Tablet coating processes must fulfill multiple requirements to achieve precise coloring and taste masking, as well as enteric coatings, retarded release coatings or an active ingredient application. Syntegon’s new Sepion coater meets five key requirements of tablet coating.
Closed material handling
The entire process sequence should be closed from filling to emptying and cleaning. The new Sepion series eliminates the need to open doors during the ongoing process, since it is filled and emptied via tubes with clamp connections integrated into the front door, which can be equipped with split valves.
As uncoated tablets break easily, the Sepion coater ensures that they slide into the mixing drum smoothly and gently. Sampling is just as easy and uncomplicated thanks to the sampling cylinder. The mixing drum is emptied by means of reverse rotation via a closed system: specially shaped discharge baffles guide the tablets quickly and gently to the discharge opening in a continuous tablet stream, allowing a 500-liter drum to be emptied in just a few minutes.
Containment
Safe containment is especially important to protect machine operators, products and the environment. When developing a new system, the containment concept should be considered right from the start. For example, the basic Sepion version can be upgraded to a containment coater with user-specific options. These essentially consist of split valves, safe-change filters and extended cleaning.
Flexible batch sizes
The Sepion coater is extremely flexible when it comes to batch sizes: the drum can be filled with product from a minimum of 10% up to a maximum of 100% of the working volume, thus offering wide application possibilities. The design of the mixing baffles ensures gentle and thorough mixing at any fill level. The mixing quality was examined in extensive tests, where tablets with three coatings were mixed. At 100% filling, the specified relative standard deviation (RSD) of the mixture of less than 3% was undercut during the tests after 8 minutes.
Automatic spray arm
The automatic spray arm ensures that the correct distance of the spray nozzles to the tablet bed, as well as the correct inclination of the spray nozzles can be set automatically for all filling heights. The alignment is done either recipe-controlled or via an optional distance sensor. Depending on requirements, two variants of the spray arm are available: the standard and the pro spray arm. With the standard spray arm, each spray nozzle is supplied with a separate liquid line. The pneumatic connection of the nozzles partly takes place via hose connections.
The pro spray arm with its mechanical connection of the spray nozzles ensures all pneumatic connections and enables the connection of a common liquid supply and return, which greatly simplifies installation and cleaning. The spray nozzles are positioned along the spray arm by a tool-free quick-connect system without hose connection. This avoids misalignments, while greatly reducing setup and cleaning times.
Process optimization for best coating results
During development, the focus was also on significantly reduced process times while maintaining high yields. Hence, the drum was lengthened in relation to its diameter. On the one hand, this allows a higher number of spray nozzles. On the other hand, the longer drum results in a flatter tablet bed, allowing the individual tablet to pass through the spray zone more frequently. The combination of both features facilitates higher spray rates and more uniform coating with shorter process times. Extensive tests with different tablets and filling quantities in comparison with an established coater have shown: the Sepion coater achieves significant improvements in process times while minimizing the RSD of the coating.
Accordingly, the new Sepion coater is suited for all applications – from cosmetic, non-functional coatings to enteric coatings, retarded release tablets and active ingredient coatings. The Sepion coater also achieves very good values in terms of yield, i.e. 98%. The effective use of the coating suspension saves process time, minimizes product use and reduces cleaning efforts. The new, highly flexible Sepion coater is available in six sizes: from 175 and 250 through 350 and 500 to 750 and 1,000 liter capacities.
