A number of factors affect the cost of sterilization, which make cost comparisons in general very difficult.

In a competitive environment, price and cost are not always related, but the following factors need to be defined before an answer can be given:

1.       Product characteristics.  Material type, product construction and presentation, and packaging.  All have an effect on the suitability of the sterilization method and the process cost.

2.       Dose required for irradiation and time and gas concentration for EtO.

3.       Volumes.  EtO is a batch process, and sterilizers come in many different sizes.  If the product provided does not fill the useable space, for whatever reason the cost per unit will rise.  Batch records cost the same for  1 pallet or 20 pallets!

4.       The sterilization company has very high capital investment in all systems, but how old and written down is the equipment?

5.       Do you include initial and on-going validation requirements?

The most effective sterilization process is one where the product has been designed from day one for one of the major sterilization methods.  Too often, sterilization is not considered until a product is in late stage development, thus making sterilization a “best fit.”