Expert Services
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Plant and facility design in compliance with GMP
• sterile/aseptic processes
• oral solid dosage forms
• semi-solid dosage forms
• liquids
• ointments
• nasal sprays
• APIs.
Our design executions include all process steps from formulation to finished products,
including specific processes such as freeze-drying
• conceptual design, basic design, detailed design, construction and qualification
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Warehouse design, QC lab design (physico-chemical and microbiological), R&D lab design; all in compliance with GDP,GMP, and GLP
• conceptual design, basic design, detailed design, construction, qualification
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Clean utilities: purified water (PW), water for injection (WFI), pure steam (PS), clean gasses
• conceptual design, basic design, detailed design, installation (including orbital welding), automation and qualification
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HVAC
• conceptual design, basic design, detailed design, installation, qualification
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BMS and EMS process automation
• conceptual design, basic design, detailed design, installation, qualification
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Cleanroom systems
• conceptual design, basic design, detailed design, installation, qualification
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Requirements and specifications: URS, FRS and SRS
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On-site construction project management and start-up support
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System commissioning
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Consulting
• idea development, feasibility study, technical solutions, selection of equipment
• GMP, GLP, ISO, FDA and WHO guidelines
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