Integrity and Quality—
The Tutoplast® Cleaning Process Has No Equal

The Tutoplast Process stands alone as the world’s first science-based process that addresses the essential issues associated with biological grafts.

It has set standards for clinical requirements for storage handling, biomechanics and healing.

Because of the Tutoplast cleaning process, NeoForm™ is void of antigens, pyrogens and other chemical residue that can lead to infection or tissue rejection.

And, NeoForm represents the characteristics of the ideal tissue graft.

• Same size and structure as the tissue being replaced
• Sterile, non-antigenic and non-toxic
• Brief preparation time for implantation
• Biocompatible
• Extremely low risk of disease transmission
• Remodeling, uniform quality
• Stores at room temperature
• Long shelf life
• Long, reliable history of use

Tutoplast® processed bioimplants have been safely used in over 1.5 million patients without any known cases of disease attributed to the graft.

The Tutoplast® Process— Step By Step

1) Careful Donor Selection and Serological Testing

Every donor is subject to extensive next-of-kin interviews and a comprehensive physical assessment. Serological testing is performed in accordance with FDA and AATB requirements.

This assures only donors with negative results for diseases such as HIV-1, HIV-2, Hepatitis B and C, HTLV-1, HTLV-2 and syphilis are chosen. In fact, our extensive exclusion protocol far exceeds AATB standards.

The result

• Only tissue from donors with the lowest social and clinical risks is procured.

2) Osmotic Treatment

To fully eradicate bacteria and viruses, tissue is treated several times with alternating baths of hyperosmotic saline and distilled water.

The result

• Cells burst and are washed out.
• Antigenicity located in cell membranes is removed, preventing rejection.
• Potentially hidden viruses within cells are exposed and rinsed out.
• Bacteria are killed and washed away.

3) Oxidative Treatment

All tissue is treated twice with 3% hydrogen peroxide.

The result

• Residual soluble proteins are destroyed and washed out.
• Bacterial spores and non-enveloped viruses (e.g. HAV, HBV) are inactivated.
• Collagen is preserved.

4) Alkaline Treatment

Tissue is treated for one hour with 1N sodium hydroxide, which afterwards is neutralized.

The result

• Viruses, genetic material and DNA/RNA are destroyed.
• Prions are inactivated.
• Collagen biomechanics are not affected.

5) Solvent Dehydration

Moisture is removed from tissue using multiple acetone baths, which is then extracted in a vacuum chamber.

The result

• Dry tissue contains less than 5% water content.
• Tissue is virtually sterile and can be stored at room temperature.

6) Low-dose gamma radiation

Low dose gamma radiation is used to terminally sterilize the implant.

The result

• Radiation completely penetrates the tissue.
• Tissue is sterile according to GMP with a Sterility Assurance Level (SAL) of 10^-6.
• Tissue is residue free and biomechanics are not affected.

7) Individual mechanical testing

Samples are tested for their minimum breaking strength.

The result

• Tissue has consistent quality and high tensile strength from package to package.

8) Complete documentation

All donor protocols, test protocols, in-process protocols and individual reference samples are archived for a minimum of 10 years. In addition, all packaging, shipping and billing documents are coded with recovery organization, donor and tissue type.

The result

• Protocols can be checked in case of complaints, and reference samples can be retested with potentially more sensitive tests.
• Every individual product can be traced to the distributor, doctor or hospital.
• Every processing batch is guaranteed for sterility.
• Each unit can be traced back to its original donor.