ETERNAL INK IS CERTIFIED STERILE
Eternal Ink is dedicated to providing the safest tattoo ink to artists. A key part of this pledge is producing a sterile, microbe-free ink. To ensure our tattoo ink is sterile requires strict handling during the process. This extends beyond the ink ingredients, bottles, agitators, seals, and caps. A sterile product requires a sterile environment during the preparation, mixing, and bottling. This also includes the mixing equipment, the facility, and the persons working within the facility.
To build a controlled environment, Eternal Ink constructed a two-story facility dedicated to state-of-art, high-tech ink manufacturing. The 8,000 sq. ft. building is located on the Eternal Ink property in Brighton, Michigan. The tattoo ink preparation and mixing laboratories are housed on the second floor. Ink pouring, bottling, and packaging equipment are located on the first floor. Certified clean-room areas are located throughout building. A HEPA Air Filtration Systems controls the atmosphere providing the cleanest environment possible. Surfaces are continually sanitized, and all employees undergo training and wear PPE. By merging the expertise from multiple industries and incorporating the latest in product manufacturing, the Eternal Ink facility is an international testament of best practices in manufacturing, ingredient handling, and product safety.
To validate Eternal Ink as a ‘sterile’ product, we 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.
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
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.
ETERNAL INK IS CERTIFIED STERILE
Eternal Ink is dedicated to providing the safest tattoo ink to artists. A key part of this pledge is producing a sterile, microbe-free ink. To ensure our tattoo ink is sterile requires strict handling during the process. This extends beyond the ink ingredients, bottles, agitators, seals, and caps. A sterile product requires a sterile environment during the preparation, mixing, and bottling. This also includes the mixing equipment, the facility, and the persons working within the facility.
To build a controlled environment, Eternal Ink constructed a two-story facility dedicated to state-of-art, high-tech ink manufacturing. The 8,000 sq. ft. building is located on the Eternal Ink property in Brighton, Michigan. The tattoo ink preparation and mixing laboratories are housed on the second floor. Ink pouring, bottling, and packaging equipment are located on the first floor. Certified clean-room areas are located throughout building. A HEPA Air Filtration Systems controls the atmosphere providing the cleanest environment possible. Surfaces are continually sanitized, and all employees undergo training and wear PPE. By merging the expertise from multiple industries and incorporating the latest in product manufacturing, the Eternal Ink facility is an international testament of best practices in manufacturing, ingredient handling, and product safety.
To validate Eternal Ink as a ‘sterile’ product, we 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.
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
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.
