Quality Control Systems

AorTech’s quality management policy ensures the highest commitment to quality in all aspects of Elast-Eon™ and Elast-Eon™ component manufacturing.  This commitment to excellence is essential for our long-term customers and the patients that benefit from Elast-Eon™ based devices.

Implementation and maintenance of systems compliant with ISO 9001 and ISO 13485
Independently audited by TQCSI and our customers
To ensure all staff feel like they make a valuable contribution to the company, our customers and ultimately patients.

Our quality control department ensures that every batch of Elast-Eon™ and every Elast-Eon™ component is tested to the relevant standards and meets the specifications agreed with our customers.  Our testing capabilities include:

-Purity - FTIR, GC, HPLC, and GC/Mass Spectrometry

-In Process Control – Hydroxyl and NCO content, FTIR, NMR, Karl Fischer tests

-Routine Elast-Eon™ Specification – MFI, tensile properties, hardness, Molecular weight, Rheometers

-Cleanliness – particle counts, gel counts, microscopic inspections

-Polymer Characterization– GPC, DMA, DSC, extractable species, solubility

-Applications Development – Surface energies, crack growth, fatigue, creep

-Processability – Each batch is extruded into 6 french tubing and assessed prior to shipment

Our team has a significant experience in developing, standardizing and validating test methods.  We often work closely with our customers to develop testing that is meaningful to the performance of their device.