Pharmaceutical Manufacturing Plant
A sterile fill-finish plant with Grade A cleanrooms and clean utilities, qualified and validated inside the construction schedule.
- Owner
- Confidential
- Location
- U.S.
- Market
- Industrial Infrastructure
- Delivery
- Design-build
- Scale
- 340,000 SF
- Completed
- 2024
A sterile fill-finish plant with Grade A cleanrooms and clean utilities, qualified and validated inside the schedule so the first batch could be released on time.
A pharmaceutical plant is not finished when the building is. Cleanrooms, water for injection, clean steam and process equipment all had to pass installation, operational and performance qualification before any product could be made. Documentation had to meet regulatory standards from the first weld, and the owner had a product launch date that depended on releasing the first batch.
The approach.
- 01
Qualification planned at kickoff
Validation engineers joined our team at kickoff, so test protocols were written while systems were still being designed.
- 02
A clean build protocol
Cleanroom areas were built under staged cleanliness rules, with access control, gowning and cleaning before each step.
- 03
Records captured as we built
Weld logs, material certificates and inspection records for clean utilities were captured digitally as the work happened.
- 04
Turned over by system
Each system was handed to the owner’s validation team in sequence, so qualification ran in parallel with finishing work.
The outcome.
“In this plant the paperwork is part of the building. A weld without its record is a weld you have to cut out.”
Quality manager, PerryWester
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