Preventing Microbial Contamination in Tattoo Inks
On October 24, 2024, FDA issued guidance for tattoo ink manufacturers and distributors to assist in the prevention of tattoo ink contamination with microorganisms. FDA provided steps that can be taken to prevent possible contamination. The published guidance includes examples of known areas of insanitary conditions and contains recommendations to involved parties to prevent serious adverse health effects due to microbial contamination.
Examples of Insanitary Conditions:
Preparing or packing tattoo inks in facilities not suitable for such activities (for example, in spaces that are difficult to clean and sanitize).
Ink, ink components, and primary packaging containers held uncovered, especially near open air ducts, potentially exposing them to airborne microbial contaminants.
The presence of ink and ink components held in containers that have not been cleaned and sanitized.
Insanitary mixing of tattoo inks, including:
The use of containers and utensils that are not cleaned and sanitized.
The use of containers without covers that expose in-process inks to microbial contaminants from the air.
Lack of appropriate attire by personnel during manufacturing, including failure to use hairnets, lab coats, aprons, gowns, masks, or gloves.
Failure to equip employee restrooms with soap and water, or the lack of signage directing employees to wash their hands.
Disposal of used personal protection clothing in the production area.
Storage of packaged products in locations that render them susceptible to contamination.
Recommendations:
Test ink and ink components for microbial contamination or purchase these materials from suppliers that test for microbial contamination. Discard any materials that contain microorganisms at any level that may harm any consumer if present in the finished product.
Ensure that the manufacturing process does not introduce microbial contamination (clean and sanitize equipment and provide personal protective equipment to employees).
Ensure that any sterilization method used is valid.
Ensure that any cleaning or sterilization method does not adulterate the finished product.
Take corrective measures to prevent the release of any final product that microbiological testing shows contains microorganisms at any level that may harm any consumer and reexamine manufacturing and validation procedures to determine the cause of the final product contamination.
Establish good manufacturing practices (GMPs) that pertain to cosmetics generally.
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