Hose systems for medical and pharmaceutical applications are subject to the highest requirements—in terms of material purity, process reliability and reproducibility. BIW is ideally equipped for these demands: with its own cleanroom for applications where such an environment is essential, and an ISO 13485-certified production environment that also provides the right solution for demanding standard applications.
BIW operates its own cleanroom for applications where this environment is genuinely necessary. However, the majority of its medical and pharmaceutical products are manufactured in the regular production environment in accordance with ISO 13485.
Does that sound like a compromise? It is not. This production environment is anything but ordinary: machinery, processes and working conditions are designed to achieve a level of cleanliness that reliably meets elevated requirements—without the effort and cost of a full cleanroom where one is not strictly necessary. The result: technically tailored solutions that remain economically viable.
Hose systems for medical and pharmaceutical applications must have low emissions and remain process-stable, consistently maintain defined material properties and integrate safely into existing manufacturing and assembly processes.
To achieve this, BIW relies on addition-cured (platinum-cured) silicone grades that do not require plasticisers, solvents or other critical additives. The materials comply with standards such as USP Class VI, EP 3.1.9, BfR XV and FDA CFR 21 §177.2600. The smooth inner surface reduces the inclusion or adhesion of particles and makes cleaning easier—an advantage that pays off every day during ongoing operation.
One specific example is BIW’s medical technology portfolio: reusable, autoclavable breathing hoses; heated hoses that maintain a constant breathing-air temperature and prevent condensation; double-lumen hoses; and hoses for supplying media in ventilation and dialysis systems. These are complemented by moulded and assembled components for medical devices.
All products are manufactured using modern extrusion and injection-moulding processes. They comply with international standards such as USP Class VI and ISO 10993 and are designed to provide biocompatibility, kink resistance and temperature resistance. The focus on reusability is no coincidence: durable solutions reduce operating costs and meet the growing demand for sustainable products in healthcare.
BIW has all the necessary manufacturing capabilities in-house: its own compound development with more than 5,000 formulations, extrusion, injection moulding—HTV and LSR—as well as assembly and finishing. This provides control over every step, consistent quality across production series and solutions that do not depend on external suppliers.
Not every sensitive application requires a cleanroom. But every application requires a product that can be relied upon. BIW provides both—and helps customers choose the right level from the very beginning: technically suitable and economically sound.
Would you like to know which solution is right for your application? Get in touch with us.
This article is based on a technical article by our partner Haberkorn: Hoses for the Most Demanding Cleanroom Applications.
