Meeting Stringent FDA Requirements with Advanced Folding Technology

The FDA's commitment to clear patient information means high-quality pharmaceutical package insert production isn't just good practice – it's essential for compliance. As regulations evolve and information requirements grow, manufacturers face the challenge of fitting extensive details onto often delicate, lightweight paper, folded into incredibly compact sizes. This complexity demands more than standard folding equipment; it requires a dedicated Pharmaceutical Insert and Outsert System.

PIOS T600

Meeting these challenges head-on requires expertise in handling thin paper, achieving precise folds down to miniature sizes (like 1.125” x 1.125”), and managing complex formats with high panel counts (from 12 up to 350 panels). Furthermore, processes must align with cGMP standards and traceability requirements like serialization.

This is where Speed Folding Machine excels. Their dedicated Pharmaceutical Insert and Outsert System is specifically engineered for these rigorous demands. Built around robust 520/600mm width professional pharmaceutical package insert folding machines, the system integrates modular knife units for intricate cross-folds and specialized pressing units for tightly finished leaflets. Options like gluing, wafer sealing, and banding cater to diverse needs, including married outserts or booklets. By choosing a specialist like Speed Folding Machine, pharmaceutical companies ensure their inserts and outserts meet the highest standards of quality, compliance, and precision demanded by the industry and regulators.