Tissue Safety

Tissue Safety

The Science Of Sterilization

Through its innovations, RTI Surgical, Inc. (RTI) continuously raises the bar of science and safety for biologics – from being the first company to offer precision-tooled bone implants and assembled technology, to inventing fully-validated sterilization processes that include viral inactivation steps. Three such processes – the BioCleanse ® Tissue Sterilization Process, the Tutoplast Tissue Sterilization Process and the Cancelle SP® DBM Sterilization Process – have a proven combined record of more than eight million biologic implants sterilized through RTI’s proprietary validated sterilization processes with zero confirmed incidence of implant-associated infection. Validation studies have been performed for each process based on tissue type using appropriate challenge microorganisms.

When possible, RTI has advanced beyond the use of aseptic processing alone, which does not fully address inactivation of microorganisms inherent to the donor tissue. Sterilization processing adds a measure of safety above screening and testing alone. To achieve sterilization, individual processes should be validated by tissue type. Validation should include tissue penetration, viral inactivation, removal of a wide range of organisms using most difficult case testing and retention of biocompatibility and tissue functionality.

BioCleanse® Tissue Sterilization Process, Tutoplast Tissue Sterilization Process, Cancelle SP® DBM Sterilization Process:

  • Are validated sterilization processes.
  • Thoroughly penetrate tissue.
  • Inactivate pathogens and remove bacteria, viruses, fungi and spores.
  • Designed to preserve biomechanical/biochemical integrity and native tissue.
  • Are scientifically proven.
  • Are validated by individual tissue type based on most difficult case testing using most difficult to kill organisms.

*Data on file at RTI Surgical®


RTI Surgical’s allograft constructs/spacers and most sports medicine soft tissue implants are processed through its patented BioCleanse Tissue Sterilization Process, an automated, pharmaceutical-grade process. The BioCleanse Process is used on grafts that provide a natural biologic scaffold in orthopedic, spine and sports medicine procedures.

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The Tutoplast Tissue Sterilization Process is a chemical sterilization methodology originally developed more than 40 years ago by Tutogen Medical to sterilize and preserve tissue for implantation. Membrane and soft tissue augmentation grafts, as well as bone implants, sterilized through the Tutoplast Process are used in hernia repair, dental and other procedures.

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RTI demineralized bone matrix is sterilized through the Cancelle SP® DBM Sterilization Process, which is designed to preserve protein activity. (DBM) osteoinductive (OI) potential is verified by 100% lot testing after irradiation. In their final form, the DBM grafts serve as bone void fillers in many applications, including spine, trauma, joint reconstruction, extremities and dental surgeries.

*Performance data from studies may not be representative of performance in humans. Refer to the package inserts for more information.

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