Every pen is manufactured under four independently-audited frameworks. Every lot is then third-party tested by an outside ISO 17025 laboratory before it ships.
Primary framework
cGMP. Pharmaceutical-grade manufacturing.
The framework regulators require for human-grade drug manufacturing. Every step is documented, every batch is traceable, every release is signed. The pen is made the same way prescription drugs are.
Audited annually
ISO 9001. Quality system.
Every process documented, every batch traceable. The audit is external, not in-house.
Legally defensible
ISO 17025. Lab accreditation.
The standard required for analytical results to be considered competent in court. Held by both the manufacturer and the independent lab.
Air particles verified
ISO 14644. Cleanroom classification.
Maximum airborne particle counts measured by an outside body, not by the manufacturer. The pen fill happens inside.