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					air mail                                                             N E W S
                                                                     M A G A Z I N E
                                                                     F R O M
                                                                     C A M F I L
                                                                     2 0 0 2
                                                                                   F A R R




       S   P   E   C   I   A   L      E      D   I   T   I   O   N




                   Fantastic pharma
4    Selecting HEPA filters for manufacturing processes
5    GMP for medicinal products
8    Serving the global pharma and biotech industries

10   Testing and validation

11   Air filtration protection for anthrax
                                                            Fantastic
                                                                           pharma



Pharmacy is a venerable profession dating                prompting labs around the world to find new                national authorities – such as the FDA in the U.S. –
back to the 8th century. The first pharmacies            antibiotics and cures.                                     review the drug. This regulatory approval can take
in Europe were plying their trade in France in               These new strains could turn once-conquered            another one to two years.
the late 1100s, and across the Atlantic, the             diseases into epidemics and make common infec-
profession debuted in the United States around           tions tougher to heal. The threat of bioterrorism has      Seeing the light at the end of
the time of the American Revolution in the               only made new R&D and drug production even more            a long tunnel
1770s. The United States was largely depen-              urgent.                                                    After years of costly research, pre-clinical and safe-
dent on Europe for drugs until World War I cut               Now armed with gene-hunting tools, today’s             ty studies, clinical trials and regulatory approval, the
off the supply and stimulated U.S. production.           drug-makers are applying the genetics revolution           green light is given. When a drug is approved for
                                                         further down the costly R&D chain to test unused           marketing, it is combined with ingredients to convert
Pharmaceutical R&D has blossomed and revolution-         compounds, allowing them to better judge if they will      it to liquid or capsule form. A pilot plant is usually
ized medical practice ever since. There was the          succeed as marketable drugs.                               required to identify manufacturing problems before
advent of sulpha drugs in the 1930s, penicillin in the                                                              mass production starts.
1940s and then antibiotics in the mid-20th century.      A long process                                                 However, many more millions must be invested
The latter have been hailed as one of the important      The typical process of traditional drug research           before the drug-maker can recoup the cost and
social revolutions in history because they have          varies, depending on the research area. In general,        enjoy the fruits of a drug’s commercial success.
nearly eliminated infectious disease.                    it takes two to 10 years to target and discover a              The product must be manufactured and
                                                         drug by screening thousands of compounds that              launched quickly in the race to beat competitors,
The hunt for new drugs                                   interact with the target. Pre-clinical testing takes two   which might launch a product based on a totally
However, the pharmaceutical (“pharma”) industry          to three years, during which only a fraction of the        different concept but with similar medicinal benefits,
today is multi-billion-dollar business with a never-     compounds are screened.                                    and the drug-maker must maximize on the product’s
ending mission, since bacteria have developed                Clinical testing, performed in several phases,         potential before the patent expires, leaving the stage
resistant strains to nearly every succeeding drug,       can take a total of five to eight years. After that,       free for inexpensive generics to make their debut.


  2    AIR MAIL SPECIAL EDITION
The first step in the long journey to manufacturing                                     E   D   I   T   O   R   I   A   L
and marketing begins with the design of the
production line. All pharmaceutical production
processes have to comply with rigid regulations and
standards to ensure maximum safety for the patient      New leadership
and for all personnel involved in producing and
handling the drug, and for environmental protection.    for the new millennium
    Examples of these standards are Good
Manufacturing Practices (GMP) and how national
inspection bodies and drug producers interpret          At the end of August I was given the challenge to take over
them (see separate article).                            as President of Camfil Farr AB and CEO of the Camfil Farr

                                                        Group, succeeding Jan Eric Larson, who is now Active
Air process systems – the heart of
pharmaceutical production                               Chairman of the Board.

                                                            I’ve been with Camfil since 1982 and was most recent-
The production process and safety aspects deter-
mine the performance requirements of a pharma-          ly Vice President of Sales and Area Manager for Europe.

ceutical production line’s air process systems, which   My new role is to manage all Group operations, while Jan




                                                                                                                                                        PHOTO: LEIF W
must provide for everything from indoor climate         Eric focuses on strategic issues and maintains relation-
control to defining and controlling temperature,        ships with key suppliers.
humidity and cleanliness parameters.
                                                            Moving forward, we intend to further consolidate and expand our group. Our platform
    Here, the key word is cleanliness. As in the food
                                                        for growth will be with the same, corporate values, culture and spirit that have paved the
processing, aerospace and semiconductor indus-
                                                        way for Camfil Farr’s success since 1963.
tries, pharma production requires pristine conditions
that can only be achieved in cleanroom facilities           As the industry leader, Camfil Farr will not change its course – we will continue to

equipped with high-efficiency air filtration systems.   provide added value and benefits for customers with our world-class air filtration solutions.
More on this inside AirMail, where you can read more    Today, Camfil Farr is better equipped than ever to lead the air filtration industry and
about the products and know-how of Camfil Farr, the     contribute to our customers’ success.
world-leading supplier of air filtration products for
                                                            This special issue of AirMail – devoted to our capabilities in the pharma industry –
the global pharma industry.
                                                        illustrates this leadership. Drug manufacturers large and small, national and international,

                                                        have relied on us for decades to meet their filtration needs.

                                                            They can choose from the broadest product range on the market to meet any clean

                                                        air requirement in production facilities that must comply with some of the toughest

                                                        national and international standards with regard to good manufacturing practice and

                                                        quality control.

                                                            Look inside and you will see and read about Camfil Farr filtration products that safe-

                                                        guard production, boost operating performance and maintain cleanliness standards for the

                                                        best life cycle cost. We provide everything from the highest security filters like Cambox

                                                        Security, to the highest performance HEPA/ULPA filters and grid systems, among other

                                                        Camfil Farr innovations for air process systems and cleanrooms.

                                                            This leadership was not achieved easily. It is based on extensive global experience and

                                                        R&D synergies at Camfil Farr companies around the globe, plus participation in the work of

                                                        national standards bodies and research of technical institutes in Europe and the U.S.



                                                            Good reading!




                                                            Alan O’Connell

                                                            President & CEO




                                                                                                                            AIR MAIL SPECIAL EDITION                    3
                                                                                                                  PHOTO: TONY STONE
                                                                                                                                      Camfil Farr
                                                                                                                                      software makes
                                                                                                                                      the selection easier


                                                                                                                                      Selecting HEPA and ULPA filters and
                                                                                                                                      accessories (housing, mounting frames,
                                                                                                                                      etc.) is far from easy. Filter efficiency, the
                                                                                                                                      application, lifetime, running cost, unit cost
                                                                                                                                      and accessibility are important criteria.
                                                                                                                                          Camfil Farr has developed a range of
                                                                                                                                      software for optimising filter selection,
                                                                                                                                      including HEPA/ULPA selection, cleanroom
                                                                                                                                      design, chemical/carbon selection and life
                                                                                                                                      cycle cost. Most of the software is available
                                                                                                                                      upon request.

                                  Selecting
                     HEPA filters for
          the pharma/biotech
                                     industry
                                                                                                                                      Camfil Farr’s pharmaceutical
                       By Sean O’Reilly, Cleanroom Segment Manager, Camfil Farr Group
                                                                                                                                      Segment Manager
                                                                                                                                      The pharmaceutical industry is becoming
The semiconductor industry was – and still is – the     the wrong selection or specification of filters, due to
                                                                                                                                      more international and global in scope.
driver for building more efficient and “cleaner”        the many different standards and customer require-
                                                                                                                                          To co-ordinate Camfil Farr’s world-wide
products (low outgassing). A semiconductor fab          ments today. This is why each cleanroom project
                                                                                                                                      activities for this segment, Camfil Farr has
basically has a standard design, while pharmaceuti-     must be discussed on a case-by-case basis with the
                                                                                                                                      established an internal group and communi-
cal manufacturing involves many different types of      owner, designer, contractor and supplier to pool
                                                                                                                                      cations network to support customers and
processes, with each placing different demands on       collective knowledge before a detailed specification
                                                                                                                                      Camfil Farr sales representatives specialis-
air filtration. In the pharma industry, no two clean-   is written. This eliminates costly mistakes.
                                                                                                                                      ing in air filtration for the pharmaceutical
room facilities are the same (unless they are for the       Today, we are getting closer and closer to
                                                                                                                                      industry.
same owner).                                            having “one” standard for cleanroom classification
                                                                                                                                          Heading     the group is Sean O’Reilly,
     The following general guidelines on selecting      meeting the requirements for GMP for Europe and
                                                                                                                                      who is Camfil Farr’s Cleanroom Segment
high efficiency air filters for the pharma industry     the FDA in the U.S. Many countries in the Asia-Pacific
                                                                                                                                      Manager. Located in Camfil Farr Malaysia,
deal mainly with filters in the HVAC system – the       area, such as Japan and Australia, use their own
                                                                                                                                      he has been working with the cleanroom
make-up and terminal exhaust filtration. Many issues    national standards that are generally applicable to
                                                                                                                                      industry since 1995.
must be dealt with when we talk about filtration        “home-grown” manufacturers. If a U.S. or European
                                                                                                                                          ”The pharma and biotech industries, with
in the industry: global and local standards, filter     manufacturer invests in Asia, they will generally
                                                                                                                                      their enormous R&D budgets, will play an
economy, filter efficiency, filter location, environ-   follow their “national” standards.
                                                                                                                                      extremely important role in the production of
mental effects of used filters, the cleanroom classi-
                                                                                                                                      many life-saving drugs. Filters are and will
fication and filter testing.
                                                           This article is available in its                                           continue to be a critical part of the installa-

Filter testing – in-house and in-situ                      full length at our website                                                 tion to maintain the cleanliness of these
                                                           www.camfilfarr.com/News                                                    products,” Sean O’Reilly says.
There are many reasons why filters “fail” on site –
bad packing, transport damage, handling by inexpe-         www.camfilfarr.com
rienced personnel – although the most common is


 4     AIR MAIL SPECIAL EDITION
                                              GMP for
                                         medicinal products
                                                                       By Gordon J. Farquharson*, Bovis Lend Lease Pharmaceutical



                    Two directives laying down principles and              Cleanroom and contamination control technology          and validated methods of preparation and opera-
                    guidelines for Good Manufacturing Practice             is part of GMP. GMP is not static; it evolves and       tional procedures. Sole reliance for sterilising or
                    (GMP) for medicinal products were adopted by           develops as demands increase, and as technology         other quality aspects must not be placed on any
                    the European Commission in 1991, the first for         allows us to do a job in a better, more secure or       terminal process or finished product test.
                    medicinal products for human use (Directive            quality-assured way. Because of this, the FDA in the        The GMP guidance does not lay down detailed
                    91/356/EEC), the second one for veterinary             U.S uses the term “cGMP” or Current Good                methods for determining the microbiological and
                    use (Directive 91/41 2/EEC). Detailed guide-           Manufacturing Practice.                                 particulate cleanliness of air, surfaces, etc.
                    lines in accordance with those principles are              Within the EU GMP, Annex 1 concerns itself with     Reference is made to other compendia such as the
                    in the Guide to GMP, used in assessing applica-        the manufacturer of sterile medicinal products and      CEN or ISO standards, e.g. EN ISO 14644, parts
                    tions for manufacturing authorisations and as          contains all the requirements that demand the use of    1-7, and EN 1822.
                    a basis for inspection of manufacturers of             classified cleanrooms and HEPA filters.
                    medicinal products.                                                                                            General
                                                                           Principle                                               The manufacture of sterile products should be
                                                                           The manufacture of sterile products is subject to       carried out in clean areas, entry to which should be
                    Part of QA                                             special requirements in order to minimise risks of      changing rooms for personnel and airlocks for
                    GMP is that part of Quality Assurance (QA) which       microbiological, particulate and pyrogen contamina-     equipment and materials. Clean areas should be
                    ensures that products are consistently produced        tion. Much depends on the skill, training and correct   maintained to an appropriate cleanliness standard
                    and controlled to the quality standards appropriate    attitudes and practice of the personnel involved. QA    and be supplied with air that has passed through
                    to their intended use and as required by the market-   bears a particularly great importance, and this type    filters of appropriate efficiencies. The various opera-
                    ing authorisation or product specification.            of manufacture must strictly follow carefully defined   tions of component preparation, product prepara-
PHOTO: TONY STONE




                                                                                                                                                  AIR MAIL SPECIAL EDITION
                                                                                                                                                                                      5
tion and filling should be carried out in separate       tees, review and ultimately vote on developed docu-   Standards of the pharma industry
areas within the clean area.                             ments for approval. These are agreements in place     GMPs and cGMPs
                                                         to prevent ISO and CEN from doing parallel work in
                                                                                                               A good example of these relationships can be seen
How new standards are written                            the same subject area (Vienna agreement).
                                                                                                               in the development of the ISO/EN 14644 and 1468
The development and publication of official stan-            For CEN member countries (EU and EFTA coun-
                                                                                                               families of contamination control and cleanroom
dards occurs at either national or multi-national        tries), CEN standards become national standards
                                                                                                               standards for cleanrooms and controlled environ-
level. The adoption and use of standards is general-     and must replace any existing standards in the same
                                                                                                               ments.
ly voluntary unless they are embodied in some            subject area. If ISO work is parallel voted in CEN,
                                                                                                                   May 1999 was a red letter month for all
way in legislation. Standards are intended to be a       then it carries the same weight as if it had been a
                                                                                                               involved in environmental contamination control
mechanism for the buyer and seller of goods and/or       CEN initiative.
                                                                                                               when the new world-wide standard for airborne
services to have a platform for technical specifica-
                                                                                                               cleanliness was published by CEN and ISO. EN/ISO
tion and performance agreement.
     National standards are generally prepared and
published by national standards bodies. The experts
contributing to the work will usually be nominated
from trade or technical associations into the rele-
vant technical committee that is set to prepare the
standard.
     Multi-national standards are mainly developed
by two organisations: the International Standards
Organisation (ISO), based in Geneva, and the
Committee for European Normalisation (CEN),
based in Brussels. The member countries of each of
these organisations have the right to request that
work be carried out in a particular subject area, vote
on such requests to do work, contribute as active or
observer members of particular technical commit-




 6     AIR MAIL SPECIAL EDITION
14644-1 has emerged from work begun in CEN in                        for U.S. Federal Standard 209E. Within Europe, the
1992 and taken up by ISO, following a request from                   GMP already makes reference to the ISO Cleanliness             A most
the U.S. to do so. All European nations must adopt                   Classes. Those working in this sector would be well
the standard within six months; South Korea, Japan
and the U.S. are expected to replace existing
                                                                     advised to prepare by developing detailed know-
                                                                     ledge of the standards and developing a plan for
                                                                                                                                    novel filter
standards, or adopt the ISO standard, in a short                     their integration. It is important to remember at this         Cambox Security voted
time. This work is unprecedented multi-national                      juncture that the U.S. requested that ISO undertake            “Best Technical Novelty of the Year”
co-operation in the development of contamination                     the work with the objective of developing a truly
control standards that will affect our lives in many                 international consensus in the basic specification of
ways. The pharmaceutical and medical devices                         clean environments.
industries will find great advantage in seamless
worldwide standardisation.
    These standards concern performance require-
ments in particulate classification, HEPA filter selec-
tion and testing, room pressurisation, air change
rates, uni-directional velocity and performance
monitoring.


Summary
The new CEN/ISO standards will have an impact the
                                                                                                                                    Roland du Puy, Camfil Farr, (to the right), receives the
industry in many ways, and we need to be prepared
                                                                                                                                    certificate from Roger Nydahl, R3.
                                                                                      Gordon J. Farquharson
by first understanding their scope, and then by
                                                                                                                                                             At a recent symposium of
having a strategy to implement the standards for                           *Chartered       Engineer        and      Principal
                                                                                                                                                             the Nordic Association for
particular applications. Designers of cleanroom and                        Consultant      with     Bovis     Lend      Lease
                                                                                                                                                             Contamination Control and
clean air device installations should ensure any new                       Pharmaceutical, based in the U.K. Mr.
                                                                                                                                                      3
                                                                                                                                    Cleanrooms (R Nordic), Camfil Farr’s exhaust
applications comply with the new standards in paral-                       Farquharson has more than 20 years of
                                                                                                                                    filter Cambox Security-1000 stole the show
lel with established standards. This will ensure that                      experience of processes and facilities used
                                                                                                                                    when the participants tapped it “Best Technical
as the new standards are progressively adopted,                            by the health care, life science and
                                                                                                                                    Novelty of the Year”. Cambox Security shared
one will be ready to accommodate them.                                     semiconductor industries, including design,
                                                                           construction, audit and validation work.                 the honour with a mobile calibration system
    Operators of existing installations are likely to
                                                                           Recently, he has been heavily involved                   from another company.
see the standards in a different light. Those who
                                                                           in the development of the new CEN/ISO                         Cambox Security-1000 is a proprietary
operate ISO 9000 or EN 46,000 quality systems are
                                                                           Cleanroom Contamination Control Standards                product featuring a special high-security housing
likely to see early pressure from the relevant asses-
                                                                           that will be part of the standardisation inte-           incorporating a Camfil Farr Absolute filter with
sors for the use of the new standards. The pharma
                                                                           gration process in this field over the next              an efficiency of 99.99 percent on 0.3 µm partic-
industry outside Europe is much more likely to be
                                                                           five years or so.                                        les. The housing has less of a risk of leakage
influenced by the United States, and the timing of
                                                                                                                                    and a better efficiency for deadly micro-
the adoption of ISO 14644-1&2 as a replacement
                                                                                                                                    organisms.
                                                                                                                                         The filter is used to clean exhaust air from
                                                                                                                                    air handling systems in P4 and BSL-3class
        EN/ISO 14644-1:1999 (published standard)
                                                                                                                                    laboratories. Since these facilities research and
        Part 1- Classification of airborne cleanliness
                                                                                                                                    study the deadliest viruses and bacteria, it
        This standard is one of the most critical elements of the work of ISO Technical Committee 209. It sets out the particle
                                                                                                                                    is imperative that all dangerous substances
   classification system to be applied to cleanrooms and clean air devices. The particle classification is undertaken using a
                                                                                                                                    are removed from ventilation air before it is
   formula that is illustrated by appropriate tables and graphs. Close inspection of the particle numbers related to the nearest

   equivalent classes in preceding standards will show the reader the close linkage to previous American, British, Continental
                                                                                                                                    exhausted.

   European and Japanese standards (see table/Different classification systems).                                                         The main advantage of Cambox Security is
                                                                                                                                    that it is equipped with measurement sections
        EN/ISO 14644-2:2000 (published standard)                                                                                    before and after the filter cabinet, allowing tests
        Cleanrooms and associated controlled environments                                                                           of the filter’s efficiency on site.
        Part 2- Specification for testing cleanrooms and associated controlled environments to prove continued compliance.               R3 Nordic is a non-profit organization and
        This is the sister document to 14644-1 and sets out the basic requirements for monitoring and testing to demonstrate that   a member of ICCCS, the umbrella organisation
   classification compliance continues to be achieved.
                                                                                                                                    for international co-operation in the field of
        In the ISO 14644 standard family, eight more parts will be included.
                                                                                                                                    contamination control.




                                                                                                                                                AIR MAIL SPECIAL EDITION                 7
                              Serving the global pharma
                              and biotech industries
PHOTO: SYDSVENSKA DAGBLADET




                              Camfil Farr is the world leader in air filtration   BMC Biomedical Center, Lund                               Alcon Couvreur, Glaxo Smith Kline (GSK) and Sanico.
                              products for the worldwide pharma industry.         University, Sweden                                             Sanico, a producer of OTC and ethical drugs,
                              In Europe, the Group has air filter reference                                                                 cosmetics and health food products, has a 26,600-
                              installations at all major pharmaceutical                                                                     square-meter production facility containing 75 clean-
                              production facilities (approximate number                                                                     rooms with a total surface of more than 5,000
                              in parentheses) in Belgium (11), Finland (8),                                                                 square meters (Classes D and E), equipped with
                              France (30), Germany (41), Ireland (14), Italy                                                                Camfil Farr’s Sofdistri ceiling diffusers and H14
                              (74), the Netherlands (7), Portugal (1), Spain                                                                HEPA filters. Several laminar-flow booths are used
                              (4), Switzerland (8), Sweden (3) and Turkey (4).                                                              for controlling incoming products and for weighing
                                   In North America, Camfil Farr serves the                                                                 in production.
                                                                                  This 41,000-square-meter facility, attached to the
                              major producers (see separate article).
                                                                                  Faculty of Medicine, houses 90 research groups and
                                   Other references can be found in Benin,
                                                                                  700 scientists performing pre-clinical and clinical
                              Brazil, Bulgaria, Iran, Egypt, Honduras, India,
                                                                                  experimental research in neurology, cell biology,
                              Israel, Jordan, Malta, Morocco, Oman,
                                                                                  physiology, immune systems and oncology. Camfil
                              Pakistan, Puerto Rico, Rumania, Slovenia,
                                                                                  Farr´s Swedish company has delivered all filters
                              Syria, Venezuela and Yugoslavia.
                                                                                  for the supply and exhaust air systems used in bio-
                                   Here are a few references from our
                                                                                  medical research areas, plus the air filtration for the
                              customer portfolio.
                                                                                  general HVAC systems.


                                                                                  Filtration applications for producers
                                                                                  in Belgium and the Netherlands
                                                                                  Camfil SA in Belgium has several applications in the
                                                                                  pharma industry. Customers include Baxter, UCB,           Laminar-flow booth at Sanico.


                               8     AIR MAIL SPECIAL EDITION
                                                                                                                                                                             PHOTOCOLLAGE: KENNET RUONA
GSK’s new RX83 site in Wavre for anti-hepatitis           housings equipped with Midilar filters. Exhaust air is    which is resistant to temperatures up to 350 ºC.
vaccines uses 200 Absolute filters, notably MDGS,         filtered through Megalam H10 filters.                     Ten Termikfil 6P6 filters are used.
MXGS and MGGS, together with painted Sofdistri                Camfil France also provided filters for cabins            Among earlier pharmaceutical articles in AirMail
ceiling diffusers for filters, which are 66 or 110 mm     with laminar airflow, Megalam type U filters with         you can read about the Jean Mérieux P4 High
deep. Hi-Flo (F9) is used for pre-filters, while H10      liquid seal and Camsecure, a bag-in/bag-out con-          Security Laboratory in France (AirMail No. 2, 1999)
Sofilairs with FCBL housings are the post-filters.        tainment system originally designed for the nuclear       and Pfizer’s production facilities in Amboise, France,
    In the Netherlands, Camfil BV has equipped            power industry. Twenty-six Camsecure systems in           for producing Viagra™ (AirMail No. 1, 1999).
Solvay Pharmaceutical (vaccine cell production) with      Inox 316L were installed in powder transport
Sofilair Absolute and Panolair Micretain exhaust and      circuits. All installations comply with GMP and FDA
supply air filters.                                       standards.
    Sofilair has the largest filter area in the world
and is the filter of choice for the pharma industry.      …while Lilly uses Termikfil in
Large flows of air can pass through the filter with a     sterilisation tunnels
low pressure drop and low energy consumption.             Lilly’s plant in Fagersheim, near Strasbourg, uses
                                                          one of the largest sterilisation tunnels for the criti-
A jewel of an installation in Sanofi                      cally process of drying cartridges for injection pens.
Synthélabo in France…                                     The tunnel was originally equipped with Japanese
In 1999, Sanofi-Synthélabo finished an important          high-temperature filters, but in order to expand pro-
project to produce a new type of molecule at two          duction, reduce maintenance and guarantee a flow
chemical sites in Aramon and in Sisteron. Camfil          of sterile air, a new solution was needed. Camfil Farr
Farr’s French company supplied housings and filters       France conducted a feasibility study, proposing
for treating outdoor air and Sofdistri ceiling diffuser   use of its unique mini-pleated Termikfil panel filter,                         Termikfil.




                                                                                                                                   AIR MAIL SPECIAL EDITION           9
In the pharma industry, HVAC installa-                                                                             Complete “function” control
tions in critical production areas need                                                                            The definition on a cleanroom “ is a room, where the

to be certified upon installation and                                                                              content of particles are under control “ says Jesper

then once every six months in accord-                                                                              Kure. The complete HVAC installation is therefore of
                                                                                                                   vital importance, in order to obtain a certain clean
ance with the requirements of author-
                                                                                                                   zone level. All aspects must be considered: filtra-
ities (FDA or EU-GMP).
                                                                                                                   tion, air changes, flow patterns, pressure difference
                                                                                                                   must be in complete control, otherwise the card
Health authorities expect that a pharma plant’s
                                                                                                                   house will collapse. If only one pressure direction
HVAC systems are ‘under control’, since they are a
                                                                                                                   between the cleanroom and a less clean room is
critical parameter in drug production. National and
                                                                                                                   wrong, “ you can install as many HEPA filters you
international health authorities carry out periodical
                                                                                                                   would like, and still not reach the desired room
inspections to ensure that manufacturers comply
                                                                                                                   classification”.
with current regulations.
     It is therefore important that test procedures
                                                                                                                   Camfil Farr’s expertise
and complete documentation related to these HVAC
                                                                                                                   in cleanroom filtration
test are carried out in accordance with these
                                                                                                                   The demands and requirements from the pharma-
requirements.
                                                                                                                   ceutical industry are changing rapidly, and Camfil
     “The new ISO 14644 standard will probably be
                                                                                                                   Farr     sales     staff   are   continuously   updated
the future working document for designing all clean-
                                                                                                                   on the standards through a global network of
rooms, since the standard is industry-specific,
                                                                                                                   competence. Furthermore, a cleanroom software
describing standards for the hospital sector, the
                                                                                                                   calculation program has been developed to support
food industry, pharma industry and electronics
                                                                                                                   owners and designers of cleanrooms. This program
industry,” says Jesper Kure.
                                                                                                                   provides a solid background in cleanroom tech-
                                                                                                                   nology and is available worldwide.
Many HVAC tests in
                                                                                                                          To understand the needs of our pharmaceutical
pharma facilities
                                                                                                                   customers, many Camfil Farr companies have
HVAC systems in pharmaceutical production plants
                                                                                                                   selected key sales people to handle this segment
are tested in many different ways, depending on the
                                                                                                                   alone. This ensures that we know the process in the
different room classifications.
                                                                                                                   pharmaceutical production and expectations from
     Jesper Kure gave the following examples:
                                                                                                                   national and international health authorities (FDA).
• Testing of the number of air changes
                                                                                                                   As the delivery capability and short delivery times
• Downflow test of UDF units
                                                                                                                   are critical during shutdown periods, Camfil Farr has
• Testing of room pressure differences
                                                                                                                   improved the communication between our own pro-
• Testing of HEPA filters (leakage measurements)
                                                                                                                   duction and our customers. A good planning and
• Room classification / Particle measurements
     Based on the above, the cleanroom is
                                                                        Testing                                    understanding is vital for a combined success.

classified.
                                                                              and                                  *Jesper Kure is head of a specialist team, the NNE
HEPA filters – a critical component
                                                                                                                   Test Group, within Novo Nordisk Engineering A/S,
“HEPA filters are a critical component in clean-
rooms,” says Jesper Kure. “Measurements of in-situ
                                                                   validation                                      Denmark. He has worked with HVAC testing and
                                                                                                                   validation processes for the pharmaceutical industry
leaks are often performed during a very limited                     Interview with Jesper Kure*
                                                                                                                   for many years.
time period – typically during shutdown periods. The
delivery capability of the filter manufacturer is deci-
sive in the event that the filter has to be changed       trained personnel. Incorrect handling and installation
because of leaks and cannot be repaired on site.          is often the cause of leakage in new filters. Detailed
Fast delivery is also critical – problems with the        installation instructions from the manufacturer will
HEPA filters can cause expensive downtime. That’s         also help eliminate this problem”.                          Please read the complete interview
why many pharmaceutical companies are starting to             Mistakes are also made when the wrong filter            with Jesper Kure at our website
maintain their own stocks of filters on the premises.”    housing is selected. A wide variety of housings are         www.camfilfarr.com.
     Problems can also develop when filters are           available on the market, making selection difficult.
installed, continues Jesper Kure. “HEPA filters must      Unless the filter is designed for a specific housing,       www.camfilfarr.com
be handled and installed with the greatest care by        a leak-free installation cannot be guaranteed.


10     AIR MAIL SPECIAL EDITION
                            PharmaSeal ®
                            – a North American
                            innovation
In North America, Camfil Farr has a strong presence in the pharma industry.                                         every six months. In large production suites, with
                                                                                                                    many terminal filter units, this is a daunting task. It
Noted manufacturers like Abbot Laboratories, Merck, Bayer, Bristol-Mayers,
                                                                                                                    is also expensive as the area is typically closed to
Squibb, Glaxo Wellcome, Eli Lilly, Pfizer, A.H. Robbins, Roche Laboratories, Smith
                                                                                                                    production during the certification process.
Kline Beecham, Warner Lambert, Wyeth-Ayerst and others count on Camfil Farr
                                                                                                                        Camfil Farr’s PharmaSeal® filter has been de-
for their air filtration needs from HVAC to world-class cleanrooms.                                                 veloped in association with several pharmaceutical
                                                                                                                    manufacturers to address the needs of their
Many rely on the Camfil Farr sales force’s technical     quality product production are met. Most pharma-
                                                                                                                    facilities. It has become the basis of design for
expertise, as well as the quality of our products.       ceuticals look past the FDA guidelines and have pro-
                                                                                                                    many pharma projects in North America and around
These organizations often seek guidance in applying      duction areas approaching cleanliness levels that
                                                                                                                    the world.
the latest guidelines as dictated by the U.S. Food       were historical only in the semiconductor industry.
and Drug Administration (FDA). Market repercus-              Camfil Farr also works directly with some phar-
sions are felt throughout the world, as many of          maceutical manufacturers to develop new products
                                                                                                                      Please read about the pharmaceutical
these customers have a presence in other countries       meeting tomorrow’s air quality needs. The Camfil
                                                                                                                      industry in North America and Camfil
throughout the globe.                                    Farr PharmaSeal® is a product of this cooperation.           Farr’s PharmaSeal ® at our website
    Camfil Farr also participates directly with the                                                                   www.camfilfarr.com/News
FDA, providing guidance relating to product applica-     PharmaSeal ®
tion, presenting technology advancements and             In North America, critical pharmaceutical areas              www.camfilfarr.com
sharing information to assure that high standards of     must be certified upon installation, and thereafter




 HEPA filters – the only true air filtration
          protection for anthrax
                     On Camfil Farr’s website you        should be secure in buildings.                             area is provided with complete positive overpres-
                         can     find   a   document         Given the current state of world affairs, bio-         sure protection.
                         titled “Anthrax: Definitions,   terrorism may include spores disseminated by the               The document also deals with the importance of
                               Questions, Answers &      aerosol route, causing inhalation anthrax.                 air changes and gives general tips and advice for
                               Precautions”, a special                                                              dealing with suspected anthrax exposure.
                               release of information    How HEPA filters help
                               from Camfil Farr in       The only true air filtration protection for anthrax is a
                               response to current       HEPA filter. To be effective, the document explains,
                               developments in the       the air distribution system must take outside air in
                         United States. The material     through the filter and push back this filtered air back
is for informational purposes only.                      out through the leak paths in a building.
    The four-page leaflet in portable document               The HEPA filter thus creates a slight positive
                                                                                                                      For more information go to
format (pdf) explains what anthrax is, describes the     overpressure in the facility, creating a balloon effect
                                                                                                                      www.camfilfarr.com/News. Additional
symptoms of the disease and how Anthrax spores           that helps keep contaminated air from entering the
                                                                                                                      web pages are also listed in the document
can infect humans.                                       building.
                                                                                                                      for more information on the subject.
    As a biological weapon, anthrax may be inhaled           HEPA units that merely cleanse the recirculation
by humans. Since HVAC air distribution systems may       air would provide little protection against anthrax-         www.camfilfarr.com
be a path to contamination, access to these areas        laden air that is sucked into a building, unless an


                                                                                                                                   AIR MAIL SPECIAL EDITION           11
                                                                                                                                    Exhibition and trade show
                                                                                                                                         schedule 2002
                                                                                                                                                JANUARY
                                                                                                                                  14-16, ASHRAE, HVAC, Atlantic City,
                                                                                                                                              NJ, USA

                                                                                                                                               FEBRUARY
                                                                                                                                      5-9, Interclima, Paris, France

                                                                                                                                                 MARCH
                                                                                                                                       5-7, CFIA, Rennes, France
                                                                                                                                 6-10, FinnBuild 2002, HVAC, Helsinki,
                                                                                                                                                 Finland
                                                                                                                                 19-23, Nordbygg, Stockholm, Sweden

                                                                                                                                                 APRIL
                                                                                                                                 16-18, Semicon Europa 2002, Munich,
                                                                                                                                              Germany

                                                                                                                                                  MAY
                                                                                                                                 6-8 OTC 2002 – Offshore Technology
                                                                                                                                 Conference, Relian Park, Houston, TX,
                                                                                                                                                  USA
                                                                                                                                      12- 16, 17th Congress of the
                                                                                                                                   International Federation of Hospital
                                                                                                                                          Engineering, Bergen,
                                                                                                                                                 Norway
                                                                                                                                    13-16, R3, Sandefjord, Norway
                                                                                                                                     15-16, Air Expo, HVAC, Zellic,
                                                                                                                                          (Brussels), Belgium

                                                                                                                                                  JUNE
                                                                                                                                  11-12, PowerGen, (Turbines) Milano,
                                                                                                                                                Italy
                                                                                                                                   18-21, Cleanrooms Europe 2002,
                                                                                                                                       Frankfurt/Main, Germany
Equipment you can count on                                                                                                                    SEPTEMBER
                                                                                                                                  23-25, APTA/IPTE, HVAC, Las Vegas,
                                                                                                                                               NV, USA
                                      In the nineties Camfil    taminated air in the pharmaceutical, biological and nuclear
                                                                                                                                               OCTOBER
                                      Farr decided to de-       industry.
                                                                                                                                    23-26, VVS Dagene, Lilleström,
                                      velop a test method,          Camfil Farr then developed CamCount. The test system                       Norway
                                      to detect possible        is able to detect leaks at MPPS in the filter and in the
                                                                                                                                 CAMFIL FARR AIRMAIL is a world-wide
                                      leakages     and    to    ceiling system with measuring probes installed in the unit.      publication for Camfil Farr customers.
                                                                                                                                 Available in nine languages.
                                      check efficiency of       This is done with laser particle counters and can be
                                                                                                                                 Published by:
                                      Hepa-filters mounted      evaluated with adapted software in a mobile unit. This
                                                                                                                                 Camfil AB, Industrigatan 3.
                                      in ventilation systems.   enables you to test several filter units with one mobile unit.   SE-619 33 Trosa, Sweden.
Sample of CamCount installation.                                                                                                 Tel. +46 156 536 00.
                                                                                                                                                                          Edition: 30,000 copies. Printed in Sweden


                                      The test had to be            A mobile, dismountable version for our service tech-         Fax. +46 156 167 24
carried out in situ, which means that the filters could not     nicians is also available so that we can offer this service if   E-mail: info@camfil.se
                                                                                                                                 www.camfilfarr.com
be dismounted and the ventilation system could not be           so required by our customers.
                                                                                                                                 Publisher:
opened. This is especially important when testing con-                                                                           Lennart Schröder
                                                                                                                                 Director, Corporate Communications,
                                                                                                                                 Camfil Farr Group
v




                                                                                                                                 Editor:
                                                                                                                                 Margareta Swahn Forsling
Want to know more?                                    Head Office
                                                                                                                                 Tel. +46 156 536 18
For further information please contact the            Camfil AB, Industrigatan 3, SE-619 33 Trosa, Sweden.                       Fax +46 156 536 87
Camfil Farr subsidiary or agent closest to you,       Tel +46 156 536 00. Fax +46 156 167 24.                                    E-mail: margareta.swahn@camfil.se
                                                                                                                                                                           YMER REKLAMBYRÅ




or phone, write or fax to Camfil Farr head-
quarters.


www.camfilfarr.com

				
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