West Pharmaceutical Services has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. "Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products," according to a company statement.
“Quality by Design is an essential element in helping pharmaceutical manufacturers meet regulatory guidelines for safety and efficacy,” said Donald E. Morel, Jr., Ph.D., West's chairman and chief executive officer. “West is embedding QbD in manufacturing from raw materials through delivery. NovaPure components incorporate a variety of high-quality processes and features designed to ensure component reliability and provide an unrivaled level of quality for our customers, which ultimately can aid in the safety and efficacy of their drug product for the patient.”
Developing the line, West used a comprehensive quality target product profile (QTPP) based on the needs of its customers and their end users. Critical quality attributes (CQAs), determined with the patient in mind, have been built into the development process to help ensure quality, safety and efficacy throughout a drug product’s lifecycle. The line's features and processes include: a FluroTec® barrier film to protect barrier against extractables and provide lubricity without the need for silicone oil, validated wash and sterilization processes that help ensure consistency of stopper preparation, 100% vision verification to assure low particles, and lot-to-lot extractable profile to assure material consistency
NovaPure components are available globally with reduced lead time and are provided in optimized packaging to help ease transition through manufacturing environments. The components are supported by a series of unique service features that help assure the latest compliance and customer satisfaction requirements are met, according to West.
