The accreditations
Four independent marks behind every pen.
Manufacturing, quality management, laboratory accreditation, and cleanroom control. Each is verified by an independent body.
Audited annually
Current Good Manufacturing Practice
The regulatory standard that governs how a pharmaceutical product is physically made, from raw-material intake to final fill.
What it certifies
That manufacturing happens on a validated line with controlled facilities, calibrated equipment, trained personnel, and a complete batch record for every lot. Each step is documented and the whole system is re-audited every year.
Why it matters to you
It is the line between a compound mixed in an uncontrolled space and one produced to hospital-grade procedure. cGMP is what makes a pen reproducible lot to lot, not a one-off, and what makes a problem traceable to the exact batch it came from.
Verified · on file
Cert. SWS-Q-900714
Quality Management System
The international standard for a quality management system, the documented framework that keeps quality repeatable across an entire organisation.
What it certifies
That suppliers are vetted, deviations are logged and investigated, corrective actions are tracked to closure, and the whole process is reviewed on a fixed cycle, not left to individual judgement.
Why it matters to you
A single batch can pass a test by luck. ISO 9001 certifies the system behind the batch, so quality is the default outcome of the process rather than a happy accident.
Verified · on file
Cert. SWS-T-170714
Testing and Calibration Laboratories
The global benchmark for the technical competence of a testing and calibration laboratory.
What it certifies
That the lab analytical methods are validated, its instruments are calibrated against traceable references, and its results are scientifically defensible, verified by an external accreditation body, not self-declared.
Why it matters to you
It is why a purity figure on a certificate of analysis can be trusted. Anyone can print 99% pure; an ISO 17025 lab has proven that the measurement itself is accurate and reproducible.
Verified · on file
Cert. SWS-C-146714
Cleanroom Classification
The standard that classifies a cleanroom by the number and size of airborne particles permitted per cubic metre of air.
What it certifies
That the environment in which peptides are filled is held to a defined, measured particle grade, with the air monitored and the classification re-verified rather than assumed.
Why it matters to you
Peptides are filled into pens in controlled air to limit contamination. The classification is documented proof the room meets a hospital-grade particle limit, not just that it looks clean.
Verified · on file
