Any company producing a healthcare product with the expectation of sterility is eventually faced with the same questions. Can my product be terminally sterilized? If yes, by what method? Will a traditional, well documented method like gamma irradiation, electron beam, ethylene oxide, heat (dry or moist) or a more non traditional, even novel approach provide the assurance I must have and still provide the product performance and safety needed?
The best advice in this area is always to start early. This is critical since validation data can be obtained in development studies and clinical trial batch production. Also, if it does not work, other options can be considered early. Decisions made with the sterilization method in mind may limit problems later. Even simple choices on a final format or vehicle of delivery may be given proactive consideration if the sterilization process is also considered. Remember, an irradiated drug is considered potentially a different drug than the un-irradiated version. Testing the effectiveness, stability and impurities of an un-irradiated version means additional testing if you do not test irradiated material. Testing early avoids wasted time getting required data.