Corvan Fill-Finish Facility

P—198

ISO 7

Clean-room class

Corvan Fill-Finish Facility

Client

Life-science manufacturer

Client

Life-science manufacturer

Location

Raleigh, NC

Sector

Healthcare

Delivery

EPCM

Value

$210M

Duration

30 months

Status

Completed

Year

2025

§ 01 — Overview

A GMP fill-finish suite validated first time

The challenge

A GMP fill-finish suite with ISO 7 clean rooms, where validation determined the launch date of a new product.

Engineering approach

Validation engineers were part of the design team from the first review, so every system was designed to be qualified.

Execution

Installation, operational and performance qualification passed first time, and the suite was released to production on schedule.

§ 05

Key metrics

ISO 7

Clean-room class

First time

Qualification

Process systems

EPCM

Delivery

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