Pulsed electron beam sterilization
In-line e-beam sterilization system
In-line e-beam sterilization system
ITHPP has developed an in-line e-ebam sterilization technology. This innovative system uses pulsed electron beams to sterilize products and negates the requirement for the use of chemical products (EtO, H2O2). Cost effective, this quick and continuous flow processing might be an alternative to gamma equipment and batch processing. More over the unique parameters allow for a high dose rate, low energy consumption and a clear efficiency of treatment.
E-beam system: electron beam sterilization process
E-beam process consists of exposing the products to an electron beam accelerator. When the product is subjected to this type of (beta) radiation, the microorganisms within the product are eradicated. Indeed, one of the consequences is the creation of single and double strand breaks in the DNA of those microorganisms; causing their death and thus leading to sterility.
Pulsed Electron beam sterilization processing: a technology based on high pulsed power
For more than 20 years, ITHPP has been developing high-pulsed power systems (HPP). High-pulsed power technologies consist of delivering an energy from a quasi-static source within a very short pulse duration thus generating extremely high powers. Based on this principle, ITHPP has developed pulsed electron beam sterilization equipment, which achieve very high-power electron beams at very high dose rates which can reach several hundred of kGy per second.
Pulsed Electron beam sterilization processing offers many advantages
- Faster processing times
Operation in pulsed mode delivers the same amount of electrons as in continuous mode but much faster, which allows higher processing rates.
Processing times are shorter, and depending on the complexity of the product, an Assurance Sterility Level (SAL) of 6 log can be reached in less than a quarter of second.
- An in-house solution that fits into a production line.
ITHPP offer a turnkey solution, which can integrate into a new or already existing production line. It is no longer necessary to use external contractors to decontaminate / sterilize products.
- A safe solution
ON/OFF system which does not generate ionized radiation when the system is shutdown. The maintenance and services operations are facilitated and safe.
- An eco friendly solution
This ionizing radiation system does not generate any residues.
- A solution tailored to the product
The electron beam exit window can be modulated according to the product and the configuration of the customer’s production line. Such an adaptability enables a homogeneous electron beam from the outset.
- In line with standards
- ISO 11137-1 Sterilization of health care products – Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- ISO 11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
- ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.
- Part 1: Determination of a population of microorganisms on products.
- ISO 11737-2 2010 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV.
- Practice for dosimetry in radiation processing.
Simulation and dosimetry skills to support customers
ITHPP support their clients in the definition of their electron beam sterilization equipment and provide them with highly effective simulation tools, a laboratory equipped with an e-beam machine, and a class 1 microbiological laboratory.
ITHPP teams have essential tools and expertise to design an equipment by electron beam in order to help their customers in the development and the definition of the machinery parameter.
- To determinate the required energy to flow through the thickness of the product as well as the necessary energy to keep in line with client specifications in terms of production rates.
- To guarantee, with a mapping dose, that the minimum and maximum doses meet client expectations, regardless of the product complexity.
- For radiation protection in order to size and design the self-shielding of the system and safety of the customer’s premises in accordance with safety standards (NF C-15 160, NF C 15-164, NF C 74-100 and NF M 62-105).
- For the conduct of dosimetry studies to confirm that, the minimum dose is reached on all surfaces of the product to be processed and to guarantee the expected sterility assurance level (SAL).
A solution adapted to every type of product
A solution available on a very wide range of energy
Each product has its own specificity and complexity. In order to offer reliable and efficient equipment adapted to each product, ITHPP provide solution operating on a wide range of energy: from 50 keV to 5MeV.
- A solution that integrates into a production line
ITHPP design complete pulsed e-beam sterilization units according to customer specifications, including conveyors and shielding, which can be integrated into a production line according to their space constraints.