Prefilled Syringes Quality By Design: Designed,Sealed And Delivered

Prefilled Syringes Quality By Design: Designed,Sealed and Delivered

Author: Kay Schmidt, Catalent Pharma Solutions, Editor, PMPS

To run a successful prefilled syringe manufacturing operation, there is an increasing need to integrate quality by design into the assessment of a sterile manufacturing facility. The design, engineering and construction of high technology pharmaceutical space for prefilled syringes is technically uncompromising, requires significant financial investment, and demands the careful attention of knowledgeable people if it is to meet and anticipate the standards demanded by regulators, manufacturers and ultimately by caregivers and patients. When designed and executed correctly, however, a well-maintained facility and infrastructure promotes the precise control of product quality, and ultimately helps a supplier achieve optimum cost for a product throughout its marketed life.