Q. What is pathogen inactivation?
A. A pathogen is any agent that causes disease, including bacteria, fungi, protozoa, viruses and prions. Pathogen inactivation is a process designed to render a biological product non-infectious. A complete pathogen inactivation process encompasses both bacterial and viral inactivation and unconventional pathogens (such as prions which are thought to cause Creutzfield-Jacob syndrome, or “Mad Cow Disease”). The extent of pathogen inactivation can never be absolute, but rather is calculated as the probability that a living organism is present to potentially infect the patient.

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Q. What is the Clearant Process®?
A. The Clearant Process® is the only current pathogen inactivation technology that substantially reduces all types of pathogens in biological products while keeping the overall structure intact. Based on a unique combination of patented and trade secret technologies, the Clearant Process® uses gamma irradiation.

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Q. How successful has the Clearant Process® been to date?
A. To date, Clearant has been successful in the application of the Clearant Process® to biological products including serum protein, enzymes, growth factors, antibodies, tissue and cell culture supplements. Only the Clearant Process® is designed to significantly inactivate every known pathogen that can cause the transmission of infection to patients from biologics and tissue. (Contact us for more information about the technology and results obtained using the CLEARANT PROCESS® )

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Q. Is the Clearant Process® designed to inactivate all types of pathogens?
A. Yes. Data shows that the Clearant Process® inactivates viruses (lipid enveloped and non-enveloped, DNA and RNA, double- and single-stranded), bacteria (gram positive and negative, aerobic and anaerobic), fungi, spores and the causative agents for transmissible spongiform encephalopathies (TSE's). The level of inactivation required to establish safety with respect to TSE’s has not been established. These are all of the known types of pathogens.

While Clearant has not tested each individual pathogen in the categories listed above, it can be predicted with a high level of confidence that the Clearant Process® would be effective against virtually all pathogens based on the fact that all currently known pathogens are comprised of either nucleic acid or TSE's. First, the Clearant Process® destroys the nucleic acids that comprise the genomes of the vast majority of pathogens, and so inactivates any organism with a genome. Second, the inactivation of TSE's, agents that may lack a nucleic acid component, has been an empirical observation made repeatedly over the years by independent investigators working with different strains of TSE's. Hence, the work by Clearant scientists, supported by a significant body of scientific literature, has demonstrated that all pathogens that have been examined have been susceptible to some degree to gamma irradiation that forms the basis for the Clearant Process® .

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Q. What are the benefits of the Clearant Process®?
A. The Clearant Process® is broadly effective against all types of pathogens, while maintaining the integrity of the biological product. It is a technology that meets both current and emerging global regulatory standards of inactivation of pathogens and, unlike other current methods, is designed to be applied to various product states.

The Clearant Process® can be integrated into various stages of product processing/manufacturing including the final sterile barrier container which provides terminal sterilization. It is readily validated and scalable.

The Clearant Process® enhances product safety in a single step. This improvement in product safety provided by the CLEARANT PROCESS™ is expected to enable new products and/or increased sales of existing products whose use today is limited or prohibited by the risk of infection transmission.

You can learn more about the benefits of the Clearant Process® by clicking here.

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Q. Can the Clearant Process® be applied to a final sealed container?
A. Yes. The Clearant Process® is designed to be applied as a final sterile barrier container pathogen inactivation step. That means doctors and their patients can be confident that no additional pathogens, or intermediate contamination were introduced into the product after being inactivated by the Clearant Process®. Materials as diverse as polyethylene, metallocized films, polyethylene terephthlate, glass, elastomer, spunbound polyolefins (e.g. such as tyvek) have been used successfully with the Clearant Process® as sterile barriers.

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Q. Is the Clearant Process® designed to be applicable to multiple physical product states?
A. Yes. Thus far the Clearant ProcessTM has been applied to paste, liquid, powder and various forms of tissue implants.

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Q. Does the Clearant Process® address both current and emerging regulatory requirements for viral safety?
A. Yes. The Clearant Process® addresses many changing regulatory requirements worldwide including: proven effectiveness against a broad range of pathogens (including lipid enveloped and non-enveloped viruses); the demand for robust viral inactivation methods; and increasingly strict standards for viral safety and sterility assurance for human and animal derived products, biotech products, biologics used in manufacturing and biologics regulated as devices, drugs or tissues.

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Q. How can I get more information about using the Clearant Process®?
A. Companies, Tissue Banks and Research Facilities can click here for more information about how to Contact Clearant or for more details about becoming a user of the Clearant Process® . You'll be able to request more information directly from Clearant.

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Q. Will the human source materials used in my surgical procedure be sterilized so that germs from the donor won’t harm me?
A. Some materials from donors are sterilized to kill dangerous germs called pathogens. Some are just aseptically processed, which means they are processed in a sterile environment, but not actually sterilized. You have a right to ask which type will be utilized in your procedure. The Clearant Process uses radiation to sterilize the donor materials, called allografts, in back, neck, knee and similar surgeries to prevent infections from allografts. Radiation is commonly employed in industry to sterilize medical devices, such as syringes, needles and catheters and is also used by the Clearant Process®. Allografts exposed to the Clearant Process® are sterile. Ask your Doctor.

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Q. I have heard about recent scandals about tissue banks, should I be concerned about my surgical procedure?
A. If your procedure uses an allograft, it is tissue which originated by the gift of a deceased person to help heal others. The allograft tissue must be collected carefully from donors who are thoroughly screened for suitablility. The BTB scandal alleges that the allograft tissue was not voluntarily given as a gift and that safety and screening procedures could not be assured. The allografts from BTB which were not implanted have mostly been removed from distribution and will not be transplanted. Discuss your concerns with your doctor.

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Q. Would a sterilization process have rendered those allografts safe for use?
A. No. A sterilization process such as the Clearant Process® would have reduced the risk of disease transmission to the recipients of the allografts which were not properly screened. The safety and screening procedures must always be followed, however, to assure safe allografts for surgical usage.

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Q. Is an allograft or biological substance treated by the Clearant Process® still radioactive?
A. No. The Clearant Process combined proprietary protective chemicals and processing controls with the same gamma radiation (cobalt-60 source) commonly used to sterilize medical devices such as syringes, needles and surgical staples and to kill insects in produce. The cobalt-60 is welded into steel rods and is not mixed with the goods being exposed to the radiation energy it emits. Cobalt-60 only emits radiation energy, and can not create a fission reaction of the type which generates electricity and is used in nuclear arms. Processing is completed before the allograft is released for surgical use and does not emit radiation after processing.

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