Schwarzenbek, March 3, 2021 – The tablet presses in the classic i Series have been a guarantor of excellent tablet production for decades. This production efficiency reaches a new level with the machines in the new i Series. The first machine was the F10i, a single rotary press for smaller batches. It is now being followed by the F30i, which will supplement the new i-generation to include a high-performance double rotary press as of March 3, 2021. Designed for large batches, the F30i permits an output of up to 1.6 million tablets per hour.
Like the F10i, this second tablet press is distinguished by a dust-tight standard design, digital connectibility, containment capacity, and cross-generation system compatibility. “In the development of new machines, we work closely with our customers in order to anticipate their future requirements,” explains Jörg Gierds, Senior Product Manager at Fette Compacting. “For the new i Series, we fully reinvented our classic i Series and aligned it to the specifications of state-of-the-art production environments. As a double rotary press, the F30i is eminently suited for high production volumes which means it is predestined for typical blockbuster medication.”
Two-layer tablets and operator protection
The F30i is optimized for the production of two-layer tablets. It avails of extremely fast sampling of the first layer via which the tablet weight can be precisely monitored and regulated. This mechanism works with electro-pneumatic 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.
The F30i also focuses on operator protection. Like the F10i, it is consistently dust-tight in the standard variant – from the press room through to the connections between the machine and process equipment. This not only protects operators from toxic substances but from every type of exposure. Stable underpressure in the interior prevents any dust from being released from the machine. When processing active or highly-active pharmaceutical ingredients, the F30i can also be equipped with an appropriate containment package. Containment features special sensors monitoring the safety of the system as a whole and issuing warnings in the event of any overpressure arising.
Extra operator safety is guaranteed by a fully-automated tableting process, whereby containment need never be interrupted between filling and tablet removal. Operators can access the machine interior via glove ports in the window flaps which are permanently 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 cladding parts to be cleaned have been reduced by 71 percent compared to the predecessor models.
Compatible and connectible
Like all tablet presses in the new i Series, the F30i displays cross-generation system compatibility. Despite its innovative design, all process-related assemblies are identical to those of the classic i Series, enabling die and turret rotors to be adopted from the earlier generation. Practical experience with the F10i has confirmed that the downward compatibility of the new i Series reduces the effort involved in validation and qualification from several weeks to only a few days, thereby making it possible to benefit from huge savings in costs.
As Pharma 4.0 is gaining in significance, the F30i is equipped with the technical requirements 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 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).
Software and ease of use
The F30i attaches great importance to user friendliness. Several software solutions ensure that even less experienced operators can retain an overview of all parameters and avoid operating errors, whereby support is provided in the form of 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 process equipment. Vibrations and audible sounds provide tactile feedback on contact with the multi-touch display, thereby providing additional safety during entries.
Ease of operation is also provided by a workflow operation wizard which guides users step by step through standard procedures with easily comprehensible instructions. The wizard can also be used to save work steps, define process sequences, and open checklists. Additional software support is offered by the SmartInterface app which enables production processes to be monitored practically in real time via mobile end devices. This means that production managers retain a full overview of manufacturing regardless of their location and can plan personnel deployments more proactively.