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S N O I T U L O S Y E K N R U OPERATING T S M O …

OPERATINGROOMSTURN-KEYSOLUTIONSK limaoprema 78A, CRO-10430 Samobor, Croatia | T. +385 (0)1 33 62 513 | F. +385 (0)1 33 62 | ROOMS TURN-KEY SOLUTIONSOPERATING ROOMSAIR FILTRATIONVALIDATION AND SERVICESPROTECTIVE HOODSAND CABINETSCLEANROOM FURNITUREK limaoprema Cleanroom and rooms turnkey rooms (Building Management System)..25 Operation of filters according to data on coarse and fine ceiling filter duct filter duct filter with grille duct filter duct filter filter with active coal filter and hoods and laminar flow hood laminar flow hood laminar flow hood laminar flow hood safety cabinet KTB-NS (Class II)..52 Microbiological safety cabinet KTB-VS (Class II)..53 IVF sterilization and scrub and wire furniture and years of experienceMore than 220 employeesProductionEngineeringEquippingS erviceValidationInstallationMore than m production, warehouse, office spaceThousands rendered squaresof OPERATING roomsKlimaoprema is a leading Croatian manufacturer of OPERATING rooms, clean-rooms, ventilation and air-conditioning offer complete engineering turn-key solutions which includes design, engineer-ing, production, installation, validation (GMP classes A, B, C, D), service, ventilationand air-conditioning systems and automatics.

40 years of experience More than 220 employees Production Engineering Equipping Service Validation Installation More than 16.000 m² production, warehouse,

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Transcription of S N O I T U L O S Y E K N R U OPERATING T S M O …

1 OPERATINGROOMSTURN-KEYSOLUTIONSK limaoprema 78A, CRO-10430 Samobor, Croatia | T. +385 (0)1 33 62 513 | F. +385 (0)1 33 62 | ROOMS TURN-KEY SOLUTIONSOPERATING ROOMSAIR FILTRATIONVALIDATION AND SERVICESPROTECTIVE HOODSAND CABINETSCLEANROOM FURNITUREK limaoprema Cleanroom and rooms turnkey rooms (Building Management System)..25 Operation of filters according to data on coarse and fine ceiling filter duct filter duct filter with grille duct filter duct filter filter with active coal filter and hoods and laminar flow hood laminar flow hood laminar flow hood laminar flow hood safety cabinet KTB-NS (Class II)..52 Microbiological safety cabinet KTB-VS (Class II)..53 IVF sterilization and scrub and wire furniture and years of experienceMore than 220 employeesProductionEngineeringEquippingS erviceValidationInstallationMore than m production, warehouse, office spaceThousands rendered squaresof OPERATING roomsKlimaoprema is a leading Croatian manufacturer of OPERATING rooms, clean-rooms, ventilation and air-conditioning offer complete engineering turn-key solutions which includes design, engineer-ing, production, installation, validation (GMP classes A, B, C, D), service, ventilationand air-conditioning systems and automatics.

2 The entire know-how in this sector isthe result of our own research and experience we gain from our foundation in 1975. until today when Klimaopremais modern well-organized manufacturing company made up of excellent profession-als, engineers and designers, superior quality CNC machinery, test laboratory, ERPinformation system for business process management, quality management systemcertified to ISO 9001, programme for product selection and continuing developmentof new products in compliance with applicable international regulations and company employs over 220 people at the central location and registered officein Samobor, Croatia and disposes of m of manufacturing and warehousingarea including the are a company attractive to people looking for a job, where the existing employ-ees are satisfied and the business partners receive all the assistance they need inproject applications have been confirmed in practice and meet the most stringent regu-lations pertaining to the pharmaceutical.

3 Hospital, chemical and food catalog is just a way to meet us. Personal contact and meeting clients specialrequirements is our mission and our staff, with their knowledge, engineering experi-ence and energy will realize your CLEANROOM SOLUTIONS 3We design OPERATING rooms and cleanrooms in medical, pharmaceutical, food, elec-tronic and other industries affected by contaminants from the environment and first phase of the design is the creation of Conceptual design. The second phaseis making Basic design. The third phase is making Detailed design. At the end As-build design is high quality hospital or manufacturing plant rises from a good foundation, whichmakes initial phase of making Conceptual design important. Here the estimate of theinvestment is done. The dimensions of the object and scope of the project are beingdefined. Scope of the project consists of manufacturing processes, the equipmentlist, energy sources that will be used and the necessary processes are carried out in a number of high production lines and CNCmachines that guarantee minimal production time and products of world-class manufacturing process is controlled by ERP information system that guar-antees efficient flow of information needed for quick response.

4 As a company focused to future we constantly strive for new opportunities and innovativesolutions. We encourage originality and creativity of individuals and teams in order tooffer customers the equipment for cleanrooms, air-conditioning and ventilation systems,which ensure healthy and pleasant stay in the area and energy efficiency of the plant. OPERATING room and Cleanroom installation will be done by our experienced workers,in short time space will become pure cleanroom area that meets all of the guidelinesand in a cleanroom area means maintaining the building and validation of the unitand complete cleanroom space. It is about maintaining the newly built or reconstructedcleanroom space and related facilities. Regular servicing, maintenance and validationof equipment or facility ensure safety in use and longer life of the CLEANROOMSOLUTIONSENGINEERINGVALIDATIONI NSTALLATIONPRODUCTIONO perating room and Cleanroomdesign and engineering in medical,pharmaceutical, food, electronicand other industriesProduction of OPERATING rooms, Opera-tion ceilings, Cleanrooms, Laminar flowHoods and Booths, MicrobiologicalSafety cabinets, Weighing/Containmentbooths, Special devices, FurnitureOperating room and Cleanroominstallation and equippingValidation & Service4 DESIGN AND ENGINEERINGDESIGN AND ENGINEERINGAs-built stateWe design OPERATING rooms and cleanrooms in medical, phar-maceutical, food, electronic and other industries affected bycontaminants from the environment and other sources.

5 Technological solutions Architectural solutions HVAC design Electrical wiring DDC & BMSD esign carried out in accordance with national regulations andstandards as well as GMP and FDA of an acceptable design in terms of an investmentamount. We tailor our services to each customer separately, li-stening to their needs and desires. We propose solutions anddesign, develop and realize the customer's DESIGNBASIC DESIGNCONCEPTUAL DESIGNKLIMAOPREMA - OPERATING ROOMS 5 OPERATING ROOMS BASED ONTURNKEY PROJECTSO perating rooms refer to spaces in which surgery, scientific re-search and actions are performed during which the contactwith pollutants such as dust, airborne microbes and aerosolparticles must be avoided. OPERATING room is a defined and controlled space designed tominimize and control entry, generation, collection, and retainingof particles (contaminants). The space in which the filtered airis blown into has a positive pressure compared to surroundingareas under all OPERATING conditions and the air is effectivelywashed out.

6 The space in which all relevant parameters: tem-perature, relative humidity, noise, lighting, and other parame-ters are strictly Cleanroom Solutions designs OPERATING roomsand cleanrooms that meet the requirements for the number ofparticles at-rest and in operation. The requirements are definedfor each room (class) are classified according to the number and sizeof particles permitted per volume of air. The standards defineair purity. Large-scale numbers like "class 100" or "class 1000"refer to the US FED STD 209E and indicate the number of par-ticles in size of m or larger particles per cubic foot of , class 100 according to US FED 209E standard pro-vides that the number of particles in size of m or largersizes must not exceed the value of 100 particles per 1 ft .Small-scale numbers refer to ISO 14644-1 standards deter-mining decimal logarithm of the particle numbers in size of m or larger particles per cubic meter of air.

7 Accordingly, forexample, a cleanroom ISO class 5 has the maximum of 105 =100,000 particles per m . Since 1 m is approximately equal to35 ft , these two standards are relatively equal when it comesto measuring particles of m, although the testing stan-dards are different. A common indoor air approximately be-longs to the class or ISO the design and production technique for operatingrooms we carry out full scope of the project as well as equipoperating rooms. We are permanently oriented to customerswhose needs are monitored and analysed with special care bydesigning OPERATING rooms and cleanrooms in hospitals, phar-maceutical plants, pharmacies, production facilities in food in-dustry, engineering plants, electronic industry plants and the leading manufacturer of OPERATING rooms andcleanrooms in Croatia and the region, KlimaopremaCleanroom Solutions has proven its quality notonly by the finishing product, but through knowl-edge and professionalism of staff that performdelivery, installation, manufacturing and com-munication with business partners.

8 Contact us with confidence and Klimao-prema Cleanroom Solutions will design,manufacture, assemble and equip your op-erating room according to your inceptiveidea, as well as validate and service it ROOMSOPERATING ROOMS 78 OPERATING ROOMSC omponentsOperating room is designed in the same way the house is de-signed. All the elements that make up a house like walls, ceil-ings, windows, doors, floors and other components alsocomprise the OPERATING room. The house is a safe home to thehouse owner, as well as the OPERATING room is a safe place forsurgeons and other rooms must be designed, constructed and adaptedto fit operations performed in them. The project is carried outso as to reduce the risk of contamination, dust and other im-purities to a minimum , temperature, humidity and ventilation must complywith the requirements of the operation and shall not affect thequality of actions or the functioning of the would be best to if the flow of people, materials and equip-ment would be unidirectional to the largest possible extent toavoid the possibility of mixing and schedule must allow for an orderly and logical dis-tribution of the materials and equipment in order to avoid thepossibility of cross-contamination and exclude the risk of omit-ting or replacing any phase of the operation or ROOMS91.

9 Swing door2. Absolute ceiling filter FAC3. Ventilation duct4. Scrub sink5. Exhaust surgical grille OPR6. Sink7. Stainless steel furniture (cabinet, table, etc.)8. Inclined outflow box KIK9. Cove profile10. Floor11. Wall panels (42, 62, 82 mm)12. Shelf13. Sliding door14. Operation ceiling SIP15. Control elements16. WindowWalls, ceilings and floors in OPERATING rooms should be madeof watertight material, smooth, crack-free and easily washable,while the finishing processing of walls, ceilings and floors mustbe basic process fuels are an integral part of the plant, andtheir distribution to the place of consumption should be carriedout the shortest routes as possible while the connection to theequipment should be made from the designing and installing power lines and fittings it wouldbe best to avoid dents and provide for their maintenance out-side the OPERATING room. The drains should be of adequate size and with no possibilityof overflowing, back is necessary to ensure an adequate exhaust system to controlcontaminants in case of a possible contamination of space, aswell as to maintain the required cleanliness of the OPERATING access to the facility must be controlled and limited to au-thorized persons via a controlled-access or a card ROOMS10 Wall panelsSPECIFICATION The panel, as a wall segment, is made of double-walledsheet folded around the edges (sandwich panels), rein-forced with a frame Panel walls can be made from:- Galvanized steel sheet laminated in colour 25 m thick- Aluminium sheet laminated in colour 60 m thick- Galvanized steel sheet laminated in antibacterial colour110 m thick- Aluminium sheet laminated in antibacterial colour 110 m thick- Stainless sheet (option.)

10 Lamination in antibacterialcolour 110 m thick) The panel walls are filled with expanded polyester (EPS- styrofoam) or rockwool giving the panel excellent mec-hanical, thermodynamic and damping properties. Option:Panel walls filled with aluminium honeycomb Panels are designed as watertight - all the grooves bet-ween the panels are filled with cleanroom silicone Channels for distribution of electrical wiring are providedwithin the panel system Standard wall colour is RAL 9002, other colours availableon request Panel thickness: 42, 62, 82 mm Option: walls with lead protection, radiation protec-tionOption 1. Floor aluminium profiles mounted on the constructionlevelled floor, followed by the installation of PVC or Epoxy floorOption 2. Profiled aluminium floor profilesmounted on the finished floor (PVC or Epoxy)PROPERTIES Strength Smooth bump free surface Easy cleaning and maintenance Porous, water-repellent Resistance to abrasion, chemicals Thermal and sound insulation Corrosion protection LongevityASSEMBLY Panels are mounted in a rigid aluminium floor profile Fixing carried out via aluminium "H" profile (before laying thefloor) or "U" profile (on the laid down floor)


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