Nimenrix Project: Qualification of Pharmaceutical Equipment
The Pfizer Sanford, NC facility is responsible for manufacturing components for the company’s vaccine portfolio, including Prevnar 13. In addition, the Pfizer Sanford site is home to the state-of-the-art gene therapy manufacturing facility, which provides the ability to produce and supply both clinical and commercial scale quantities of critical life-changing gene therapy medicines to patients living with rare diseases around the world.
Sequence Scope: Qualification of Pharmaceutical Equipment
This project involved the full Equipment C&Q scope for various equipment including ultrafiltration skids, centrifuges, clean utilities, and ethanol supply and waste systems. Sequence was responsible for developing the strategy and performing integrated functional/performance testing to demonstrate the facility was fit for production of a conjugate vaccine to protect against Neisseria Meningitidis.
What is the qualification of pharmaceutical equipment?
Equipment qualification is an important part of many industries, but perhaps most especially the pharmaceutical and biosciences industry where FDA regulations require stringent adherence to tests, inspections and ongoing assessments to ensure that each piece of equipment in the production process adheres to preset standards for reliable performance. The qualification of pharmaceutical equipment ensures that this equipment or ancillary systems have been properly installed, function correctly and, perhaps most importantly, produce the desired result. Sequence can help your company walk through each step of this detailed qualification process to provide validation for the entire manufacturing process.
Pfizer facility produces Nimenrix which is a conjugate vaccine that helps to provide protection against invasive disease caused by the bacteria Neisseria meningitidis types A, C, W-135 and Y. Source. The qualification of the pharmaceutical equipment within the facility ensured the facility was fit to produce a quality product that met with FDA approval to fight this disease.