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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/.
The two most common means of sterilizing elastomeric parenteral packaging components are steam autoclave and gamma irradiation processes. When appropriately validated, both processes are very effective at eliminating concerns around microbial contamination of the components used for container closure of sterile liquid, lyophilized or powder drug products. Despite the ability of both methods to reach the required sterilization specifications and requirements, the overall impact that these processes have on the elastomeric component can be quite different.
<p><em>A scientific poster by: Clara Goodfield, Eugene Polini, Amy Miller and Wayne Curry</em></p><p><em>The ideal sterilization process destroys all microorganisms rapidly with minimal adverse impact on the chemical and physical properties of the elastomeric closure. Developing and validating an acceptable sterilization process is critical to the drug product quality. This study served to help understand the potential deterioration of physical and chemical properties, the possible impact to functionality and the potential changes to the extractable/leachable profile as a result of sterilization</em></p>
West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
<p><strong>J. Riter, A. Janssen, D. Engels</strong></p><p>Cracking of elastomeric needle shields and tip caps is a costly problem for pharmaceutical manufacturers. Cracked components can cause leaks that can result in loss of drug potency and sterility and may lead to a safety risk for the person administering the drug and the patient. This cracking has been attributed to ozone degradation of the elastomer formulations.</p>
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