BIOCHROMADERM® , RADSAFE® and BIOCHROMAEYES® ?

Laboratoires BIOTIC Phocea define their pigments for medical tattooing as skin implants.

For this purpose, we are ISO 13485 certified and our pigments are certified as a CE class IIb medical device under Directive 93/42/EEC.

This quality requirement is present at every stage in the manufacture of our medical inks.

Design

The first design phase involves drawing up a specifications file in order to obtain formulas that are biocompatible and reproducible. The many safety tests (challenge tests, eye irritation tests, etc.) performed verify the human body’s complete tolerance of our products, regardless of the body part tattooed (dermis, mucous membrane, eyes).

The second design phase involves validating the manufacturing protocol by performing a risk analysis validated by a COFRAC-accredited certifying body.

Some views of BIOTIC Phocea’s research laboratory

Selection of raw materials

Laboratoires BIOTIC Phocea imposes very strict requirements in selecting raw materials. They are selected according to the following criteria:

    1. Selection of raw materials
      • Legislation: all raw materials (pigments, dispersant and additives) comply with tattoo legislation (French and European) and the criteria required for Medical Device status (French and European pharmacopoeia).
      • Purity: All raw materials are analysed, as required by law, and have an impurity level under the maximum level permitted.
      • Quality: Pigments are selected according to their tint strength, stability in skin and resistance (to light, temperature, solvents, etc.).
      • Origin: Depending on demand, the products selected may be natural or ORGANIC.
      • Control: An internal control of these criteria is conducted upon each delivery of raw materials, in addition to the analysis reports provided by the manufacturer.
      • Recording: All of these criteria are recorded, allowing for ascending traceability.
    2. Manufacturing process

Sifting

Mashing

Dispersion

Light booth

Penetrometer

pH meter

Spectrophotometer

Viscometer

3. Sterilization phase

In order to ensure the sterility of its products, Laboratoires BIOTIC Phocea has chosen to sterilize its pigments by gamma radiation using the VD MAX25 method.

This industrially validated 1 x 10-6 radio sterilization technique enables products to be sterilized in their final packaging, making it possible to open the peel-pouch containing the pigment in a sterile working environment. In addition to injecting germ-free pigments (a probability of finding non-pathogenic bacteria of less than 1 in one million) into the skin, mucous membranes or eyes, there is no contamination of the working environment.

The blue light of the gamma irradiator

Relaease

Following sterilization, the products are quarantined, then inspected by a qualified, responsible person before being made available to users. A sample of each production batch is kept.

  • The inspections conducted are identical to the manufacturing process (colour, viscosity etc.), ensuring that the products are fully compliant with the standards and quality requirements pertaining to medical devices
  • Other inspections are also performed (labelling compliance, verification of the irradiation certificate, compliance with the irradiation protocol and the dose administered).

Cartography extract

Radiation certificate