X-ray sterilization

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Table 2: throughput comparison (m3/hour).

Figure 1: plan view of a three-row pallet X-ray irradiation facility for low-density packages.
Figure 2: plan view of a rotating pallet X-ray irradiation facility for high-density packages.

Figure 3: illustration of a four-pallet rotational X-ray irradiation facility.

Figure 4: diagram of an eight-pallet rotational X-ray irradiation method with automatic equipment for exchanging the upper and lower load.

Table 1: dose uniformity ratio comparison.

Table 2: throughput comparison (m3/hour).

Figure 1: plan view of a three-row pallet X-ray irradiation facility for low-density packages.

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High-energy X-rays (bremsstrahlung) are a form of ionizing energy that
provide an attractive alternative to nuclear gamma rays for irradiating large
packages and pallet loads of medical devices. Their penetration is sufficient to
treat multiple pallet loads of low-density packages with low dose uniformity
ratios.

X-ray sterilization is a clean process that does not leave a toxic residue in the products.
At typical dose levels, the small temperature rises do not damage plastic materials.
Modern, high-power X-ray generators have processing rates and costs comparable to
other sterilization methods.

X-RAY CHARACTERISTICS
High-energy X-rays are high-frequency, short-wavelength electromagnetic photons.
These are emitted by high-energy electrons when they are deflected by atomic nuclei.
The efficiency for X-ray emission increases with the electron energy and the atomic
number of the target material. Thin sheets of tantalum are used for the long targets that
are needed for irradiating tall pallet loads of products. The X-ray energy spectrum is
very broad, with the maximum photon energy being the same as the kinetic energy of
the incident electrons. With maximum X-ray energies of 5MeV or 7MeV (million
electron volts), the product penetration is greater than that provided by large,
uncollimated arrays of cobalt-60 sources (1-3).

In contrast to nuclear gamma rays, which are emitted in all directions, high-energy

X-rays are concentrated in the direction of the incident electron beam, and their angular
dispersion decreases as the electron energy increases. The high intensity in the forward
direction enhances the efficiency for X-ray utilization and allows a reduction in the size
of the irradiation room. Only a few product carriers need be in the treatment room at
one time. This minimizes the treatment time per carrier and facilitates the irradiation of
small batches of products with different densities and dose requirements.

X-RAY STERILIZATION METHODS

In order to obtain good dose uniformity and efficient X-ray utilization, product loads
must be irradiated from opposite sides by passing at least twice by the X-ray target. The
optimum thickness for two-sided treatment increases as the package density decreases.
With 5MeV X-rays, the optimum thickness is about 2.6m (8.5ft) for an average density
of 0.1g/cm3. A three-pass conveyor system as shown in Fig. 1 would be suitable for
pallet loads of low-density packages containing lightweight medical devices, such as
syringes, bandages and empty plastic containers.

The narrow angular dispersion of high-energy X-rays allows the irradiation of a single
pallet while it is rotating in front of the X-ray target. This method, which is enhanced
with collimators and variable rotation speeds, is called a Palletron®. The conveyor
system shown in Fig. 2 would be suitable for high-density packages with heavier
products, such as bottles filled with parenteral solutions. With low-density packages, a
single rotating pallet would have less than the optimum thickness for efficient utilization
of 5MeV or 7MeV X-rays (4).

A more appropriate system for irradiating low-density packages is shown in Fig. 3. This
arrangement consists of four pallets placed on one turntable. An extension of this
method that provides lower Dose Uniformity Ratios (DUR) and higher throughput rates
consists of eight pallets placed in two levels on one turntable, as shown in Fig. 4. These
better results are obtained by exchanging the upper and lower sets of four pallets and
irradiated the entire assembly a second time. Specialized equipment accomplishes this
exchange automatically (5, 6).

The data presented in Tables 1 and 2 have been obtained by Monte Carlo mathematical
simulation of the absorbed dose distributions. Table 1 shows how the dose uniformity
ratio varies with the product density. With the four-pallet arrangement, the DUR is
below 2.0 for densities below 0.20g/cm³. With the eight-pallet arrangement, the DUR
remains well below 2.0 for densities between 0.05 and 0.2g/cm³. These results can be
obtained with 7MeV X-rays.
Table 2 shows how the throughput rate varies with the product density. With the four-
pallet arrangement, the throughput varies from 18.5m3/h for a density of 0.05g/cm³ to
12.5m3/h for a density of 0.20g/cm³. With the eight-pallet arrangement, the
throughput at 0.20g/cm³ is higher by a factor of 1.27 and varies from 23.5m³/h at
0.05g/cm³ to 16.8m³/h at 0.20g/cm³. These results can be achieved with a powerful
IBA Rhodotron accelerator, which is rated for a continuous electron beam power of
700kW at 7.0MeV. Experimental validation of these concepts is in close agreement with
the mathematical simulations.

CONCLUSION

Processing of products and materials with high-energy X-rays was first proposed over
40 years ago and commercial use of this method for sterilizing medical devices was
initiated about 15 years ago. Several electron beam facilities in Europe, Japan and North
America are equipped for both electron beam and X-ray sterilization, and a new facility
intended only for X-ray sterilization will soon be operating in Belgium. X-ray processing
is growing as a result of recent increases in the beam power ratings of industrial electron
accelerators, which can generate intense X-ray beams.

REFERENCES

1. M. R. Cleland, X-Ray Processing: A Review of the Status and Prospects,

Radiation Physics and Chemistry, Vol. 42, Nos. 1-3, pp. 499-503, 1993.
2. J. Meissner, M. Abs, M. R. Cleland, A. S. Herer, Y. Jongen, F. Kuntz, A.
Strasser, X-Ray Treatment at 5 MeV and Above, Radiation Physics and
Chemistry, Vol. 57, Nos. 3-6, pp. 647-651, 2000.
3. Standard Practice for Dosimetry in an X-Ray (Bremsstrahlung) Facility for
Radiation Processing, ISO/ASTM 51608:2002(E), ASTM International,
West Conshohocken, Pennsylvania, 19428-2959 USA.
4. F. Stichelbaut, J.-L. Bol, M. R. Cleland, O. Gregoire, A. S. Herer, Y.
Jongen, B. Mullier, G. Rose, M. Vander Donckt, The Palletron: A High
Dose Uniformity Pallet Irradiator with X-Rays, American Institute of
Physics, AIP Conference Proceedings, Vol. 680, pp. 891-894, 2003.
5. J.-L. Bol, M. R. Cleland, A. S. Herer, J.-P. Hubeau, B. Mullier, F.
Stichelbaut, A High-Performance X-Ray System for Medical Device
Irradiation, to be published in Radiation Physics and Chemistry, 2006.
6. J.-L. Bol, F. Stichelbaut, B. Mullier, M. Abs, A. S. Herer, X. Dupuis, X-Ray
Configurations for Sterilization, to be published in Radiation Physics and
Chemistry, 2006.

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