Quality and safety stages of Orbone® Allografts
Orbone® Cell and Tissue Bank is successfully audited by the tissue bank that our technology is transferred as well as USFDA, ANVISA and other European authorities to provide products to global markets, in the assurance of the quality provided by eCOO® Technology. The Netherlands Tissue Bank conducts these inspections one-to-one and completely at the Orbone® Tissue Bank facility.
All tissue groups produced by Orbone® are released after the European quality standards of Netherlands Tissue Bank Leader Biomedical Holding B.V. are applied after the quality and safety stages are successfully passed.
Orbone® applies European quality and safety standards in all tissues it collects. Tissues are sent to contracted serological testing laboratories for the possibility of infectious diseases. These tests are performed and published by a certified laboratory. Human tissues processed in the Orbone® Tissue Bank include, among others, the results of 12 negative tests covering Hepatitis B, Hepatitis C, Syphilis and HIV. The tissues are obtained from donors who fulfill all the requirements of quality and safety by the European Directives “human tissues and cells 2004/23EC, 2006/86EC and 2006/17EC”.
Virus Blocking Feature
According to validation studies completed with the allografts cleaned with Orbone® eCOO® scCO2 application, high virus inhibition had been observed. The results were seen well above European standards. (Virus blocking is greater than 6 logs, Source: Virus Prevention studies guide: Design, participation and comments of virus inactivation and blocking studies February 1996)
As a result of the investigations, it has been shown that the bone treated with eCOO® scCO2 preserves the biomechanical properties of the bone tissue, which the bone had before the procedure.
eCOO® scCO2 Advantages
Our Tissue Bank prefers to obtain bones from living people in order to offer end-user surgeons the best quality in terms of biomechanical properties. Many different advantages of living human-derived bone grafts over cadaver have been proven in surgical operations used in Europe.
Main advantages of receiving grafts from living donors;
- The biggest advantage of grafts taken from living people is that they can be traced completely and safely from the donor to the recipient patient, and the end product has reached the highest quality, so it guarantees safety in operations.
- Receiving grafts from living persons gives the tissue bank the advantage of choosing noble products that meet strict criteria and high quality standards.
- Considering the follow-up of the transplanted patient, the grafts have ideal properties for osteoconduction in filling and regeneration operations, regardless of the surgical site, and ensures bone integration and intra-osseous development.
- The grafts’ properties are similar to untreated human bone in terms of biochemical composition, structure and mechanical properties.
- Preservation of the mechanical properties of the grafts produced by our Tissue Bank facilitates the adaptation of bone regeneration, especially of the femoral heads, during arthroplasty recycling, compared to living bone.
- The grafts addres a wide spectrum of applications from orthopedic surgery to dental surgeries.
- The grafts can be stored at room temperature and presented in ready-to-use packages for surgical intervention.
To increase the quality of bone tissues and to produce reliable tissues;
- Bone tissues are not taken from old donors.
- Bone tissues are not taken from people with a hernia (femoral) or fracture in their neck.
- Bone tissues of poor quality (perforated, etc.) and weak matrix are not taken.
- According to the regulation limiting today’s standards (European 2007/17/CE), bone tissues whose donor records cannot be determined completely are not taken.
- Bone tissues are not taken from people who have had risky diseases.
- The origin of the bone tissues that had been collected from living people is known in detail (hospital, surgeon, patient).
For these reasons, it is known in detail that the diseases the donor had during bone collection, and the patient to be treated are completely protected from the diseases. In addition, eCOO® scCO2, which operates with expert quality technology and high standards, completes this process safely.