SPOC - The Single Point of Contact according to the highest GMP standards of the pharmaceutical, biotechnological, chemical and food industries, such as: Engineering, design and production of a complete system EN ISO 9001 ISO 3834-2 EN ISO 14001 EN ISO 1090 EX3 GMP Integrated CIP / SIP Complete automation System compliant with CFR part 11 Field of Expertise Project development. Basic design consultation. Process development and consultation. Detailed design - P&ID development. 3D modelling. Technical specifications. Process calculation (heat transfer, pressure, flow). Software calculation and design of pressure vessels. Structural design & FEM analysis Project management. Execution: production, inspection & testing, assembly, automation Qualification Validation support Maintenance support PHARMACEUTICAL AND BIOTECH Design and production of process systems: PW, water purification systems WFI, water for injection systems PS, clean vapor systems SOLVENTS, solvent systems Washing systems PROCESS GAS SYSTEMS: Compressed air, Nitrogen system. Design and production of equipment PHARMACEUTICAL TANKS, REACTORS, BIO-REACTORS (pressure vessels)HEAT EXCHANGERS (pressure equipment)STERILIZATION VESSELSVESSELS FOR MIXINGPIPELINE SYSTEMS INCLUDING PLATFORMS AND SKID ASSEMBLIESCIP STATIONS Project documentation TECHNICAL DOCUMENTATION – P&ID, equipment list, process description, technical drawings, 3D model, layout Hardware specifications Software specifications Design qualifications Project quality plan Qualification plan Sequence matrix Functional specification List of signals Wiring diagrams Risk analysis Certificates of materials in contact with the Product CE mark BUILT-IN Equipment instructions and manuals Welding documentation Calculators of measuring instruments PRODUCT quality control reports (pressure test, NDT test, roughness test, etc.) Passivation documentation Working instructions, system maintenance recommendation, spare parts ATEX documentation Installation qualification documentation Documentation of operations qualification CERTIFIED QMS SINITECH INDUSTRIES D.O.O. BY TŰV NORD ADRIATIC
