SARS-CoV-2 Vaccines – Primary Packaging Challenges

Developing a SARS-CoV-2 vaccine presents numerous and unprecedented challenges; prominent among them are greatly accelerated timelines. Ordinarily for a new drug product, there is sufficient time for selection/evaluation of the vial/stopper packaging system – one that guarantees quality and safety from manufacture through delivery. This is not the case for a SARS-CoV-2 vaccine where the primary packaging system must be chosen quickly, creating a higher risk.

This risk can be mitigated by selecting the best performing stoppers, namely stoppers with FluroTec^® film. This is discussed in a new report by West scientists: Elastomer Stoppers with FluroTec Film: The Right Choice for SARS-CoV-2 Vaccines.

Employing the chemical properties of fluoropolymers, stoppers with FluroTec film: (1) reduce migration of leachables, (2) reduce interaction with drug product, and (3) enable excellent container closure integrity at low temperatures. Globally available and market accepted, based upon West analyses, they are FDA/EMA approved for over 125 drugs, including three vaccines and 30 novel drugs. Available in multiple formats and sizes (serum/lyophilization, 13/20mm), they can accommodate a variety of vaccine formats (currently six are in development). Taken altogether, stoppers with FluroTec film are clearly the best choice, and enable the lowest risk, for SARS-CoV-2 vaccine package systems.

For more information, contact an account manager or Technical Customer Service (TCS) representative.

FluroTec^® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

FluroTec^® technology is licensed from Daikyo Seiko, Ltd.