To meet the growing patient need for Large Volume Parenterals (LVP), increasingly complex packaging systems must be designed and thoroughly qualified to accommodate various solutions. The intricate nature of these packaging systems, combined with the high maximum daily doses they contain, presents significant challenges in evaluating extractables and leachables (E&L). Ensuring control over E&L levels in LVP is critical for maintaining the safety, quality, and efficacy of the final product.
This presentation will explore the complexities involved in E&L testing for LVP packaging systems. It will emphasize the importance of leveraging existing regulations, such as Pharmacopeial and food compliance standards, and highlight the need for effective collaboration with raw material suppliers. Such collaboration is essential for acquiring the necessary knowledge to design accurate and comprehensive E&L assessments.
One of the major challenges in E&L testing for LVP is the requirement for extremely low detection limits. Given the extended duration of LVP treatments and the high volumes involved, even impurities at parts per billion (ppb) levels, such as Nitrosamines, can pose significant analytical challenges. This presentation will discuss strategies for achieving the required sensitivity and specificity in E&L testing to detect these low-level impurities.
Approaching LVP packaging design with a focus on E&L risk assessment from the early stages of the product’s life cycle, particularly during material selection, is crucial. By integrating E&L considerations into the material selection process, manufacturers can develop an effective E&L strategy that ensures patient safety and product compliance.
Participants will gain insights into the best practices for controlling E&L levels in LVP, including the design and implementation of rigorous testing protocols. The presentation will also cover the importance of early-stage E&L risk assessment and how it can contribute to the overall success of the E&L strategy, ensuring that LVP products meet all regulatory requirements and maintain the highest standards of safety and quality.