The BioCleanse® Process
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Facts About the BioCleanse® Tissue Sterilization Process
RTI Biologics' allograft and xenograft implants are sterilized through its patented BioCleanse Tissue Sterilization Process.
BioCleanse is the only technology available today that sterilizes tissue, is scientifically and clinically proven to eliminate donor-to-recipient disease transmission risk and preserves tissue strength and biocompatibility. The BioCleanse track record speaks for itself: RTI has distributed more than half a million sterilized implants since March 2000 with
zero incidence of infection.
The BioCleanse process sets a new standard for tissue safety. It has been validated to eliminate viruses, bacteria, fungi and spores, and remove blood, lipids and marrow.
Allografts are used in almost 1 million surgical procedures in the United States every year. Although the risk of disease transmission through allograft transplantation is low, the BioCleanse process essentially eliminates that risk. Tissue processed through BioCleanse has an unmatched level of safety. The BioCleanse process completely penetrates tissue and eliminates a broad range of contaminants, and unlike other processes, is able to inactivate the most resistant organisms, such as non-enveloped viruses and spores.
What are the advantages of the BioCleanse process?
Sterility: The BioCleanse process eliminates bacteria, fungi and spores, as well as enveloped and non-enveloped viruses such as HIV and hepatitis. Under conventional processing methods, the chances of viral transmission are exceedingly low. The BioCleanse process reduces this risk even further, eliminating the risk of donor-to-patient disease transmission.
Consistent quality: The BioCleanse process allows for automation of critical steps in tissue processing to ensure reproducible sterilization of each allograft.
Regulatory compliance: The BioCleanse process is an automated, validated process designed to meet or exceed current and future tissue regulations.
Tissue functionality: The BioCleanse process sterilizes without altering the strength or biocompatibility of allograft.
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