ETERNAL INK: Sterile Ink Validation
STERILE INK VALIDATION: The microbiological data results and Sterility Assurance Level (SAL) attained, overwhelmingly demonstrate Eternal Ink exceeds all known processes within the industry for providing a verifiably ‘sterile’ tattoo ink.
— Mollie Holter
President, Principal-Microbiologist MicroBio Consulting, LLC
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.
MicroBio Consulting, LLC | MicroBio Consulting is a global company helping clients to be “Best in Class” and “First to Market”. We are committed to the development of science,scientists, and medical technology in Medical Alley and beyond. Our experts in sterilization and microbiologist have decades of combined experience in the sterilization and microbiology testing of medical devices, pharmaceuticals and food products. MicroBio Consulting services over 70 clients with their microbiology and sterilization requirements.