life sciences industry insights - andrews filter

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, Camfi l Farr’s HVAC expert in North America, reviews the history and present state of the ASHRAE standards. Jan Andersson, Deputy Managing Director and Head of Marketing for Camfi l Farr in the Nordic Countries, updates us on the European EN779 norms. Tomm Frungillo, Camfi l 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 fi lters and energy saving trends related to air fi ltration in the Life Sciences fi eld.

- Sean O’Reilly

Contents

A Message from the 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

This year marks the tenth year since my appointment as President & CEO of Camfi l Group, and our fi rst Pharma AirMail special. The Bio-Pharma industry remains one of our key businesses which helps drive our own product development and feeds other business units from the application challenges the industry demands.

Our philosophy has remained the same — we continue to de-velop 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 specifi cally 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 sup-port no matter where they manufacture. We are the only air fi ltration company who is positioned to do this and we benefi t greatly from the industry continuing to choose us for their air fi ltration needs.

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 orga-nization from the production fl oor 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 seg-ment and remain the industry’s vendor of choice.

Camfil Farr 3

Alan O’ConnellPresident and

Chief Executive Offi cerCamfi l Farr

“Clean air is our contribution to society.”

- Alan O’Connell

“Sustainability means that you meet the needs of the present and the future with the lightest footprint possible.”

In 2001 Camfil Farr published a spe-cial edition of AirMail, a news maga-zine 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 estab-lished in the 1100’s.

In the United States, the Pharma in-dustry began at the same time as the American Revolution in 1770’s. This industry revolution began with the arrival of sulfur 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 advance-ment has nearly eliminated infec-tious 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 expe-rience within the Pharmaceutical sector helped foster the focus neces-sary to expand presence and activity globally. In 2000, Camfil acquired Farr Company, virtually doubling their size and giving them the foot-print 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 sup-porting “Big Pharma” and associ-ated 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.

Industry InsightsSean reflects on the industry changes over thelast decade, both inside and outside of Camfil Farr.

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 ag-gressive 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.

Credit: Pharmaceutical Engineering

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Sean O’Reilly, Global Director

Cleanroom& Bio-Pharma Segment

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).

The F2000 or Sofilair Green offers longer life, fewer changeouts and significantly reduced energy costs.

Pfizer remains # 1 and passes the $50 billion mark for the first time 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 Scher-ing 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 spend-ing spree with the 2010 acquisition of Germany’s Ratipharm, not long after the Barr Labs purchase. 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. In other words, Camfil Farr was “green” be-fore it was trendy to be green!

The surge in energy costs over the last decade has almost forced the industry to adopt products and services that are much more sustain-able. The industry, while historically slow to react, now has multiple en-ergy 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 im-possible 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.

Industry Insightscontinued...

CREO software for air handler unit filter optimization and LCC Camfil Farr 5

In 2010 Camfil Farr upgraded the re-nowned 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 Own-ership (TCO) calculation. For the first time, customers can make informed and educated decisions in a scientif-ic 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 simula-tion 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 introduc-tion into the North American market, and has been used by consulting engineers to design Bio-Pharma facilities since the beginning of the millennium.

In another industry first, at the beginning of 2011 Camfil Farr launched CREO (Cleanroom Design & Energy Optimization) which is essen-tially 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 develop-ment with significant improvements planned. It will be formally launched at our North American Sales Meeting in April of 2012.

We have some very interesting technical articles to follow in this publication. I would like to thank everybody who contributed.

Clean room design software simplifies clean room design and air filter selection using industry standards and design criteria.

Industry Insightscontinued...

CREO Software

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Camfil Farr appreciates all of our customers support over the last de-cade and looks forward to continued partnerships.

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 fi ltration. I was very surprised to see that pharmaceutical GMPs (Good Manufacturing Practice) and biosafety regulations and guidance haven’t materially changed at all. Indeed, if you look closely at the latest version of the EU GMP Annex 1, you will see the same lack of specifi city about the use of terminal HEPA fi lters……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 infl uence on the classifi cation of all cleanrooms. The fi nal major consideration I want to address is our responsibility for energy saving and sustainabil-ity, and in particular aspects of energy saving in HVAC systems.

GMP Requirements

GMP is a combination of documented regulations that set goals and objec-tives, and application of best practice which are often undocumented indus-try 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 ster-ile products manufacturing facilities.

When thinking about how to keep up-to-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 technol-ogy, with the objective achieving the highest level of product quality assur-ance.” Within the field of air filtration and distribution, we have seen some significant developments in our under-standing of the technology. In particu-lar, 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 ter-minal 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 prod-ucts 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 inter-esting 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

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 sub-stantiated 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 accept-able 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.

Contamination Control Practice in the Life Sciences– Clean Room and Bio-Containment Applications

Table 1: The basic classifi cation table proposed in ISO DIS 14644-1:2010.ISO Classifi cation Number (N)

Maximum concentration limits (particles/m)

0.1 μm 0.2 μm 0.3 μm 0.5 μm 1.0 μm 5.0 μm

ISO Class 1 10

ISO Class 2 100 24 10

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 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

Gordon FarquharsonB.Sc.(Hons); C.Eng.UK Expert ISO TC209 Principal, Critical Systems LtdGuildford, Surrey, GU1 2SY, UK.e-mail [email protected]+44 (0)7785 265 909

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Be prepared, the ISO cleanroom standards are being revised.

ISO Technical Committee 209 has been working on the revision of the basic airborne cleanli-ness 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 im-prove the standard specifically to address the following:

• Simplify the classification pro-cess, 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 re-quired to current thinking and indus-try requirements.

• Avoid any radical change to the prin-ciples of the current ISO cleanliness classes 1-9.

So, this was the challenge, and the DIS (Draft International Standard) was

Table 2: Proposed table for determining the number of sample locations in ISO DIS 14644-1:2010

Area (m2) Less than or

equal to

MinimumNumber

of Sample Locations


equal to

MinimumNumber

of Sample Locations


equal to

MinimumNumber 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

published for public comment and national vote in December 2010. The proposed revised standard has some important new and revised require-ments. 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 ap-propriate 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 geo-metric” distribution, which is the statistical model for sampling with-out replacement. This is a significant change from current practice, and means that each time a zone is clas-sified, the sample locations may be different. If a firm has determined through a risk assessment, that cer-tain locations need to be examined specifically, then these should be designated in addition to the ran-

domly selected locations. Recogniz-ing 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 macro-particle 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 sci-ences 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 discus-sion, seminars, and now publications concerning in particular energy effi-ciency and green chemistry. I reviewed the green credentials on a number of multinational pharmaceutical com-pany websites, and found it clear that the firms were painting a picture of social responsibility and care for the environment (greenhouse gases main-ly). However, each time I have been involved in the project, where sustain-able design is being considered, then

Megalam Green is the next generation of HEPA filters launched by Camfil Farr utilizing

a plastic frame and replacing traditional anodized aluminum; another industry first.

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Contamination Control Practice in the Life Sciencescontinued...

in virtually every case, it has the es-sential 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 Bio-pharma 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 compo-nents. 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 efficien-cy, pressure drop, filter life, disposal and purchase costs should be taken into account. Doing a good job needs an effective partnership between sup-pliers and industry professionals. As a designer and specifier, I use Camfil Farr’s energy saving software to help make the optimum selections. In criti-cal aseptic processing and research applications, these predictive tools are also essential to ensure air filtra-tion life between replacement is long enough to avoid system disruption during critical operations.

Biosafety Applications

Finally, I thought I would look at some biosafety air filtration issues. Rather like the Pharma GMPs, biosafety regulations around the world set clear performance objectives, not engineer-ing 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 in-situ leak testing (face scan or average volumetric test).

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 ef-fectively bio-decontaminate filters and housings to a defined level of perfor-mance using the reference spore form-ing indicator organism indicated by the gas or vapor 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 pressur-ization 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 effec-tive, and sustainable. Success requires a real partnership between all stake-holders in the business, and we need to think of filtration solutions, not just filter elements as products.

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

Filter Class

(Group)

Particle Size

for Testing

Global Values Local/Leak Values

Collection Efficiency

(%)

Penetra-tion(%)


(%)

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

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Contamination Control Practice in the Life Sciencescontinued...

Pharmaseal — a fully welded terminal housing with integrated VCD, aerosol injection

and measurement controls, with options of different diffusers is the industry’s standard.

Filter Pharma Focus – Quality, Productivity and Energy Reduction

Why Air Filters in Pharma?

Reliable and robust HVAC systems are paramount to the operation of clean-rooms for pharmaceutical produc-tion. 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 produc-tivity and energy efficiency go hand in hand with the lowest cost of ownership when the correct filter at a slight pre-mium 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 consump-tion in pharmaceutical production it is beneficial to reassess some traditional ways of thinking. Fairly simple measures can both “green” and “lean” the produc-tion.

HEPA Filter Choice and Quality

Quality seen as “low leak rate” and “no bleed through” is ensured through choice of quality filter media, filter to housing seal and correct installation and certification. Bleed through is a phenomenon often quoted for ex-cessive filter failure normally linked to aerosol challenge type, filter efficiency selected and higher than expected velocity. However, having all of these aspects in control there is still one other issue to consider: the volume of air flowing through each filter. A standard 24” by 24” (600 mm by 600 mm) HEPA filter might have a nominal flow of 90 feet per minute (0.45 m/s) and will serve its purpose at this flow; how-ever by adding or choosing larger filters, they will perform even bet-ter because the filtering efficiency increases as the airflow decreases. The filters will present less leaks and the risk of bleed through from a velocity point of view is reduced. One of the leading Pharma com-

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-qual-ification results”.

For the pre-filters the situation is similar — lower airflow for a given filter in-creases filtering efficiency, lifetime and decreases pressure drop thereby reduc-ing energy costs.

HEPA Filters and Productivity

An inherent part of running pharma-ceutical cleanroom production is the recurring tests. Pharmaceutical compa-nies have to demonstrate compliance with GMP requirements and for HVAC performance this requires tests such as room pressure differential, smoke stud-ies, 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 consum-ing 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 discus-sions within the industry about what repairs are acceptable from the sup-plier 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.

Table 3 notes the IEST Filter Classifica-tion commonly used in the USA. It is

Sean O’Reilly summarizes the feedback from end users on the use and importance of fi lters in the operations within the Pharmaceutical industry.

Table 3: IEST-RP-CC001

Filter Type

Particle Sizefor Testing

Global Values Local Leak Values


(%)

Penetration (%)


(%)

Penetration (%)

Multiple of GlobalEfficiency

(%)

A 0.3a ≥ 99.97 ≤ 0.03

B 0.3a ≥ 99.97 ≤ 0.03 Two-Flo Leak Test

E 0.3a ≥ 99.97 ≤ 0.03 Two-Flo Leak Test

H 0.1-0.2 or 0.2-0.3b ≥ 99.97 ≤ 0.03

I 0.1-0.2 or 0.2-0.3b ≥ 99.97 ≤ 0.03 Two-Flo Leak Test

C 0.3a ≥ 99.99 ≤ 0.01 ≥ 99.99 ≤ 0.01 1

J 0.1-0.2 or 0.2-0.3b ≥ 99.99 ≤ 0.01 ≥ 99.99 ≤ 0.01 1

K 0.1-0.2 or 0.2-0.3b ≥ 99.995 ≤ 0.005 ≥ 99.992 ≤ 0.008 1.6

D 0.3a ≥ 99.999 ≤ 0.001 ≥ 99.99 ≤ 0.005 5

F 0.1-0.2 or 0.2-0.3b ≥ 99.9995 ≤ 0.0005 ≥ 99.995 ≤ 0.0025 5

G 0.1-0.2 ≥ 99.9999 ≤ 0.0001 ≥ 99.999 ≤ 0.001 10

a Mass median diameter particles (or with a count median diameter typically smaller than 0.2 μm as noted above).b Use the particle size range that yields the lowest efficiency.

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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 fre-quency, 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 estima-tion of the life for a HEPA filter.

In reality it can take years, in theory de-cades for HEPA filters to reach their final pressure drop (twice the initial is the historic rule of thumb assuming ‘nor-mal’ 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, Chlo-rine Dioxide, H2O2 noting no detrimen-tal 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 purchas-ing 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 ben-efit 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.

Energy Costs

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 pres-sure drop limits over all standard com-ponents for new installations — cooling and heating surfaces, ducts and air filters.” For filters, these pressure drops are listed in Table 1.

HEPA Media

Camfil Farr has traditionally utilized glass fiber media when supplying our customers globally in Pharmaceutical air filtration applications. Media his-torically utilized in the microelectron-ics industry has some recent visibility in Pharma. PTFE (Teflon) has some interesting characteristics such as lower initial pressure drop (no real proven life-time data in Pharma), excellent mechan-ical strength and its hydrophobic (ability

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 sub-stantial 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.

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 availabil-ity, cost and questionable site testing requirements limits applications for this media today.

Conclusion….Filter Choice

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.

Filter Pharma Focuscontinued...

Table 1: ASHRAE 52.2 & EN779 ValuesFilter ValueASHRAE Standard 52.2(Eurovent EN779)

Maximum InitialPressure Drop

(inches w.g./ Pa)

Recommendedpressure 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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Table 4: EN1822 ClassificationsFilter Class

Particle Size

for Testing

Global Values Local Leak Values

CollectionEfficiency

(%)

Penetration (%)


(%)

Penetration (%)

Multiple of GlobalEfficiency

(%)

E10 ≥ 85 ≤ 15

E11 ≥ 95 ≤ 5

E12 ≥ 99.5 ≤ 0.5

H13 MPPSa ≥ 99.95 ≤ 0.05 ≥ 99.75 ≤ 0.25 5

H14 MPPSa ≥ 99.995 ≤ 0.005 ≥ 99.975 ≤ 0.025 5

U15 MPPSa ≥ 99.9995 ≤ 0.0005 ≥ 99.9975 ≤ 0.0025 5

U16 MPPSa ≥ 99.99995 ≤ 0.00005 ≥ 99.99975 ≤ 0.00025 5

U17 MPPSa ≥ 99.999995 ≤ 0.000005 ≥ 99.9999 ≤ 0.0001 20a MPPS - Most Penetrating Particle Size

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 damp-ers 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 com-pressor 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 sup-plied 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, mate-rial sanitization and gowning. The rules

of thumb for air change rates in clas-sified 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 hu-man 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 hu-mans 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 “ven-tilation on demand” can be used. It was also stated : ”In a newly constructed facility we have seen this principle ap-plied to the gowning rooms, the ventila-tion 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 con-sumption”.

Dedicated Units (FFU’s)

The air supplied to a Pharma cleanroom serves three purposes:

Filter Pharma Focuscontinued...

1. Cleaning the air2. Establishing a pressure cascade3. 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 pharma-ceutical plant.

Items 2 and 3 can be achieved by pass-ing 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 pre-pared for “ventilation on demand” and/or “nighttime setback.”

Summary

I would like to thank those who contrib-uted to this article. There are multiple initiatives supporting the industry’s de-mands to reduce energy costs. Reducing air change rates, smarter fan and motor selection, ‘mini-environments’ or isola-tor 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.

Camfil Farr 12

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 Dos-age (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 Pharmaceuti-cal 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 indus-try. 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”.

With that direction, the APC division set out to find what needed to get done to penetrate this market for dust collec-tion. The best place to start was with the world’s largest manufacturer, Corpo-rate 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 discus-sions 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

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 col-lector.

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 Camfil Farr, we take a logical approach to com-paring HemiPleat™ cartridges to competitor’s cartridges and esti-mate ownership costs and savings. This tool allows us to compare energy consumption including CO2 footprint, consumables including cartridge unit cost, shipping and inventory costs, and maintenance including labor, disposal and down-time.

2. Independent Surrogate OEL Test Data illustrating the potential capability of particulate contain-ment (below 1 mg/m³). The Gold Series Camtain™ dust collection system has been surrogate tested for validated performance verifica-tion. The ISPE GPG “Assessing the Particulate Containment Perfor-mance of Pharmaceutical Equip-ment” surrogate testing protocol was used as a guideline with an independently contracted, AIHA ac-credited 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 continu-ous liner discharge operations. The GS Camtain™ can contain highly potent, toxic or allergenic com-pounds 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

Tomm Frungillo,Camfi l Farr APC

VP of Focus Markets & Latin America Sales

Camfil Farr APC Containment Dust Collector completew/Deflagration Suppression System

Camfil Farr 13

a new concept but one that works. Vertical cartridge design utilizes gravity to help shed dust into the collection hopper and more effi-ciently utilize compressed air clean-ing from the top down, allowing for lower pressure drop and longer cartridge life.

4. Technical Superiority especially regarding NFPA and ATEX require-ments – Deflagrations are a major concern for dust collectors and their surrounding environments. NFPA and OSHA along with CE/ATEX pro-vide specific direction in this area. Control measures such as explosion venting, chemical suppression and isolation systems may be required depending on the physical char-acteristics 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 insur-ance carriers.

Camfil Farr APC has enjoyed very suc-cessful years in the Pharmaceutical industry. Gold Series units on pharma-ceutical applications are now through-out 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 regu-larly 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 majorpharmaceutical company.

Camfil Farr Air Pollution Control (APC)continued...

Camfil Farr 14

The Total Cost of Ownership (TCO) 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™”.

AIR POLLUTION CONTROL

Life Cycle Comparison Report4-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.

Compressed Air Savings in Comparison (2080 Hours)

$46.53

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

Maintenance and Disposal Category

Labor Savings $58.33

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

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 addi-tion, 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 mini-mum requirements, the filter can sometimes be repaired or it is scrapped. HVAC filters are not indi-vidually 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 ac-tual 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 35 mpg 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 resis-tance 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, contaminat-ing 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

The History of HVAC Air Filter Testing Don ThornburgDirector of R&D, Camfi l Farr USA

Don has chaired numerous committees, including 52.2 promoting improved air

fi ltration for industry users.

Air Filters Testing Standards ComparisonASHRAE Standard 52.2-2007B ASHRAE 52.1-1992 EN 779 2002

Minimum Effi ciency

Reporting Value

Composite Average Particle Size Effi ciency, % in Size

Range, microns

Average Arrestance

Average Dust Spot Effi ciency

Average Effi ciency at0.4 micron

Range 1 Range 2 Range 3MERV 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 G3 80< A ≤90

6 n/a n/a E3 ≥ 35 85 20-25

7 n/a n/a E3 ≥ 50 90 25-30 G4 90< A

8 n/a n/a E3 ≥ 70 92 30-35

9 n/a n/a E3 ≥ 85 95 40-45 F5 40< E ≤60

10 n/a E2 ≥ 50 E3 ≥ 85 96 50-55

11 n/a E2 ≥ 65 E3 ≥ 85 97 60-65 F6 60< E ≤80

12 n/a E2 ≥ 80 E3 ≥ 90 98 70-75

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 H10Note: The fi nal MERV value is the highest MERV where the fi lter data meets all requirements of that MERV.

Camfil Farr 15

filter. In the USA, the organization known as ASHRAE (American Society of Heating, Refrigerating, and Air-Con-ditioning 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 profession-ally 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 stan-dard 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 differ-ences, 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 ASHRAE 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 Par-ticulate 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-ing Devices for Removal Efficiency by Particle Size

• EN-779:2002 – Revision to EN-779:1993

• ASHRAE Standard 52.2-2007B – Revi-sion to 52.2-1999

The 1968, 1976, and 1992 versions of Standard 52/52.1 and the EN-779:1993 standard were very similar since all of these documents evaluat-ed filters for the following and all used ASHRAE dust as shown as follows: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 “Ar-restance”, 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.

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 up-stream and one from the downstream side of the test filter. It is an Average efficiency based

on the clean filter efficiency and subsequent efficiency measurements taken after various stages of loading the filter with synthetic ASHRAE test dust. Unfortunately, this syn-thetic 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. This value is commonly called “Dust Spot” or sim-ply “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.)

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.

Resistance to Airflow - This is the measure-ment of the differential pressure loss result-ing from moving air through an air filter. It is measured at 4 different air flow rates. Commonly call “Pressure Drop” or “Initial” resistance.

The History of HVAC Air Filter Testingcontinued...

Camfil Farr 16

Typical air filtration design for a Pharmaceutical manufacturing facility

F9 (M15)

H14Type K

The 1999 release of ASHRAE Standard 52.2 included the same Resistance to Airflow as the 52/52.1 series, but introduced the follow-ing 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 0.3 μm to 10.0 μm 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 load-ing 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 varia-tions 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 per-formance below that point. ASHRAE went with a higher upper limit to be able to provide particle removal ef-ficiency 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 Effi-ciency – ASHRAE made a bold move in getting away from the artificially inflated average efficiency values produced by loading a filter with ASHRAE dust. EN-779 continued the historical trend of using the inflated averages.

• ASHRAE 52.2 uses the minimum ef-ficiency curve at all 12 particle size ranges from each of the loading steps. In almost EVERY filter tested, the mini-mum 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 electro-static 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 ap-proach 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 main-tenance where the Standards Commit-tee meets at least twice a year to dis-cuss and propose changes that would be beneficial to users of the standard. Most quality air filtration manufactur-ers 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 devices.


Camfil Farr 17

A technician views air filter testing results from one of the test ducts at Camfil Farr’s air filter technology center in Sweden.


The result and recommendation of that research was to replace exist-ing 30g loading of ASHRAE dust as a filter conditioning step. The Appendix J procedure replaces this with a chal-lenge using fine aerosol of KCl (potas-sium 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:

“Some fi brous media air fi lters have electrostatic charges that may either be natural or imposed upon the media during manufacturing. Such fi lter may demonstrate high effi ciency when clean and drop in effi ciency dur-ing their actual use cycle. The initial conditioning step of the dust-loading procedure described in this standard may affect the effi ciency of the fi lter but not as much as would be ob-served in actual service. Therefore, the minimum effi ciency during test may be higher than that achieved during actual use.”

In other words – “your actual mileage may vary”. The optional KCl condi-tioning step is the outcome of mul-tiple ASHRAE funded research proj-ects and industry input. These studies have shown that coarse fiber media enhanced with an electrostatic charge perform differently in real-life applica-tions. Coarse fiber media depends on this electrostatic charge to achieve

the published filter efficiency (MERV value). As atmospheric air passes through the filter with 99% of the par-ticulate 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 impinge-ment and diffusion. They do not lose efficiency over time and typically, their rated MERV will be the same MERV obtained when testing using the op-tional method in Appendix J. The user may take comfort that the published efficiency of the filter will be consis-tent throughout the life of the filter.

Why is Appendix J Non-Mandatory?

To most reasonable adults this proce-dure 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 com-panies 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 try-ing 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. 52.2-2007B fits the definition since the Committee “does not like it, but they can live with it”.

Camfil Farr 18

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).


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 ver-sion of EN-779 will switch to a mini-mum 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 (electro-static charge). This remains the big-gest 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 oper-ating 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 proce-dure 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 impor-tant – in the users system and while operating under the actual field condi-tions. 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 perfor-mance results in China, Germany, or in the USA.

What to do in the Mean Time?• When specifying air filters, require the

manufacturer to provide a complete 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 MERV-A 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 electrostat-ic charge, which dissipates and loses efficiency over time.

• Always consider the Total Cost of Own-ership (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 ap-proach the customer will always win.

ReferencesThe 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.

Camfil Farr 19

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 annu-ally. A ZEB is basically a residential or commercial building with greatly reduced energy needs through effi-ciency gains.

These “ZEBs” will need effective ventilation supplying high indoor air quality (IAQ), which in turn will re-quire the use of high-quality air fil-ters.

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 – to-day, 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 respi-ratory problems. Clean filtered air, on the other hand, leads to improved work performance, reduced absen-teeism 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 mini-mum class for guaranteeing accept-able IAQ.

Unfortunately, there is a paradoxical relationship between filter classes and energy savings because the bet-ter 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 spiraling, the cost of cleaning, supplying and exhaust-ing 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 low-est pressure drop development, such as those manufactured and mar-keted by Camfil Farr, help custom-ers reduce energy costs. Simply put, less energy is required to “push” air through the filters, which also main-tain their efficiency longer, compared to low-cost products with poorly functioning filter media and/or insuf-ficient filtration area.

In Eurovent’s Product Group 4B “Air Filters” (PG4B), we have discussed pressure drop considerably and the energy classification of filters. The

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 labeled according to their an-nual energy consumption, initial effi-ciency and minimum efficiency (ME).

Let me now comment on EN779:2011.

A Welcomed Initiative

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 0.4 μm particles.

Camfil Farr, in its position as a lead-ing air filter manufacturer, welcomes the new standard and considers it a step towards improving IAQ. The industry has now voted for tougher requirements for air filters. National

Jan Andersson is Deputy Managing Director and Head of Marketing for Camfi l 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.

EN779:2011A Step in the Right Direction

Camfil Farr 20

Table 1: Classification of Air Filters 1

Group Class Final Test Pressure

Drop(Pa)

Average Arrestance (Am) of Synthetic

Dust(%)

Average Efficiency (Em) of 0.4 micron

Size Particles(%)

Minimum Efficiency2

of 0.4 micron Size Particles

(%)

Coarse

G1

250

50 ≤ Arr < 65

G2 65 ≤ Arr < 80

G3 80 ≤ Arr < 90

G4 90 ≤ Am

MediumM5

450

40 ≤ Em < 60

M6 60 ≤ Em < 80

Fine

F7 80 ≤ Em < 90 35

F8 90 ≤ Em < 95 55

F9 95 ≤ Em 70Notes1 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.

versions will be available, after which the former standard will no longer apply.

In Camfil Farr’s view, the new stan-dard will help eradicate a number of problems related to filter perfor-mance.

One of these problems is associated with electrostatic-charged synthetic filters. These filters usually demon-strate good initial filtration efficien-cy while they keep their charge, but tend to discharge extremely rapidly, often after just a few weeks of opera-tion. F7 performance in the lab for an electrostatically charged filter can therefore decrease to F5 in real op-erating conditions, and sometimes even more. Their cleaning ability de-teriorates considerably as a result. Unfortunately, far too many Euro-pean buildings are now using elec-trostatically charged F7 filters that have medium efficiency (ME) values between 5 and 10 percent. As a con-sequence, as much as 90 to 95 per-cent 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 ma-terials offering considerably higher particle separation.

Not All Filters Are the Same – Even in the Same Class

Regrettably, the price for this will in-clude higher pressure drops and in-creased energy consumption.

Camfil Farr has one concern about the new classification: while the “worst” filters will vanish from the market,

there is a possibility that “good” fil-ters will be made “worse”. Although energy savings can be achieved by having the lowest possible pressure drop, such development could be ret-rograde.

For example, on 0.4 μm 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 posi-tion on this is clear: we will not lower the efficiency of our Hi-Flo filters. Air quality would deteriorate approxi-mately 40 percent if we did. How-ever, there is a risk that other manu-facturers will not think like us. They may see the standard as an oppor-tunity 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 stan-dard imposes tougher requirements even if the requirements are not as tough as we would have liked and do not meet the quality standards set

Camfil Farr 21

EN779:2011continued...

Available from www.camfilfarr.com.

for our own air filters.

We welcome further debate and dis-cussion on this.

For further information download our brochure, “New filter standard EN 779:2011”, available in PDF format on our website www.camfilfarr.com.

The European procedure includes certifi ed

performance, specifi cally, airfl ow, initial effi ciency

at 0.4 micron, minimum effi ciency at 0.4 micron

and estimated annual energy consumption.

A

B

C

D

E

F

G

Réf.

: 03-

2011

02

AIR FILTERS

ENERG EFFICIENCY CLASSY IE IAIJA

m3/hNominal airflow :

Eurovent 4/11

EN779

%Initial efficiency 0.4 μm : Minimum efficiency 0.4 μm :

%kWh/annumAnnual Energy Consumption :

A

F5

MANUFACTURERRangeModel

Local designation

Setting the Standard for Air Quality and Filter Technology

Camfil Farr Road ShowThe 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 performance under local air quality conditions.

Promoted to local politicians, manufacturers and customers, it advocates clean air as a human right.

World’s Most Advanced Testing LaboratoryCamfil Farr’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 LaboratoriesOur 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 competitor’s filters) perform in your environment!

Camfil Farr 22

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 Representativesplease consult your country’s page on www.camfilfarr.com.

Camfil Farr www.camfilfarr.com

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.

© 2

011

Cam

fil F

arr

Locations Worldwide to Serve You

Camfil Farr 23

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