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Vol. 1 No. 1 - Sterilization Procedure
for Keystone Dental Bone Grafting Products
Keystone Dental is committed to providing safe and efficacious bone graft products that improve the quality of human life. One way we accomplish this is by ensuring that every bone graft product we ship has been sterilized as the last step in the manufacturing process.
Keystone Dental bone graft products are sterilized under a validated procedure involving the use of electron beam (e-beam) irradiation that is performed after final product processing and packaging. E-beam sterilization is commonly used in the healthcare industry to sterilize items such as medical devices and tissue-based products. It is important to note that aseptic processing alone cannot eliminate the possibility of contamination.
E-beam sterilization is a form of ionizing radiation that is an effective means of destroying microorganisms and their reproductive cells. Generally characterized by its low penetration and highly charged rates, e-beam sterilization exposes the product to a concentrated charged stream of electrons produced through the acceleration and conversion of electricity. As the product passes through the electron beam, it absorbs energy from the electrons. This absorption of electron energy alters various chemical bonds, thus destroying the reproductive cells of microorganisms.
There are published studies and internal data which demonstrate that e-beam sterilization is not harmful to DBM (demineralized bone matrix) or its bioactivity at the doses used to sterilize our products.1 Other methods of sterilization, however, may interfere with biological properties such as osteoinduction as well the biochemical integrity of the tissue.
Furthermore, exposure to e-beam lasts only seconds while other methods may last several hours or generate significant levels of heat within the material. E-beam also allows for precise control of given doses to ensure that each package receives uniform exposure.
By incorporating sterilization as the last step of the manufacturing process, Keystone Dental provides bone graft products that feature the highest standards of safety - a primary concern of surgeons and patients alike.
Vol. 1 No. 2 - Safety of Demineralized Bone Matrix
Demineralized bone matrix (DBM) consists of the organic portion of bone, including the osteoinductive factors such as bone morphogenetic proteins (BMPs). The removal of the mineral portion of bone exposes the BMP signal to the surrounding tissue, allowing the induction of bone formation.
Keystone Dental takes many steps to ensure that the DBM we provide is of the highest quality and safety. This includes obtaining tissue only from those tissue banks that comply with all tissue banking standards as provided by the Food and Drug Administration (FDA), the American Association of Tissue Banks (AATB), and the Clinical Laboratory Improvement Amendments (CLIA).
Donor Screening and Testing
Keystone Dental utilizes only DBM from AATB-accredited tissue banks. Each lot of DBM is obtained from a single human donor and is not pooled with other donors. Potential tissue donors are rigorously screened by the tissue bank in compliance with AATB standards and FDA requirements, which include:
- Complete medical and social history to help identify and eliminate high-risk donors
- Review of age, date/time of death and refrigeration, and a physical examination
- Serological testing performed by a CLIA-certified laboratory
The donor must test negative or non-reactive for the following:
- Human Immunodeficiency Virus Type 1 & 2 Antibody
- HIV Type 1 DNA using Polymerase Chain Reaction or HIV p24 Antigen
- Hepatitis B Surface Antigen and Hepatitis B Core Antibody
- Hepatitis C Antibody
- Human T-Lymphotropic Virus Type I & II Antibody
- Syphilis Using FDA-Approved Tests
Tissue recovery takes place using aseptic protocols in a controlled environment. Futhermore, there is evidence that the bone demineralization process used to produce DBM inactivates HIV-1 and hepatitis B and C viruses.2,3
Product Sterility
Our bone graft products are produced in HEPA filtered clean rooms with environmentally/microbiologically monitored air. After final packaging, each package is sterilized by a validated electron beam (e-beam) method to a sterility assurance level of between 10-4 and 10-6. While other sterilization methods such as dry heat, gamma irradiation, and ethylene oxide have also been shown to inactivate viruses, they can be detrimental to the biological and physical properties of allograft bone. Evidence indicates that e-beam sterilization does not negatively impact the DBM or its bioactivity at the doses used.1
In summary, these strict donor-screening and tissue-testing standards and regulations ensure a high measure of safety with the bone graft products that Keystone Dental provides.
References
1 Wientroub S, Reddi AH. Influence of irradiation on the osteoinductive potential of demineralized bone matrix. Calif Tissue Int 1988; 42:255-60. [return]
2 Scarborough NL, While EM, Hughes JV, et al. Allograft safety: viral inactivation with bone demineralization. Contemp Orthop 1995;31(4):257-61. [return]
3 Mellonig JT, Prewett AB, Moyer MP, et al. HIV inactivation in a bone allograft. J Periodontal 1992;63(12):979-83. [return]
