Meeting Stringent Regulatory Standards

In the ever-changing healthcare market from at-home medical devices to antimicrobial properties and medical grade materials, we work with you to help meet strict industry regulations. Many of our medical grade thermoplastics can withstand various sterilization methods, including autoclave, gamma, e-beam and EtO. Some materials are potentially biocompatible and adhere to healthcare management change policies.

 

We work with you to help comply with the following regulations:

  • ISO 10993 Substance Management Lists
  • USP Class VI End Use Compliance

We also offer medical grade materials that are:

  • Non-phthalate polymers
  • BPA-free resins
  • Halogen-free resins
Fluid and Drug Delivery

Fluid and Drug Delivery

These applications require a high level of sterility, biocompatibility, chemical resistance, clarity, as well as low extractables for auto-injectors, inhalers, syringes, catheters, tubing, lures and drip chambers.

Cardiovascular and Blood Care

Cardiovascular and Blood Care

For extra-corporeal systems, blood collection and separation, filtration and storage, we provide materials that offer biocompatibility, chemical resistance, clarity, sterility and good flow for processing.

Healthcare Packaging

Healthcare Packaging

Our healthcare thermoplastics protect packaged products from moisture, light, oxygen and contaminants. Primary and secondary applications include packaging for pharmaceuticals and medical devices – closures, pouches and prefilled syringes. Sustainable packaging solutions are available.

Labware and Diagnostics

Labware and Diagnostics

Petri dishes, pipettes, cryogenic storage tubes, droppers and specimen analysis equipment can benefit from our range of thermoplastics that deliver low-temperature resistance, low-protein binding, clarity, rigidity and sterility.

Monitoring Devices and Imaging

Monitoring Devices and Imaging

For monitoring and imaging devices, we offer thermoplastics that provide a variety of required properties, including chemical resistance, durability, flame retardancy, impact resistance, indoor UV stability and colorability. 

Non-woven Disposables

Non-woven Disposables

We offer materials that deliver colorability, sterility, strength and weight for diapers, incontinence products, surgical disposal gowns and women’s hygiene products.

Orthopedics

Orthopedics

Bone cement mixers, external bone fixation devices, instrument handles, trays and cases require thermoplastics that deliver biocompatibility, sterility, dimensional stability, impact, and chemical resistance and colorability 

Respiratory Therapy

Respiratory Therapy

Our thermoplastics also help to prevent failures due to environmental stress cracking and chemical attacks. These products are used in respiratory masks, ventilators, CPAP devices, nebulizers and tracheal tubes. These applications require materials that provide biocompatibility, soft touch, comfort and reliability. 

Surgical Instruments

Surgical Instruments

As surgical devices, including trocars, retractors, speculums, forceps and electrosurgical instruments, become smaller and more complex, we offer solutions that provide strength, durability, and freedom of design for miniaturized instruments. 

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