Pharmaceutical and nutrition manufacturers face ever-increasing development costs, more stringent regulatory requirements, fluctuations in demand, and increasingly complex product portfolios. Now more than ever, they are dependent on efficient processes, whereby untapped efficiency reserves can often be found in production. For this reason, Fette Compacting has developed a comprehensive range in the form of Lifetime Efficiency, which includes the systematic improvement of all production processes. This holistic concept is broken down into three phases along the production life cycle: development, production and modernization. 

Comprehensive view of tableting tools
Within the framework of the production phase, the entire technology portfolio is reviewed with all of its associated services and consulting. The focus is often attributed to machines but the Lifetime Efficiency approach goes even further: tableting tools also play a role, for example, when it comes to holistic optimization of the production process. The high quality of punches, segments and dies is confirmed in harmonious interaction with the machine, turret and tools used. As a system partner, Fette Compacting provides support in perfecting this interaction and continuously optimizing the entire value-added chain.

The essential prerequisite for such system harmony is that tableting tools are always in perfect condition. As a result, manufacturers of pharmaceutical and nutrition products, those responsible for quality, and the supervisory authorities demand permanent compliance with the good manufacturing practice (GMP) standards for tool handling. With a GMP-compliant quality management system, manufacturers safeguard product quality and meet the requirements of the health authorities. In order to comply with these requirements, Fette Compacting collaborates with specialized providers to rely on high-quality system solutions for tool management, cleaning and polishing.
 

Automation and standardization
In principle, these requirements are best complied with by producers increasing their degree of automation and keeping the number of manual interventions to a minimum. With EasyCare, Fette Compacting is now offering such an appropriate hygiene system for tableting tools, which primarily relies on fully-automated and standardized processes.

One key element is represented by the TRI.EASY tool box, which makes it possible to transport, store and clean tableting tools in a single container. This reduces the logistical effort for the individual work steps to a minimum. Together with washable trays featuring predefined positions for punches, segments, dies, bellows, and dust caps, the box forms a compact and standardized unit.

The best cleaning results of tableting tools require that chemistry and mechanics work together perfectly. The wash trays are therefore also eminently suitable for a fully-automatic cleaning plant made by ARUNA AG (model SDC800) with an integrated drying unit and GMP-compliant hygiene design. This guarantees residue-free removal of deposits. The cleaning process is coordinated to the care of tableting tools and includes preservation as well as the cleaning cycles. Once the care program with deconex CIP power-x has finished, the tools are perfectly preserved with deconex HT 1191 from Borer Chemie AG when they leave the system. The cleaning and preservation agents are perfectly coordinated and achieve the very best result when combined, while the remaining corrosion protection is approved as a food additive.

Maximum hygiene with automatic surge cleaning
This so-called automatic surge cleaning prevents cross-contamination and ensures maximum hygiene. Unlike the two other cleaning processes commonly used in the industry – manual and ultrasonic cleaning – it is marked by maximum operational safety and reproducibility. Add to this the fact that all process steps can be documented in detail and verified in a report.

Process monitoring, dosing of the cleaning agent, adjustment of the parameters, as well as drying and preservation all run entirely independently during automatic surge cleaning. Thanks to this maximization of efficiency, the ARUNA SDC800 cleans more than twice as many punches per hour than a comparable ultrasonic cleaner. And as all components are washed in trays, operators do not have any direct contact with tools or chemicals when unloading the cleaning system. This particular GMP requirement cannot be met by more manual cleaning processes which are also more time-consuming.

Closed-circuit efficiency
Although manual polishing of the punches is possible, consistent quality is not reproducible over complete punch sets of up to 120 punches. An automatic cleaning machine from Nortec (model PA500 pharma) is just one of the many high-performance machines deployed within the framework of EasyCare. It specializes in polishing tableting tools and features special holders for punches and dies. The punches are returned to optimum condition after use for the production of tablets and counteract sticking. This is where Lifetime Efficiency comes full circle: holistic solutions not only achieve better results, but also counteract the causes of the respective problem.