TEI proprietary process
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- Epidermis, hair, muscle, and fascia are removed to isolate dermis
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- A series of chemical and mechanical treatments remove cellular components and potentially infectious agents, while preserving the biological properties and structure of the native collagen
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- The product is freeze dried, cut, inspected, packaged, and terminally sterilized
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Viral and TSE Safety
The TEI manufacturing process includes chemical steps validated to ensure inactivation of potentially contaminating viruses. In addition, TEI specifically designed its biologic matrix to safeguard against the possibility of transmitting prion-related Transmissible Spongiform Encephalopathy (TSE) diseases, including variant Creutzfeldt Jakob Disease (vCJD), the human form of Bovine Spongiform Encephalopathy (BSE), commonly known as Mad Cow Disease. All TEI’s products have passed the rigorous criteria for TSE safety certification by the European Directorate for the Quality of Medicines. Skin and all fetal tissues have been designated safe by the World Health Organization and EU scientific committees as no detectable levels of TSE infectivity have been identified in these tissues. The source tissues for TEI’s products are selected and processed in accordance with strict US and European regulatory requirements; tissue is obtained only from animals certified fit for human consumption.
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Sterility
TEI’s products are terminally sterilized via exposure to ethylene oxide gas. The cycle has been validated to provide a sterility assurance level of 10-6 with undetectable levels of ethylene oxide chemical residuals.
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| TEI biologic matrix Proprietary process Features & benefits |
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