QUALITY AND SAFETY
All our sutures comply with European Pharmacopoeia standards. and the requirements of the European Directives for Medical Devices, Directive 93/42 EEC and Directive 2007/47 EEC.
Alloy 300 silicone
Always thinking of covering every surgical need of the surgeon, the R&D department of Laboratorio Aragó has incorporated in its needles the most advanced technology in design, alloy and coatings.
All the needles assembled by Laboratorio Aragó are 300 siliconized alloys.
High resistance to deformation and breakage.
Accurate penetration in the tissues both in the initial puncture and in the continuous.
Laser technology guarantees the balance of the thread caliber with the needle diameter, offering the minimum tissue trauma.
Precision design Special steel ensures full efficiency even in the most precise surgery.
Safe and smooth passage through the fabric guaranteed.
At the forefront of fibers
Laboratorio Aragó has extensive experience in the development and manufacture of sutures and specialized fibers.
The range of fibers covers a wide range of compounds for the practice of surgical professionals and always comply with international standards. Its reputation and commitment to innovation and manufacturing excellence are the result of the creation of several products in the absorbable, non-absorbable and specific range of micro sutures.
Laboratorio Aragó suture materials are widely used in different surgical applications, such as the fixation of cardiac valves, cardiovascular anastomosis, orthopedic fixation, closure of arterial accesses, laparoscopic suture devices or gastrointestinal and gynecological surgery.
The manufacturing excellence coupled with a constant interest in the needs of customers has generated a wide range of high-quality medical sutures, unique in its class and highly valued by surgical professionals.
Consult our range of fibers here.
Protection and easy storage
Non-Absorbable Sutures: materials with a microbiological barrier, formed by a special plastic complex compatible with both sterilization systems, gamma and ethylene oxide, transparent and impermeable to gases, welded to a peelable Tyvek sheet, easy to open or to a medical paper, with an indication of manufacturing batch, expiry date, type of sterilization, EC marking and product bar code.
Absorbable Sutures: material with a microbiological barrier, formed by an aluminum complex, impermeable to gases and humidity, perfectly welded, peelable, easy to open, with indication of the manufacturing batch, expiry date, type of sterilization, EC marking and product bar code.
(European Pharmacopoeia, breaking strength tables for absorbable and non-absorbable fibres)
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.
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.
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).
The effect of gamma radiation on microorganisms is well known and quantified.
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.
Length, diameter, strength and elasticity.
Control of packaging material
Needle thread union, labeling and packaging.
Length, diameter and strength. Gamma Ray and Ethylene Oxide sterilization according to standards. (ISO 11137 and ISO 11135) Absorption of synthetic sutures.