Critical processes presenting challenges
The processing of biodegradable polymers and polymer melts is a critical process. Whether it involves the synthesis of lactide-based polymers, the production of medical implants or the manufacture of PLGA microspheres for controlled release, any variation in the material flow affects the end product.
In many of these applications, even slight variations in composition, temperature or dosage are undesirable. A stable and controllable production process is therefore essential.
For medical applications, the quality of the process is of paramount importance. After all, the final properties of the polymer – such as strength, degradation rate, structure and processability – must be predictable.
The biggest process challenges within this application are:
- High viscosity and thermal sensitivity: Polymer melts require minimal mechanical shear and a controlled residence time to prevent degradation of the material.
- Extreme dosing accuracy: In drug-delivery systems and thin membranes or coatings, microscopic variations in the material feed directly determine the layer thickness and drug release.
- Scale up from R&D to production: Micro-processes and expensive raw materials in the laboratory and pilot phases require a seamless transition to results that can be reproduced at scale.