medical fluoroplastics

We offer bespoke fabrications and product development for medical device applications.

Our expertise in processing fluoropolymers means that over the years we have solved a wide variety of product and application issues for our medical device customers. By using a combination of custom in-house fabrication techniques and custom-built tooling we can develop custom components very quickly.

With our considerable knowledge of thermoforming, vacuum forming, welding and flanging, we can produce almost any medical component in PTFE, FEP, PFA and PVDF at relative low cost. The custom fabrication processes we use are particularly economic with small and medium volumes, compared with conventional fluoroplastic processing.

We can apply all our processing techniques to the fluoropolymer tubing, heat shrinkable and sheet products we stock to create custom fluoropolymer products.

Inert, non-toxic and bio-compatible are properties sought after by our medical device manufacturers. Our fluoropolymer tubing finds applications as intravenous catheters, heating coils, instrumentation plumbing and containment bags.

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Medical Tubing

Filled Tubing

As the tube is being extruded, a Bismuth Trioxide Filler can be added to the fluoropolymer, which then makes the tube visible to X-Ray. This is sometimes referred to as 'radio-opaque' tubing, used for catheters.

This filler can be applied as an identification stripe if preferred, rather than having the filler throughout the whole tube.

Multi-Lumen Tubing

We can also offer multi-lumen medical grade tube made under cleanroom conditions that is made to order to your exact requirements.

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Medical Fluoroplastic Services

Full traceability on all materials
USP Class VI and FDA compliant raw polymers
Large variety of production techniques
Service available on most thermoplastics
Processing and assembly
Very rapid product development and production of samples
Development service
Dedicated clean production area

Fabrication Techniques

Thermoforming and vacuum forming
Sheet fusion butt welding
Tube end welding (plugging)
Tip forming
FEP & PTFE coating
Flanging and flaring
Seam welding
Heat shrink & sealing
Heat setting
Pressure forming
Transfer moulding

Facilities & Certifications

We have a dedicated clean production area for the processing of products to be used in the medical device field and all our digital verniers are regularly calibrated to meet the requirements of ISO 9001:2015.

All medical products come with full resin data traceability and certificates of conformity. From stock, we can usually offer FDA 21 CFR regulatory raw polymers, and USP Class VI compliant raw polymers are made to order.

All our fluoroplastic materials are ROHS and REACH compliant and we are working to an ISO 9001:2015 quality system. A copy of our certificates can be found in our Policies & Statements.

Fluoroplastics can be sterilised and their suitability for use with ETO, Autoclave and Gamma does vary. Please refer to the table below to choose the best material for your application.

Compatibility with Sterilisation Methods
Polymer	ETO	Autoclave	Gamma
PTFE	Excellent	Average	Poor
FEP	Excellent	Excellent	Good
PFA	Excellent	Excellent	Poor
ETFE	Excellent	Excellent	Good
PVDF	Excellent	Excellent	Good
PEEK	Excellent	Excellent	Excellent