With as little as two grams of sample material, the F Lab 10 gives users key insights into the material properties of active ingredients and excipients.
Whether a tablet can be reliably compressed at production scale depends largely on the properties of the starting material. Once these are understood, processes can be fine-tuned and formulations optimized accordingly. In early development, however, active ingredients are often scarce and expensive. The F Lab 10 powder compaction analysis unit from Fette Compacting delivers a detailed picture of material behavior from as little as two grams of sample material, providing a reliable foundation for the entire journey to production.
How a powder behaves under pressure, whether it compresses evenly, how cleanly it releases from the die on ejection – these properties determine whether a formulation will later run smoothly on the tablet press or call for costly late-stage corrections. The sooner this information is available, the more precisely formulations can be developed and process parameters set.
That is exactly where the F Lab 10 comes in. It analyzes how powdered active ingredients and excipients behave during compaction, compression, and ejection, exposing critical material properties long before scale-up to production begins.
The analysis unit is more than an isolated laboratory device. It is part of a holistic development approach with which Fette Compacting supports pharmaceutical manufacturers across the entire product lifecycle. At its core lies the principle of Quality by Design (QbD): quality is not simply checked at the end but built into the product and process from day one. The key is to systematically understand how the Critical Material Attributes (CMAs) interact with the required Critical Quality Attributes (CQAs) of the finished tablet. “Only those who know the critical material properties of their starting materials can derive robust formulations and stable processes from them,” emphasizes Doreen Dunst, Application Specialist at Fette Compacting. The F Lab 10 makes precisely these relationships visible.
A complete analysis in four steps
The F Lab 10 cuts complexity without sacrificing depth. Together with a scale, micrometer, tablet tensile analyzer, and its integrated analysis software, it delivers a comprehensive view of a powder's compaction properties in remarkably little time.
The workflow follows four steps: the F Lab 10 first compresses the powder into a tablet; weight and dimensions are then recorded and breaking strength tested; and finally, the software evaluates the data automatically. A complete compaction analysis is available in under an hour.
A minimal quantity is all it takes
In early development, active ingredients are often expensive and available only in limited quantities. Every gram spent on analysis is a gram unavailable for further testing. The F Lab 10 needs just two grams of sample mass per test. “That is a decisive advantage, especially for particularly expensive active ingredients,” explains Dunst. “Even with the smallest quantities, we can generate meaningful data, replicate compression behavior, and draw valuable conclusions.”
With a maximum compression force of around 10 kilonewtons and punch diameters ranging from 3 to 15 millimeters, the unit covers a wide variety of test series. Its compact design at just 24 kilograms and straightforward cleaning make it easy to integrate into existing laboratory environments.
Intelligent software support
The integrated dashboard analysis software handles the evaluation work. It automatically captures measurement data from every connected device and generates reports in compliance with United States Pharmacopeia Chapter <1062>. Intuitive color codes allow material and formulation comparisons at a glance. “The results are presented in a way that lets users operate the system safely and efficiently, even without deep expertise in compaction analysis,” says Dunst. This makes it possible to correlate Critical Material Attributes with the Quality Attributes of the end product – fully in line with the Quality by Design approach.
From lab result to production
The F Lab 10 realizes its full potential as part of an end-to-end concept. The insights gained into compaction behavior form the starting point for further product and process development. Fette Compacting carries this approach forward consistently with its R&D Solutions and Production Services. The data remain useful across the entire product lifecycle, from formulation development through process optimization to in-process control in production. “The result is a seamless flow of information that secures the transition from lab to production and prevents costly missteps in development,” says Dunst.
The F Lab 10 at a glance
- Minimal material use: from two grams of sample mass per test
- Fast results: complete compaction analysis in under an hour
- High compression force: up to 10 kilonewtons
- Flexible punch sizes: diameters from 3 to 15 millimeters
- Intelligent evaluation: automated analysis software
- Compact and mobile: 24 kilograms, easy to clean, quick to integrate into existing labs