC;&#x201C; Life Sciences Industry Insights
CAMFIL FARR is the worldâ&#x20AC;&#x2122;s largest and leading manufacturer of air filters and clean air solutions There is a good chance that, at this very moment, you are breathing clean air that has passed through an air filter manufactured by us. Our products can be found everywhere from offices to clean rooms for sensitive electronics production, mines, factories, hospitals and nuclear power stations. Camfil Farr is a global company with 29 subsidiaries, 23 production plants and an extensive network of agents in Europe, North America and Asia.
www.camfilfarr.com For further information please contact your nearest Camfil Farr office.