We are excited to announce that Cytiva will be hosting a poster session at our upcoming Extractables and Leachables conference.
Their poster will explore the critical topic of extractables validation in process filters, focusing on how different autoclaving conditions can impact the safety and quality of pharmaceutical products.
This research is particularly relevant for professionals in the pharmaceutical industry who are dedicated to ensuring product safety.
Participating in a Leachables and Extractables conference is an exciting opportunity for several reasons. Firstly, it's a fantastic platform for professionals to exchange knowledge and stay updated on the latest advancements in the field. These conferences bring together experts from various sectors, including pharmaceuticals, biotechnology, and regulatory bodies, fostering a collaborative environment for learning and innovation. One of the most valuable aspects of these conferences is the opportunity to discuss and address current challenges related to leachables and extractables. These issues are critical for ensuring the safety and efficacy of drug products, as well as compliance with regulatory standards. By participating in these discussions, professionals can gain a deeper understanding of risk assessment, testing methodologies, and the latest regulatory expectations. Moreover, the networking opportunities are invaluable. Engaging with peers, industry leaders, and researchers can lead to new collaborations, partnerships, and insights that drive innovation and improve practices. Sharing experiences and solutions with others can help professionals refine their approaches to tackling leachables and extractables in their own organizations. Lastly, attending such a conference demonstrates a commitment to professional growth and staying at the forefront of the industry. It’s a platform that not only enhances one's expertise but also contributes to the overall advancement of the field. This collective effort ultimately plays a significant role in safeguarding public health, which is the paramount goal for everyone involved in this work.
The risk assessment and extractables study with challenging AET
In our research, we've focused on the validation of extractables in process filters, which is crucial for ensuring the safety and quality of pharmaceutical products. Generally, it's assumed that harsher autoclaving conditions lead to more extractables, representing worst-case scenarios. However, we've found that this isn't always the case for filters flushed after autoclaving. Under certain conditions, harsher autoclaving might actually result in fewer extractables due to the fixed amount of additives being affected differently.
This discrepancy highlights a potential pitfall in risk assessment processes. If the risk assessment is based on what appears to be less severe extractables results, it could lead to an underestimation of the actual risk posed to the drug product. This misalignment may eventually compromise drug safety and efficacy. Therefore, our research emphasizes the need for a comprehensive and nuanced approach to evaluating extractables, taking into account various processing conditions. This ensures that risk assessments are accurate and that pharmaceutical products remain safe for consumer use.
In our study, we aimed to examine the impact of different autoclaving conditions on the extractables profiles in Nylon capsule filters. To achieve this, we used four filters from an identical lot number. Two filters were subjected to autoclaving at 125 °C for 30 minutes, while the other two were autoclaved at 135 °C for 60 minutes. Post-autoclaving, the filters were flushed with 2 liters of 50% ethanol in water at ambient conditions. Following this, the flushed filters were extracted in 1000 mL of 50% ethanol in water at a controlled temperature of 40 ± 2.5 °C for 4 hours.
Our research revealed that worst-case autoclave conditions did not necessarily lead to higher levels of organic extractables. This outcome is likely because the primary organic extractables are polymer degradants formed during the autoclaving process. Under harsher autoclaving conditions, there was increased degradation both on the surface and within the material, bringing more degradants to the surface. However, the solvent flush primarily removed extractables present on the surface.
In contrast, for antimony (Sb), an additive present in a fixed amount within the filter and not generated through autoclaving, the worst-case conditions resulted in lower Sb extractables. This occurred because the harsher conditions facilitated the migration of Sb to the surface, where it was more effectively flushed away.
These findings underscore the importance of accurately replicating process conditions during testing, particularly when flushing filters post-autoclave. Our study highlights the need for careful consideration of autoclaving and flushing scenarios in extractables validation procedures to ensure representative results that truly reflect the operational environment.
The worst-case autoclave conditions led to lower amounts of antimony (Sb) extractables. Sb is an additive present in a fixed quantity within the filter
By highlighting the impact of sterilization processes on flushed filters, our research provides regulators and industry professionals with deeper insights into how different autoclaving conditions affect extractables profiles. This deeper understanding can aid in the development of more accurate and representative testing protocols. this could lead to enhanced safety and quality assurance practices in drug production.
Discussions at this conference around extractables and leachables (E&L), especially concerning materials like filters, can play a pivotal role in advancing safer and more effective pharmaceutical manufacturing. These dialogues foster a collaborative environment where industry experts, researchers, and regulators can share the latest findings, challenges, and innovations related to E&L.
