Syntegon, a technology partner to the pharmaceutical and biotech sectors, has added the Sepion 75 to its Sepion range of tablet coaters, extending the series to pilot scale. The new unit is intended to support manufacturers and contract development and manufacturing organisations (CDMOs) managing greater product diversity, smaller and more variable batch sizes, and containment requirements associated with highly potent active ingredients.

The Sepion 75 completes Syntegon’s coater portfolio, which otherwise spans six size variants ranging from 175 to 1,000 litres capacity, covering outputs from early development through to commercial manufacturing.

The new tablet coater offers a high degree of flexibility, processing batch sizes from 10 to 100 percent of its maximum working volume.

Batch flexibility across development stages

The coater is designed to process batch sizes across a wide operating range, from 10 to 100 per cent of its maximum working volume. Two interchangeable drum sizes within the same machine cover batch volumes of 8 to 75 litres, allowing both early-stage development batches and larger pilot runs to be processed without redefining process parameters.

An optimised drum geometry combined with the spraying system is intended to improve process air usage and shorten processing times. An automatically adjustable spray arm maintains spray positioning across different filling levels, which supports reproducible coating conditions across batch sizes, including for functional coatings.

Fritz-Martin Scholz, Global Product Manager at Syntegon, commented: “By extending the Sepion series to the pilot scale, we support pharmaceutical manufacturers in simplifying development and scale-up while maintaining consistent process principles across production stages.”

Across the Sepion series, material handling during filling, sampling and discharge is closed, limiting manual intervention during these steps. Containment up to Occupational Exposure Band 5 (OEB5) is available as an option across the range, achieved through split valves, safe-change filters and extended cleaning configurations. Syntegon says this is intended to improve operator safety and reduce contamination risk while supporting compliance with current pharmaceutical manufacturing requirements.

Consistency from pilot to commercial scale

Syntegon notes that consistent process principles across the Sepion series are intended to allow direct transfer of process parameters between pilot and commercial scale, supporting reproducibility as products move through development stages.

For more information, visit: www.syntegon.com

Digital issue: Please click here for more information

The Sepion 75 extends the established Sepion series to the pilot scale and supports efficient development and scale-up.