OMEGA Concept

• manufacturing workshop for liquid forms,
• raw materials storage,
• preparatory workshop (fixed or mobile, on balances or by volumetric analysis, etc.),
• laboratory and laboratory equipment,
• clean rooms and clean room equipment,
• hospital, private clinics, technical equipment in health services.

• production and distribution of ultra-pure water, WFI water, pure steam according to regulations in force,
• CIP/SIP stations suited to the pharmaceutical industry (single use, with possible drying in place),
• production/distribution of process chilled water, recycled water,
• production/distribution of process compressed air and instrument airair, process vacuum,
• pure and ultra pure gases, toxic,
• chemical products, pumping lines,
• thermal decontamination station for biological effluents,
• networks and processing of effluents from acid/solvent processes, toxic substances, fluorinated substances, ammonia, etc.,
• production and distribution of medical fluids.

For the latter, OMEGA Concept is certified as follows:
ISO 13485 - Medical devices - Quality Management System
EC marking according to Appendix II.3 of the Directive 93/42/CEE relating to medical devices.

• design, implementation of “downstream meter” gas networks made of black steel or PE,
• conformity with network standards, extension of networks on industrial sites,
• recommendation, implementation and testing of cathodic protection
• maintenance and service contract of gas pressure regulation stations.

• definition of PID and dimensioning notes,
• dimensioning of the networks and the units,
• equipment specification,
• detailed studies: skid - piping - boiler making,
• installation plans.

• system specification and design,
• functional analysis
• system development and configuration,
• test protocols (FAT/SAT).

• skids,
• implementation of plastic piping PVC, PE, PPH, PVDF, ECTFE, reinforced by stratification, SVR, dual envelope networks for dangerous fluids,
• implementation of stainless steel piping: 304L, 316L, electro-polished, stainless steel of Ra 0.2 to 0.8 µm,
• laboratory or production equipment (fume cupboard, lab bench, glove compartment, chemical cupboard, transfer cupboard) in PVDF, PPH, PVC, stainless steel, etc.,
• electrical cabinets
• boilerwork (storage and transfer tank, reactor, column, etc.) in plastic material such as PVDF, PP, PVC (bare or reinforced SVR), SVR block, stainless steel, etc.,
• structural framework and composite structure (footbridge, staircase, railing, ladder with crinoline, slotted floor).

• mounting and assembly of all the elements (skids, pumps, boilerwork, etc),
• realization of piping (manual and automated orbital TIG welding, joining, IR, etc.),
• connection of process machines,
• tests on networks: sealing tests, Helium tests, H2O - O2 tests, particulate tests,
• non-destructive testing (sweating, radio, endoscopic, dielectric, etc.),
• passivation if necessary,
• thermal insulation,
• instrument assembly and wiring,
• electrical cabinets.

• factory acceptance tests (FAT),
• site acceptance tests (SAT),
• instrumentation calibration, adjustments, equipment,
• start-up.

• implementation of installations according to various regulations: CGMP, BPF, GAMP, FDA, CFR21, etc.,
• Installation Qualification (IQ),
• Operational Qualification (OQ),
• assistance with Performance Qualification (PQ).