Bluestar Silicones announced the allocation of dedicated production capacity in Europe for medical grade high consistency silicone rubber (HCR), reinforcing its global manufacturing network and enhancing supply security for European healthcare and pharmaceutical industry.

Bluestar Silicones’ transparent, high consistency silicone rubber roll.

The newly allocated capacity will support the production of silicone materials specifically designed for pharmaceutical tubing and fluid transfer applications, a critical segment of the rapidly growing biopharmaceutical and healthcare industries.

High Consistency Rubber technology platform

Based on Bluestar Silicones' proven High Consistency Rubber (HCR) technology platform, the allocated production capacity is dedicated to platinum-cured polyaddition silicone grades suitable for extrusion and related tubing processes.

These materials combine the mechanical robustness and processability expected from HCR silicones with the extreme purity required for healthcare applications. Polyaddition HCR technologies are also recognized for their excellent processing performance, exceptional dimensional stability and lack of toxic by-products.

Meeting healthcare qualifications

The materials produced under this allocation are designed to meet rigorous healthcare qualification requirements, including biocompatibility assessments as well as extractable and leachable testing protocols commonly required for pharmaceutical processing and biopharmaceutical manufacturing applications.

These performance attributes make them well suited for tubing systems involved in the transfer, processing and handling of sensitive pharmaceutical products.

Manufacturing upgrades

To accommodate healthcare production requirements, Bluestar Silicones has implemented targeted upgrades and qualification measures on the manufacturing equipment involved.

While leveraging existing industrial-scale assets, the company has carried out the necessary investments and process adaptations to minimize contamination risks and ensure robust batch-to-batch consistency when transitioning between industrial and healthcare manufacturing campaigns.

These measures include enhanced production controls, dedicated cleaning and validation procedures, and operational safeguards designed to support the purity expectations associated with healthcare applications.