This piece was written by Mario Gisbert, Director of Pigmentalia, and co-authored by Jasper Scholtes, Director of Goldeneye UK.
This summary is intended to highlight the rigorous process that tricopigmentation pigments are subjected to before they are used by technicians.
The prepared colouring agents (pigments) used in tricopigmentation are subject to strict regulation at European and national levels. International authorities have published the prerequisites to grant authorisation for the prepared colouring agents. Without fulfilling these requirements, it is not possible to proceed with the sale of the pigments.
The colouring agents should always be sterilised!
The Resolution of the European Council on tattooing and micropigmentation released in 2008 and derived from the decision published in 2003 warns about the health risks if certain substances are implanted. The health risks are of two types: those that result from the use of harmful ingredients and those resulting from microbiological contamination due to incorrect preparation or packaging containers.
The colouring agents used in scalp micropigmentation cannot contain a series of ingredients which could be harmful for health, such as aromatic amines or ingredients considered to be carcinogenic, mutagenic or reprotoxic, and other ingredients that could cause hypersensitivity. Aftercare is also strictly controlled.
To prevent the microbiological contamination of the prepared colouring agent within the container, the Resolution of the European Council on tattooing and micropigmentation released in 2008 states that the prepared agents for tricopigmentation and scalp micropigmentation must be sterilised and conditioned in a container which keeps them sterile until their application.
How are pigments manufactured?
The pigments used in tricopigmentation require “Good Manufacturing Protocols” not only to adhere to international legislation but also to obtain a final product that gives the desired and safe results.
STEP 1 – Quality Control of the raw materials
STEP 2 – Pigment Weighing
STEP 3 – Pigment Procedure (Second Quality Control)
STEP 4 – Pigments Sifting
STEP 5 – Weighing and mixing the excipients
STEP 6 – Adding of the base powder to the excipient
STEP 7 – Homogenisation
STEP 8 – Third Quality Control
STEP 9 – Product Packaging
STEP 10 – Labelling
STEP 11 – Gamma Ray sterilisation
STEP 12 – Microbiologic control
STEP 13 – Batch released for sales after final quality control