Image Credit: Jordi Labs
One of the most vital types of lab testing for medical device products is extractables and leachables (E&L) analysis. These elements are made up of a wide range of small molecule species, which can have negligible to severely harmful effects if they are permitted to propagate through the manufacturing chain to the point of entrance into the human body.
A critical, if less obvious, form of lab testing that is necessitated from both ethical and regulatory perspectives is detecting and identifying E&L contaminants in medical devices such as syringe components and polymeric blood bags.
Jordi Labs supplies an E&L lab testing service, which is robust and has proven successful in supplying the data required to verify medical devices meet regulatory specifications. This article outlines two of their case studies in the medical device lab testing sector.
Extractables & Leachables in Medical Grade Polymer Sheets
Medical grade polymer sheets and films are utilized to create anti-microbial barriers and laminates for a wide range of functionalities. Wound care products, surgical garments, device packaging, hospital mattress covers, and many more products are made up of polymeric film materials.
To ensure exacting levels of quality control (QC) and quality assurance (QA), each of these must have a comprehensive analysis of the polymer formula for distinct applications.
Jordi Labs extracted, identified, and quantified E&L contaminants successfully in three distinct polymer species: polycarbonate (PC), thermoplastic polyurethane (TPU), and silicone. They have quantitatively summarized various small molecule compounds within the polymer sheets at microgram (μg) concentrations with good degrees of confidence.
Extractables & Leachables in Nylon Syringe Filters
Syringe filters are employed to filter small to medium volumes of organic or synthetic substances quickly and reliably prior to intravenous application. The potential ramifications of E&L contaminants propagating through to end-product syringe filters are immediately obvious.
It is crucial that these components undergo sufficient lab testing to meet regulatory QC standards. To develop robust profiles of a polymer formula with regards to its extractable and leachable elements, Jordi Labs successfully characterized a full list of the E&L contaminants in nylon syringe filters.
Quantitative data collected through various mass spectrometry methods were utilized to build a qualitative analytical report, which was designed to help eliminate sources of contamination from the manufacturing chain.
E&L Lab Testing with Jordi Labs
Jordi Labs specializes in advanced lab testing for some of the most regulated sectors around the globe. It supplies solutions for quantitatively assessing food contact materials, medical devices and pharmaceuticals, to detect, quantify, and identify E&L contaminants that may arise from various sources in the production chain.
This information has been sourced, reviewed and adapted from materials provided by Jordi Labs.
For more information on this source, please visit Jordi Labs.