Bluestar Silicones has 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 customers, it adds.
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. The initiative strengthens Bluestar Silicones’ ability to serve customers requiring high-performance silicone elastomers that meet stringent healthcare standards and demanding regulatory expectations.
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 recognised for their excellent processing performance, exceptional dimensional stability and lack of toxic by-products.
“Expanding our healthcare manufacturing footprint in Europe demonstrates our commitment to supporting customers in the pharmaceutical and medical device value chain with reliable, high-quality silicone solutions,” said Lisbeth Langsager, Regional Market Manager at Bluestar Silicones. “This capacity allocation complements our global healthcare manufacturing capabilities and provides additional flexibility to serve the growing demand for medical-grade tubing applications.”
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.
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.
The allocation further expands Bluestar Silicones’ healthcare portfolio, which already serves a broad range of medical and biopharmaceutical applications including medical tubing, drug delivery systems, diagnostics, wound care, wearable healthcare solutions, and other sensitive body-contact applications.