Train 2 Commercialization: Commissioning and Installation / Operational Qualification
Commissioning and Installation Qualification (IQ) Client Overview
The Pfizer Sanford, NC facility is responsible for manufacturing components for the company’s vaccine portfolio, including Prevnar 13.
Train 2 was designed and validated to support full‐scale development activities for a multi‐product portfolio capable of producing purified bacterial polysaccharides and proteins, as well as glyco‐conjugates suitable for use in clinical trials.
The Train 2 manufacturing area is divided into process areas such as: Media, Buffer, Fermentation, Recovery, Purification, Alcohol and Chemistry.
Commissioning and Installation Qualification Support Services
Sequence was responsible for providing the planning, strategy, and execution of Commissioning, Installation Qualification, and Operational Qualification deliverables to support the scale up of the existing facility to enable commercialization of existing product lines. The specific scope included various support functions such as development of the first Automation Commissioning strategy for the site, risk assessments based on FMEA analysis, and development and/or updates to automation specifications on a DeltaV controls platform.
As a result of this project, the Pfizer facility will continue to manufacture components for various vaccines, such as Prevnar 13