Precision Flow for Critical Bioprocessing
From thermoplastic elastomers (TPE) and silicone tubing to overmolded sanitary ends and biopharma-grade fittings, Freudenberg Medical is your one-stop partner for single-use systems for your biopharma production processes.
In biopharma, customers often struggle to ensure the purity, reliability, and scalability of fluid handling systems in high-stakes, regulated environments.
At Freudenberg Medical, we support our customers by offering a broad range of customizable and off-the-shelf solutions designed to meet the needs of pharma, lab, and bioprocessing applications quickly and at scale. With 12 global manufacturing sites, we are well-positioned to provide reliable availability and regional support, streamlining access to the resources and markets our customers need.
What sets our team apart is the depth of experience and attention to detail we bring to every project. From robust documentation including validation protocols and product manuals to comprehensive extractables and leachables (E&L) testing, we help you navigate complex challenges with confidence.
Biopharma Manufacturing Solutions
We manufacture premium tubing, connectors, and assemblies designed for bioprocessing and critical fluid transfer.
All Freudenberg Medical biopharma tubing products are manufactured in controlled cleanrooms in the United States, Germany, and Ireland. Our operations adhere to strict ISO 13485 certified medical device quality systems. Material certification and lot traceability are included with every product. A compendium of material tests and compliance statements is available upon request.
Biopharmaceutical companies trust us to deliver high quality solutions on time and within budget.
International Reach. Local Support.
GMP Facilities
Comprehensive Documentation incl. Product & Material Validation Guide
12 Global Manufacturing Sites
Our Biopharma Product Solutions
To meet the growing needs of our pharmaceutical customers, we are constantly iterating, improving and developing new product lines to ensure competitiveness and optimal performance. This includes delivering custom molded silicone and thermoplastic components.
Whether it’s off the shelf solutions or customizable solutions that can be adapted to your specific requirements, our knowledgeable team is equipped to add value, unlock product potential and facilitate your pharmaceutical demands.
Silicone Tubing Solutions for Biopharma applications
A MANUFACTURER’S Q & A
The world’s leading pharmaceutical and medical device companies rely on Freudenberg to deliver an extensive selection of high-quality silicone tubing and fluid processing solutions. Cleanroom manufactured in the U.S. and Germany, Freudenberg offers two different platinum-cured silicone product lines, PharmaFocus® Premium and HelixMark®
Peroxide and platinum are used as catalysts in the manufacturing process to cure silicone. In the extrusion process, they help to convert the elastomer into its final tubing form. Using peroxide as a catalyst results in byproducts that require additional processing (heat) to drive off volatiles that may be left in the tubing, and could potentially increase leachables. Using platinum to cure the silicone leaves none of the derivatives in the tubing that are associated with peroxide-cure systems. This is why platinum-cured silicone is the superior choice when considering silicone for more critical applications in medical and pharmaceutical fluid transfer. At Freudenberg Medical, we only extrude platinum-cured silicones that are classified as USP Class VI medical grade and nothing less (no food or industrial-grade silicones).
We also do not extrude peroxide-cured silicones. There are companies that extrude both platinum and peroxide cured silicones in the same facility and on the same equipment — which can lead to cross-contamination. We have pharmaceutical and medical device customers that audit our facility specifically to ensure that we only extrude platinum-cured materials, because they have had issues with contamination in the past when tubing suppliers process both peroxide and platinum materials in their facility and on their equipment. If product purity is a concern, it makes sense to purchase your tubing from suppliers that only process platinum-cured silicones.
At a minimum, one should ensure that the tubing supplier has a controlled manufacturing environment and a stringent quality system. Freudenberg Medical’s U.S. silicone extrusion facility manufactures finished medical devices that require a medical device quality management system (ISO 13485) as well as FDA registration. FDA registration confirms that the facility is regularly audited by the FDA. An FDA-registered supplier complies with extremely strict quality procedures and processes. This warrants that the products manufactured are of the highest quality and consistency. The tubing we make for medical device implant applications is manufactured in the same manner and on the same equipment as the tubing our pharma customers would purchase for their fluid transfer applications.
For highly sensitive fluid processing, we recommend using the most premium silicone material as well as verifying the purity of the extrusion process and manufacturing environment to safeguard against foreign matter or contaminants within the tubing or on the surface of the tubing. The silicone should be medical grade and tested to meet USP Class VI biocompatibility requirements. Additional testing and material characterization depends on the individual risk assessment and the contacting media and processing conditions.
Our HelixMark® product line has recently introduced Double Braided Silicone Tubing, ideal for high-pressure transfer-type applications. Double Braided Tubing is manufactured using a complex, multistep process that incorporates two separate strong layers of polyester fiber braiding between the extruded layers of USP Class VI platinum-cured silicone (inner core, middle layer and outer overcoat). Double Braided Tubing is difficult to manufacture and requires specialized equipment, complex systems and procedures, as well as advanced silicone extrusion expertise. Visit our website to learn more.
If your application requires large quantities of tubing or longer lengths of tubing, we can customize any of our tubing options (ID/OD or silicone material used) to accommodate your needs. We can offer longer length coils, tubing on spools and special bulk-packed style containers.
More questions for Freudenberg?
Freudenberg has designed and manufactured silicone tubing for biopharmaceutical applications for over 30 years
Sealing and Filter Technology
As a global technology group, Freudenberg is uniquely positioned to drive innovation and deliver superior technological solutions across 40 markets and thousands of applications. Find out which high-quality solutions other Freudenberg companies have to offer to bring your pharma production to the next level:
