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ETERNAL INK: Sterile Ink Validation

OVERVIEW: Tattoo inks have historically been manufactured without a measurable standard of sterilization. Tattoo ink manufacturers can merely expose their products to an arbitrary dose of gamma irradiation and describe their product as ‘sterile’. This is done without having the testing data to substantiate the ‘sterile’ label claims. It is a loophole because in truth, this process describes an attempt to sterilize, but does not guarantee the ink is ‘sterile’. Eternal Ink implemented a third-party validation study to confirm the effectiveness of their sterilization process. The resulting microbiological testing data clearly demonstrates, with statistical confidence, Eternal Ink provides a ‘sterile’ tattoo ink

STERILE INK: To validate their ink as a ‘sterile’ product, Eternal Ink went above and beyond the accepted industry standard. MicroBio Consulting, LLC, was engaged to verify the sterile quality of Eternal Ink. MicroBio Consulting implemented a dose-confirmation study to document, test and validate the sterile status of Eternal Ink following exposure to a sterilization process. This was a multi-stage, extended process using an FDA-certified microbiology laboratory. Eternal Ink products were analyzed on a microscopic scale to determine how each needed to be sterilized to ensure product safety and customer health and wellbeing. The successful completion of the dose-confirmation provides the validation for Eternal Ink to attach a ‘sterile’ label claim to their product by demonstrating the attainment of a sterility assurance level (SAL) of 10e-6.

For continued quality control, Eternal Ink performs on-going quarterly dose-verification testing studies. The tests ensure the validated radiation sterilization dose continues to remain effective at killing microorganisms. The test results provide the sterility assurance level (SAL) validating Eternal Ink as sterile.