Iso ISO9001-2000

Arlelis’ claims
Artelis: ISO9001-2000 certified (valid until December 2023)
Raw-materials suppliers: ISO9001-2000 certified
Subcontractors: ISO9001-2000 certified (Gentaur)
Raw materials characteristics
USP class-VI polymers only
Gamma-irradiation-resistant polymers
Flammable polymers (no halogens)
No polymer-generating particles
Manufacturing conditions
Injection under laminar flow Class 10,000
Assembly in clean-room Class 10,000
Ultra-clean packaging produced in clean-room Class 10,000
Quality control
100% functional test
Dimensional tests according to AQL standard +/-4 Σ

Outsourcing agreements signed with all subcontractors qualify for the Artelis Quality Label. Every step of the bag-manufacturing process, as well as package assembly, takes place in a controlled environment under clean-room ISO Class 5 conditions at rest.

Mixing Systems
The 3D Internal Circulation Loop
The Newmix™ Jet-Drive™ Mixing System
Technical Specifications
Application notes

Disposable bioreactors
The Artelis/ATMI