Lonza’s existing powder media suite required upgrades to achieve cGMP standards in order to continue manufacturing product. Improvements looking to be gained included improvement of process flow, congestion relief, crease facility capacity, Provide EU/FDA Compliant layout and environment and provide EU compliant airlocking. This project was scheduled for three phase in order to accommodate ongoing operations.
Phase 1 included installation of new airlocks and high speed roll up doors to properly segregate the Powder suite. Additionally, the walls of the existing room were lined with heat welded takiron and a new epoxy floor installed to provide GMP finishes throughout the suite. Completing the finish work was particularly difficult due to the existing utilities exposed within the room that could not be removed (or recessed) without adding substantial cost to the project. New ductwork was installed during this phase to prep for connection to a new AHU to be installed under the future phases. New suites were also constructed to house pre-blending operations and a relocated CIP skid.
Phase 2 included installation of new Material & Personnel Airlocks, Chemical Storage and Weigh/Dispense Suite. The Weigh/Dispense Suite was purpose built with multiple down flow booths to accommodate specific products and personnel protection. Finishes within the Phase 2 suites matched those installed under Phase 1, including takiron walls, epoxy floors and epoxy painted ceilings. Additionally, a new 15,000 CFM AHU was installed during this phase to provide the necessary air changes to accommodate the program. The AHU installation included rooftop dunnage and platforms, along with new plant utility distribution.
Phase 3 included demolition of the existing Weigh/Dispense Suite, replaced by the Phase 2 suite. This area was then converted to a Chemical Staging and Personnel In Airlock. The finishes in Phase 1 &2 were carried through to Phase 3, and the new HVAC system was extended and leveraged to provide the appropriate air changes.
Once Phase 3 was complete, the Powder Media Suite was compliant with cGMP standards, achieved uni-directional flow and was operationally optimized for the program going forward. The project was completed on time and within budget.