In January, Stevanato Group’s Paolo Golfetto,cochair of the joint PDA/Pharmaceutical Manufacturing Forum (PMF) task force on achieving zero defects for visible particles, welcomed the task force to a face-to-face meeting at Ca’ Foscari University in Venice.

During the two-day meeting, the task force worked together to align on a common, harmonized rationale to support a practical industry-wide guidance, intended for use with existing compendial, regulatory and industry standards. This would then be used to better identify visible particulate matter. Multiple workgroups within the task force met to identify a visible particle-size threshold, review the gap analysis done for analytical methods (elastomer and glass components) and develop validation strategies. The full task force, comprised of pharmaceutical manufacturers and suppliers, agreed that providing a well-balanced perspective on best practices best served all parties involved.

The task force has identified gaps in current risk assessments and methods used to detect and quantify visible particles. As a result, it has developed FMEAs for elastomer and glass components to help identify where the highest risk areas are for particulate contamination throughout the manufacturing process, and how to effectively control these risks. The task force will be seeking to validate their methods in the coming months to ensure that best practices are being applied, and that appropriate corrective actions to mitigate risks are being taken.

PDA cordially thanks the Stevanato Group for hosting the full duration of this meeting, especially recognizing Golfetto, Mauro Stocchi and Gianmaurizio Fantozzi for organizing the tour of the OMPI, Optrel and SPAMI glass manufacturing facilities as a kickoff for Phase 2 of this ongoing initiative. PDA would also like to thank all the staff who made themselves available to support the 20+ task force members over those two days: Alessandro Zannini, Riccardo Stocco, Gaetano Baccinelli and Omar Pastrello from SPAMI; Alessandro Zannini and Gaetano Baccinelli from Optrel, and Alessandro Morandotti, Alessandro Faidutti and Barbara Lucato from OMPI.