MEDICAL DEVICE STERILIZATION

Beamcomplex has developed compact complexes with built-in electron accelerators that can be installed in hospitals, medical sterilization centers and medical manufacturing plants to sterilize syringes, blood transfusion systems, endoprostheses and much more. Please refer to Trends in Sterilization (IAEA)

TECHNOLOGY OF MEDICAL DEVICE STERILIZATION USING ELECTRON ACCELERATORS

E-BEAM | X-RAY

Electron accelerators use high energy of electrons and X-Rays as a method of sterilization. Electron accelerators generate and accelerate electrons that pass through materials and products, inducing breaks in the DNA of pathogens, thus sterilizing the materials.
Products can be treated in tightly sealed packaging, which prevents them from recontamination.

E-beam and X-Ray treatment of materials and products is environmentally friendly technology as it uses only electricity.


EFFECTS OF STERILIZATION
WITH ACCELERATED ELECTRONS
  • Complete elimination of all pathogens, viruses and bacteria.
  • The only sterilization method for products in all types of tightly sealed packaging made of any materials.
  • Guarantee of sterility for products in tightly sealed packaging for the entire shelf life.
  • The structure of the polymers and other materials does not change with E-beam sterilization compared with Co-60 sterilization.
  • The quickest sterilization method, many times faster than Co-60 or ethylene oxide sterilization.
  • No residual radiation in treated products
STERILIZATION COMPLEXES
Complex Designed for Installation Directly in Medical Device Plants/Hospitals
Complexes for Sterilization of Medical Devices

Technical Specification
A complex is a container-type and ready-to-install system. It does not require additional construction work and can be integrated with the existing conveyor and other production systems without shutting down the manufacturing processes. No reloading of the products in special containers is required.

Equipment

1. Electron accelerator (energy of 1 to 5 MeV)
2. Built-in conveyor system
3. Control system
4. Radiation monitoring system
5. Cooling system
6. Ozone exhaust system
Notice
Sterilization complexes enable to sterilize individually packaged medical devices both separately and in boxes. When the complex is located at your facility, the most convenient option for sterilization of medical devices is sterilization of individually packaged products in a single layer. After sterilization, the individually packaged products can be placed in a sterile box. For this method, it is possible to use a compact electron accelerator with an energy of 1 to 5 MeV, which features small mounting dimensions and low energy consumption during operation.
THROUGHPUT AND POWER COSTS CALCULATION
Applications
The electron accelerator installed in a complex generates E-beams or X-rays that pass through a packaging and sterilize medical devices. There are 3 options of medical device sterilization:

  1. Sterilization of surfaces of individually packed medical devices (for example, implants) with E-beams,
  2. Sterilization of both external surfaces and internal cavities of individually packed medical devices (for example, syringes) with E-beams or
  3. Sterilization of a large number of boxed products with X-rays.
Sterilization Complex for Boxed Medical Devices
Location
Medical device plants and sterilization centers

Purpose
Processing in boxes with the dimensions up to 500mm x 500mm x 500mm;
Treatment can be done in X-ray and E-beam modes;
High processing speed: up to 14400 kg/hr in E-beam mode, 720 kg/hr in X-Ray mode;

Minimum dimensions:
2.3m X 2.3 m X 2.3m (metal radiation shield).
On-site Installation Options
  • Installation of the complex in metal radiation shield
  • Installation of the complex in casing which is the basis for concrete radiation shield
  • Installation of the electron accelerator in the bunker underground so that the conveyor system with the products comes to the surface
Benefits of Having Complexes on Site
  • QUALITY CONTROL
    • Complete control over the sterilization process ensures products quality
  • INDEPENDENCE
    • In-house complex provides independence from third party sterilization service providers, which is extremely important in case of emergency situations, such as pandemic
  • CONTAINMENT
    • Placing the complex directly at production facilities enables to avoid additional expenses for transportation of products and materials to third party sterilization facilities
    • No need for spending time and money for loading/uloading