The Extractables & Leachables (E&L) process involves evaluating the final container closure system in which a drug will be distributed, whether it is a bottle, tube, syringe, or blister pack. The drug manufacturer must ensure that the components in contact with the drug do not pose a toxicological risk and that the container is stable enough to securely house the drug substance.

The process begins with an “extractable” analysis, designed to identify any potential substances that could come from the container closure system. The “leachables” analysis involves monitoring these substances within the actual drug product to ensure their presence does not introduce risk.

Infinity Laboratories offers a distinct level of E&L services through its St. Louis lab, a boutique facility with a reputation for high-quality service. Decades ago, the St. Louis lab established itself as a leader in E&L services, growing in both size and expertise. The lab’s success is driven by strong site leadership, a customer-centered approach, and the dedication of its highly respected analysts.

One key advantage of the St. Louis lab is the opportunity for customers to interact directly with the same chemists throughout the entire process. This continuity ensures a deep understanding of each project, providing customers with answers and solutions without the need to go through additional layers of management or other locations. Additionally, Infinity Laboratories uses a project management structure that offers customers a single point of contact, allowing for swift communication, often within the same day, and at most within 24 hours.

The work conducted by Infinity Laboratories is essential in preparing a toxicological risk assessment for the FDA. Toxicologists use the findings to determine whether a product or medical device is safe for final use. A comprehensive extractables study considers all fluid paths in the drug delivery device or all contact surfaces in the container-closure system. The goal is to assess how the drug product is stored and what it comes in contact with, ensuring the proper study design.

A common challenge in the E&L process is dealing with different dosing levels, especially for large volume parenterals, which require a low detection threshold. This threshold, known as the analytical evaluation threshold (AET), is determined by toxicological dose-based limits and study design. If the methods employed do not account for the appropriate AET, it could result in missing crucial components during analysis.

Often, customers approach Infinity Laboratories after years of development and millions of dollars invested, only to discover that changes are necessary due to what is found in the E&L analysis. For example, one customer recently had to change the adhesive used in their container-closure system after a potential leachable was detected. Such changes, late in the development process, can be challenging and delay commercialization, but Infinity Laboratories helps customers quickly identify and resolve these issues.

Thanks to the lab’s nimble size, Infinity Laboratories can often begin projects immediately, unlike larger companies, where it may take months to begin a project. Customers at the St. Louis lab can expect rapid turnaround times, which is crucial for meeting tight deadlines.

The scientists at Infinity Laboratories are among the finest in the industry, with years of specialized experience in E&L services. Their expertise with the instrumentation and methodologies employed in these studies sets them apart, offering customers an unparalleled level of service.

Customers seeking a knowledgeable and experienced partner in extractables and leachables services are encouraged to reach out to Infinity Laboratories. The team is equipped to guide them through every step of the process, ensuring the highest quality results.