{"id":1253,"date":"2023-08-05T08:28:32","date_gmt":"2023-08-05T08:28:32","guid":{"rendered":"https:\/\/aragogamma.com\/wp\/faq\/"},"modified":"2026-05-22T07:29:21","modified_gmt":"2026-05-22T07:29:21","slug":"faq","status":"publish","type":"page","link":"https:\/\/aragogamma.com\/en\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"
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Radiating trust since 1970<\/h1>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n
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Frequently Asked Questions<\/h2>\n<\/div><\/div>\n\n
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Why Gamma Rays?<\/h5>

Gamma-ray treatment makes it possible to modify the physical, chemical and\/or biological properties of irradiated materials, even in their final packaging, thanks to the high penetration capacity of photons.<\/span><\/p>\n

It is compatible with numerous materials, produces no process waste, and does not induce radioactivity.<\/span><\/p>\n<\/div><\/div>\n\n

What is gamma radiation?<\/h5>

Gamma rays are a form of electromagnetic radiation with extremely high energy because they have a very short wavelength (100 x 10-12 m); therefore, they can cause changes in the atoms of the matter with which they interact (ionizing radiation).<\/span><\/p>\n

The process by which a material is deliberately exposed in a controlled manner to the action of a radiation source is known as irradiation.<\/span><\/p>\n

Industrial irradiators that use an energy source or radionuclide, mainly Cobalt-60, incorporate ionizing radiation technology in order to harness the energy emitted by photons to controllably modify the physical, chemical and\/or biological properties of irradiated materials.<\/span><\/p>\n

The unit of measurement for the irradiation process is defined as the energy absorbed by matter per unit mass (J\/kg) and is the Gray, usually expressed in kGy. In the past, the unit of measurement rad (absorbed dose rate) was used. <\/span><\/p>\n<\/div><\/div>\n\n

What is the irradiation process like?<\/h5>

The product to be irradiated enters the irradiation cell through the entry labyrinth, moves around the sources via an automatic transport system, accumulating dose along the route, and exits, once the treatment has been completed, through the exit labyrinth.<\/span>
The transport route is selected so that photons penetrate the product from both sides, making the received radiation (the absorbed dose) as uniform as possible.<\/span><\/p>\n<\/div><\/div>\n\n

Process characteristics<\/h5>

A large proportion of industrial irradiators are used as sterilization facilities. The main advantages are as follows: <\/span><\/p>\n

High penetration \/ Final sterilization<\/strong> <\/span>
Due to the high penetrating power of the gamma photons emitted by Cobalt-60 (1.17 and 1.33 MeV), products packaged in hermetically sealed containers are irradiated in their final packaging.<\/span><\/p>\n

\"Cold\" process<\/strong>
Slight increase in product temperature during the process.<\/span><\/p>\n

Safe and clean<\/strong> <\/span>
It leaves no residues on the product (the energy of the emitted photons is below 10 MeV).<\/span><\/p>\n

Monitoring and control of a single variable
<\/strong>The only variable parameter to be controlled is time. The absorbed dose (Gy \u2013 Gray) by the product to be irradiated depends on the exposure time to the radioactive sources.<\/span>

Dosimetric release
<\/strong>By using dosimeters (film or PMMA), the dose received by the product is guaranteed and enables its parametric release.<\/span><\/p>\n

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

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

Simple validation<\/strong> <\/span>
A highly precise and reproducible process.<\/span><\/p>\n<\/div><\/div>\n\n

Sterilization<\/h5>

One of the most developed applications is the use of this technology for the sterilization process.<\/span><\/p>\n

Gamma irradiation is a physical means of decontamination\/sterilization, as it kills bacteria by breaking down bacterial DNA, which inhibits bacterial division. Gamma rays, emitted from Cobalt-60, are pure energy, similar in many ways to microwaves and X-rays. Gamma rays delivered during radiation sterilization destroy chemical bonds by interacting with the electrons of atomic components. Although gamma rays are highly effective at killing microorganisms, they do not create residues, nor do they have sufficient energy to induce radioactivity. <\/span><\/p>\n

For sterility purposes, the microbiological population of raw materials and\/or components, the microbial barrier properties of packaging, and the control of the environment in which the product is manufactured, assembled, packaged and\/or stored must be taken into account.<\/span><\/p>\n

The ultimate responsibility for ensuring that all sterilization operations and product quality control checks are appropriate, adequate and correctly carried out lies with the manufacturer. However, the irradiator is responsible for delivering the required dose to the product in accordance with validated process specifications. <\/span><\/p>\n<\/div><\/div>\n\n

Validation and responsibilities<\/h5>

Validation of the sterilization process is carried out in accordance with the following standards:<\/span><\/p>\n

UNE EN-ISO-11137 \"Sterilization of health care products\"<\/span>
Good Manufacturing Practice (GMP) for medicinal products for human and veterinary use and applicable annexes.<\/span>
AAMI TIR29 \"Guide for process characterization and control in radiation sterilization of medical devices\"<\/span>
AAMI\/ISO TIR13004 Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD<\/span><\/p>\n

Product validation (PQ-CCF) mainly consists of the following stages:<\/span><\/p>\n

- Study of the compatibility of materials with gamma radiation<\/span><\/p>\n

- Determination of the verification dose and establishment of the sterilization dose based on the product bioburden and the selected method (see table).<\/span><\/p>\n

- Establishment of the maximum acceptable dose<\/span><\/p>\n

- Dose mapping: Study of dose distribution in the product to determine the location and magnitude of the minimum and maximum absorbed dose, as well as determination of the relationships between doses and the routine verification position to establish control limits.<\/span><\/p>\n

- Determination of the product load configuration in the irradiation containers<\/span><\/p>\n

- Issuance and final approval of the product treatment specification. <\/span><\/p>\n

View the form <\/span>here<\/a>.<\/span><\/p>\n<\/div><\/div>\n\n

Qualification example<\/h5>

View qualification example<\/a><\/p>\n<\/div><\/div>\n\n

Comparison of validation methods<\/h5>

View comparison of validation methods for gamma-ray sterilization<\/a><\/p>\n<\/div><\/div>\n\n

Treatment request<\/h5>

View treatment request<\/a><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>","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-1253","page","type-page","status-publish","hentry"],"yoast_head":"\nFAQ - Aragogamma<\/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:\/\/aragogamma.com\/en\/faq\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FAQ - Aragogamma\" \/>\n<meta property=\"og:url\" content=\"https:\/\/aragogamma.com\/en\/faq\/\" \/>\n<meta property=\"og:site_name\" content=\"Aragogamma\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-22T07:29:21+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:\\\/\\\/aragogamma.com\\\/en\\\/faq\\\/\",\"url\":\"https:\\\/\\\/aragogamma.com\\\/en\\\/faq\\\/\",\"name\":\"FAQ - 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