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bespoke fabrications

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 item in PTFE, FEP, PFA, & 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

 

We understand every application is different and requires precise fluoroplastic solutions. To discuss your requirements, contact our customer service team:

Email us