Created through a collaboration of L&C BIO’s engineering, research & development and operations departments, AlloClean utilizes a combination of treatments of antibiotics, alcohol, peroxide (cut tissue only) and multiple water rinses.
The deep penetrating cleansing, with minimal tissue manipulation, results in microbial inactivation.
Before tissue is processed, serological and microbial testing takes place. Tissue is subjected to microbiological testing at recovery and must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from processing or transplantation.
L&C BIO maintains all testing records, which include, but are not limited to
Antibody to the Human Immunodeficiency virus, type 1 and type 2(anti-HIV-1/2)
Nucleic acid test(NAT) for HIV-1(HIV-1 NAT)
Antibody to the Hepatitis C virus(anti-HCV)
Nucleic acid test(NAT) for HCV(HCV NAT)
Hepatitis B virus surface antigen (HBsAg)
Antibody to the Hepatitis B core antigen(anti-HBc)
Nucleic acid test(NAT) for HBV(HBV NAT)
RPR(or STS or VDRL) for Syphilis
After processing is complete, additional microbial verification takes place where tissue is once again tested for contamination, assessed for acceptability and packaged.
Tissue must be free of specific aerobic/anaerobic microorganisms and fungal contaminants whose presence would preclude tissue from transplantation.
While the exact process differs depending on the allograft produced, each piece of tissue is:
Sampled for final microbial testing using swab cultures
Evaluated to a specification to ensure graft acceptability
Packaged in a sealed, sterile pouch
Labeled with: donor, tissue, product IDs, size, description, expiration date and storage instructions