Fresenius Kabi
GMP Isolator Suite
-
£2m
-
60m2
-
16 weeks
Following a negotiated tender process and influenced by global business drivers to improve manufacturing workflow, T-SQUARED was appointed as preferred contractor to significantly refurbish and upgrade an existing GMP suite to house two new state-of-the-art 4-glove isolators for TPN manufacturing.
T-SQUARED’s design and project management team was significantly challenged by the existing facility architecture. Improvements required the complete strip-out and removal of existing ceilings, finishes and features along with a building extension to open-up sufficient footprint to accommodate the isolator installation.
Facility features included the extension of the fire rated envelope, enhancements to the critical HVAC infrastructure along with integration of automated and active pass- through hatches for material transfer. With resilience features incorporated by housing the isolators within a GMP Grade C environment, and for operational efficacy by treating the full internal envelope with a complete vinyl finish to walls, floors and ceilings.
Facility testing and proving was captured through a comprehensive validation life-cycle process including DQ, IQ and OQ execution.
This is a good example of what T-SQUARED offer to our clients. Offering best value and delivering to meet the regulatory requirements without compromise.
