Medical Device Sterilization

Turnkey Sterilization Solution


Beamcomplex produces equipment for sterilization of medical devices:

1) Our company manufactures compact complexes with electron accelerators for placement in sterilization centers and medical manufacturing plants. The complexes are used to sterilize syringes, blood transfusion systems, endoprostheses and other devices as well as medical waste from hospitals with ionizing radiation (E-beam and X-Ray). The installation of the complex takes up to 6 months.

2) Our company also constructs centers with electron accelerators near medical device manufacturers to provide them with sterilization services.

IONIZING RADIATION TECHNOLOGY FOR MEDICAL DEVICE STERILIZATION

Beamcomplex suggests advanced solutions for E-beam and X-Ray sterilization. Electron accelerators use high energy of E-beam and X-Ray as a method of sterilization. Electron accelerators generate and accelerate electrons that penetrate the product and sterilize all internal and external surfaces of medical devices and packaging. The dose for processing medical devices is 15 kGy.

THROUGHPUT AND POWER CONSUMPITON
Energy/Power Mode Product packaging Throughput Electricity consumed
2.5 MeV / 25 kW E-Beam Individual packaging 5760 KG/H 0.08 kW/KG
5 MeV / 50 kW E-Beam Large size packaging 11880 KG/H 0.12 kW/KG
5 MeV / 100 kW E-Beam Large size packaging 23760 KG/H 0.17 kW/KG
5 MeV / 50 kW X-Ray Large size packaging 576 KG/H 0.12 kW/KG
5 MeV / 100 kW X-Ray Large size packaging 1188 KG/H 0.17 kW/KG

APPLICATIONS

The electron accelerator installed in a complex generates E-beam or X-Ray that pass through a packaging and sterilize medical devices.

There are 3 options of medical device E-beam/X-Ray sterilization:

  1. Sterilization of surfaces of individually packed medical devices (for example, implants) with E-beam.
  2. Sterilization of both external surfaces and internal cavities of individually packed medical devices (for example, syringes) with E-beam.
  3. Sterilization of a large number of boxed products with X-Ray.
STERILIZATION COMPLEX FOR BOXED MEDICAL DEVICES

Location – medical device plants and sterilization centers.

Details:

— Processing in boxes with the dimensions up to 500 mm X 500 mm X 500 mm;
— 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 – 2.3 m X 2.3 m X 2.3 m (metal radiation shield).

ON-SITE INSTALLATION OPTIONS
  1. Installation of the complex in metal radiation shield.
  2. Installation of the complex in casing which is the basis for concrete radiation shield.
  3. Installation of the electron accelerator in the bunker underground so that the conveyor system with the products comes to the surface.
ADVANTAGES OF MEDICAL DEVICES STERILIZATION USING COMPLEXES WITH ELECTRON ACCELERATORS

E-beam and X-Ray sterilization ensures complete elimination of all pathogens, viruses and bacteria and guarantee of 100% sterility for products in tightly sealed packaging for the entire shelf life.

The only sterilization method that enables to sterilize products in all types of tightly sealed packaging made of any materials.

Ability to process medical devices in a single layer in individual packaging and then pack them into boxes in a clean room.

The structure of polymers and other materials does not change when sterilized with accelerated electrons.

The fastest sterilization method.

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ADVANTAGES OF HAVING COMPLEXES AT PLANTS PRODUCING MEDICAL PRODUCTS
Quality ControlComplete control over the sterilization process ensures products quality.
IndependenceIn-house complex provides independence from third party sterilization service providers, which is extremely important in case of emergency situations, such as pandemic.
ContainmentPlacing 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/unloading.
Seamless integrationThe complex's conveyor system is directly connected to the plant’s internal conveyor system. The seamless integration eliminates the need for a plant shutdown.
ADVANTAGES OF IONIZING RADIATION TREATMENT OF PRODUCTS COMPARED TO GAS FUMIGATION
High SpeedSterilization by gas fumigation is a time-consuming process. Sterilization of medical products by ionizing radiation ensures high processing speed (sterilization time for 1 box with 100 syringes is 5 seconds).
Any PackagingSterilization by gas fumigation requires imported expensive gas-permeable packaging. Sterilization of medical devices by ionizing radiation is carried out in any locally produced packaging.
Any ProductNot all types of products can be sterilized using gas fumigation. When using ionizing radiation, there are no such limitations, i.e. any types of products made of any material can be processed. It enables to process products made of new polymeric materials thus expanding the segment of processed products.
No Supply-Related RisksFumigation gas is imported, which creates risks if supply chains are disrupted. The ionizing radiation in our electron beam sterilization equipment is generated exclusively by electricity.
Eco-FriendlyAfter sterilization, the fumigation gas is released into the atmosphere, polluting it. Ionizing radiation is a green technology.
Safe for PeopleNo risk of chemical poisoning for humans.

Scientific Reports

Medical Sterilization. IAEA

Sterilizing medical products

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Trends in Radiation Sterilization of Health Care Products. IAEA

Gamma irradiators for radiation sterilization

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Medical Device Sterilization. NIH

Radioactive sources and alternative technologies in sterilization

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