Home
|
Biomaterials

Process Technologies

Evergen

Our biomaterial processing expertise allows us to adjust our methods to meet the needs of specific clinical applications and procedures, considering factors such as strength and biochemical properties to support consistent performance.

Evergen's Process Technologies

  • Designed to preserve biomechanical/biochemical integrity and native tissue
  • Scientifically proven, validated sterilization processes that thoroughly penetrate tissue
  • Validated by individual tissue type based on most difficult case testing using most difficult-to-kill organisms
  • Validated to inactivate and/or remove a panel of specific and model viruses under most difficult-case conditions as well as bacteria, fungi and spores
  • Evergen’s proprietary xenograft processing methods preserve the collagen matrix and tissue integrity while removing viable cells, resulting in biocompatible tissue

BioCleanse® Tissue Sterilization Process

The BioCleanse® Tissue Sterilization Process is an automated, pharmaceutical-grade system that sterilizes tissue to a Sterility Assurance Level (SAL) of 10-6. It combines mechanical pressure with detergents and sterilants to penetrate the tissue, remove blood, lipids, and pathogens. Repeated rinses with pharmaceutical-grade water ensure the tissue is free of debris and chemicals, leaving it biocompatible.

Tutoplast® Tissue Sterilization Process

The Tutoplast® Tissue Sterilization Process is used to sterilize and preserve allograft and xenograft implants. The process includes osmotic, oxidative, and alkaline treatments to break down cell walls, inactivate pathogens, and remove bacteria. Solvent dehydration preserves tissue structure for shelf storage. Low-dose gamma irradiation ensures a sterility assurance level (SAL) of 10-6 for the final packaged graft.

Cancelle SP® DBM Tissue Sterilization Process

Demineralized bone matrix (DBM) is sterilized using the Cancelle SP® Sterilization Process, which preserves protein activity, functionality, and biocompatibility. DBM osteoinductive potential is confirmed by 100% lot testing post-irradiation. The process involves oxidative treatments, alcohol washes to remove pathogens and debris, followed by cleansing rinses to eliminate residual chemicals. Finally, low-dose gamma irradiation achieves a sterility assurance level (SAL) of 10-6.

SIS Processing

Porcine SIS material is processed to remove viable cells, inactivate viruses, and eliminate pathogens while preserving its fibrous and porous structure. The ECM’s complex architecture, including collagen and non-collagenous components, is maintained for optimal cell interaction, function, and growth. Each product is crafted to meet global quality standards and is terminally sterilized for its specific clinical application.

Advancing regenerative biomaterial solutions.