Tutogen – Tutoplast – Tutodent 09/06
Tutogen – Tutoplast – Tutodent 09/06
Tutogen – Tutoplast – Tutodent 09/06
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<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong> <strong>–</strong> <strong>Tutodent</strong> <strong>09</strong>/<strong>06</strong>
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
<strong>Tutoplast</strong> ® certifies<br />
Experience: > 30 years<br />
Applications: > 250.000 / year<br />
Process Proprietary<br />
Processing: Individually, no pooling<br />
Products: 100% tissue<br />
Procedures: Validated<br />
Sterilization: Validated<br />
Viruses: Validated inactivation<br />
Prions: Inactivated<br />
Shelf life: 5 years
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
<strong>Tutoplast</strong> ® certifies<br />
Storage: At room temperature<br />
Quality Evidence: By reference samples<br />
Traceability: Donor to patient<br />
Biomechanics: Preserved<br />
Tissue Engineering: Optimal matrix<br />
Remodeling: Complete<br />
Tissue compatibility: Excellent
For personal use<br />
OSMOTIC<br />
TREATMENT<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
The <strong>Tutoplast</strong> Process ®<br />
OXIDATIVE<br />
TREATMENT<br />
DELIPIDIZATION<br />
TISSUE DONATION<br />
DEHYDRATION<br />
STERILIZATION<br />
SHAPING,<br />
PACKAGING
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Tissue Donation<br />
Consent for donation �<br />
Selection criteria<br />
(AATB/FDA) �<br />
Interview with relatives �<br />
Autopsy �<br />
Procurement by<br />
medical professionals �<br />
Serum tests in double CLIA �<br />
Controlled shipment �<br />
Tissue receiving lab
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Delipidization<br />
� individual processing (no pooling)<br />
� processing of tissue batches<br />
� medical device standards: GMP<br />
� validated process<br />
Ultrasonic treatment to remove<br />
lipids. Enables effective penetration<br />
in subsequent steps.
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Osmotic treatment<br />
� disrupts cell wall integrity<br />
� exposes intracellular<br />
material for removal or<br />
destruction<br />
� denaturation of proteins<br />
� removal of antigenicity<br />
treatment by saline solutions<br />
of various concentrations
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Oxidative Treatment<br />
� Removes antigenicity<br />
multiple implantation test<br />
� Inactivates viruses:<br />
Cumulative clearance factors of<br />
• Pseudorabies virus<br />
≥ 11.5 enveloped DNA virus<br />
• Sindbis virus (model Hepatitis C virus)<br />
> 10.8 enveloped RNA virus<br />
• Polio Sabin 1 virus<br />
≥ 12.6 non-enveloped RNA virus<br />
• HIV 1<br />
> 8.3 enveloped RNA virus<br />
Ear bones <strong>–</strong> PLIF - Trachea
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Dehydration by solvents<br />
� removes water from the tissue<br />
� inactivates viruses<br />
� inactivates prions<br />
experimentally 3 log reduction<br />
� makes the tissue storable<br />
at room temperature<br />
dehydration by multiple<br />
acetone treatment
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Sizing<br />
� For traditional allografts still<br />
band saws are used<br />
Sawing of processed bone:<br />
precision: ± 1 mm
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Shaping<br />
� For specialities CNC<br />
machines are used.<br />
Shaping the bone:<br />
precision ±0,1 mm
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Shaping<br />
• Detail
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Packaging<br />
� Individual packaging<br />
� Individual labeling<br />
Use of a multifunctional<br />
packaging machine<br />
for moulding, cutting and<br />
sealing
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong><br />
Low dose γ -irradiation<br />
� Inactivation of any microbial<br />
contamination in the final<br />
packaging<br />
� Validated sterilization<br />
SAL10 -6<br />
� Validated low dose to<br />
maintains biomechanics<br />
Rack with Co 60 rods in basin<br />
of D 2 O: Tschernonski effect
Thank<br />
You<br />
For<br />
Attention<br />
And<br />
Time<br />
<strong>Tutoplast</strong> cogwheel<br />
For personal use<br />
<strong>Tutogen</strong> <strong>–</strong> <strong>Tutoplast</strong>
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