Extractables and leachables (E&L) analysis is one of the most important forms of lab testing for medical device products. These elements comprise a broad range of small molecule species that can have negligible to severely harmful effects if allowed to propagate through the manufacturing chain to the point of entrance into the human body.
Detecting and identifying E&L contaminants in medical devices such as polymeric blood bags and syringe components is a critical, if less obvious, form of lab testing that is necessitated from both ethical and regulatory perspectives. Jordi Labs provides a robust E&L lab testing service that has proven successful in providing the data needed to verify medical devices meet regulatory specifications.
This blog post will explore two of our success stories in the medical device lab testing sector.
Extractables & Leachables in Medical Grade Polymer Sheets
Medical grade polymer sheets and films are used to create anti-microbial barriers and laminates for an extensive range of functionalities. Surgical garments, wound care products, hospital mattress covers, device packaging, and many more products are comprised of polymeric film materials. Each of these requires a comprehensive analysis of the polymer formula for distinct applications to ensure exacting levels of quality control (QC) and quality assurance (QA).
Jordi Labs successfully extracted, identified, and quantified E&L contaminants in three distinct polymer species: thermoplastic polyurethane (TPU); polycarbonate (PC); and silicone. We were able to quantitatively summarize multiple small molecule compounds within the polymer sheets at microgram (μg) concentrations with good degrees of confidence.
If you would like to explore this application in more detail, read our full E&L lab testing case study.
Extractables & Leachables in Nylon Syringe Filters
Syringe filters are used to rapidly and reliably filter small to medium volumes of synthetic or organic substances prior to intravenous application. The potential ramifications of E&L contaminants propagating through to end product syringe filters are immediately apparent. It is vital that these components are subjected to sufficient lab testing to meet regulatory QC standards.
Jordi Labs successfully characterized a full list of the E&L contaminants in nylon syringe filters to develop robust profiles of a polymer formula with regards to its extractable and leachable elements. Quantitative data gathered through various mass spectrometry techniques were used to build a qualitative analytical report for our clients. This was designed to help eliminate sources of contamination from the manufacturing chain.
You can read this full E&L lab testing case study in more detail.
E&L Lab Testing with Jordi Labs
Jordi Labs specializes in advanced lab testing for some of the most regulated sectors worldwide. We provide solutions for quantitatively assessing food contact materials, pharmaceuticals, and medical devices to detect, quantify, and identify E&L contaminants that may arise from numerous sources in the production chain.