Pilot Plant Retrofit

Pilot plant compliance retrofit to meet Phase II climic trials criteria and an adequate level of GMP guidelines. Work involved:

Modification of HVAC to establish pressure differentials between suites and cascading flows clean to dirty spaces.
Modification and upgrade of decontamination system including a higher-level system automation and new under-floor drain system.
Examination and redesign of WFI system to implement recommended modifications to equipment and piping.
Selection and specification of new Pure Steam Geneartor/WFI Condenser.
Redesign of process skids to improve material and staff flows. Required re-verification of all P&ID's to ensure proper re-installation.
Revision of O2 delivery system for a liquid N2 system including EQ.
Architectural modifications including flooring, walls and suite access.