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Andrea Straka, Senior Technical Account Specialist, will present “Sterilization Effects on Elastomer Characteristics and Functionality in Sterile Parenteral Drug Products” at the PDA Annual Meeting in San Antonia, Texas, April 7-9, 2014.
The poster focuses on the effects choices for container closure system sterilization can have on product manufacturing, long-term stability and functionality in use.
To drive efficiencies in utilization of manufacturing floor space, sterile product manufacturers are employing more ready to use/fill containers and closure systems. Elastomeric closures (vial stoppers and syringe pistons) are sterilized by either gamma irradiation of steam autoclave prior to introduction to the sterile space. Each sterilization technique has advantages and disadvantages, however, the data presented in this poster will illustrate the negative effects caused by gamma irradiation do outweigh the advantages.
Because of the complex nature of rubber, the effects of gamma irradiation are immediate, cumulative, more damaging to the polymer, and they continue over time well after the radiation exposure is over. Studies were conducted to evaluate extractables on steam sterilized and gamma irradiated halobutyl elastomers. The gamma irradiated samples showed higher levels of extractables, mainly degradation products of ingredients and the polymer. These extractables could become leachables in a drug product and cause unpredictable issues for the drug. Machinability studies were performed on gamma irradiated and steam sterilized syringe pistons and the steam sterilized pistons had fewer issues during sorting and tracking on the filling line. Finally, break-free and travel force testing was performed on assembled syringe pistons in glass barrels. Again, the gamma irradiated samples showed higher break-free forces, which could be an issue during the administration of the drug to the patient.
For more information or to register to attend the PDA Annual Meeting, visit http://pdaannualmeeting.org/.
Take an in-depth look at the science behind containment & delivery of injectable medicines in the West Knowledge Center.