Support begins even before a machine starts operating

The question of how cost-conscious and efficient production will be starts with the tablet’s desired properties and the customer’s sales planning. For instance, it is possible to calculate precisely which tablet press is best suited for manufacturing on the basis of the tablet shape and the planned output. With 15 different machine types, Fette Compacting has a wide portfolio for tablet production. As a result, it is relatively easy to identify which of the machines represents the optimum response to a customer’s particular requirements. Things become more complicated when there are also detailed questions about the punch shape, compacting tools and process equipment. In this case, every minor adjustment can have major effects on production. At this point, if not before, consulting with the machine manufacturer is recommended.

Application engineers can additionally provide assistance if the shape of the tablet has not yet been definitively decided. In this event, early-stage consulting is worthwhile so as to avoid difficulties down the road. As an example, it is frequently the marketing department that defines the tablet design. However, if design factors alone are allowed to prevail without any thought for the production conditions, there can be significant drawbacks when the tablets are actually made. These can be so serious that they add up to an hourly production deficit of 100,000 units – and some formats cannot even be manufactured at all. Expertise from the machine supplier provides an effective way to prevent such problems.

Further pre-production support is advanta-geous during the scale-up. Consulting in this area is a good idea above all for pharmaceutical companies that want to take a newly developed tablet and transfer it from galenics to volume production as quickly as possible. Some customers used to start a second development phase at this juncture, especially after the laboratory tests, with the objective of reproducing the tablet developed in the lab on their production systems. In this regard, the galenics press proved a convincing performer with its immediate scale-up. It allows the parameters of the tablet to be transferred to the required machine immediately – with 99 % accuracy at the first attempt. This also means there is no need for complicated simulation calculations, which saves a great deal of time.

In ongoing production too, technical tweaks can have enormous effects on the output rate and product quality. Continuous technical support is decisive. As far as tablet compacting tools are concerned, for example, Fette Compacting has its own punch development and production facility with tolerances that exceed the specification in the TSM (Tableting Specification Manual) or EU standards. With the FS12 punch format, for instance, it is possible to achieve a 40 % performance boost compared to the EU19 format owing to the higher number of punches and comparable dwell time. As a result, downtime is reduced, as are maintenance complexity and the consumption of spare parts.

It is crucial to guarantee a supply of essential spare parts to all sites. Fette Compacting organises spare part shipments via a logistics network comprised of the company headquarters in Germany (Schwarzenbek) as well as eight subsidiaries in Asia, China, France, India, Latin America, Mexico, Spain and the USA. To ensure an optimum supply of genuine parts, the manufacturer carries out a risk analysis of all key assemblies to enable appropriate packages to be put together.

Worldwide support has to function smoothly, particularly in the event of a technical malfunction. Generally speaking, pharmaceutical companies complain that communication pathways are too complicated or associated with lengthy waiting times. Furthermore, conventional modem connections often do not permit remote maintenance to troubleshoot mechanical or process-related problems.

The “Service Portal” set up for the pharmaceutical industry promises a new type of network architecture. This digital platform is operated by Fette Compacting together with partners in the Excellence United alliance of leading German manufacturers. If a machine breaks down, service technicians can quickly find a solution via an SSL remote access. Worldwide, more than 600 specialists are ready to provide immediate further assistance to customers at all stages of production.

Global Customer Support also has a long-term dimension: continuous lifecycle management can significantly extend the service life of tablet presses. With machines that normally operate round-the-clock, efficiency starts with adequate operator training. All training courses conform to the personnel qualification required by the FDA in accordance with 21 CFR part 11 § 211.25. Fette Compacting’s Competence Centres provide a wide range of training courses in various languages.

The technical quality and service life of the tablet presses can also be increased by optimising the application. OEE (Overall Equipment Effectiveness) consulting offers enormous improvement potential for the line as a whole. To calculate the OEE, Fette Compacting has developed a model consisting of four components: Tool Management, Maintenance Management, Customised Training and Production Excellence. The results delivered by a machine depend on the optimal interplay of all these factors.

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