Biotek Colors are gueranteed by the productive quality of Biotek Labs, with ISO9001 and GMP. Respond fully to the racomandation included in REACH as well as being characterized by pharmaceutical grade guaranteed by the purity of raw materials and the constant research for maximum performance with minimum risk.
The analysis test as expressed by REACH are executed by the main chemical/analytical laboratory in the world, a reference point according to the dispersion in artificial tear, CTL Berlin and laboratories of the University of Pavia. Fracos.
According to tests, Biotek colors can be declared:
BIOTEK colors are declared STERILE. They are subjected to 25 KGy radiation sterilization dose which guarantees the sterility level defined by the UNI EN ISO 11137 - related to the sterilization processes of "Sterilization of Medical Devices and Health Care".
In addition, BIOTEK colors are offered in the new AIRLESS dispenser and have been subjected to accelerated aging tests, which demonstrate the product integrity and stability and ensuring a shelf life period up to 5 years.
At Pavia University laboratories has been completed complex and expensive tests on volunteers which allow us to assert the absolute tolerability of our pigments.
Negative Cytotoxicity
Negative phototoxicity
Negative Pro-sensitization
Negative Eye irritation
Negative Patch human test
Negative Challenge test
Negative Microbiological Test
Negative Intradermal Test (SP)
Negative Bacteriological test
Negative Aromatic amines
Negative Nickel Test
Studies carried out by leading scientists show that there is no proof of interaction between colors by PMU and Magnetic Resonance. Particularly in the world of Biotek colors, the focus on the choice of raw materials and the use of new low-strength pigments excludes possible serious complications in Magnetic Resonance technique on people with a Biotek pigment plant.
Biotek colors are a perfect mix of organic and inorganic pigments with low amounts of heavy metals. In PMU treatments only a few milligrams of color for treatment are implanted. This data have to provide tranquility to people with PMU treatments about the lack of problems in undergoing diagnostic investigations.
We are sure there is more quantity of Nikel in a chocolate than in a Biotek color
In 28 years, Biotek worldwide customers have been undergone over 10 million treatments without ever experiencing allergic reactions to nickel. In the new BioResistent range, thanks to the selection of the best raw materials and pigments, up to 200 times with less Nikel than in the past, make it possible to state that the possible traces present are below the threshold that causes a possible allergic reaction in humans.
Biotek colors are Nikel Tested and all tests on volunteers in our clinical researches show any reaction to Nikel.
We dedicate resources and attention to the safety of our products to ensure you always serenity.