Case study – R&D study of dental product manufacturing process optimization by instrumented micro-pilot

Sector: Pharmacy

Customer type: Group

Contact department: R&D / Industrialization

The Customer encounters textural non-conformities in industrialization in the manufacture of a dental product in the process of being certified by the FDA. He asks RHEONIS to better understand the causes and factors of influence of these variabilities and to consider the appropriate optimizations of his process and its incoming control.

An approach combining expertise and behavioral R&D for the dental pharmaceutical sector

RHEONIS has put its expertise in industrial processes, experimental plans and its unique Behavioral R&D methods at the service of the Client. instrumented micro-pilot.

As part of this multi-phase collaboration, the following actions were carried out:

  1. On-site diagnosis of the manufacturing process
  2. Expertise and critical analysis according to the approach of Industrial Phenomenology the approach and test data by experience plan carried out by the Customer
  3. Synthesis and presentation of the elements of analysis and recommendation of an appropriate study approach
  4. Implementation of the study approach in a micro-pilot mixer instrumented on a rheometer with machining of blades adapted to the product texture
  5. Realization of the study and conclusions on the variability factors at the material and process levels of mixed
  6. Synthesis in a report and operational recommendations

Progress in the establishment of the Design-Space and improve the process operationally

During the preparation of a formulation containing around ten ingredients, the industrialization tests do not make it possible to establish a satisfactory design space.

The instrumented micro-pilot approach makes it possible to study quickly and with low material consumption both the impact of the inputs and the mixing conditions (speeds, durations, etc.) in the various stages of incorporation. Various parameters can be monitored during preparation, allowing critical steps and their impact on process conditions to be identified.

Thus, the influence of the various parameters on the variabilities are quantified, making it possible to determine the optimized conditions in the conduct of the process and the control of the inputs and drawing the contours of the design space for the parameters of interest.

The advantages of our behavioral approach for the pharmaceutical sector

Expertise oriented Quality By Design (QBD)

Study approaches requiring only small amounts of material

Focus on phenomena and on-site diagnosis for a drastic reduction in experimental plans

Studies, conclusions and recommendations oriented towards operational optimizations

Do you have any questions or would you like to discuss your pharmaceutical projects and issues with us? Do not hesitate to contact us.

Last Updated on February 14, 2022 by Vincent Billot