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Allograft Safety
Products
from Bone Bank Allografts are subject to an exacting quality assurance
process which ensures maximum allograft safety. Our rigorous quality
assurance program meets both the Federal Food & Drug Administration
(FDA) regulations and American Association of Tissue Bank (AATB)
Standards
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The
SteriGraft™product line utilizes the GraftShield™
process, an extensive program which begins at donor screening
and continues throughout processing and final release.
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Donor
Screening & Recovery
A
meticulous donor screening system has been developed to assure
that only uniform, high quality tissues will be recovered and
processed.
*Donor
Review - An extensive donor screening process is conducted to
review medical / social history. Only those donors that meet our
standards and screening requirements are qualified to be accepted
for donation. This rigorous screening process is performed in
an effort to eliminate potential donors with risk factors, which
may contribute to the transmission of infectious disease.
*Donor
Recovery - Our donor recovery partners and their staff are held
to the high standards implemented by the American Association
of Tissue Banks. Specific policies and procedures are followed
to ensure that donor tissue is recovered appropriately and aseptically.
*Lab
Testing - In accordance with FDA regulations and AATB Standards,
donor tissues are tested by laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and carefully
analyzed using the latest technology in order to confirm that
the donor is free from the following infectious diseases:
HIV I / II, Hepatitis B/C, Syphilis, HTLV I/II
Processing
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*Tissue
Cleansing - To prepare for processing, tissues are sanitized
using GraftCleanse™. This proprietary blend of cleansing
compounds significantly reduces bio-burden and allows for
an aesthetic white appearance.
*Sterilization
- GraftShield™ utilizes a low dose radiation sterilization
method that is validated in accordance with ISO 11137-2
Method 1. Terminal sterilization is achieved with allografts
in their final packaging.
*Custom
Processing Machines - Traditional CNC processing machines
are often used to process multiple donors with only the
ability to disinfect but not sterilize the equipment between
processing cases. We have designed and built custom equipment
that enables individual equipment sterilization between
cases, thus eliminating the risk of cross contamination
- a significant advance in the safety of processing human
tissue allografts.
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*Allograft
Performance - Each allograft is evaluated at the time of processing,
packaging, labeling, and again just prior to release to ensure
that high quality tissue is being made available for transplantation.
QA Program
Both
the FDA and the AATB have strict mandates for quality assurance
procedures. BBA is in compliance with all standards for tissue
banking and federal regulations promulgated by the FDA under Title
21 CFR 1271. Our donor screening, recovery, testing, processing,
packaging, distribution, and tracking systems guarantee allografts
identified with the SteriGraft brand are among the safest and
highest quality allografts available.
Our
Allografts - Allograft Safety - Download
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