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About iSQUARED CONSULTING
iSQUARED CONSULTING has been providing professional consulting and engineering staff services for pharmaceutical and biotechnology companies since 2013. We support engineering projects ranging from design, through procurement, FAT/SAT and installation, start-up, and commissioning. We have executed small remediation projects, as well as worked on larger CAPEX projects, where we typically augment the client's internal group to act as owner's representatives.
Consulting Services
Project Management and Project Controls
· Resource planning and managing
· Budgetary Estimation and Tracking
· Change Control
· Interface with different project players
· EPCM Management
· Construction Management
· System and Equipment Vendor
· Consultants
· Risk assessments, process analysis within workflow studies
Engineering and C&Q
Expertise in the following manufacturing processes and support services:
· Plasma Fractionation
· Bulk Manufacturing
· Cell Culture
· Fill Finish (Sterile)
· Clean Utilities
· Laboratory Facilities
The provision of qualified engineers in an owner’s representative capacity to assist and work with EPCM firms throughout the engineering project lifecycle, including:
· Scope Analysis
· Process Design (Conceptual, BOD, Detail Design)
· Construction
· FAT, SAT, Startup
· Commission and Qualification
Expertise with a broad range of process equipment based on manufacturing processes and ancillary equipment:
· Plasma Fractionation (process vessels, modular skid design, filter presses, TCM skids, water baths and bottle cutters)
· Bulk Manufacturing (process vessels, UFDF skids, Chromatography skids)
· Cell Culture (Bioreactors)
· Fill Finish (Filling Machine, Sterile Filtration Skids, Stoppering Machine)
· Clean Utilities (CIP design, CIP skids, some SIP design)
· Laboratory equipment (Biosafety cabinets, Incubators, Refrigerators and Freezers)
Automation
· Design, development, implementation, and commissioning/validation of a wide variety of industrial control systems