SAFETY
All our sutures comply with the European Pharmacopoeia standards and the requirements of the European Directives for Medical Devices, Directive 93/42 CEE and Directive 2007/47 CEE.
Free of any bacteriological load
thanks to the application
of Gamma Rays.
Maximum quality in our
products with rigorous
reference standards.
Sterilization process
A large part of the industrial radiators is used as sterilization facilities. The main advantages are the following:
High Penetrability / Final Sterilization
Due to the high penetrating power of the gamma photons emitted by the Cobalt 60 (1,17 and 1,33 MeV) the products conditioned in hermetic packages, are irradiated in their final package.
“Cold” process
A slight increase in product temperature during processing.
Safe and clean
Leaves no residue in the product (energy of the emitted photons is less than 10 MeV)
Monitoring and control of a single variable
The only variable parameter to control is time. The absorbed dose (Gy – Gray) by the product to be irradiated depends on the time of exposure to radioactive sources.
Dosimetric release
Through the use of dosimeters (film or PMMA) the dose received by the product is guaranteed and allows its parametric release.
No quarantine required
The treated product can be used immediately (dosimetric release and absence of residues).
High Effectiveness
The effect of gamma radiation on microorganisms is well known and quantified.
Simple validation
Highly precise and reproducible process.
Learn more about Aragogamma.
Exhaustive control of sutures
All our sutures comply with the standards of European Pharmacopoeia 8th edition, and American Pharmacopoeia USP XXXIX and Ed. 2016 and the requirements of the European Directives for Medical Devices, Directive 93/42 EEC and Directive 2007/47 EEC.
An exhaustive analysis of the raw materials, as well as the entire manufacturing process and final product, are manufactured in a clean environment to minimize pollution.
The needles used for their production are of the highest quality and undergo rigorous quality control.
Control of raw materials
-Testing of atraumatic needles
Apart from tests on needle dimensions (length, diameter, hole size and depth), steel type and cosmetic aspects, Bending, Ductibility, Penetration and Corrosion tests are performed to ensure quality.
-Fiber Tests
Length, diameter, strength and elasticity.
Control of packaging material
-Process control
Needle thread union, labeling and packaging.
-Final control
Length, diameter and strength. Gamma Ray and Ethylene Oxide sterilization according to standards. (ISO 11137 and ISO 11135) Absorption of synthetic sutures.