Lab Solutions. Your
products and processes -
systematically optimized.
Lab Solutions is our service providing you with a comprehensive insight into your raw materials, production parameters, and quality characteristics. With this knowledge, we enable you to produce according to the Quality by Design (QbD) approach. Regardless of whether your product is in the development or already in the market phase: We determine Critical Material Attributes (CMAs) of the raw materials, Critical Process Parameters (CPPs) of production and Critical Quality Attributes (CQAs) of the final product through a comprehensive range of analyses. With many years of experience in the pharmaceutical industry, process engineering and mechanical engineering we guide you in designing your production efficiently and to the highest quality using Quality by Design.
Physical powder characterization
- Particle size distribution
- Densities, Hausner Ratio, Angle of Response
- Loss on Drying
- Water Activity
- Rheology
- Blend uniformity
Powder analysis and assessment (CMAs)
In our laboratory, we analyze, characterize and evaluate your powder formulations using a variety of methods. We look at the physical parameters that significantly influence the flow properties, compacting behavior and tableting characteristics of your powder. This enables a comprehensive understanding Critical Material Attributes (CMAs) of your raw materials and their impact on the tableting process and thus on the quality of your product.
Pulveranalyse und Bewertung (CMAs)
Wir charakterisieren und bewerten das Pulver physikalisch. Unabhängig davon, ob sich Ihr Produkt noch in der Entwicklungsphase oder schon in Produktion befindet: Unsere vielfältigen Analysetechni-ken führen dazu, dass die Pulvermischung stabil ist, reibungslos fließt und sich leicht verdichten lässt.
Process Development (CPPs)
By combining the knowledge gained from powder and compacting analyses with tableting tests, we work with you to determine the Critical Process Parameters (CPPs) of your production. This is how we achieve:
- Cost-efficient production through increased output and reduced losses
- Compliance with technical requirements
- Adherence to regulatory standards
Characterization of Quality Attributes Regarding:
- Dimensions
- Hardness
- Friability
- Disintegration
- Weight uniformity
- Content Uniformity (UV/VIS, HPLC, NIR)
Critical Quality Attributes (CQAs)
Critical Quality Attributes are crucial parameters that manufacturers strictly control and monitor throughout the production process to ensure the quality, safety and efficacy of the final product. Our analytical services also include the determination of content uniformity, disintegration time and friability, which are key aspects of tablet quality.
Pulveranalyse und Bewertung (CMAs)
Wir charakterisieren und bewerten das Pulver physikalisch. Unabhängig davon, ob sich Ihr Produkt noch in der Entwicklungsphase oder schon in Produktion befindet: Unsere vielfältigen Analysetechni-ken führen dazu, dass die Pulvermischung stabil ist, reibungslos fließt und sich leicht verdichten lässt.
The Services at a glance:
- Lab services for material and tablet characterization
- Powder Compaction Analysis
- Data and Know-how driven optimization of R&D and production processes
- Trials including pre-defined as well as customized characterization of materials and tablets according to your needs
What is and will
continue to be important.
Articles and reports on current developments and technological innovations. For even more efficiency!
Want to know more about our services?
Please do not hesitate to contact us if you require more information and detailed advice. We look forward to receiving your phone call or email.
Global Customer Support
Fette Compacting GmbH
Grabauer Str. 24
21493 Schwarzenbek
Germany
Performance Consulting
