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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.
West has put considerable effort into understanding the multiple ways elastomeric components can be impacted by these sterilization processes. The two major areas of focus have been on drug product compatibility and filling line machinability. Per the studies conducted at West, steam sterilized elastomeric components had more desirable results both in terms of the extractable profile and the performance of the components on the filling line.
A machinability study was performed using one of West’s 1mL long syringe plunger designs. The study was composed of six sample sets of the same 1mL long plunger design, but of two different elastomeric formulations (4023/50 Gray and 4432/50 Gray) and three different methods of sterilization (steam autoclave processing, 10-20 kGy gamma irradiation and 40-50 kGy gamma irradiation). The goal of this study was to evaluate each sample set in the feeder bowl and tracks at various filling line speeds from 200 units/minute to 600 units/minute, and determine if the machining performance requirements were met.
The study results showed that the performance of the steam sterilized plungers was equal or better at the various filling line speeds than the plungers gamma irradiated to 10-20 kGy. The results from the study also showed that plungers gamma irradiated to 40-50 kGy performed considerably worse than the other two sterilization methods, and could not meet the machining requirements at the middle and higher range filling line speeds.
While many other elastomeric manufacturers of prefilled syringe plungers will gamma irradiate components to levels approaching 40 kGy, which is very close to the maximum a halobutyl rubber can withstand, West recommends the use of steam sterilization for elastomeric components. Upon customer request West will gamma sterilize elastomeric components at levels of 10-20 kGy.
For any questions and inquiries regarding the compatibility and machinability studies comparing steam to gamma sterilization processes please email Simon.Cote@westpharma.com or TCS.Americas@westpharma.com.
Moore’s Law states that the number of transistors in a circuit doubles approximately every two years. This once lofty prediction proved accurate and has been the basis for long-term planning, not just for the semiconductor industry, but research and development in general.
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (<em>Elemental Impurities – Limits</em>) and USP <233> (<em>Elemental Impurities – Procedures</em>) have replaced USP <231> (<em>Heavy Metals</em>). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (<em>Elastomeric Closure for Injections</em>), which is used for testing of elastomeric closures, still references USP <231>.
The development of new biosimilar products has increased over the past several years. Europe and Asia Pacific have been leading the industry with the greatest number of biosimilars being introduced to the market. Given the demand to reduce medical costs for patients, this trend is expected to increase globally in the coming years.
As drug development continues to evolve, further advances in delivery technologies will help to refine the overall drug delivery system, from improvements to safety and performance of delivery devices, to primary containers with consistent and higher-quality components.<br />
The need to provide vaccines for the SARS-CoV-2 pandemic has presented the pharmaceutical industry with unprecedented challenges. Among them are accelerated timelines for development/approval and unanticipated volumes for manufacture/delivery. Ordinarily for a new drug product, there is ample time for selecting the primary package system and establishing component availability.
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