Pace Analytical Life Sciences has developed a comprehensive approach towards extractable and leachable testing on medical devices. These studies are designed to identify extractables, which are soluble substances removed from material when treated with solvent, and leachables, which are chemicals removed from a medical device by the action of water and other liquids related to the use of the device. Extractables and Leachables may be composed of both organic substances and inorganic substances typically coming from additives, lubricants, accelerators, monomers and high molecular weight oligomers from incomplete polymerization, residual solvents, degradation products from temperature, absorption, hydrolysis, oxidation, corrosion or dissolution, or from the process itself like mould release agents and anti-static and anti-stick agents.
Our approach towards extractables and leachables testing is to first perform either an exhaustive extraction (extractables), in which multiple extractions are performed until the amount of residues in a subsequent extraction is less than 10% of that detected in the first extraction.
In general, we perform the exhaustive extraction part of the study first. At this stage the extractables and leachables are not known and we perform screening methods to assess materials. We will extract the component in polar solvents, non-polar solvents and water and also heat for a specified amount of time. These extracts are then analyzed using high performance liquid chromatography-photo diode array detection-mass spectrometry (HPLC-PDA-MS) to identify organic (semi-volatile) material from the component, gas chromatography-mass spectrometry (GC-MS) to identify organic (volatile) material from the component and inductively coupled plasma-optical emission spectroscopy (ICP-OES) to identify metals from the component. Ion Chromatography (IC) can also be used in some situations. We also will perform USP <661> Physiochemical tests for nonvolatile residue, residue on ignition, heavy metals and buffering capacity. When we have identified the possible extractable materials from the component, we optimize and validate the analytical method for these compounds of concern.
Once we have analytical methods in place to determine the possible extractables from a component we can conduct the simulated use extraction (leachable) test. Typically the simulated use extraction study is performed on the device during routine use using an extraction method with an appropriate medium that simulates product use. At this point it is imperative that all of the analytical methods have been validated to meet ICH Q2 (R1), USP <1225> or point-of-use validation requirements.
Our extractables and leachables testing program for medical devices utilize the following analytical instrumentation:
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their extractables and leachables testing are successfully executed.
We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited.
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