Solvay-specialty-polymers-radel-ppsu-for-healthcare

For over 30 years, Radel® PPSU has provided a strong, lightweight alternative to metal in sterilization cases and trays, implant trials, surgical instrument handles, and a host of other medical and dental devices. It can absorb tremendous impact without cracking or breaking, even after prolonged and repeated exposure to high temperatures, chemical disinfectants, hot water and steam. 

Radel® PPSU is compliant with ISO 10993 biocompatibility testing and is suitable for limited exposure applications having less than 24 hours contact with bodily fluids and tissue. It is compatible with all commercial sterilization technologies, including steam sterilization, ETO, gamma radiation, and vaporized hydrogen peroxide. It can be steam sterilized over 1,000 cycles without significant loss of properties or appearance, making it an excellent candidate for reusable medical devices.

 

Colors for Healthcare

Radel® PPSU provides a wide selection of opaque and transparent standard colors that are ISO 10993 biocompatible and supported by extensive data in FDA Master Access Files. Custom colors are available through our partners.

Radel-PPSU-Standard-Colors-for-Healthcare

Sterilization

Radel® PPSU resins are compatible with all commercial sterilization methods. Medical device companies should validate the material and device performances under the conditions that best simulate the intended use. Exposure to chemicals and disinfectants in combination with associated sterilization method should be considered to assess their cumulative effect on the material.

Sterilization Capabilities of Radel® PPSU

Steam sterilization, 18 min at 134° > 1,000 cycles
Ethylene oxide gas

100 cycles

Vaporized hydrogen peroxide 200 cycles
High-energy gamma radiation 40 kGy

 

Cleaning and Disinfection 

Multiple factors must be considered when evaluating a material’s compatibility with cleaning agents and disinfectants. This includes material selection type of reagent, reagent concentration, temperature, time, and residual or applied stress on the fabricated part. Stress can be caused by an external load applied during use or by residual internal stress in the molded part due to processing. Evaluation of the finished device should consider how stress and reagent interaction could lead to cracking.

Medical device companies should validate the performance of the material and the device under the design criteria and conditions that best simulate the intended use. Exposure to chemicals and disinfectants in combination with the specified sterilization method should be considered to assess their cumulative effect on the material.

Results from PDI Healthcare’s compatibility study of several of our specialty polymers with their Sani-24®, Sani-HyPerCide™, Sani-Prime® and Super Sani-Cloth® disinfectants are available for performance testing and cosmetic testing.

Radel® PPSU offers excellent resistance to commonly used hospital disinfectants  

Aseptisol®

Isopropyl Alcohol, 70%

Sani-24®

Bleach Solutions, 10%

Lysetol® FF

Sani-Cloth® HB

Cavicide®

Manu-Klenz®

Sani-Cloth® Plus

Envirocide®

Puristeril Plus®

Sani-HyPerCide™

Cidex®

Phenols, 2%

Sani-Prime® 

Grotanat®

Quaternaries

Super Sani-Cloth®

Hydrogen Peroxide, 3%

Sporotal® 100

Wex-Cide®

 

Biological Safety

As a proactive partner with healthcare OEMs for more than 30 years, we understand the stringent industry requirements designed to ensure biological safety and protect the public’s health. We offer comprehensive regulatory support, including ISO 10993 biocompatibility testing, FDA Master Access Files, and region-specific regulatory specialists that can assist and support your submissions, petitions, and certificate requests.

 

Design Freedom

In addition to significantly reducing weight and cost, metal-to-plastic conversion gives engineers greater design freedom. It can be processed using standard melt processing techniques and lends itself to post-fabrication operations such as ultrasonic welding, adhesive bonding, and laser marking as well as heat staking, threading, and machining. 

 

Technical & Regulatory Support

At Solvay, we understand the importance of responsive customer support and work hard to earn your confidence in us as a materials supplier. Our dedicated healthcare team provides the product development, technical know-how, and regulatory support you need to grow your global business. This includes assistance with material selection, plastic design, Moldflow® process modeling, Finite Element Analysis (FEA), and fabrication and assembly techniques. Other services include materials training, on-site processing support, product testing, and failure analysis.

Deep dive into Radel® PPSU

Radel-PPSU-HC-Starter-Kit

Download the Starter Kit and receive:

  • Product overview
  • Product technical specification
  • Comparison to other transparent polymers
  • Design & processing guidelines

Radel® PPSU delivers vibrant colors with long-lasting performance. It is a super-tough, high-heat, transparent polymer used in the healthcare industry for over 30 years. It can withstand prolonged and repeated exposure to harsh chemicals, moisture, and high temperatures and still absorb tremendous impact without cracking or breaking. Radel® PPSU has been tested under ISO 10993 biocompatibility standards and a Master Access File (MAF) is on record with the U.S. Food and Drug Administration (FDA). It is available in 16 standard colors (opaque and transparent) and custom colors are available through our partners. Typical applications include: Orthopedic equipment  •  Sterilization cases & trays  •  Medical and dental devices. 

Download the Starter Kit