Infinity Laboratories Products & Solutions
Extractables and Leachables Testing
Infinity Laboratories has decades of experience supporting the development of drug-device combination products, medical devices, and pharmaceuticals by providing a full suite of analytical testing. Our testing services support research and development and regulatory submission activities.
Extractables and Leachables (E&L) studies are in-depth analytical investigations of the chemical interactions between a medical device and a drug product or the human body itself. The primary purpose of an E&L investigation is to identify any potential chemicals derived from the interaction of the constituent parts and then to determine the impact to human health and/or drug efficacy that those chemicals pose. This identification is an extractables/leachables profile. Organizations that seek to provide guidance for medical device E&L studies include the FDA, ICH, and ISO.
Extractables are substances in a medical device which can be “pulled out” using stressing conditions such as strong solvents, elevated temperatures, and/or increased surface area. Substances observed in this stage are characterized and identified per FDA guidelines and further evaluated by a toxicologist to determine if the substance is a potential hazard. Common extractables include plasticizers, surfactants, processing aids, degradants, and other materials.
Leachables are substances in the medical device that leach or “come out” under normal conditions of exposure over the natural lifespan of the product. Sources of leachables are potentially numerous and can include anything from residual manufacturing solvents to ink and adhesives from labels of secondary packaging material. FDA guidelines monitor known extractables and leachables to ensure human exposure levels do not exceed appropriate safety limits.
The International Organization for Standards (ISO) guidance ISO 10993: Biological evaluation of medical devices describes the expectations for medical device extractables testing (a part of the “chemical characterization” of medical devices) in a subsection of the larger document and within the broader scope of medical device testing.
At Infinity Laboratories we specialize in chemical characterization of medical device materials for regulatory filings. Our medical device extractables and leachables program is constructed around ISO 10993-12 (sample preparation) and ISO 10993-18 (chemical characterization). We routinely carry out exhaustive extractions (assessed by gravimetric analysis), simulated-use extractions, accelerated aging studies, and leachable studies—all per ISO 10993 guidance. Extraction solutions are typically evaluated, depending on solvent utilized, by LC-MS, GC-MS, and ICP-MS. The end report of an extractable study will list detected compounds and their in-sample concentrations.
Understanding the complex chemical interactions in medical device materials is critical to designing a proper extractables and leachables program. Our team has years of experience working with diverse pharmaceutical products and a variety of medical device materials including polymers, metals, ceramics, and composites. We understand how to characterize ancillary chemicals associated with device production such as plasticizers, fillers, additives, cleaning agents, and release agents. We are prepared to flag any materials which need further toxicological evaluation or analysis.
While our forte may be drug-device combination products, this requires us to have an in-depth knowledge of the devices themselves. This knowledge includes a thorough understanding of the raw materials that make up those devices, how these raw materials interact with each other, and what other materials or chemicals they may come in contact with while being manufactured.
Infinity Labs leverages its wealth of medical device and pharmaceutical knowledge to provide the following services:
- Extractables and Leachables
- Chemical Characterization
- Elemental Impurities
- Method Development/Validation
- USP 661 and 665 Testing
- Stability Testing
We continuously work to enhance and protect patient lives through the critical testing services that we provide. We believe we can make a difference in the lives of patients worldwide. Our goal is to go Beyond Testing and become a partner in the success of our customers.