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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 siliconed

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. 
Perfect penetración: in the fabrics both in the initial and continuous puncture. 
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 guaranteed fabric.

At the forefront of fibres

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 is the result of the creation of several products in the absorbable, non-absorbable and specific range of microsutures.

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 gynaecological surgery.

A 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.

Mobirise

Protection and easy storage

Non-Absorbable Sutures: materials with 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 indication of manufacturing batch, expiry date, type of sterilization, CE marking and product bar code.

Absorbable Sutures: material with microbiological barrier, formed by an aluminium complex, impermeable to gases and humidity, perfectly welded, peelable, easy to open, with indication of manufacturing batch, expiry date, type of sterilization, CE marking and product bar code.

Mobirise
Mobirise
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Sterilization process

A large part of the industrial radiators are 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 Cobalto-60 (1,17 and 1,33 MeV) the products conditioned in herme- tic packages, are irradiated in their final package.

"Cold” process
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, labelling 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.

Laboratorio Aragó