laminar flow hoods and booths - klimaoprema€¦ · 4 laminar flow hoods and booths are an integral...

Laminar FlowHoods and Booths

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Klimaoprema Cleanroom Technology is a leading Croatian manufacturerof equipment for cleanrooms. We offer complete engineering „turn key“solutions which includes design, construction, manufacturing, installationand validation (GMP Classes A, B, C, D), service and installation of HVACand automatics. The entire know-how in this sector is the result of ourown research and development. Our applications have been confirmedin practice and meet the most stringent regulations pertaining to thepharmaceutical, chemical and food industries.The experience we gain from our foundation in 1975. until today whanKlimaoprema Cleanroom Technology is a modern company with excellentengineers, quality CNC machine park, testing laboratory, ERP informationsystem for business process management and ISO 9001:2008 certified.The company employs more then 200 workers at a central location andheadquarters in Samobor, Croatia, which is the production site also. Thefactory covers 9.300 m² production, storage and office space. We striveto be the company to which people want to come to work, in which em-ployees are satisfied and business partners receive all necessary assistancein the implementation of projects.This catalog of laminar flow hoods and booths is just a way to meet us.Personal contact and meeting customers specific requirements is our mis-sion and our staff, with their knowledge, engineering experience and ene-rgy, will realize your idea.Technical data and dimensions given in catalog are standard.Upon request, variety of performance and other dimensions ofproducts are possible.

... we go further

... to absolutely clean air!

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Laminar Flow Hoods and Booths ..................................................................................4Laminar Flow Hoods ...........................................................................................................6• Portable Laminar Flow Hood, KTP-A ...............................................................6• Horizontal Laminar Flow Hood, KTH-S ..........................................................7• Vertical Laminar Flow Hood, KTV-S ...................................................................8• Vertical Laminar Flow Hood, KTV-A ..................................................................9

Microbiological Safety Cabinets (Class II) ..............................................................10• Microbiological Safety Cabinet, KTB-NS.......................................................10• Microbiological Safety Cabinet, KTB-VS........................................................11

UV Hoods ..............................................................................................................................14• UV Sterilizer Hood...................................................................................................14

IVF Hood ...............................................................................................................................15Laminar Flow Booths ...................................................................................................................16Interspace filter device, MFU .......................................................................................18Weighing/Containment Booths...................................................................................19• Weighing/Containment Booth, VKA ................................................................19• Weighing/Containment Booth, VKO................................................................20• Weighing/Containment Booth, VKL .................................................................21

Special devices .................................................................................................................................22Validations ............................................................................................................................................23Service ....................................................................................................................................................24Device application .............................................................................................................................25

Content

What we can do for you?

Investor

Project designEngineering

Production

Assembly

EquippingValidations

Service

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Laminar Flow Hoods and Booths are an integral part ofevery laboratory and modern medicament production fa-cility. Production of medicaments includes the entire Phar-maceutical Technology treatment which consists of shapingthe finished product, production or receipt of goods andmaterials, processing technology and equipment, qualitycontrol, storage and delivery.Production of medicaments must be in accordance withclearly defined procedures, regulations and requirements -Law on Medicaments and Medical Products, PIC recom-mendation, GMP standards, FDA and PDA technical reportsand all in order to reduce the risk of microbiological con-tamination and particulate contamination to a minimum.Klimaoprema Cleanroom Technology produces LaminarFlow Hoods and Booths, Microbiological Safety Cabinets,Weighing/Containment Booths and many special devicesthat are designed in accordance with EU GMP standardsand customer gains a reputation of a medicament manufac-

turer to the highest standards of quality.We are designing the entire cleanroom production facilitiesand making validations, confirming that the equipment isfunctioning properly, in accordance with regulations, properapplication and in compliance with customer needs.We are designing cleanrooms for sterile medicament pro-duction in which air is supplied through the appropriate fil-ter efficiency (HEPA) that is necessary to maintain thedifference in pressure between the individual zones. Spacesmust be designed to meet the requirements for the numberof particles: at-rest and in operation, and these conditionsmust be defined for each room (class) separately. Filteredair must have a positive pressure relative to surroundingareas in all operating conditions and must effectively flushthe area.Laminar Flow Hoods and Booths are designed in the waythat repairs are done from the technical area which is out-side of the clean area and the replacement of filters is done

Laminar Flow Hoods and Booths

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from the clean area. Parts of manufacturing equipment thatcomes into contact with the product must not be reactive,additive or absorptive to the limit that can affect productquality. Equipment should be designed for easy resizing ofthe series, cleaning and sanitisation.Laminar Flow Hoods and Booths are protecting the oper-ator, the item of work and working environment from pos-sible contamination or biologically hazardous materials(biohazard) during the study or work with micro-organismsand microbs. Infectious particles, bacteria and viruses, uni-cellular and multicellular heterotrophic organisms are haz-ardous substances with which one can work only in laminarflow protection devices.Laminar air flow is clean, uniform flow of fluids (liquids andgases) in parallel layers, without interference between themand without turbulence.It is important to choose an optimal solution with optimalcosts. When purchasing the product, customer also gets the

training to work on the device and is secured with serviceand maintenance that will be done by our certified engi-neers and technicians.It is often necessary to ensure a clean sterile conditionswhere there is limited space and equipment in it. Pharma-cies and small manufacturing plants have no reason toworry because we offer special devices that are made tothe user’s requirements and restrictions that inhibit the useof standard devices. Based on its special function devicesprovide operators protection, item of work protection,open pharmaceutical substances protection and cooling therecycle air.We are permanently oriented toward customers whoseneeds we monitor and analyze with particular care, produc-ing and delivering Laminar Flow Hoods and Booths for theproduction of medicaments in the form of ampoules,tablets, film tablets, capsules, ointments, gels, emulsions, sus-pensions and syrups.

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Laminar Flow Hoods

Portable Laminar Flow Hood, KTP-A

l Protection: item of work protectionl Laminar flow: laminar, verticall Air flow velocity: 0.25-0.45 m/s, adjustablel Cleanliness class: ISO class 5(4), 100(10) class accor-ding to U.S.F.S. 209 E, GMP class A

l Operating: manually controlled parameters from thecontrol panel

l Built-in materials: powder coated steel and specialcleanroom profiles

l Work plate: perforated, polished stainless steell Work space: protected by glass shieldsl Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard

l Filter replacement: from above, without entering thework space

l llumination: fluo lamp, >750 luxl Noise: Low noise levell Takes up little space

Technical features:

The hood takes air through pre filter which holds largerparticles. Then the fan pushes the air towards the abso-lute HEPA filter. Due to the special air distribution system,laminar air flows into the work space where provides ahigh level of cleanliness.

Operation principle:

l UV bactericide lightl Differential pressure gauge for HEPA filter controll Connections for media (gas, air, vacuum, water)l Work hours counterl UV light work hours counterl Possible construction of stainless steel

Additional equipment:

Type KTP-A II KTP-A IV

Outer dimensions (mm)width x depth x height

494 x 556 x 950 645 x 710 x 950

Work space (mm)width x depth x height

459 x 459 x 470 610 x 610 x 470

HEPA filter H14 (EN 1822) mm 457 x 457 x 69 610 x 610 x 69

Air quantity (m³/h) 450 600

Max. power (W) 130 180

Voltage/Frequency (V/Hz) 230/50 230/50

Weight (kg) 40 50Other dimensions and performancesaccording to customer request

Technical data: HEPA filtered air

Ambient air

Recirculating air

KEY:

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Horizontal Laminar Flow Hood, KTH-S

l Protection: item of work protectionl Laminar flow: laminar, horizontall Air flow velocity: 0.25-0.45 m/s, adjustablel Cleanliness class: ISO class 5(4), 100(10) class accor-ding to U.S.F.S. 209 E, GMP class A

l Operating: microprocessor controlled parametersfrom the control panel

l Built-in materials: powder coated steel l Work plate: polished stainless steell Work space: stainless steel AISI 304l Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard

l llumination: fluo lamp, >750 luxl Safety: visual alarms of unfavorable conditionsl Work hours counterl UV light work hours counterl Noise: Low noise level

Technical features:

The hood takes air through pre filter which holds largerparticles. Then the fan pushes the air towards the abso-lute HEPA filter. Due to the special air distribution system,laminar air flows into the work space where provides ahigh level of cleanliness.


l UV bactericide lightl Electrical socket in the work space 230 Vl Connections for media (gas, air, vacuum, water)l Differential pressure gauge for HEPA filter controll Base stand (height: sitting - 750 mm, standing - 950 mm)l Possible construction of stainless steel


Type KTH-S I KTH-S II KTH-S III KTH-S IV


970 x 1025 x 880 1275 x 1025 x 880 1580 x 1025 x 880 1885 x 1025 x 880


940 x 500 x 610 1245 x 500 x 610 1550 x 500 x 610 1855 x 500 x 610

Max. power (W) 1600 1600 1650 1650

Max. conn. power on socked (W) 550 550 550 550

Voltage/Frequency (V/Hz) 230/50 230/50 230/50 230/50

Weight (kg) 200 255 285 315

Technical data:

Other dimensions and performances according to customer request

HEPA filtered air

Ambient air

Recirculating air

KEY:

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Vertical Laminar Flow Hood, KTV-S



l Built-in materials: powder coated steel l Work plate: perforated, polished stainless steell Work space: stainless steel AISI 304, electrical lifting ofthe front protective glass shield

l Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard


Technical features:

Fan directs air flow toward HEPA filter. Filtrated air lami-narly flows into the work space. One part of air, 25-30%,goes out, into environment, toward operator. Second partof air, 70-75%, circulates back through work spacethrough HEPA filter. Exhaust air is substituted with a newone which enters the system through pre filter class G4.


l UV bactericide light (15 W, 30 W, 36 W)l Electrical socket in the work space 230 Vl Connections for media (gas, air, vacuum, water)l Differential pressure gauge for HEPA filter controll Base stand (height: sitting - 750 mm, standing - 950 mm)l Possible construction of stainless steel


Type KTV-S I KTV-S II KTV-S III KTV-S IV


1030 x 825 x 2200 1335 x 825 x 2200 1640 x 825 x 2200 1945 x 825 x 2200


885 x 610 x 620 1190 x 610 x 620 1495 x 610 x 620 1800 x 610 x 620

Max. power (W) 1800 1800 1850 1850



Weight (kg) 270 300 320 350

Technical data:


HEPA filtered air

Ambient air

Recirculating air

KEY:

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Vertical Laminar Flow Hood, KTV-A




l Work plate: polished stainless steell Work space: protected by glass shieldsl Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard


Technical features:

The hood takes air through pre filter which holds largerparticles. Fan directs air flow toward HEPA absolute filter.Due to the special air distribution system, laminar airflows into the work space where provides a high level ofcleanliness.




Technical data:


Type KTV-A I KTV-A II KTV-A III KTV-A IV


970 x 750 x 2020 1275 x 750 x 2020 1580 x 750 x 2020 1885 x 750 x 2020


925 x 600 x 650 1230 x 600 x 650 1535 x 600 x 650 1840 x 600 x 650

Max. power (W)) 450 520 650 750


Weight (kg) 74 85 102 120

HEPA filtered air

Ambient air

Recirculating air

KEY:

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Microbiological Safety Cabinets (Class II)

Microbiological Safety Cabinet, KTB-NS

l Protection: operator, item of work and environmentalprotection

l Laminar flow: laminar, verticall Air flow velocity: 0.25-0.45 m/s, adjustablel Cleanliness class: ISO class 5(4), 100(10) class accor-ding to U.S.F.S. 209 E, GMP class A




l llumination: fluo lamp, >750 luxl Bactericidal UV light for sterilizationl Safety: visual alarms of unfavorable conditionsl Work hours counterl UV light work hours counterl Noise: Low noise level

Technical features:

Microbiological safety cabinet circulates 70% of the con-taminated air through one HEPA filter and exhausts re-maining 30% of air flow through other HEPA filter. This air flow performance makes the system sui-table for Biosafety level 1, 2 and 3.




Type KTB-NS I KTB-NS II KTB-NS III KTB-NS IVOuter dimensions (mm)width x depth x height 1030 x 825 x 2200 1335 x 825 x 2200 1640 x 825 x 2200 1945 x 825 x 2200

Work space (mm)width x depth x height 885 x 610 x 620 1190 x 610 x 620 1495 x 610 x 620 1800 x 610 x 620

Max. power (W) 1800 1800 1850 1850Max. conn. power on socked (W) 550 550 550 550Voltage/Frequency (V/Hz) 230/50 230/50 230/50 230/50Weight (kg) 270 300 320 350

Technical data:


Contaminated air

HEPA filtered air

Ambient air

KEY:

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Microbiological Safety Cabinet, KTB-VSSpecial model with absolute pre filter for high risk laboratories

l Protection: operator, item of work and environmentalprotection

l Laminar flow: laminar, verticall Air flow velocity: 0.25-0.45 m/s, adjustablel Cleanliness class: ISO class 5(4), 100(10) class accor-ding to U.S.F.S. 209 E, GMP class A



l Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard. Additionally fitted Vpre filters

l llumination: fluo lamp, >750 luxl Bactericidal UV light for sterilizationl Connections for media (gas, air, vacuum, water)l Safety: visual alarms of unfavorable conditionsl Work hours counterl UV light work hours counterl Noise: Low noise level

Technical features:

Microbiological safety cabinet circulates 70% of the con-taminated air through one HEPA filter and exhausts re-maining 30% of air flow through other HEPA filter.Comparing to classical microbiological safety cabinet, thisspecial model has V HEPA pre filters which are built inunder the work desk. All incoming and circulation air ispurified through them. It implies that exit and work HEPAfilters are exposed to a contaminated air only during re-placement of the V HEPA pre filters.Change of V pre filters takes place under the normalwork mode. Pre filter segments are to be removed in thework space, in protective zone and then closed up in PVCbags. In this way, we assure complete protection whenservicing cabinets in which is dealed with high risk sub-stances.


l UV bactericide light (15 W, 30 W, 36 W)l Electrical socket in the work space 230 Vl Differential pressure gauge for HEPA filter controll Base stand (height: sitting - 750 mm, standing - 950 mm)l Possible construction of stainless steel


Type KTB-VS I KTB-VS II KTB-VS III KTB-VS IVOuter dimensions (mm)width x depth x height

1030 x 825 x 2200 1335 x 825 x 2200 1640 x 825 x 2200 1945 x 825 x 2200


885 x 610 x 620 1190 x 610 x 620 1495 x 610 x 620 1800 x 610 x 620

Max. power (W) 1800 1800 1850 1850



Weight (kg) 270 300 320 350


Technical data:

Contaminated air

HEPA filtered air

Ambient air

KEY:

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Technical data:

Other dimensions and performancesaccording to customer request

UV Hoods

UV Sterilizer Hood

l Protection: item of work protection, operators pro-tection from UV rays. Constant decontamination in-side the work space

l Air flow: circular recirculating flowl No.of air changes in work space: 50 changes/hl Built-in materials: stainless steel AISI 304l Glass: double layer, UV-proofl Recirculating set: inside the cabinets mask, consists ofa fan, UV lamp and filter G4 (EN 779) for dust

l UV lamp: two lamps, one inside the recirculation set,other in the work space. 8.000 work hours, UV raysdisinfects the work space by destroying the DNA/RNAfragments in the 15-30 minutes of exposure

l Time timer for UV lamps (30 min), automatic turn offof UV lamps whan opening the protective glass

l llumination: fluo lamp 15 Wl Work hours counterl UV light work hours counterl Noise: Low noise levell While the operator works, UV lamp within the

work space can not be in operation

Technical features:



690 x 515 x 555


675 x 500 x 405

UV sterilizer hood is triggerd by a key and it automaticallyruns the fan and turns on UV lamp inside the recirculatingset. Fan draws air from the work space through filter classG4 which eliminates larger contaminants and directs ittowards the UV part of recirculating set in which the UVlamp sterilizes the air. Sterilized air flows through the per-forations in the ceiling of UV hood back into the workspace, and the cycle repeats. During operation, a certainamount of air from the work space goes out under theglass and enters the room while the same amount ofroom air goes into the work space of UV hood.

Ambient air

Partially filtered air

Sterilized air

KEY:

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IVF Hood

l Protection: item of work protectionl Laminar flow: laminar, verticall Air flow velocity: 0.25-0.45 m/s, adjustablel Cleanliness class: ISO class 5(4), 100(10) class accordingto U.S.F.S. 209 E, GMP class A



l Work plate: polished stainless steell Temp.of work plate: heating plate 22°C-45°C, adjustablel Work space: protected by glass shields, distance fromHEPA filter 700 mm

l Main filter: HEPA H14, efficiency 99,995% MPPS, accor-ding to EN 1822 standard

l llumination: fluo lamp, >750 luxl Safety: visual alarms of unfavorable conditionsl Stereomicroscope: increase to min. 120 times, adapterfor the camera

l Base standl Power: 230 V, 50 Hzl UV bactericide light (15 W, 30 W, 36 W)l Work hours counterl UV light work hours counterl Noise: Low noise level

Technical features:

The hood takes air through pre filter which holds largerparticles. Fan directs air flow toward HEPA absolute filter.Due to the special air distribution system, laminar airflows into the work space where provides a high level ofcleanliness. In the work space are built heating plate, a mi-croscope and an LCD monitor.


l LCD monitor 19“l CO2 incubator capacity of 14-16 litersl Electrical socket in the work space 230 Vl Connections for media (gas, air, vacuum, water)


Type IVF I IVF II IVF III IVF IV


970 x 750 x 2020 1275 x 750 x 2020 1580 x 750 x 2020 1885 x 750 x 2020


925 x 600 x 750 1230 x 600 x 750 1535 x 600 x 750 1840 x 600 x 750

Max. power (W) 450 520 650 750


Weight (kg) 84 95 112 130

Technical data:


HEPA filtered air

Ambient air

Recirculating air

KEY:

HEPA filtered air

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l Protection: item of work protection in large area workspaces

l Laminar flow: laminar, verticall Air flow velocity: 0.25 m/s ± 20%l Possibility of air flow velocity selection - 0.30, 0.35,0.40 m/s

l Stand by mode 0.25 m/sl Cleanliness class: ISO class 5(4), 100(10) class accor-ding to U.S.F.S. 209 E, GMP class A

l Work space protected by UV stable PVC sheetsl Built-in materials: stainless steel AISI 304 (DIN 1.4301)l Operating: microprocessor controlled parametersfrom the control panel


l Pre filters class G4 to F9 (EN 779)l Safety: automatic filter and device failure control (visualand sound alarms). Additional visual filter control (ana-logue differential pressure gauge)

l llumination: integral lighting supplying 500 lux at theworking height

l UV bactericide lightl Option: Ex explosion proof design, certificates forinstalled components

Technical features:

l Booth can be hanged on ceilingl Booth can be put on fixed uprightsl Booth can be put on stainless steel swivel casters

Assembly:

The booth takes air through pre filters which hold largerparticles. Ventilators direct air toward HEPA absolute fil-ters. Due to the special air distribution system, laminarair flows into the working space, wherein it provides aircleanliness of a high degree.


Laminar Flow Booth, KA

Laminar Flow Booth

Recirculating air

Ambient air

KEY:

Technical data:

Various dimensions and performances according tocustomer request

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Interspace filter device

Interspace filter device, MFU

l Purpose: treatment of air in facilities, increasing the pu-rity of air in the room where laminar flow hood orbooth is installed, where the item of work is put nextto the device

l Installation: in the wall or partition walls between tworooms. Installation is air tight and elastically performedin order to reduce vibrations and avoid air streaming

l Operating: manually controlled parameters from thecontrol panel

l Built-in materials: steel sheet, satinl Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard

l Differential pressure gauge - additional equipment

Technical features:

Depending on the size of the room various dimensionsand performances according to customer request

Technical data:

Contaminated air from an unclean room is drawnthrough a pre filter and using the fan it is pushed throughthe absolute filter of MFU's. Thus purified, absolutely cleanair goes out in the form of divergent jets on the pure sideof MFU’s and is intensively mixed with air in clean room,increasing the purity. This cycle is continuous while theMFU is in use, while clean room is being used.Speed adjustment of MFU's is achieved through built-inspeed regulator on the wall in the non clean room.


HEPA filtered air

Recirculating air

Ambient air

KEY:

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Weighing/Containment Booths

Weighing/Containment Booth, VKA

l Protection: the booth provides an operator safe wor-king environment (by preventing the operator insidethe booth to inhale health hazardous particles), pro-tection of the booth's surroundings (by preventingdust particles, generated inside working space, to bedistributed outside of the booth), protection of openpharmaceutical substances from contamination (bymaintaining laminar air flow inside the booth and ade-quate air curtain in front of the booth)

l Laminar flow: laminar, verticall Air flow velocity: 0.30, 0.35, 0.40, 0,45 m/sl Stand by mode 0.25 m/sl Cleanliness class: ISO class 6(5), 1000(100) class ac-cording to U.S.F.S. 209 E, GMP class A


l Built-in materials: stainless steel AISI 304 (DIN 1.4301)l Air curtain: built in the entrance of the booth, preventscontamination of the work space


l Safety: automatic filter and device failure control (visualand sound alarms). Additional visual filter control (ana-logue differential pressure gauge)

l llumination: integral lighting supplying 500 lux at theworking height

l The equipment is designed for 3 shift workl Option: Ex explosion proof design, certificates forinstalled components

Technical features:

Fan directs air to flow through the package of the safeHEPA filters. Then air enters the working zone in a verti-cal laminar air flow. 10-15% of air quantity goes to thesurrounding environment, increasing overall cleanliness.On the booths bottom air is sucked through pre filters,along with 10-15% of surrounding air which makes upexactly the same air quantity which is previously exhau-sted. Afterwards air flow goes through another set of prefilters and than cycle repeats again.On the booths entrance, air curtain prevents pharmaceu-tical substances contamination and increases workingspace.


Technical data:


HEPA filtered air

Ambient air

KEY:

Partially contaminated air

Partially filtered air

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Weighing/Containment Booth, VKO


l Operator Exposure Level - 100 µg/m³l Laminar flow: laminar, verticall Air flow velocity: 0.30, 0.35, 0.40, 0,45 m/sl Stand by mode 0.25 m/sl Cleanliness class: ISO class 6(5), 1000(100) class ac-cording to U.S.F.S. 209 E, GMP class A


l Built-in materials: stainless steel AISI 304 (DIN 1.4301)l Air handling cooling unit for circulation air flowl Main filter: HEPA H14, efficiency 99,995% MPPS, ac-cording to EN 1822 standard

l Safety: automatic filter and device failure control (visualand sound alarms). Additional visual filter control (ana-logue differential pressure gauge)

l Two stage pre filters, safe change filter housingsl llumination: integral lighting supplying 500 lux at theworking height

l The equipment is designed for 3 shift workl Option: Ex explosion proof design, certificates forinstalled components

Technical features:

Fans draw air through perforation located on the workingspace lower end. Then air flow goes through two stagepre filters and package of H13 filters. Going through coo-ling unit air flow enters air distribution box. 85-90% ofoverall air quantity goes into working space via polyestercassettes. The rest of it, 10-15% goes into surrounding en-vironment. This air quantity is being made up by drawingair from outside.


Technical data:


HEPA filtered air

Ambient air

LEGENDA:


21


Weighing/Containment Booth, VKL


l Operator Exposure Level - 100 µg/m³l Laminar flow: laminar, verticall Air flow velocity: 0.30, 0.35, 0.40, 0,45 m/sl Stand by mode 0.25 m/sl Cleanliness class 5, 100, GMP class Al Operating: microprocessor controlled parametersfrom the control panel

l Built-in materials: stainless steel AISI 304 (DIN 1.4301)l Main filter, exhaust filter: HEPA H14, efficiency 99,995%MPPS, according to EN 1822 standard

l First stage filtration performed by F8 filter (EN 779)l Safety: automatic filter and device failure control (visualand sound alarms). Additional visual filter and pre filtercontrol (analogue differential pressure gauge)

l Electrical lifting of the front protective glassl llumination: integral lighting supplying 500 lux at theworking height

l Scale base standl Barrel stand on wheelsl The equipment is designed for 3 shift work

Technical features:

l UV bactericide light (15 W, 30 W, 36 W)l Electrical socket in the work space 230 Vl Connections for media (gas, air, vacuum, water)


Fans draw air through pre filters. 75-80% of overall airquantity, in laminar flow goes into working space throughmain HEPA filter, while the rest, via exit HEPA filter, goesinto surrounding.


Technical data:


HEPA filtered air

Recirculating air

Ambient air

KEY:


22

Special DevicesIt is often a case that we need to secure sterile clean zones in rooms limited with space and machinery located therein.Klimaoprema Cleanroom Technology is prepared to offer, according to customer requirements and space limitations, tailoredspecial devices in rooms, wherein standard equioment is not an option.

l Protection of the device's surroundings, by preventingdust particles generated inside working space to bedistributed outside of the booth

l Item protection from contamination in large area workspaces, by maintaining adequate laminar, absolutelyclean air flow inside the facility

l Protection of open pharmaceutical substances fromcontamination, by maintaining clean air flow inside thedevice

l An operator safe working environment, which pre-vents the operator inside the facility to inhale healthhazardous particles

l Cooling of circulated air

Protection:

Features of these devices can include, but are not limi-ted to the following:

l Dimensions of the work space (width x depth xheight) are up to customer's requirements

l Horizontal or vertical air flowl Possibility of air flow velocity selection - work model Stand by model Microprocesor controlled parameters from the con-trol panel

l Automatic filter and device failure control (visual andacoustic alarms)

l Additional visual filter control (analogue differentialpressure gauge)

l Absolute filtration performed by HEPA and ULPA filtersl Air handling cooling unit for circulation air flowl The equipment is designed for 3 shift workl Integral lighting supplying 500 lux at the working heightl Finished to recognized international GMP require-ments

l Option: Ex explosion proof design, certificates forinstalled components

Technical features:

23

Validations

l Validations are done by international rulesand norms

l According to EN 12469 norm for micro-biological safety cabinets and according toGMP or ISO standards for clean roomswe do tests and measuring

l We confirm that the devices are correct,in accordance with regulations, proper ap-plication and compliance with customerneeds

l Speed test and uniformity of air flow testl HEPA and ULPA filters integrity testl Number of particles test in work spacel Visualization flow test, smoke testl Overpressure testl Noise and vibration testl Illumination test

Features:

24

Service

l Recommended regular service andreplacement of HEPA (ULPA) filtersannually (once a year)

l Two years warrantyl Availability of replacement parts forthe entire lifetime of the device

l Fifteen years warranty on DispersetOil Particulate test (DOP test)

l Before service is performed decon-tamination of the device is done, toprotect operators, laboratory, envi-ronment, item of work and servicepersonnel in cases where the accessto the interior of the hood is inevi-table

l After each service it is necessary tovalidate the device

Features:

25

In order to protect personnel, item of work and environment, whan using laminar flow hoods and booths the followingshould be considered:

• Bio safety level• Type of laboratory• Classification of agents (micro-organisms)• Equipment biosecurity

Selection of laminar flow hoods and booths is the exclusive right of the user and depends on what it intends to use.There are some hybrid hoods that can be obtained, for example, by converting the hood of Class I to Class III by fittingcover with gloves in the work space. However, these hybrids can not meet the harsh demands of the relevant institutionsand scientists themselves to work with particularly hazardous agents.When working in a laminar flow hood or booth it is important that the operator feels comfortable. Discomfort and an-xiety can cause an accident. The operator must be able to sit or stand so that his hands are in a natural position for theworking surface of the device and must be able to reach all the items without stretching. The operator must be able tosee through the workspace, not below it, and his field of vision may not be disturbed by glass holders.Work space of laminar flow hood or booth should not be cluttered, too many products and accessories bother the airflow. Whan all the work in laminar flow device is done, fan still has to work a few minutes before turning off the deviceand fixing the front cover.

Device application

Laminar Flow Hoods:• Pharmacy and pharmacology• Laboratories and research• Biotechnology• Hospitals and clinics• Food industry• Optics• Microelectronics

UV Hoods:• Sterilization of instruments• Dentistry• Laboratories• DNA search

Microbiological Safety Cabinets (Class II)• Oncology• Pharmacy• Laboratories and research• Biotechnology• Microbiology• Genetic engineering• Hospitals and clinics• Nuclear medicine

Hood for IVF impregnation• Laboratories for extrauterine fertilization

Laminar Flow Booths• Laboratories• Pharmacy• Optics• Hospital facilities for intensive care• Industrial production• Food industry• Electronic industry

Weighing/Containment Booths• Pharmacy• Industrial production• Food industry• Electronic industry

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References

Gradna 78ACRO-10430 Samobor, CroatiaPhone: +385 (0) 1 33 62 513Fax: +385 (0) 1 33 62 [email protected]

11/2013

laminar flow hoods and booths - klimaoprema€¦ · 4 laminar flow hoods and booths are an integral...

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