Certified Quality — and the Clean Room Behind It

Two certifications, independently audited.

INTENZE holds both ISO 9001:2015 — the quality management standard — and ISO 22716, the Good Manufacturing Practices standard for cosmetic production. We hold them together, for pigment made in our own lab in the USA.

Neither certification is required by law. No regulation obliges a tattoo ink manufacturer to hold either one. We went and earned them, and we are re-audited to keep them.

What earning them required:

  • Documented quality control on every batch
  • Full traceability from ingredient to bottle
  • Independent third-party audits and ongoing compliance checks

What that means for the bottle in your hand:

  • Batch-to-batch consistency you can plan a piece around
  • A production and sterilization record behind every lot code
  • Manufacturing controls that are written down, audited and repeatable

Made in our own lab. Vegan. Gamma-sterilized, sealed and batch-coded.

ISO 9001:2015 is an internationally recognized Quality Management System (QMS) standard. It governs how a company documents, controls and improves its production process. Certifying to it required INTENZE to demonstrate:

  • Documented quality control – every batch is tested for purity, stability and performance, and the results are recorded.
  • Traceability and documentation – ingredients and process steps are logged, so a bottle can be traced back to the run it came from.
  • Continuous improvement – the process is reviewed and refined on a defined cycle, not ad hoc.

Nothing in law requires an ink manufacturer to hold ISO 9001. It is a voluntary certification, granted and maintained through independent third-party audits, documented procedure and ongoing compliance checks — and withdrawn if the audits are not passed.

Air-Shower Entry: How Anything Gets Into the Clean Room

How it works:

  1. Gowning first – personnel put on clean-room-approved protective gear: lab coat, gloves and shoe covers, before they go anywhere near the room.
  2. HEPA-filtered air shower – people and materials pass through a chamber where high-velocity HEPA-filtered jets strip off dust, fibres and skin flakes carried in from outside.
  3. Pressure separation – the chamber stops unfiltered outside air from following them in.
  4. Controlled access – only personnel trained in clean-room protocol go through, which limits the routes contamination can take.

Why the Room Matters

Pigment is mixed and filled in a filtered, access-controlled environment rather than on an open production floor. Airborne dust and particles are removed from the space before the ink is ever exposed to it. That is how contamination control and batch consistency are actually produced — by controlling the room, not by asserting the result.

What the Clean Room Gives You

  • Pigment mixed and filled in a filtered, access-controlled environment
  • Consistency controlled at batch level and recorded
  • Hygiene protocols defined under ISO 22716
  • Quality management audited under ISO 9001:2015
  • Gamma sterilization to ISO 11137, with the delivered dose recorded per run

More than pigment — a record.

Every INTENZE bottle comes with one: the batch it was made in, the run that sterilized it, and the standards the facility is audited against. That record is what you stand on when a client, a health inspector or an insurer asks a question about what went into their skin.

Check any lot code at Verify Your Ink.

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