4707 Highway 61 N, Suite 250, White Bear Lake, MN 55110
Due to the exposure directly into the body, the materials that come in contact with the skin should be sterilized.(2) Permanent tattoos utilize tattoo inks that are injected into the skin through a needle. The United States Food & Drug Administration (FDA) lists several common types of tattoos including: “body art, permanent makeup, microblading inks, and temporary tattoos i.e. henna/mehndi, and ‘black henna’”.(1)
The art of tattooing has been dated to be utilized as early as 2000 B.C. As time has evolved, tattoos have become increasingly common.(3) Originating in simple black designs, tattooing has become far more complex with time in regard to coloring, design, and content.(4) With the progression of the tattoo industry comes more regulation and government oversight. Although not specifically regulated by the FDA, in the U.S. tattoo inks are monitored closely by the FDA to limit adverse effects caused by tattoo inks.(1) MicroBio Consulting stays up to date on FDA regulations along with the regulations of other countries around the world.
Tattoo inks are manufactured globally by a variety of companies, but they are required to be manufactured and packaged sterile in several countries.
As safety and efficacy of tattoo inks is a priority for manufacturers, tattoo inks, like other medical devices, must undergo sterility testing to ensure they are free of viable microorganisms per the guidelines from the FDA.(1) Introduction of microorganisms into the skin can lead to infection, so product sterility is of the utmost importance for tattoo ink manufacturers. MicroBio Consulting can help coordinate cleanroom validation, sterility testing, and other relevant product efficacy testing with the goal of promoting safety in the tattoo ink industry.