The Clearant Process


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ABOUT CLEARANT		STERILITY DEFINED		THE CLEARANT PROCESS		SOFT-TISSUE ALLOGRAFTS		BONE ALLOGRAFTS

The Clearant Process - The Path of Complete Sterility

Clearant is proud to introduce the Clearant Process®: A powerful pathogen inactivation method designed to substantially reduce all types of pathogens in biological products.

Until now, no technology has been capable of substantially reducing all types of pathogens in biological products in their final packaging, while maintaining the integrity of the underlying protein in the product. Various current sterilization and cleansing methods exist but they cannot sterilize in their final packaging or can only destroy limited or specific types of pathogens (such as bacteria or lipid enveloped viruses) in specific types of products. The Clearant Process® substantially inactivates all types of known pathogens for products across a variety of market segments including plasma therapies, tissue allograft implants, recombinant products and blood products. In addition, Clearant achieves this sterilization in its final packaging.

The Clearant Process® uses a combination of patented and trade secret technology based on gamma irradiation that substantially reduces all types of pathogens including:

• enveloped and non-enveloped viruses
• the vegetative, spore or cyst stages of bacteria, fungi and protozoa

Clearant Process® substantially inactivates these types of pathogens while maintaining the integrity of the biological product in human hard- and soft-tissue allografts. This patented technology inactivates all types of viruses - including HIV and Hepatitis A and Hepatitis C. The Clearant Process® also achieves a level of microbial sterility that meets or exceeds that of an operating room medical device without impacting the structural or biomechanical integrity of the allograft. The implant maintains strength and elasticity, and integrates well with surrounding tissue.

The Clearant Process® is an extensively researched methodology with more than 10,000 tests to measure efficacy, and more than 8,000 successful human implants. Studies show radiation performed within the optimized conditions of the Clearant Process maintains impressive allograft strength and elasticity.

Unlike other current pathogen inactivation or sterlization techniques, the Clearant Process® can be applied at various stages of product processing/manufacturing including in the final container.


	Applications of the Clearant Process • Soft-tissue allografts • Anterior Cruciate Ligament reconstruction • Bone allografts • Other applications of the Clearant Process® How the process works

			Step 1 Grafts are pre-treated with a biocompatible radioprotectant and then frozen or freeze-dried. These processes in combination neutralize free radicals and, thus, protect tissue integrity.

			Step 2 Tissue is subjected to a powerful controlled radiation dose of 50kGy., Specialized dose mapping ensures even distribution of gamma energy preventing ineffective under- or over-radiated tissue.

			Step 3 Irradiation is conducted at a very low temperature (about -70°C) to limit free radical mobility.

			Step 4 The Clearant Process® is applied in the final package ready for opening in the operating room to achieve tissue integrity with sterility that equals the level for medical devices.