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The GraftShield™ allograft processing system is
designed to set an entirely new standard in allograft
sterilization. This system offers scientifically validated
tissue sterilization (validated to SAL 10-6 in accordance
with ISO 11137-2 Method 1) which virtually eliminates
the risk of bacterial disease transmission. The following
paragraphs provide information on the tissue processing
steps in this system.
To learn more about the various certifications of Bone
Bank Allografts and Texas Human Biologics, please click
here.
To download a PDF file of our catalog pages which discuss
allograft processing, please click
here.
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GraftCleanse™ Tissue Cleansing
The
GraftShield™ process requires aseptic
handling of all tissue throughout processing
and is based on a scientifically validated
sterilization method which results in a
Sterility Assurance Level (SAL) of 10-6
in accordance with ISO 11137-2 Method 1.
This validated process is designed to protect
the biomechanical properties of each allograft
while virtually eliminating patient risk.During
processing, tissues are treated with the
GraftCleanse™ process which includes
chemical and physical cleaning procedures
that reduce the bone marrow and lipid elements
associated with normal human tissue. Environmental
conditions under which the chemical exposure
occurs include normal atmospheric pressure,
physical agitation, 38º C ultrasonic
water bath incubation, and room temperature
dwell time.
Tissue Processing
Our
proprietary GraftSheild™ processing
system was developed to offer the following
advantages:
- Validated
GraftCleanse™ tissue cleansing method
- Custom
machinery designed exclusively by THB
for tissue manufacturing and sterilization
between each donor case
- Load
strength testing
- Controlled
exposure to freeze/thaw cycles
Our Processing Partner
Facility
Located
in the Texas Research Park in San Antonio,
Texas Human Biologics (THB) has recently
opened its new state-of-the-art human tissue
processing center. The facility was designed
and built to be in full compliance with
environmental condition requirements for
handling human tissue. All human tissues
are handled in an ultra clean environment.Specialty
features include:
- Continuous
sheet, seam welded cove base flooring
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Gasketed, sealed, and washable ceilings
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Full sheet glued Fiberglass Reinforced
Polyester (FRP), seam sealed walls
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Point of passage, magnehelic gauges for
continuous monitoring of clean room zone
pressures
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Fully adjustable High Efficiency Particulate
Air (HEPA) filter air handling system
- Magnetic
door interlocks for facility security
and air pressure maintenance
- Validated
ethylene oxide sterilization of supplies
and equipment
- Validated
steam sterilization of supplies and equipment
The GraftShield™ Advantage
- Sterile
human allograft tissues
- Final
package sterilization
- Proprietary
cleansing processes
- Bone
Bank Allografts meets the exacting FDA
regulations and AATB standards
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Click
here to return back to our allograft
safety and processing page.
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