Silicone tubing from DuPont

Products and processes designed to improve processing efficiency

Products and processes designed to reduce risk

For more than 70 years, DuPont has drawn upon the versatility and biocompatibility of silicones to help our customers develop and manufacture innovative pharmaceutical products. Yet today’s pharma and biopharma companies face a number of challenges that demand new ways of thinking—ones that help reduce the risk of contamination and improve processing efficiency, while assisting customer development of innovative new products.That’s why DuPont is positioned to go beyond the ordinary with products and processes that can help.Our ultimate goal is to help you minimize risk by providing solutions to meet the stringent performance and regulatory requirements of your industry. To that end, you can rely on

us for:

  • High-purity, BioMedical Grade, platinum-catalyzed silicone
  • Strict contamination control in manufacturing facilities

dedicated to healthcare applications

  • Exceptional change control resulting from a vertically

integrated supply chain

  • Expert technical and regulatory support to accelerate your

process validation

  • Global supply of products and services
  • Custom solutions for unique needs

Products that meet your specific needs

DuPont™ Liveo™ Pharma Tubing is designed and produced to meet our customers’ specific needs:

  • Liveo™ Pharma-50 Tubing: for standard tubing transfer and

filling operations

  • Liveo™ Pharma-65 and Liveo™ Pharma-80: cost-effective

alternatives to reinforced tubing in many operations

  • Liveo™ Pharma Advanced Pump Tubing: for up to six times

the pump life of standard platinum-cure silicone tubing in peristaltic pump applications All Liveo™ Pharma Tubing products are fully customizable:

  • Dimensions
  • Multi-lumen
  • Configuration
  • Gamma irradiation
  • Tolerances
  • Special testing
  • Marking
  • Packaging

Liveo™ Molded Assemblies offer customers the flexibility they desire:

  • Molded assemblies produced according to

customer-specific designs

  • Available in a choice of tubing formulations

according to your process requirements

  • Produced using DuPont’s BioMedical

Grade silicone elastomers

  • Produced in strictly controlled and monitored

clean manufacturing environment Liveo™ Molded Assemblies are fully customizable: wyes,tees, cross-connections, reducers, TC ends, custom sizes,marking, packaging, lengths, shape, multi-lumen, tolerances,formulations, gamma irradiation, special testing and more.

Extensive data and technical support

When you work with DuPont, you can expect dedicated

service, including:

  • Worldwide network for technical support
  • Validation and qualification support
  • Extensive data on extractables, physical properties and

performance testing

  • Regulatory expertise and support
  • Specialized testing services
  • Environmental, health and safety services

Functional benefits

  • High purity and cleanliness with regard to particulates,

endotoxins and bioburden

  • Low-extractables profile to prevent contamination

of your product; no added phthalates, plasticizers

or latex

  • Hydrophobic surface to cut fluid loss
  • Smooth inner bore
  • Stability over a wide range of conditions; suitable

for diverse applications

  • Easily sterilizable using autoclave or gamma irradiation

Dedicated production facility

DuPont is the global leader in silicone technology. Dedicated

to the production of silicone materials for medical device and

pharmaceutical applications, our FDA-registered Healthcare

Industries Materials Site has more than 65 years of extrusion

experience. Our tubing and molded assemblies are qualified to

a range of globally recognized monographs, including:

  • USP⟨87⟩ and ⟨88⟩ Class VI (Biological Reactivity) tests

(tubing and assemblies produced from Liveo™ BioMedical

Grade Elastomer)

  • European Pharmacopoeia 3.1.9 (Silicone Elastomer

for Closures and Tubing)

  • USP<661> (Physicochemical Tests – Plastics)
  • FDA Food Grade (21 CFR 177.2600)
  • Selected Sanitary 3-A standards
  • Japanese Pharmacopoeia (Section 11: Plastic Containers for

Pharmaceutical Products)

  • USP 85 Endotoxins, USP 788 Particulate matter for Injections,

USP 151 Pyrogen test

  • ISO 11737-1 Bioburden

During manufacture, we follow strict contamination control policies in accordance with appropriate principles of cGMPs to ensure consistent product purity and quality. Frequent monitoring of air, critical surfaces and equipment verifies compliance to these policies. Contamination control, batch traceability and change control all converge to improve risk management.

 

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