The documentation trail
Every Bottle Leaves a Paper Trail
Ask most manufacturers what is in the bottle and how it was made, and you get a marketing answer. Here is ours, in seven steps — each one ending in something you can open and check for yourself.
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The facility is certified, and audited to stay that way
Pigment is made in our own lab in the USA, in a facility certified to ISO 9001:2015 (quality management) and ISO 22716 (Good Manufacturing Practices for cosmetics). Neither is required by law. Both are granted by independent third-party audit, and both are withdrawn if the audits stop being passed.
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The room is controlled before the ink is
Mixing and filling happen in a clean room, not on an open production floor. People and materials enter through a HEPA-filtered air shower that strips off dust, fibres and skin flakes; the chamber keeps unfiltered air from following them in; access is limited to personnel trained in the protocol.
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Every ingredient is recorded before it goes in
Ingredients are sourced, tested and logged under documented procedure — the traceability requirement that ISO 9001 and ISO 22716 both audit against. All INTENZE pigment is vegan, with no animal-derived ingredients and no animal testing.
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Every batch gets its own record
A batch is tested for purity, stability and performance, and the results are written down and kept. That record is what makes batch-to-batch consistency a controlled output rather than a hope — and it is what any bottle can be traced back to.
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Sterilization is done by a third party, and the dose is recorded
Ink is gamma-sterilized to the ISO 11137 standard by STERIS — not sterilized in-house after filling. Each run records the radiation dose actually delivered against the specified range, and any nonconformities. Those run records are on file and published, and you can pull one up by lot code.
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Every pigment has its own safety data sheet
Not a line-level document — a Safety Data Sheet for the specific pigment, available before you buy it, so the composition information is in your hands and your client’s physician’s if it is ever needed.
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The regulatory position is stated, not implied
The FDA considers the inks used in intradermal tattoos, including permanent makeup, to be cosmetics, and the pigments in them to be color additives under the Federal Food, Drug, and Cosmetic Act. Where a range is formulated to the European REACH restrictions, that is a specific range rather than a blanket claim across the catalog — check the individual product page.
Don’t take our word for any of it
The whole point of a documentation trail is that you can walk it yourself. Take the lot code off a bottle you already own and pull up its sterilization record.