Controlled Extraction Study with Solvent Selection
In medical device testing, ensuring that materials and components are safe for patient use is paramount. A controlled extraction study with solvent selection plays a crucial role in assessing the potential leachable and extractable substances from materials used in medical devices to ensure compliance with regulatory requirements.
The purpose of this service is to identify and quantify chemicals that may be released into a device's environment during its intended use or under reasonably foreseeable conditions. This analysis helps manufacturers understand the risks associated with these compounds, ensuring they meet stringent safety standards established by regulatory bodies like the FDA, ISO, and EN.
The process typically involves selecting appropriate solvents based on the material composition of the medical device being tested. Commonly used solvents include water, ethanol, acetone, and phosphate-buffered saline (PBS). Once selected, these solvents are applied to samples of the device in a controlled manner under specific conditions to simulate real-world scenarios.
Following extraction, the resulting solutions undergo detailed analysis using advanced analytical techniques such as high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), and Fourier-transform infrared spectroscopy (FTIR). These methods provide precise quantitative data on the types and concentrations of chemicals present in the extracts.
By conducting controlled extraction studies, manufacturers can proactively address potential issues early in the product development cycle. This approach not only enhances safety but also supports regulatory compliance by providing robust evidence that devices meet relevant standards.
| Applied Standards |
|---|
| - ISO 10993-12:2018 |
| - USP : Extractables and Leachables from Medical Devices |
These standards outline the procedures for conducting controlled extraction studies, ensuring consistency across different laboratories.
Applied Standards
| Standard | Description |
|---|---|
| ISO 10993-12:2018 | This international standard provides guidance on the selection, use, and interpretation of methods for extracting substances from materials used in medical devices. |
| USP : Extractables and Leachables from Medical Devices | The United States Pharmacopeia's chapter on extractables and leachables specifies the analytical methods for determining substances that can be extracted or leached into a medical device during its intended use. |
Scope and Methodology
The scope of our controlled extraction study includes the evaluation of materials that come into contact with patients or their bodily fluids. This encompasses polymer-based products, metal alloys, ceramics, textiles, and more.
We utilize a multi-step approach to ensure comprehensive results:
- Material Identification: Determining the types of polymers, metals, or other materials used in the device.
- Solvent Selection: Choosing solvents that best simulate environmental conditions and extract potential contaminants.
- Extraction Procedure: Applying selected solvents to samples under controlled temperatures and times.
- Analytical Techniques: Utilizing advanced analytical tools like HPLC, GC-MS, FTIR, etc., to detect and quantify extracted compounds.
Use Cases and Application Examples
Controlled extraction studies find applications in various stages of medical device development:
- Early Stage Development: Identifying potential risks at the conceptual design phase.
- Mid-Stage Prototyping: Validating changes made during prototyping against initial risk assessments.
- Late Stage Manufacturing: Ensuring final products comply with regulatory requirements before commercial release.
| Use Cases | Description |
|---|---|
| Initial Risk Assessment | Determining which chemicals might be extracted based on material composition. |
| Compliance Verification | Ensuring that the device meets all applicable regulations and standards. |
