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Process Technologies

Evergen

Evergen's biomaterials' processing expertise allows us to adapt processing methods for specific clinical applications to optimize application-specific requirements, such as strength and biochemical specifications.

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

Evergen
The BioCleanse® Tissue Sterilization Process is an automated, pharmaceutical-grade tissue sterilization process that uses a complex combination of mechanical and chemical processes to sterilize tissue to a Sterility Assurance Level (SAL) of 10-6 in one full BioCleanse Process cycle. The mechanical component applies oscillating pressure in the presence of detergents and sterilants, which gently perfuse and completely penetrate the tissue. The combination of chemical agents removes blood and lipids, and inactivates or removes pathogenic micro-organisms. Repeated pharmaceutical-grade water rinses throughout the process remove debris, and final rinses remove residual chemicals, leaving the tissue biocompatible.

Cancelle SP® DBM Tissue Sterilization Process

Evergen
Demineralized bone matrix (DBM) is sterilized through the Cancelle SP® Sterilization Process, which is designed to preserve protein activity as well as functionality and biocompatibility DBM osteoinductive (OI) potential is verified by 100% lot testing after irradiation. In their final form, the DBM grafts serve as bone void fillers in many applications, including spine, trauma, joint reconstruction, extremities, and dental surgeries.

Through a combination of oxidative treatments and alcohol washes, pathogens are removed and/or inactivated, and debris is removed. Cleansing rinses remove residual chemicals and DBM-based grafts can be submitted to low-dose gamma irradiation at the end of the process to achieve a sterility assurance level (SAL) of 10-6.

Tutoplast® Tissue Sterilization Process

Evergen
The Tutoplast® Tissue Sterilization Process is used to sterilize and preserve allograft and xenograft membrane, soft tissue and bone implants. Tutoplast® Processed implants are used in plastic and reconstructive surgery, hernia repair, dental, and other procedures.

Osmotic, oxidative and alkaline (if indicated) treatments break down cell walls, inactivate pathogens, and remove bacteria. Solvent dehydration results in on the shelf tissue storage without damaging the native tissue structure. Low-dose gamma irradiation ensures a sterility assurance level (SAL) of 10-6 of the final packaged graft.

SIS Processing

Evergen
Porcine SIS material is carefully processed, disinfected and meticulously crafted a manner that removes all viable cells, inactivates viruses, and removes pathogens, while leaving the naturally fibrous and porous nature of the matrix behind. The complex architecture and composition of the ECM are retained, providing not only the structural collagen framework but also the natural non-collagenous ECM components essential for cell interaction, function and growth. Each product is then meticulously crafted to meet global quality standards with SIS material that was processed specifically for the product’s clinical application. SIS implants are terminally sterilized.
BioCleanse®
Tissue Sterilization Process
Tutoplast®
Tissue Sterilization Process
Cancelle SP®
Sterilization Process
Human Immunodeficiency Virus (HIV)
Hepatitis A Virus (HAV)
HCV Model (BVDV)
Herpes Virus Model (PrV)
Parvovirus (PPV)
 Evergen. Advancing regenerative biomaterial solutions.
 Evergen. Advancing regenerative biomaterial solutions.
 Evergen. Advancing regenerative biomaterial solutions.