Medicine
Supply and operation of centers and workshops for radiation sterilization of medical devices and pharmaceuticals based on electron accelerators from the "sterilizing" family.
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Preparation
of all necessary documentation for the radiation sterilization process up to the Process Regulations and the Process Validation Report
Regulatory documentation
available in the Russian Federation for the process of radiation sterilization
Experience
in the creation and management of the Testing Laboratory for Radiation Monitoring (ILRK) and its certification in the national system of Rosaccreditation
PURPOSE OF TREATMENT
Radiation sterilization is an industrial process of sterilization of medical devices in the final packaging, by inactivating microbiological contaminants (bacteria and their spore forms, viruses, including Covid-19); as a rule, it is the final stage of the medical device manufacturing process
LIST OF MEDICAL DEVICES
Medical clothing, underwear
and disposable medical personal protective equipment
and disposable medical personal protective equipment
Test tubes (containers) for blood sampling or other tests, disposable systems for biomaterial sampling and other analogues
Medical devices that are in constant or prolonged contact with the internal environment of the body (implantable catheters, sensors, contraceptives, orthopedic endoprostheses)
Medical devices in contact with the wound surface (dressings, anti-burn, drainage, absorbent materials, suture surgical material, scalpels, etc.)
Products that have long-term contact with mucous membranes and skin (gynecological, urological, dental instruments and materials)
Ready-made stowage kits for emergency services and emergency medicine
IN ADDITION:
Raw materials are primary sources for the synthesis of drugs and other pharmaceutical products; Packaging and containers for pharmaceutical products and medical instruments
ADVANTAGES
- 1The most effective sterilization method in the world, up to 25% of the total volume of sterilization in medicine.
- 2High productivity and quality assurance of the result.
- 3The most universal method in comparison with alternative methods of sterilization (coverage of more than 90% of the list of medical devices).
STANDARTS
ISO 11 137−1:2006 (GOST ISO 11 137−1-2011) Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11 137−2:2006 (GOST ISO 11 137−2-2011) Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11 137−3-2006 (GOST Р ISO 11 137−3-2008) Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
More than 20 standards of process control, dosimetry and validation in the field of radiation sterilization of medical devices
ISO 11 137−2:2006 (GOST ISO 11 137−2-2011) Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11 137−3-2006 (GOST Р ISO 11 137−3-2008) Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
More than 20 standards of process control, dosimetry and validation in the field of radiation sterilization of medical devices
Manufacturer of radiation technology centers based on electron accelerators
All rights reserved. 2023
All rights reserved. 2023
