Expert Services
1
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
2
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
3
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
4
HVAC
• conceptual design, basic design, detailed design, installation, qualification
5
BMS and EMS process automation
• conceptual design, basic design, detailed design, installation, qualification
6
Cleanroom systems
• conceptual design, basic design, detailed design, installation, qualification
7
Requirements and specifications: URS, FRS and SRS
8
On-site construction project management and start-up support
9
System commissioning
10
Consulting
• idea development, feasibility study, technical solutions, selection of equipment
• GMP, GLP, ISO, FDA and WHO guidelines
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