Protection

Native proteins are not amenable to sterilization by ionizing radiation due to chemical
modifications which may result in a partial or even total loss of functionality.
SPS equally protects biologics during bulk and confectioned sterilization when applying β-,
γ-radiation or ethylene oxide (ETO).

Protection of IgM antibodies by SPS using 25 kGy of beta- or gamma radiation and ETO (ISO 11135-1:2007) sterilization.

 

End-sterilization by ionizing radiation according to DIN EN ISO 11137 has a number of
significant advantages in case heat or filter sterilization are inapplicable. In more than
90 % of the cases, usage of gamma radiation is preferred over beta radiation or ethylene
oxide:

•  It penetrates large product thickness
•  There are typically no harmful residuals
•  It is reliable, easy to control, and standardize
•  It is much safer and cheaper compared to aseptic processing
•  It can be applied to bulk or readily packaged goods

Since SPS protects biologics against ionizing radiation during sterilization, application
of LEUKOCARE’s technology helps to significantly reduce costs, increase safety,
ease handling, and to simplify production protocols.

While SPS retains the activity of biologics during radiation exposure it does not protect viral or bacterial contamination.