For many years, Fette Compacting has been supplying the pharmaceutical industry with tablet presses from its classic i Series. These are deployed by manufacturers all over the world and are regarded as guarantees for efficient and flexible production processes. Fette Compacting has always collaborated closely with its customers to offer suitable innovations for future requirements in tablet production. The latest result of this permanent requirement analysis was the launch of the new i Series which entails a full overhaul of the classic series and alignment toward the specifications of state-of-the-art production environments.
The new i Series made its first appearance in the form of the F10i, a flexible and efficient single rotary press for smaller batches. March 2021 saw the new generation being supplemented by the F30i to include a double rotary press. The new machine is designed for the production of large batches and enables an output of up to 1.6 million tablets per hour, which makes it particularly attractive for the production of traditional blockbuster medication. We present the most important features of the F30i in detail here.
Focus on two-layer tablets
The F30i is optimized for the production of two-layer tablets. This should come as no surprise as the double rotary presses offered by Fette Compacting have long been handling this complex task at the very highest level. The engineers have further perfected this feature for the F30i.
The F30i offers fast sampling of the first layer via which the tablet weight can be precisely monitored and regulated. This mechanism works with electropneumatic pressure roller adjustment and sampling of the first layer ensures that sufficiently hard tablets are swiftly produced. At the same time, this reduces product loss to a minimum.
Two-layer tablets are becoming increasingly important as they enable the combination of two or more pharmaceutical substances in a single dosage form. Physical segregation of the formulations makes it possible to avoid incompatibilities and the active agents can be united with different release patterns in a single product.
Dust-tight as standard
Operator protection plays a key role in the F30i. Like the F10i, it is already consistently dust-tight in the standard variant – from the press room through to the connections between the machine and process equipment. Permanent underpressure in the interior prevents any dust from being released from the machine. For active or highly-active substances, the F30i is also available with a corresponding containment package which uses special sensors to monitor the safety of the system as a whole.
Additional user safety is ensured by a fully-automated tableting process, whereby containment need never be interrupted between filling the machine and removing the tablets. Operators can access the machine interior via glove ports in the window flaps which are monitored by the machine’s safety controls. A rapid transfer port (RTP) permits the introduction and removal of material, tools, and punches.
To protect against exposure when cleaning the machine, the surfaces of the respective shrouding parts to be cleaned have been reduced by 71 percent. Dust-tight connections between the interior and process equipment, coupled with intelligently-installed cables and lines, facilitate easy cleaning.
The double rotary press is dust-tight as standard and also available with a containment package.
Fully compatible
Like the F10i before it, the F30i is also system-compatible across generations. All process-based assemblies are identical to those of the classic i Series. The new i Series can use die and segment turrets from the tablet presses of the previous generation.
The qualification and validation of a new machine often involves several months. Depending on the complexity of the system, this project step alone can account for up to 25 percent of the investment costs. However, practical experience with the F10i has confirmed that the downward compatibility of the new i Series can reduce the effort involved in validation and qualification to only a few days.
The F30i is also compatible in terms of digitalization. After all, Fette Compacting equips its new machines with the technical prerequisites for state-of-the-art production environments. For example, the process equipment can be easily integrated using the plug-and-play principle. The open interfaces of the machine comply with the usual automation standards, enabling the F30i to be both integrated in a Manufacturing Execution System (MES) and connected to the Internet of Things (IoT).
The process equipment can be easily integrated in the F30i via plug-and-play.
User-friendliness is trumps
The easier a tablet press is to operate, the more efficiently production runs. That is why the designers of the F30i attached maximum importance to user friendliness. New software solutions ensure that operating errors can be avoided by even less experienced operators, whereby support is provided in the form of a Human Machine Interface (HMI), which permits intuitive control, monitoring, and documentation of the machine and process equipment.
Vibrations and audible sounds provide tactile feedback on contact with the multi-touch display, ensuring that the operator enjoys additional safety during entries. The HMI terminal is not dependent on the position of the tablet press but can be flexibly positioned in the room as required. This freedom increases user-friendliness and facilitates ergonomic working methods.
Furthermore, the operators can avail of a so-called Workflow Operation Wizard which guides them step-by-step through standard procedures using easily-comprehensible instructions. The wizard can also be used to save work steps, define process sequences, and open check lists. Additional software support is offered by the SmartInterface app which enables production processes to be monitored in real time via mobile end devices.
