Wound Care Solutions: ISO 10993 Certified Materials, Cleanroom Manufactured

Treating and protecting wounds after surgery or an injury is critical to a patient’s recovery process. Wound care solutions are designed to assist and speed up the body’s natural healing process. These solutions must adhere to strict standards to ensure patient safety throughout the recovery period. At UFP Technologies we work with leading wound care solutions providers to design and fabricate components and parts made from advanced medical grade materials that meet ISO 10993 standards. We have the ability to manufacture these solutions in cleanrooms and controlled environments to ensure sterility and low bioburden levels.

Our access to medical grade foams, fabrics and other specialty materials, along with our unique fabrication capabilities, allows us to create a variety of solutions to treat and protect patients' wounds throughout the healing process. This includes disposable fluid management components for negative pressure wound therapy (NPWT), topical dressings used post-surgery and implantable components to improve a patient's healing.

With multiple ISO 13485:2003 certified facilities throughout the country, housing numerous cleanrooms and controlled environments, UFP Technologies is equipped to engineer and fabricate custom wound care solutions tailored to meet your needs.

FDA Registered ISO Certified | UFP Technologies


Applications

UFP Technologies has designed and fabricated a range of wound care products and components for the medical industry including:

  • Hydrophilic wound dressings
  • Hydrophobic wound dressings
  • Negative pressure wound therapy (NPWT) components
  • Silver-plated fabrics

Materials

UFP Technologies has access to a range of advanced medical grade materials. These materials are compatible with multiple sterilization methods and can be processed and laundered in cleanroom and controlled environments. The following materials are commonly used for creating wound care components and products:

Medical foams – Our medical grade closed-cell and open-cell foams have been tested, passed and certified to comply with the ISO 10993 protocol. Many of these foams are compatible with autoclave, EtO and gamma sterilization methods. We utilize reticulated foams due to their ability to be treated and exhibit antimicrobial properties. Other foams commonly used are hydrophlic foams and silver impregnated foams.

Thermoplastic polyurethane films (TPU) – TPU is a durable plastic film that provides puncture and abrasion resistance. TPU meets USP Class VI standards for use with medical applications and is compatible with EtO and Gamma sterilization.

Fabrics – Silver coated fabrics that offer antimicrobial protection are ideal for various wound care applications.


Capabilities

UFP Technologies has five manufacturing facilities throughout the country that are ISO 13485:2003 certified and house multiple ISO Class 8 (Class 100,000) and ISO Class 7 (Class 10,000) cleanroom facilities. Acting as an extension of your R&D and engineering teams, UFP Technologies designs and develops custom wound care solutions utilizing the following capabilities and fabrication methods: