Tutogen – Tutoplast – Tutodent 09/06

Tutogen – Tutoplast – Tutodent 09/06
Tutogen – Tutoplast
Tutoplast® certifies
Experience:
Applications:
Process
Processing:
Products:
Procedures:
Sterilization:
Viruses:
Prions:
Shelf life:
For personal use
> 30 years
> 250.000 / year
Proprietary
Individually, no pooling
100% tissue
Validated
Validated
Validated inactivation
Inactivated
5 years
Tutogen – Tutoplast
Tutoplast® certifies
Storage:
Quality Evidence:
Traceability:
Biomechanics:
Tissue Engineering:
Remodeling:
Tissue compatibility:
For personal use
At room temperature
By reference samples
Donor to patient
Preserved
Optimal matrix
Complete
Excellent
Tutogen – Tutoplast
The Tutoplast Process ®
OXIDATIVE
TREATMENT
OSMOTIC
TREATMENT
DEHYDRATION
SHAPING,
PACKAGING
DELIPIDIZATION
TISSUE DONATION
For personal use
STERILIZATION
Tutogen – Tutoplast
Tissue Donation
Consent for donation
Selection criteria
(AATB/FDA)
Interview with relatives
Autopsy
Procurement by
medical professionals
Serum tests in double CLIA
Controlled shipment
Tissue receiving lab
For personal use
9
9
9
9
9
9
9
Tutogen – Tutoplast
Delipidization
z individual processing (no pooling)
z processing of tissue batches
z medical device standards: GMP
z validated process
Ultrasonic treatment to remove
lipids. Enables effective penetration
in subsequent steps.
For personal use
Tutogen – Tutoplast
Osmotic treatment
z disrupts
z
cell wall integrity
exposes intracellular
material for removal or
destruction
z
denaturation of proteins
z
removal of antigenicity
treatment by saline solutions
of various concentrations
For personal use
Tutogen – Tutoplast
Oxidative Treatment
z
Removes antigenicity
multiple implantation test
z
Inactivates viruses:
Cumulative clearance factors of
• Pseudorabies virus
≥ 11.5
enveloped DNA virus
• Sindbis virus (model Hepatitis C virus)
> 10.8
enveloped RNA virus
• Polio Sabin 1 virus
≥ 12.6
non-enveloped RNA virus
• HIV 1
> 8.3
enveloped RNA virus
Ear bones – PLIF - Trachea
For personal use
Tutogen – Tutoplast
Dehydration by solvents
z removes
water from the tissue
z
inactivates viruses
z
inactivates prions
experimentally 3 log reduction
z
makes the tissue storable
at room temperature
dehydration by multiple
acetone treatment
For personal use
Tutogen – Tutoplast
Sizing
z For traditional allografts still
band saws are used
Sawing of processed bone:
precision: ± 1 mm
For personal use
Tutogen – Tutoplast
Shaping
z For specialities CNC
machines are used.
Shaping the bone:
precision ±0,1 mm
For personal use
Tutogen – Tutoplast
Shaping
•
For personal use
Detail
Tutogen – Tutoplast
Packaging
z Individual packaging
z Individual labeling
Use of a multifunctional
packaging machine
for moulding, cutting and
sealing
For personal use
Tutogen – Tutoplast
Low dose γ - irradiation
z Inactivation of any microbial
contamination in the final
packaging
z Validated sterilization
SAL10-6
z Validated low dose to
maintains biomechanics
Rack with Co60 rods in basin
of D2O: Tschernonski effect
For personal use
Tutogen – Tutoplast
Thank
You
For
Attention
And
Time
Tutoplast cogwheel
For personal use