Bio-Pharma Segment Brochure - Filterair.info

io-pharmaCamfil FarrSegment brochureBio-PharmaCamfil Farr – clean air solutions

corporatecamfil farr world leaderC O N T E N T SCamfil Farr your global partner 2 – 3International standards 4 – 5Mini-environments 6 – 7Hi-temp filters and applications 8 – 9Safe change – BIBO systems 10 – 11Bio-Pharma plant andproduct range 12 – 13ATEX 14Bio-Pharma dust collection system 15Housings; Pharmaseal 16 – 17Software programs 18 – 19Camfil Farr capacities 20 – 21Technical services 22Accessories 23Environmental friendly products 23Camfil Farr is a world leader in clean air technologyand air filter production. Our organisationspecialises in the field of air filtrationsolutions. We are focused on research anddevelopment, state-of-the-art manufacturing,and marketing of air filtration products andservices on a global basis.The Camfil Farr group of companies is theworld’s largest designer and manufacturer ofair filters with 19 manufacturing facilitiesaround the globe.Camfil Farr takes great pride in the factthat our products are of the highest quality,offering our customers air filters with thelongest life, and lowest operating and maintenancecosts.For the past forty years we have been aleading supplier of air filtration products andservices to the Bio-Pharma Industry. Many ofour clients have multiple facilities locatedaround the world, Camfil Farr is viewed bymany of the largest Pharmaceutical manufacturersas a partner and well positioned tosupport their air filtration demands on a localand global basis.Major investments have been made in ourR&D departments located around the worldto develop products specifically for thePharmaceutical industry. It is common for usto ‘partner’ with our customers to meet andoften exceed their most demanding air filtrationrequirements.Our efforts are driven by the need to offerour clients an extensive range of productsand services, catering to many diverserequirements, whether based on technicalor commercial criteria.Strength factorsAs the global leader in air filtration, CamfilFarr offer our customers the security of along-term partnership, backed by a documentedcapability to analyse needs andsupply total air filtration solutions.We provide the best possible clean airsolutions, customised and optimised forprice and performance. We are a driver andstandard setter in the filter industry’s majortrade groups and organisations.Camfil Farr production plantsIn our major plants, filters are produced incontrolled environments. As added securityfor our key customers, we can produce thesame type of filters at multiple manufacturingsites.Camfil Farr is recognised as the numberone supplier of high efficiency filtration productsfor the Bio-Pharma industry.All our plants are of course ISO 9000certified.2

corporate• •• ••• • • •••• ••••• •Camfil AB, Sweden HQ•Camfil Farr plantsCamfil Farr companies•Camfil Farr agencies•••••• • •• ••• • ••• •• • • ••• • • •• ••••• •• •• • ••••In the USA Camfil Farr has more than 80 representatives and distributors. In Asia and the rest of Europe more than 50 agents.In our major plants, filters are produced in controlled environments.3

HEPA-ULPA filter classificationexamples of filter testingprotocolsEU GGMP1. EN 1822 High efficiency air filters (HEPA & ULPA)classification and test of filters.Eurovent 4/4 (replaced by EN 1822), however it is still used inEurope and often misunderstood, especially when specifying filterefficiency, Eurovent uses NaCl (0.65 micrometer diameter) whereasEN 1822 uses the most penetrating particle size (typically 0.15-0.2micrometer diameter). The resulting efficiency can be in the range of99.997 for 0.65 micrometer particles and 99.95 for MPPS for thesame filter.Eurovent 4/4 is a volumetric test and may not detect pinholeleaks within the filter, whereas EN 1822 involves a full media scantest, on the higher grades of HEPA filters. This test standard wouldbe the natural choice for pharmaceutical use.In the United States the term ‘bleedthru’ is commonly used,Camfil Farr’s recommends a H14 grade filter, i.e. 99.995at MPPS.Using HEPA filters with 99.99 at 0.3 micrometer when tested with athermal generator in the field at higher than recommended velocitiesoften leads the ‘bleedthru’ phenomenon. More detailed information isavailable on www.camfilfarr.info.Other testing protocols include:2. IEST-RP-CC001.4-2005 HEPA & ULPA filters (2005)3. IEST-RP-CC006.3-2004 Testing Cleanrooms (2004)4. IEST-RP-C0021.2 Testing HEPA & ULPA filter media (1993)5. IEST-RP-CC034.2 HEPA & ULPA filter leak test (1999)Specifying the desired filter efficiency at the required design velocitieswith Camfil Farr, the end user, A&E firm & M&E contractor by‘pooling’ the collective knowledge before a detailed specification iswritten for the project will eliminate costly mistakes.Table 1: Standards applicable to the American &European marketsClassification & ParticleCounting in The Room Filter Classes Testing FiltersIEST-RP-CC006.3FDA/USA US FED STD-209 E IEST-RP-CC001.4 IEST-RP-CC0021.2IEST-RP-CC0034.2GMP/Europe ISO-14644 EN 1822 EN 1822Standards International & National:Today we are getting closer and closer to having one standard forcleanroom classification meeting the requirements of GMP forEurope, the US and Asia. They generally follow the aforementionedstandards. Many countries in Asia will use their own national standards.For example, in Japan the JACA and in Australia AS1386.These standards are generally applied to manufacturers located withinthe borders of the region. However, if an American or Europeanmanufacturer invests in Asia and intends to ship product to theirhome country/continent, they will generally follow their standards(i.e. GMP, or FDA).Examples of cleanroom classification standards:1. ISO 14644 (1-9), introduced in 19992. US FED STD 209D 1992 – FDA’s Cleanroom classification(edition D was replaced by Edition E in 1998)3. US FED STD-209E, 1998 – FDA’s Cleanroom classification4. GGMP PIC/EEC ANNEX 1 (January 1997) CleanroomclassificationsBelow is a general comparison of these standardsFED STD-209D FED STD-209E ISO 14644-1 GGMP PIC/EEC1 M 1.5 Class 310 M 2.5 Class 4100 M 3.5 Class 5 A1000 M 4.5 Class 610,000 M 5.5 Class 7 C100,000 M 6.5 Class 8 D4

controlled areasHEPA/ULPA cleanroom filter testingProtocols Utilized in Camfil Farr FacilitiesFilter ClassificationsQuite a few inaccuracies and erroneous "jargon" are commonplace inthe high efficiency filtration industry. One of the key issues pertainsto nomenclature (i.e., HEPA, ULPA, VLSI, SULPA, etc.). This issueinvolves misconceptions regarding a filters efficiency and the relationshipto particle size.CEN Classification: HEPA/ULPA Filters EN 1822-1:1998Filter Overall value (%) Local value (%)Class Efficiency Penetration Efficiency PenetrationH10 85 15 – –H11 95 5 – –H12 99.5 0.5 – –H13 99.95 0.05 99.75 0.25H14 99.995 0.005 99.975 0.025U15 99.9995 0.0005 99.9975 0.0025U16 99.99995 0.00005 99.99975 0.00025U17 99.999995 0.000005 99.999975 0.000025CEN, the Comite European de Normalization, has developed aStandard, EN 1822-1:1998, based on particle counting at the MostPenetrating Particle Size (MPPS). This European Standard applies toHigh Efficiency Particulate Air (HEPA) and Ultra Low Penetration Air(ULPA) filters used in the field of ventilation and for technical processes(e.g., for clean room technology or applications in the nuclear andpharmaceutical industries).• Overall Efficiency/Penetration – the efficiency/penetration averagedover the "superficial/useable" face area of a filter element undergiven operating conditions of the filter.• Useable Face Area – the cross-sectional area of the filter element,through which the air passes.• Local Efficiency/Penetration – the efficiency/penetration at aspecific point on the superficial/useable face area of the filterelement under given operating conditions of the filter.• Leak Threshold – Local penetration greater than or equal to five (5)times the filters overall penetration.This Standard allows a classification of filters in terms of efficiencyand is, therefore, useful for both buyer and seller.IEST RP 1.4Suggested nomenclature is based on penetration at a given particlesize. Examples below:• A Filter Efficiency of 99.97 at 0.3 micrometer is classified as apenetration of 300 ppm at 0.3 micrometer.• A Filter Efficiency of 99.995 at MPPS (H14-EN1822) is classifiedas a penetration of 50 ppm at MPPS.Key definitions from this Standard include:• Penetration – The ratio of the particle count downstream of thefilter to the particle count upstream.• Efficiency – the ratio of the number of particles captured by thefilter to the number of the particles challenging the filter.5

glove boxesmini environmentsGlovebox. This is a gas-tight chamberoperated through sealed gloves.The glovebox is maintained under negativepressure.The Class III cabinet is defined as a ventilatedglovebox.Providing localized control incritical environmentsCritical processes in mini environmentsrequire a high level of localized control.Laminar Air Flow (LAF) workstations aretypically used for this purpose.In manufacturing environments, manydifferent processing areas require sterile,particle-free air, such as the assembly of electronicsproducts and sterile packaging areas inpharmaceutical plants. Contaminants present inthe surrounding air have to be removed to preventthem from negatively impacting processesand products. A filtered laminar air flow in workstations is the most effective way to createand maintain a clean working area.Ambient air enters into the top of the LAFunit under negative pressure and a pre-filterremoves large dust and dirt particles. The prefilteredair is then blown under positive pressurethrough a HEPA filter with 99.99%efficiency to provide sterile, ultraclean air in aunidirectional air flow across the entire workingarea. The speed of the air flow is calculated ata certain velocity to prevent unfiltered room airfrom penetrating the working area. Particlesoriginating from movements in the LAFworkstation are also removed.HEPA filters – the mostcost-effective solutionHEPA filters used in class 100 unidirectionalworkstations usually have an efficiency of99.99% or higher to remove particulates thatare 0.3 micron in size and are even moreeffective for particulates bigger and smallerthan 0.3 µm. An LAF work station requireshigh volumes of clean air and the solution forthis application is to use pleated filter media,which have a larger surface area than filterswith non-pleated media. When used in combinationwith the right pre-filters, the servicelife of a HEPA filter is usually three to sixyears, making it the most dependable andcost-effective solution for LAF applications.Bio-safety cabinets forthree-way protectionOriginally designed for the handling ofhazardous materials, Class II laminar flow biosafetycabinets provide the ultimate protectionin three ways – for products, operatorsand the working environment. To protect theoperator, a bio-safety cabinet functions like atraditional fume hood, except that it also protectsthe work process and the environment.Class II laminar flow bio-safety cabinets(type A and B) are commonly used today toprotect personnel, products and the workingarea. These units employ a negative pressureto protect personnel, a downflow of clean airfiltered through HEPA filters to protect theproduct, and HEPA-filtered exhaust air to protectthe environment. Because of their abilityto also protect products, Class II cabinetshave virtually made the Class I bio-safetycabinet obsolete since it can only protectoperators and the environment.The Class III cabinet, offering the highestpossible protection, is basically a ventilatedglovebox maintained under negative pressurewith supply air filtered through HEPA filters.Exhaust air from the cabinet is filtered twicethrough HEPA filters. An operator worksthrough sealed gloves in a gas-tight chamberand is effectively sealed off and protectedfrom the hazardous material he works with inthe glovebox.6

enches/cabinetsCamfil Farr has developed partnerships withthe leading, Biosafety and laminar flow cabinetmanufacturers for many years. We arevery familiar the technical requirements forthis industry, the HEPA filter of choice for theindustry is the MEGALAM.as 0.45 m/s / 90 fpm ± 10%. Due to ourControlled Media Spacing (CMS) pleatingtechnology and optional ‘laminator’ applied tothe filter pack during production, meetingthese exacting demands can be readilyachieved.Other availableCamfil Farr products forMini EnvironmentsMEGALAMOur renowned MEGALAM filter allows theOEM to maximize airflow, reduce pressuredrop, therefore reducing significant energycosts depending on the filter pack depthselected.When unidirectional airflowis a must:Safety Cabinets are known for their highrequirements in terms of laminarity. Some ofour OEM customers have demanded as lowComplete Range of HEPA FiltersThe MEGALAM filters manufactured in 3 standarddepths 45, 68 and 90 mm (nominal 2, 3and 4" packs). All filters supplied are individuallytested with full traceability to consistentlydeliver the cleanest and cost effective air forthe most demanding environments.For more information regarding Safety Cabinetstandard, refer to DIN-12950, DIN-12980,EN 12469, NSF-49, BS-5729 and NFX-44-201.(European Standard)Close pleat filter model TRSA.HEPA filters for LAF benches11 2Megalam MX filter.Megalam MD filter.23Clean AirContaminated AirNegative PressurePositive Pressure3Deltafil filter.7

hi-temp filtersproperties to assure that they are suitable fortheir intended use.”Depyrogenation and sterilization processesare used to eliminate viable matter and reducethe amount of endotoxin on vials or othercontainers used in pharmaceutical processingand distribution. These processes utilizedry heat at a prescribed temperature andduration. It is up to the pharmaceutical manuthe‘hottest’ range of filtersin the worldSilicon FilterAbsolute FRSI (Europe model)/Absolute Kseries (US model).Endotoxins are poisonous substances thatare produced in bacteria, and continue toexist after the bacteria has been destroyed.Therefore, a sterile surface may still retaindangerous endotoxins.21CFR Part 211.94 states: “Drug productcontainers and closures shall be clean and,where indicated by the nature of the drug,sterilized and processed to remove pyrogenicCamfil Farr-High-Temperature HEPA Global Spec & Technical PerformanceCeramic FilterFRSI (6"/12") FRK (6"/12") Sofilair Termikfil K Series F SeriesFRSI (150/292 mm) FRSI (150/292 mm) (high-temp) (standard & (standard &high-capacity) high-capacity)Performance & 1FRSI-600 1FRK-600 1506.23.04 6P6 24 x 24 x 12 24 x2 4 x 12Features 1FRK-1000 1FRK-1000 610 x 610 x 292 610 x 610 x 292Airflow (24” x 24”) 730/1200 cfm 730/1200 cfm 1765 cfm 700 cfm 1040 cfm 1000 cfm(610 x 610) 1240/2050 m 3 /h 1240/2050 m 3 /h 3000 m 3 /h 1200 m 3 /h 1770 m 3 /h 1770 m 3 /hEfficiency 99.99% at 0.3 µm or 99.99% at 0.3 µm 99995% at 0.3µ 99.99% at 0.3µ 99.97% 99.97% at 0.3µat Nominal Airflow 99.95 % at MPPS or 99.95 % at MPPS or 99.99% at 0.3µPressure Drop 1" w.g. 1" w.g. 1.1" w.g. 1" w.g. 1" w.g. 1" w.g.at Nominal Airflow 250 Pa 250 Pa 275 Pa 250 Pa 250 Pa 250 PaStandard Frame stainless steel stainless steel stainless steel ceramic 304 stainless steel 304 stainless steelFrame Height 6” & 11 1/2 ” 6” & 11 1/2 ” 11 1/2 ” 3.3” 6” &11 1/2 " 11 1/2 "150 & 292 mm 150 & 292 mm 292 mm 84 mm 150 & 292 mm 292 mmStandard Gasket fiber glass fiber glass silicon rolled fiber glass silicon aluminum & fiberglassAlternate Gasket no gasket no gasket no gasket no gasket no gasket no gasketAbsolute FRK (Europe model)/Absolute Fseries (US model).Sealant silicone ceramic silicon ceramic silicon ceramicStandard Separator aluminum aluminum fiber glass fiber glass thread aluminum aluminumStandard Face Grid no grid no grid no grid 2 pieces of stainless 1 piece 304 stainless(protective) steel steelAlternate Face Grid(protective)no gridMedia Type fiber glass fiber glass fiber glass fiber glass fiber glass fiber glassMedia Area (24” x 24”) 123/242 sq. ft. 123/242 sq. ft. 431 sq. ft. 130 sq. ft. 186 sq. ft. 180 sq ft(610 x 610) 11.4/22.5 m 2 11.4/22.5 m 2 40.0 m 2 12.1 m 2 17.3 m 2 16.7 m 2Mini-pleat Yes YesDeep-pleat Yes Yes Yes YesSize Availability 12 standard sizes 10 standard sizes 2 sizes 7 standard sizes 7 standard sizes 7 standard sizesSofilair HT (Europe model)/Sofilair HT(US model).Leak Rate (%) 0.05% 0.05% 0.10% 0.01% 0.03% (99.97) 0.03% (99.97%)or 0.01% guaranteed(99.99%)Leak Test at 68°F/ 20°C at 68°F/ 20°C at 68°F/ 20°C 100% individual at 68°F/ 20°C at 68°F/ 20°CConditions before thermal before thermal after thermal before thermal before thermaltreatment treatment treatment treatment treatmentMaximum Operating 482° F 662° F 446° F 662° F 500° F 750° FTemperature 250˚ C 350˚ C 230˚ C 350˚ C 260˚ C 400˚ CWeight 32 lbs. & 46 lbs. 32 lbs. & 46 lbs. 67 lbs. 5 lbs. 42 lbs. 59 lbs.14.5 & 20.9 kg 14.5 & 20.9 kg 30.4 kg 5.0 kg 19.1 kg 26.8 kgHandling Camfil Farr ‘special’ Camfil Farr Camfil FarrAbsolute packaging Absolute packaging Absolute packagingMechanical high high high medium high highResistanceTermikfil 2000 (Europe model)/Termikfil(US model).Burst Pressure 2” w.g. 2” w.g. 1.4” w.g. 2” w.g. 2” w.g.500 Pa 500 Pa 350 Pa 500 Pa 500 Pa1 MPPS – Most penetrating particle size µ- Micron F – Fahrenheit C – Celsius8

hi-temp applicationsfacturer to decide what cleaning, sterilization,and depyrogenation is appropriate for theirgiven process.The air used in the depyrogenationprocess must be filtered by leak free HEPAgrade air filters.Depyrogenation tunnels and continuousovens are continuous systems that are usedto reduce the amount of endotoxin to anacceptable level on glass or metal vials orother process containers and accessories.Depyrogenation ovens are batch systemsused to reduce the amount of endotoxin toan acceptable level on glass or metal vials orother process containers and accessories.The items being subjected to the depyrogenationprocess must remain at the specifiedtemperature for the specified time periodfor the process to be successful. Reducedheat-up and cool down periods as well asincreased maximum temperature canincrease the total throughput of theequipment.In the past, the duration of batch depyrogenationprocesses has been determined bythe ability of the HEPA filters to maintain thecleanliness class required (normally ISO Class5). Failure of the HEPA filters was a likelyevent during the heat-up and cool-downcycles. More recently, advances in HEPA filtertechnology have helped to reduce the negativeimpact HEPA filters have on the durationof the process.For many years we have produced‘traditional’ HT filters with Silicone & Ceramicbased seals. The F and K series filters producedby Camfil Farr in the USA and Europehave long been the ‘filter of choice’ for ourBio-Pharma and original equipment manufacturers(OEM) customers.Camfil Farr's Termikfil is an example ofa new high-temperature HEPA filtration technology.Specifically designed for use in depyrogenationovens and tunnels for sterilizationpurposes, Camfil Farr’s Termikfil is the onlyHEPA filter guaranteed to operate for aminimum of one year at a temperature of350°C/662°F) while maintaining the leakfreeintegrity required to pass FDA validations.The Termikfil is pre-treated, and prequalified,during the manufacturing process,with an exclusive heat preparation cycle(300°C/572°F).New high-temperature air filtration technologieshave allowed equipment manufacturersto focus on other process related issues,maximize equipment performance, andreduce the cost of equipment operation.The leading OEM’s globally choose CamfilFarr as their vendor of choice for criticalapplications, the range of filters we produceallows them to deliver equipment to their biopharmacustomers for the most demandingapplications:Our OEM CustomersCountryGlobally IncludeBausch & StrobelGermanyNIRODenmarkIcosItalyFedergariItalyTPSUSADespatchUSALytzenDenmark9

safe-changebag in/bag out BIBOToday we are concerned about contaminantsthat may be introduced into abuilding through unconventional sources.Whether contaminants are introducedthrough an outside air intake or releasedinside of a building, Camfil Farr has the airfiltration technology to remove them.Camfil Farr is the world leader in appliedtechnology for the protection of buildingsfrom chemical, biological or radiological(CBR) attacks. As an air filtration leader incleanrooms, hospital operating suites,nuclear power facilities, isolation roomsand bio-safety facilities, our experiencehelps us address the security of yourbuilding’s air quality in our changing world.PurposeThe purpose of a containment system isto filter dangerous chemical, biological,or carcinogenic contaminants from air.Containment systems, as their name infers,are also designed to contain the filteredcontaminants in a sealed housing until suchtime as the filter media needs replacementor regeneration. Containment systems canfilter out particulates, gases, or both.Containment systems can include acombination of several components,depending on the nature of the contaminantand application. These components caninclude pre-filtration, test, high-efficiency orfinal filtration, and adsorber sections mountedin series. The capacity of the system can beincreased by adding multiple sections to thesystem in parallel.Containment systems can also include anoption called bag-in/bag-out to facilitate thesafe change-out of air filters.BIBOBag-in/Bag-out systems are containmentsystems with the added option of including aPVC bag which includes integral gloves. Thebags are used to seal the containment housingwhile changing filters that are contaminatedwith dangerous matter. Utilization of very specificprocedures is required for the safe useof bag-in/bag-out systems. Camfil Farr publishesa bag-in/bag-out filter change instructionmanual for the use of our customers.The bag is sealed to a flange located atthe door opening of the containment sectionwith a shock cord. Used filters are removedfrom their mount in the housing by reachinginto the PVC gloves and sliding the filter intothe bag. The bag is then sealed and removedand a new bag is mounted to the flange. Thedoor is then closed and sealed and the unitplaced back into service.Camfil Farr BIBO solutions:FB Series housingsGB Series housingsCamsafeCamfil Farr FB Series housings, GB Serieshousings and Camsafe are designed for usein critical processes where hazardous airbornematerials must be prevented fromescaping to the atmosphere. Air filters maybe replaced using a control barrier to protectchange-out personnel from contaminantswithin the housing or contaminants capturedby the filters.The Camfil Farr FB Series housings,GB Series housings and Camsafe minimizeexposure to harmful contaminants duringfilter service through the use of a PVC bagenclosure system. The entire filter changingprocess isolates personnel from the hazardousmaterials. Although the Camfil FarrFB Series housings, GB Series housings andCamsafe are available in a basic configuration,various options specific to the applicationare available.These housings are typically used in facilitiesthat incorporate hazardous materials intheir processes.These contaminants may include biomedical,radiological, carcinogenic or othermaterials of concern.Containment systemCamfil Farr Self-Contained Isolation Systemscan provide a complete solution to applicationswhere hazardous airborne contaminants maypresent risk to facility personnel or visitors.These systems can be custom designedto remove airborne particulate, gaseouscontaminants, or a combination thereof.Typical applications include hospital isolationrooms/wards and Intensive Care Units(ICUs).Camfil Farr Self-Contained IsolationSystems are ideal for the control of airbornepathogens, viral contaminants and infectiousorganisms.10

containmentIn applications where individuals maycome into the proximity of individuals withmycobacteriu tuberculosis, the Centers forDisease Control (CDC) in USA has specifiedcertain air quality control parameters.For new projects, or renovations, a minimumof 12 air changes per hour of clean airare required. For existing systems the minimumair change requirement is 6 air changesper hour. In both cases the Guideline isspecific to the protection of employees andvisitors to the facility.Camfil Farr's Self-Contained IsolationSystems can assist your facility in meetingor exceeding these guidelines.For a copy of these guidelines contactyour local Camfil Farr Representative orCamfil Farr.Available in various customizable configurations,each unit is reviewed by ourengineering team and tested as a completesystem to ensure suitability to task.Mechanical components are matched tofiltration stages to assure deliverance ofrated airflow.Optional components such as magnehelicgages, test ports, dampers and controlmechanisms are available.Camfil Farr has the ability to supply thesystem and the filters. Component compatibilityand overall system quality are assuredfrom a single-source manufacturer.FB Housings.GB Housings.FB Housings. Camfil Farr Prefilter Housingsmate directly to Camfil Farr GB, FB, GN, andFN Seriescontainment housings.FB-r round bag-in/bag-out housing.Camsafe.Self-Contained Air Filtration Systems forHazardous Contaminant Removal.11

camfil farr cleafor the bio-ph130/30Medium efficiency pleatedpanel filter.The original pleated filter – today’sindustry standard.Contains up to 16 pleats per linearfoot/305 mm.Radial pleat construction for minimumpressure drop and maximum servicelife.Available in U.L. Class 2 or 1,in 1", 2" and 4"/25, 50 and75 mm depths.Nonwoven cotton/synthetic blendmedia.Rated as a MERV 7 filter according toASHRAE 52.2 or G4 per EN 779.4camcarb/camsorbIn carbon filtration, Camfil Farr hasa number of different solutions.Camcarb/Camsorb activated carbonfilters consist of a galvanised/stainlesssteel base plate and cylinders ofgalvanised/stainless steel containingactivated carbon. The cylinders arealso available in an environmental,green, version, produced in plastic.Filter type: Camcarb 2600-16/CM07for SO2 gas.5 3 127 13Filling machine5filtra 2000 ® /sofilair2hi-floUse a high performancefine fibre filter with a largemedia surface area. A bagfilter with alarge area (Hi-Flo M-type) is recommended.Rated as a MERV 13/14 filter accordingto ASHRAE 52.2 or F8/F9 perEN 779:2002.High capacity HEPA filter 2400 cfmat 1" pd/4000 m 3 /h at 250 Pa.Available in extruded aluminum,galvanised, plastic or stainless steelframe with gel or gasket seal.Individually tested to the latestinternational standards.96Tablet press3opakfil green/durafilMultiple close-pleat panels containmaximum media area.Excellent for low external staticpressure systems. Minimum energyconsumption.Available with header frame.Offered in MERV 11, 13, and 14, perASHRAE Standard 52.2. or F6, F7 andF8/F9 per EN 779:2002.6pharmaseal ®Roomside replaceableHEPA/ULPA ducted ceilingmodule with all-welded constructioneliminating leakage into the cleanspace.Accepts gel seal filters in efficienciesfrom 95% at 0.3 micron to 99.9995%at most penetrating particle size.May be installed in a T-bar ceiling orflush mounted in plaster or sheet rockceilings. Includes aerosol injection/diffusion system for uniform challengedistribution.Available with bubble tight, guillotineor butterfly dampers.Available in 00.63 aluminum or16 gauge 304 stainless steel.9bibo dust collectorThe Gold Series (GS) dust collector can beused in a variety of pharmaceutical dustcollection applications such as pill presses, tabletcoating, fluid bed dryers, spray dryers, and generalroom ventilation. The GS is perfect for high efficiencyfiltration in pharmaceutical manufacturing.105112

n air solutionsarma industry10wm pharmasealThe wall mounted Pharmaseal is available with 30/30 pre filter and Sofilair/Filtra2000 and Megalam panels. The test shroud allows for an overall efficiency testfrom within the room.–+534216Cleanroom/Oven87megalam ®panel filters6IsolatorPatented close-pleat manufacturingtechnology ensures low pressuredrop, uniform airflow and minimalconfiguration losses.Available in efficiencies from 95% at0.3 micron to 99.9999995% at mostpenetrating particle size.Anodized aluminum frame ensures arigid and durable pack.Various frame configurations, sealingoptions and media options available,consult factory.Each unit individually tested andcertified.11bag-in/bag-outhousingWall mounted BIBO/Safe Changehousing, available with pre, HEPA andscan sections, bubble tight damper,cover panel doors etc. Typically utilizedwhere potent or toxic compoundsare in use, minimizes theneed to decontaminate ductwork.711or121 5 1013camgrid dry/camgrid gelis a modular grid system for mounting in ceilings orwalls in Bio-Pharma cleanrooms.Camgrid system can equip:• Clean areas down to ISO 5• Local Unidirectional Airflow Protection• Complete Unidirectional Airflow Cleanroom• Non-unidirectional Airflow Cleanroom (with blank panels)Camgrid system modularity is ideal to optimise filtration coverageand reach maximum effective filtration area with minimisingturbulences.8termikfil 2000 ®Close-pleated panelresistant to temperaturesup to 662°F/350°C in continuousoperation.Unique construction assuresmaximum dependabilityand leakfree performance.The composite ceramic framereduces the thermal expansion toa minimum.Upstream and downstream diamondpoint stainless steel grids protects thefilters while handling.Efficiency >99.99% at 0.3 micronparticles.Individually tested, certified andrecorded.Applications include sterilizationtunnels and ovans.12camsafeHigh security Safe changefilter housing.Contact free BIBO.Automatic tension-regulating filterclamping device.Fast, secure filter installation, leveroperated.Optional filter seal seating test as perDIN 1946, Part 4.Sealed, welded, solid design.Tightness class B as per EN 1866 at5000 Pa.Camsafe connecting pieces can besupplied in various designs.13

atexpotentially explosive atmospheresregulationTwo important new safety directives becomefully operational across Europe. These newregulations are known as the ATEX Directivesand apply to manufacturers, suppliers andusers of equipment designed for use inpotentially explosive atmospheres (alsoknown as hazardous areas).An explosive atmosphere is defined as amixture with air, under atmospheric conditions,of dangerous substances in the formof gases, vapours, mist or dust in which afterignition has occurred, combustion spreads tothe entire unburned mixture.Directives 99/92/EC (ATEX 137), “USE”directives, requires employers to protectworkers from the risk of explosive atmospheres.Directives 94/9/EC (ATEX 95 or ATEX100A) “Equipment and Protective Systemsfor use in potentially explosive atmospheres”covers electrical and non-electrical productsintended for use in hazardous areas (gas,vapours or dust atmospheres).Compliance with both ATEX directives are alegal requirement in all European UnionMembers States from 1 July 2003.In Bio-Pharmaceutical applications, someprocesses are required to have ATEX classifiedfilters in certain zones (see table).Camfil Farr in Europe have developedATEX approved HEPA filters and housings foruse in Bio-Pharmaceutical facilities in order toavoid any electrostatic hazards from gas ordust in the ATEX zone.Camfil Farr has developed ATEX specificallydesigned versions of most of filters and filterhousings generally used in Bio-Pharmaceuticalfacilities in order to avoid any electrostatichazards in ATEX zones Gas or Dust.Camfil Farr ATEX solutions are fully certifiedaccording to ATEX Directive requirementswith the appropriate “Ex” marking,the “ATEX Declaration of Conformity” and“Instruction for use”.Table legend:ATEX user Zoning and Product Categories correspondenceZoning DefinitionsCategoriesGasZonesDustDefinitionsATEXCat.Typical ZoneSuitabilityEN 60079-10 EN 50281-30 20 A place in which an explosiveatmosphere is continually present1G Equip. suitable for zone 01D Equip. suitable for zone 201 21 A place in which an explosive atmosphereis likely to occur in normal operationoccasionally2 22 A place in which an explosive atmosphereis not likely to occur in normal operation,but if it does only occurs for short periods.2G Equip. suitable for zone 12D Equip. suitable for zone 213G Equip. suitable for zone 23D Equip. suitable for zone 2214

io-pharma dust collection systembibo – gold series camtain TMThe Only Potent CompoundSurrogate Tested Dust CollectorThe Gold Series Camtain BIBO door and BIBOdust discharge system has been personnelexposure tested with lactose as the surrogatedust for the potent pharmaceuticalcompound. Over 75 air quaiity and swab testpoints were taken during multiple changeouts of the dust and filters. This was perforedby an independent testing firm(Broadspire) who IS certified by a major pharmaceuticalcompany for potent compoundsample testing. The GS Camtain is the onlypotent compound tested dust collector onthe market today, and can handle yourtoughest applications. Full test report datais available upon request.cartridge access doors and dust dischargesystem underneath the collector. Farr hasBIBO dust collectors on pharmaceutical applicationsin the USA, Canada and Europe, Farrhas named its BIBO dust collection systemthe Gold Series Camtain.Gold Seriers on PharmaceuticalCompany ApplicationsThe Gold Series (GS) dust collector can beused in a variety of pharmaceutical dustcollection applications such as pill presses,tablet coating, fluid bed dryers, spray dryers,and general room ventilation. The GS isperfect for high efficiency filtration in pharmaceuticalmanufacturing.GS4 8180 camtain self-cleaning dust collectorfor pharmaceutical applications.Gold Series CamtainTM onPharmaceutical ApplicationsBag In Bag Out (BIBO) safe change containmentsystems are available on both the“The Gold Series BIBO Camtain isa winner for our pharmaceuticalapplications. It is way ahead of thecurve of anyone in the dust collectionindustry. The results from thepotent compound surrogate testare very positive. Nice work!”Project Engineer,Major Pharmaceutical CompanyPill press ventilation.15

housingspharmaseal terminal housingThe Camfil Farr Pharmaseal provides cleanroom level air filtration for pharmaceutical or biotechnologyfacilities as well as any other facility where clean space is a manufacturing or healthrelatedrequirement.Its unique room side replacement filter design minimizes downtime and ensures repeatableroom air cleanliness following filter service.Bubble-tight damper.Guillotine damper.Butterfly damper.Guillotine or BT damper control damperposition indicator and set screw.The Camfil Farr Pharmaseal:• Has joints and penetrations in the “filter-to-hood”interface that are of welded component construction.Leaks into the cleanroom are eliminated.• The housing is visually inspected, tested for filterfit, and then leak tested at 3.0” w.g./750 Pato ensure the housing will not leak under normaloperating conditions.• Is manufactured in various configurations of0.063 aluminum or 16 gauge/2.8 mm304 stainless steel.• May be installed in a heavy-duty T-bar ceiling orflush mounted in a plaster or sheet rock ceiling.• Damper options:– A Bubble Tight damper to isolate the roomduring filter change out or decontamination. TheBubble Tight damper also acts as a volume controldamper with the same adjustment mechanismfrom within the housing in the room.– A Guillotine damper with heavy-duty roomside adjustable linkage for precise airflow adjustmentand room air balance.– A Butterfly damper for easy adjustment ofairflow to fine-tune the balancing from within theroom.• Includes an air/aerosol distribution system foruniform dispersion of test challenge across theentire face of the filter.• Includes a raised-rib inlet collar for easy connectionto flexible HVAC air duct supply.• Housing can be insulated with 2”/50 mm foiledback fiberglass or 1”/25 mm armaflex asstandard.• Each housing is labeled with a serial numberfor full traceability of pressure tests andsoap bubble welded joints test to ensure aleak free housing.Two versions are available;A seal-welded version on modules with guillotinedampers to ensure leak free performance, or amechanically connected version on modules withbutterfly dampers, both offering a sturdy moduleconnection.• Includes a flush-mounted face grille to accommodateeasy filter change or unit service. The grillehas a 40% open area optimized to promoteuniform airflow. Various grille fastener types areavailable. The grille is also available with a hinge.• Accepts gel seal filters that are available in packdepths of 2, 3 or 4”/53, 70 or 100 mm..Recommended filter efficiency for the Pharmasealmodule is H14 (99.995 at MPPS) in accordancewith EN-1822.Aerosol dispersion system with QD (QuickDisconnect ports) and damper control mechanism.Camfil Farr’s flexible fabrication capabilitiescan supply a PharmaSeal for virtually anycleanroom requirement. Custom sizes can bemanufactured with special trims, and built upbanks with single inlet collars for multipleunits where horizontal or vertical airflow isrequired.The PharmaSealis available with abubbletight damper,a guillotine damperor a butterfly damper.16

containmentpharmaseal exhaust housingWall Mount Exhaust Housingwith a HEPA and a PrefilterOptionThe Pharmaseal exhaust housing is a simple, yethighly effective solution for exhaust and recirculationapplications in pharmaceutical andbiotechnology facilities, hospitals, surgical suitesand animal labs.The CamfilFarr Pharmaseal room sidereplaceable exhaust housing:• Allows a maintenance-friendly filter changefrom within the room, through a removablestainless steel filter face grille, ensuring contaminantcontainment, the clean spaceremains uncompromised.• Enclosure is manufactured from 0.063aluminum or 316/316L stainless steel. Allunits includes 304 stainless steel grille andtrim.• Is bubble leak tested to 3.0” w.g./750 Pa toensure that the housing will not leak undernormal operating conditions. The housing isalso visually inspected at the factory and testedfor filter fit before shipment.Each unit includes a label which allows forfull traceability of the testing procedure.• Includes all mounting hardware and a choiceof an inward-turned flange, an outward-turnedflange or an integral plenum with 10” or 12”/250 or 300 mm round flex duct connection.• The unit includes integral flush perimeter trim.Unit may be mounted in sheet rock walls,plaster, or conventional aluminum or stainlesssteel honeycomb panels.• Is available in four standard filter configurations,a 4”/100 mm filter with prefilter, a4”/100 mm filter without prefilter, a Filtra2000 filter with prefilter and a Filtra 2000filter without a prefilter.• Includes integral filters guides that ensureproperfilter fit within the gel to knife edgealignment with the filter.• Includes a static pressure port and quick-disconnectports for convenient room side filterevaluation• Optional test shroud and sampling ports allowall efficiency measurements from the roomside.Pharmaseal Exhaust Housing installed in acleanroom wall offers an astheticaly pleasingroomside appearance.Same unit with testing shroud mounted on thePharmaseal frame for overall filter efficiencytesting from within the room.Pharmaseal Exhaust Hood Test ProcedureDownstream aerosol sample port1. Remove grille from Pharmaseal.Exhaust duct2. Install test fixture to hood, Note: The flexiblehose of the downstream aerosol sample port inthe test fixture must be attached to the quickdisconnect fitting in the hood just before actuallyattaching test fixture to hood.3. Connect photometer to test fixture upstreamaerosol sample port and the downstream aerosolsample port.Downstream aerosolsample portTest fixtureAerosol dispersion portCeiling line4. Connect smoke generator to aerosol injectionport.5. Conduct test of filter.PhotometerUpstream aerosolsample portSmoke generator6. If result is acceptable, remove test instrumentsand test fixture.7. Replace grille on Pharmaseal.17

lccenergy saving software programsLCC SoftwareThe Life Cycle Cost (LCC) software is a toolwe have used successfully for many years inthe Bio-Pharma industry.The volatile oil and energy markets andthe ever increasing cost of supplying cleanair are critical for this industry.The LCC software allows us to simulatedifferent combinations of filter types with thedesired efficiency to maximize lifetime,reduce energy costs and number of filterchanges which can save the Pharmaceuticalmanufacturer valuable resources. An additionalbenefit is the positive effect reducedmotor power and disposal has on the environment.After filter survey’s are carried out at themanufacturing facility, we can input the existingfilter set up in the air handling units andoptimize the selection of the lowest LCC filtercombination for the facility in question.Parameters the softwareincludes are:Type of filters in use:• Outside air condition (environmental conditionin the plants location)• Airflow• Current change out conditions (we canselect filters being changed on time orpressure drop)• Number of filters in the air-handling unitsE = q x p x h x 1000Where:E = energy output/yearq = airflow m 3 /sp = differnece in pressure droph = operating time hours/year(year round operation 8,760 h) = fan efficiency• Current energy cost• Installation cost• Disposal and cleaning costsCamfil Farr filters have proven to be the topfilter in several independent tests and competitionsabout the lowest Life Cycle Cost.The energy consumption is easilycalculated with the formula stated above.Example of printout from the LCC computer program.18

designed softwareCleanroom design softwareCamfil Farr has designed a software programwhich allows us to simulate the actual operatingconditions when multiple parametersare selected:Selection options include:• Particle size of interest, 0.1, 0.3 or 0.5micron• Particles generated from the process andactivity from people in the room• Dimensions of the room• No. of air changes/airflow• Ventilation effectiveness• Amount of recirculated air from 0 – 100%• Pre and terminal filter efficienciesEN 1822 software programThe Camfil Farr EN 1822, former PQ program,allows engineers/end users the opportunityto ”maximise” HEPA/ULPA selection.By simply inputting the actual filter dimension,desired efficiency and airflow/facevelocity, the program automatically showsyou the actual efficiency at 0.3 µm andMPPS (Most Penetrating Particle Size), thetypical and maximum air resistance acrossthe selected media pleat depth and theMPPS particle size.Chemical/carbon filtersoftware programThe Camfil Farr chemical/carbon selectionprogram is designed to help users anddesign engineers to estimate lifetime andefficiency of chemical/carbon filters againstspecific target gases at given concentrations.The software program clearly demonstratesCamfil Farr’s continuing commitmentto serve our customers and optimise filterselection for the Bio-Pharma segment.Protocol from EN 1822 computer program showingpenetration vs size of a Megalar H14 filter.Interface from Chemical/Carbon computer program.Example of printout from the Clean Roomcomputer program.19

&dcamfil farr testing capacitiesASHRAE test rig.SEM (Scanning Electron Microscope)Camfil Farr has severaltest rigs around the worldCamfil Farr maintain a strong commitment toquality control and R&D.We have rigorous in-house and on-goingfield trials to ensure all products arecompliant with specification.ASHRAE test rigWe were the first air filtration company inEurope to invest in our own Eurovent 4/9 &EN 779:2002 test rigs.The test rigs have undergone rigorous'round robin' tests to ensure consistency offilter evaluation with independent test laboratories.Camfil Farr USA was also the first airfiltration company to install our own ASHRAE52.21.1999 test rig. Both rigs can now offerthe 'discharging' step of 'electrostraticallycharged media's'(commonly known as syntheticmedia's) already adopted in Europeand soon to be adopted in the USA.By having a number of our own test rigswe can test new filters as well as used filtersfrom the field to build up our own databaseof how filters work and perform in real life.Standards have so far been concentrating onfinding fast, economical methods to classifyfilters.SEMThe scanning electron microscope with EDAXcapability is another example of our commitmentand investment to R&D. This uniquetool, allows us to identify and quantify contaminantsin the air and in used filters inorder to further improve and understandhow filters perform in real life. The SEM issituated in our corporate R&D facility inTrosa, Sweden.20

strategy/environmentMolecular filter test rig.Media test rig.Media test rigThe Media test rig allows raw chemicalmedias to be evaluated under a wide range ofconditions and challenged with a wide variety ofgases and vapours. Multiple parallel test linesallow simultaneous evaluation of medias fordevelopment and quality assurance purposes.Molecular Filter test rigThe molecular media test rig and the uniquefull-scale chemical filter test rig at our corporatehead-quarters in Trosa, Sweden areexamples of the significant investment madein the field of molecular filtration.In this unique facility, full size gas filterscan be operated in the rig under a widerange of temperature and humidity conditionsand challenged with different gases. The efficiencyand life are determined using an arrayof sophisticated gas detection equipment.Full scale test deviceOne of Camfil Farr’s latest investments is ourfull scale test device used to evaluate filtrationneeds under extreme continuous conditions.Using this apparatus, we can modify all ofthe important parameters such as airflow, relativehumidity, temperature and salt content.The device can be used with air or othergases and will allow rapid prototyping, productvalidation, evaluation of competitive productsand for research and development testing.HEPA testing protocolAll Camfil Farr Absolute filters are scannedand tested in the factory using a laser particlecounter. After gaining approval, each filterreceives an inspection label stating its serialnumber, efficiency for MPPS particles as wellass pressure drop at the test flow rate.EN 1822 test rig.StrategyWe continually seek to develop existingmaterials and identify new medias. Wemaintain strategic relation-ships withkey suppliers to ensure we secure premiummaterials tailored to our specificrequirements.21

technical servicesexternal testing capabilitiesEurovent (EU 4/10) in-Situ Filter testing.Mobile media test results.Camfield laboratory inside view.Camfield laboratory outside view.Eurovent (EU 4/10) in-SituFilter TestingHow can filter users differentiate manufacturersclaims and make intelligent decisions asto what pro-ducts are applicable to meet theirneeds?Historically, many depended upon testreports. Unfortunately, today's testing laboratorymethodologies may not give a truebarometer of a filters performance over timeas these filters are not tested under real lifeconditions.Camfil Farr addresses these concerns byperforming actual on-site filter performanceevaluations using industry defined procedures.The final report includes a particle sizeversus efficiency analysis detailing the filtersability to capture large particles, down tosub-micron size respirable particles that mayaffect health or processes. Pressure dropdata, relative to a filters actual life within asystem, and its overall effect on system airflowand use of energy is also detailed.Mobile media testerMicrofine media fibres, coarse media fibres,synthetics, polyesters, which filter media willprovide the efficiency required to ensure thatyou are protecting the health of your building’soccupants or ensure that your processis as clean as it needs to be?Camfil Farr now offers our Mobile MediaTester to answer your filter performancequestions and demonstrate that you areobtaining the particle removal efficiency youare paying for.This portable testing system can evaluateany high-efficiency flat-sheet filter mediaincluding samples obtained directly from yourfilter stock, existing air handlers or samplesas you request from your filter distributor.Contact your Camfil Farr distributor for amedia evaluation at your facility today.Airaudit serviceThe airaudit service of Camfil Farr has as ourmain objective to verify, maintain or improvethe quality of filtration of your installation.Sampling of air is made before and afterthe filter house or individual filter stages anda qualitative and/or quantitative analysis ofthe air will be reported.Qualitative analysis is an electronic microscopeanalysis of particles collected in theair.Quantitative analysis is a counting of individualparticles per volume of air. CamfilFarr's report will include recommendationsand advise on possible solutions to reduceoperating cost by improving the efficiencyand reliability of your installation.Mobile test rigAnother new investments is Camfil Farr’smobile approach to filter tests consists of amobile test rig installed in standard 20-footcontainer.Tests can be performed on eight differentfilters simultaneously in four different airducts. The mobile test laboratory documentsthe actual performance of filters in the applicationthey are intended for, with completecontrol over the operating parameters.Customers see, right on their site, whatthe most cost efficient and effective filtrationsolution will be for their air handling system,building or process. Customers can alsoparticipate in monitoring the results.Accelerated tests are also possible to testfilters at a higher airflow with the exact samedust load, to shorten the test period andsimulate a long-term test.22

accessories / environmentAccessoriesCamfil Farr provides the suitably designedaccessories in order to install and achieveperfect working of filtration solutions as:– Ceiling grids: like Camgrid the ceiling gridsolution– Frame and clamping devices: like Magna-Grid– Safety accessories like Bubble-tightIsolation dampers round or rectangularCamgrid dry/Camgrid gelCamfil Farr Camgrid modular ceiling grid systemcombined with Camfil Farr HEPA/ULPAMegalam panel filters is specifically designedto supply highly filtered air into Bio-Pharmacleanrooms via a pressurised plenum.Camgrid system can equip:– Clean areas down to ISO 5– Local Unidirectional Airflow Protection– Complete Unidirectional Airflow Cleanroom– Non-unidirectional Airflow Cleanroom(with blank panels)Camgrid system modularity is ideal to optimisefiltration coverage and reach maximumeffective filtration area with minimising turbulences.HEPA frameThe Camfil Farr HEPA frame Magna-Grid is anfactory assembled Absolute filter supportmodule designed to ensure that the systemefficiency equals the filter efficiency. It incorporatesswing bolt filter fastening assemblieswith equibearing clamps to provide uniformfilter sealing pressure.Round Low-Leak or Bubble-Tight Isolation DampersCamfil Farr Round Isolation Dampers create abarrier between hazardous contaminants andthe filter change out components typical to acontainment system. The Camfil Farr roundisolation damper is available in either a lowleak 1 or bubble-tight 2 model.Rectangular Bubble-TightIsolation DampersCamfil Farr rectangular isolation dampers arebubble-tight when tested to 10" w.g./ 2500 Pa.1. Low-leak isolation dampers are testedin the closed position at + 10" w.g./2500 Paby the pressure decay method per applicablesections of ASME N510-1995.2. Bubble-tight dampers are tested in theclosed position at + 10" w.g./2500 Pa tobubble-tight specification per applicablesections of ASME N510-1980.Camgrid.Round Low-Leak orBubble-TightIsolation Damper.HEPA framefor AHU.Rectangular Bubble-TightIsolation Damper.Environmental friendly productsHi-Flo G.Megalam Green.Sofilair Green.A major cornerstone of our philosophy isour commitment to the environment. In allour product categories we manufactureproducts to obtain the lowest life cycle cost(LCC). These filters are the lowest energyconsuming filters in the market place, thereforegood for the environment.We constantly strive to develop filtersthat have the longest lifetime during operationand to minimize the cost of disposal.In certain markets in Europe the locallaws dictate we incinerate filters after use.Today it is common for us to supply filterswith ‘no metal parts’. Our renowned Hi-FloBag Filter and Opakfil/Durafil and Riga-FloASHRAE filters have long been producedwhich allows for incineration.We have now added HEPA filters to our‘eco friendly’ product pallet. The Sofilair &Megalam filters are now available in totallyinsinerable versions.Manufacturing and supplying filtersthat protect the environment and deliver thelowest LCC will continue to be the numberone factor in our research & developmentdepartments.23

On world standards......Camfil Farr is the leader in clean air technology andair filter production.Camfil Farr has its own product development, R&Dand world wide local representation.Our overall quality goal is to develop, produce andmarket products and services of such a quality that weaim to exceed our customers expectations.We see our activities and products as an expressionof our quality.To reach a level of total quality it is necessary toestablish an internal work environment where all CamfilFarr employees can succeed together.This means an environment characterised by openness,confidence and good business understanding.www.camfilfarr.comArtwork: Ymer Reklambyrå AB. Printer: Trosa Tryckeri AB, Sweden, ©Camfil Farr 051120.FOR FURTHER INFORMATION PLEASE CONTACT YOUR NEAREST CAMFIL FARR OFFICE.YOU WILL FIND THEM ON OUR WEBSITE.English edition no. 1 20051215