New double rotary press by Fette Compacting

It is dust-tight, connectable, system-compatible, and optimized for the production of two-layer tablets: in the form of the F30i, Fette Compacting is launching the second tablet press in its new i Series.

Fette Compacting has a new product. This spring, the machine manufacturer based in Schwarzenbek is launching the F30i tablet press. This double rotary press is designed for the production of large batches and permits an output of up to 1.6 million tablets per hour which predestines it for the manufacture of classic blockbuster medication in particular.

The F30i is the second tablet press in the new i Series offered by Fette Compacting which also includes the F10i single rotary press. Sooner or later, features such as a dust-tight standard design, digital connectivity, containment, and system compatibility are sure to make this new machine generation the standard in pharmaceutical production.

Focus on two-layer tablets

The F30i is optimized for the production of two-layer tablets. It features very fast sample extraction of the first layer which can then be used to precisely monitor and regulate the tablet weight. The mechanism works with an electro-pneumatic compression roller and ensures that during sample extraction of the first layer, tablets of sufficient hardness can be produced swiftly. At the same time, it reduces product losses to a minimum.

Two-layer tablets are increasingly gaining in importance in modern pharmaceutical production as they enable the combination of two or more active pharmaceutical ingredients in a single dosage form. Physical segregation of the formulas ensures that incompatibilities are avoided and active ingredients with differing release patterns are united in a single preparation. 

Dust-tight for user protection

The F30i directs further attention to user protection. Like the F30i, it is consistently dust-tight even in the standard version, from the compression chamber through to the connections between the machine and the process equipment. This not only has the aim of protecting operators from toxic substances but also from any type of exposure.  

Stable underpressure inside the tablet press prevents dust from escaping from the F30i which can also be equipped with an appropriate containment package for products containing active or highly-active pharmaceutical ingredients. In this case, special sensors monitor the safety of the system as a whole and warn of any potential overpressure.

A fully-automated tableting process offers additional operator safety. Containment need never be interrupted between filling the machine and removal of the tablets. When the machine stops, the operators can access the interior via glove ports in the window flaps. The tightness of these glove ports and window flaps is monitored by the machine’s safety controls. A Rapid Transfer Port (RTP) also permits materials, tools and punches to be passed in and out through the airlock.  

As the operators are also exposed to the processed active ingredient while cleaning the machine, the surface of the cladding parts to be cleaned on the F30i has been reduced by 71 percent compared to the previous models. Along with dust-tight connections between the interior and the process equipment, intelligently-installed cables and lines also ensure that the F30i can be precleaned both swiftly and safely.

Fully connectable

Like the F10i before it, the F30i is also system-compatible across generations. All process-related assemblies are identical to those of the classic i Series whose machines are already used by numerous manufacturers around the world. Die turrets and segment turrets for the new i Series can be seamlessly adopted from the tablet presses of the earlier generation.

This is likely to be an important factor for many manufacturers. After all, qualification and validation of a new machine often takes several months. Depending on the complexity of the system, this project step can account for up to 25 percent of investment costs. However, practical experience with the F10i has shown that the downward compatibility of the new i Series can reduce the effort involved in validation and qualification to just a few days.

The F30i is also connectable in terms of digitalization as Fette Compacting equips the machines in the new i Series with the technical prerequisites for state-of-the-art production environments. For example, the process equipment can be easily integrated in line with the plug-and-play principle. The machine’s open interfaces comply with the usual automation standards which allows the F30i to be both integrated in a Manufacturing Execution System (MES) and connected to the Internet of Things (IoT).

User friendliness is a true triumph

The easier a tablet press is to operate, the more efficient production will be. Fette Compacting knows this, too, which is why the company attaches such great importance to user friendliness when it comes to the F30i. Several software solutions ensure that operating errors can be avoided even by less experienced operators. This is supported by a Human Machine Interface (HMI) whose terminal can be freely positioned in the room and permits intuitive control, monitoring and documentation of the machine and its process equipment.

Furthermore, operators can avail of a so-called Workflow Operation Wizard which guides them step-by-step through standard procedures with easily comprehensible instructions. The wizard can be used to save work steps, define process sequences, and call up checklists, for example. Additional software support is offered by the SmartInterface app for monitoring production processes in real time via mobile end devices.

Contact: Jörg Gierds, Senior Product Manager at Fette Compacting, Jgierds@fette-compacting.com