Quantification of Extractable Residue by Gravimetric Analysis
The Quantification of Extractable Residue by Gravimetric Analysis test evaluates manufacturing and cleaning residues, such as oils, lubricants and detergents, found on newly manufactured medical devices and/or single use implants. It’s important to assess these surface residues in order to minimize potential adverse biological responses to surface contamination and extractable residue.
This test complies with the ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. Nelson Laboratories participated on the ASTM committee that developed the standard for this test method.
|RMM110 - Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.||
|RMM115 - Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration||
RMM110 - Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.
RMM115 - Residual Manuf. Material, ASTM F2459: Insoluble/Soluble Residue Determination, per filtration
Turn Around Time
Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.
|RMM110||Residue: Gravimetric Analysis, ASTM F2459 (quantitation), per ext.||14|
RMM110: At least one sample set per solvent type (Samples may be pooled or tested individually)
Study OutlineThis test method is used to detect and quantify extractable residual manufacturing materials on medical devices. The residues are extracted from the devices in an appropriate solvent using sonication. The extract is evaporated to determine the extractable residue. The residue can then be qualified by infrared spectroscopy or the residue amount can be separated into soluble and insoluble residue.
The extraction solvent is chosen based on the solubility of the target residue(s) and the characteristics of the device material(s). Several solvents may be required if more than one type of residue may be present on the device(s). Examples of possible solvents include water, chloroform, methylene chloride, hexanes and 2-propanol.
In order to meet the criteria specified in ASTM F2459, the extraction parameters must be adjusted in order to achieve an extraction efficiency of greater than 75%. There are two techniques which can be used to determine extraction efficiency: spike recovery and exhaustive extraction.
The spike recovery technique uses positive controls which contain a known level of contamination. The positive controls are created at Nelson Laboratories using clean devices which are spiked with a known amount of the target residue(s). The sponsor must provide samples of the target residue(s). Spike recovery positive controls only need to be extracted once.
The exhaustive extraction technique uses positive controls which contain an unknown level of contamination. The positive controls are normally created by exposing devices to the regular manufacturing processes but then not subjecting them to the cleaning process being validated. These are “real-life” positive controls. Exhaustive extraction positive controls should be extracted until no significant increase in the cumulative residue level is detected upon re-extraction, or until the amount extracted is less than 10% of what was detected in the first extraction.
Limits for the target residue(s) may be established based on the recovery level or reduction comparison when comparing clean devices and positive controls. The sponsor is responsible for preparing specific risk assessment and justifications to ensure that regulatory reviewers can determine the rationale for a test plan and any established limits for residue levels.