{"id":905,"date":"2021-11-27T17:23:37","date_gmt":"2021-11-27T17:23:37","guid":{"rendered":"http:\/\/laboratorioarago.com\/calidad-y-seguridad\/"},"modified":"2026-07-27T16:37:07","modified_gmt":"2026-07-27T14:37:07","slug":"safety","status":"publish","type":"page","link":"https:\/\/laboratorioarago.com\/en\/safety\/","title":{"rendered":"Safety"},"content":{"rendered":"\n

SAFETY<\/span><\/h1>\n

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.<\/span><\/p>\n<\/div><\/div><\/div><\/div>

Free of any bacteriological load
thanks to the application
of Gamma Rays.<\/p>\n<\/div><\/div>

STERILIZATION<\/a><\/div><\/div>

Maximum quality in our
\nproducts with rigorous
\nreference standards.<\/p>\n<\/div><\/div>

CONTROL<\/a><\/div><\/div><\/div><\/div>

Sterilization process<\/h2>\n

 <\/p>\n

A large part of the industrial radiators is used as sterilization facilities. The main advantages are the following:<\/p>\n

High Penetrability \/ Final Sterilization<\/strong>
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.<\/p>\n

\"Cold\u201d process<\/strong>
A slight increase in product temperature during processing.<\/p>\n

Safe and clean<\/strong>
Leaves no residue in the product (energy of the emitted photons is less than 10 MeV)<\/p>\n

Monitoring and control of a single variable<\/strong>
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.<\/p>\n

Dosimetric release<\/strong>
Through the use of dosimeters (film or PMMA) the dose received by the product is guaranteed and allows its parametric release.<\/p>\n

No quarantine required<\/strong>
The treated product can be used immediately (dosimetric release and absence of residues).<\/p>\n

High Effectiveness<\/strong>
The effect of gamma radiation on microorganisms is well known and quantified.<\/p>\n

Simple validation<\/strong>
Highly precise and reproducible process.<\/p>\n

Learn more about Aragogamma<\/a>.<\/p>\n

 <\/p>\n<\/div><\/div><\/div><\/div><\/div>

Exhaustive control of sutures<\/h2>\n

 <\/p>\n

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.
\nAn 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.
\nThe needles used for their production are of the highest quality and undergo rigorous quality control.<\/p>\n

Control of raw materials<\/strong>
\n-Testing of atraumatic needles
\nApart 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.
\n-Fiber Tests
\nLength, diameter, strength and elasticity.<\/p>\n

Control of packaging material<\/strong>
\n-Process control
\nNeedle thread union, labeling and packaging.
\n-Final control
\nLength, diameter and strength. Gamma Ray and Ethylene Oxide sterilization according to standards. (ISO 11137 and ISO 11135) Absorption of synthetic sutures.<\/p>\n

 <\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-905","page","type-page","status-publish","hentry"],"yoast_head":"\nSafety - Laboratorio Arago<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/laboratorioarago.com\/seguridad\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Safety\" \/>\n<meta property=\"og:url\" content=\"https:\/\/laboratorioarago.com\/seguridad\/\" \/>\n<meta property=\"og:site_name\" content=\"Laboratorio Arago\" \/>\n<meta property=\"article:modified_time\" content=\"2026-07-27T14:37:07+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/laboratorioarago.com\\\/seguridad\\\/\",\"url\":\"https:\\\/\\\/laboratorioarago.com\\\/seguridad\\\/\",\"name\":\"Safety - 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