A regulatory date, set in stone.
Novacore had already told regulators when its new plant would start commercial production. Any slip in construction or validation would delay a product launch worth more than $2M a day in revenue.
- 42,000sq ft of ISO 5–8 clean rooms
- 3,800validation tests before start-up
- $2M+in revenue at risk per day of delay
Clean rooms fail validation for small reasons: a leaky ceiling grid, a damper set at the wrong pressure, a weld that traps product. Novacore needed a builder who would treat commissioning and qualification as part of construction, not an afterthought once the walls were up.
We joined under a design-build contract with Novacore’s process engineers embedded in our design team from day one.
Build it to pass the test.
We wrote the validation plan before the construction schedule, then built the schedule backward from the first test date.
- 01
Prefabricate the clean rooms
Modular wall and ceiling panels were fabricated off site and installed by a dedicated crew trained on Novacore’s gowning rules.
- 02
Test as you go
Every room was pressure- and particle-tested at 50% and 90% completion, so problems surfaced while walls were still open.
- 03
One turnover package
Commissioning records, weld logs and as-built models were handed over in a single digital package, ready for the FDA inspector.