Enhanced Process Monitoring and Control Technology.. (BIO-POLYTEC)
Enhanced Process Monitoring and Control Technology to Accelerate Development of Bioresorbable Polymeric Medical Devices
Start date: Dec 1, 2013,
End date: Nov 30, 2015
The manufacture of bioresorbable medical devices for temporary implantation inside the human body is growing into a high-value industry with many benefits over traditional devices. Bioresorbable devices do not need a removal operation, reducing patient trauma and significant healthcare costs. Due to the ability to add antibacterial or antibiotic drugs and to control the release rate at the implant site, such devices can reduce the number of post-operative complications and open up possibilities for new therapies.However, development times for new devices can be lengthy and extremely expensive. Bioresorbable materials have a high cost and are difficult to process, resulting in high scrap rates. The addition of fillers such as bioactive particles further complicate the manufacture. In Bio-PolyTec, sensor technology - centering on optical spectroscopic techniques - will be developed for in-process monitoring of the key quality measures of polymer degradation and additive dispersion. The availability of this information in real-time rather than after time-consuming and expensive laboratory testing represents a significant improvement in Quality Control for bioresorbable devices as well as enabling better process control. The influence of typical processing procedures on the degradation and mixing and hence subsequent bioresorption/release behaviour and mechanical properties will be fully investigated for the commercial products of the consortium SMEs to optimise their processes to achieve specific and consistent product requirements. In particular the processing of Polylactic Acid (PLA) and dispersion of bioactive Calcium Phosphate particles for orthopaedic implants will be investigated among other polymer/filler systems.The innovations in sensor technology will extend outside the consortium to enable other device manufacturers to reduce scrap rates and hence production costs for bioresorbable devices. The 'trial-and-error' guesswork is taken out of the process development stage for new products, significantly reducing the time and cost and stimulating activity in the market. Possible batch-to-batch variation will be eliminated, avoiding adverse behaviour of the products after implantation in a patient.
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