FT-IR Spectroscopy: Chemical Composition and Material Identification
Fourier-Transform Infrared Spectroscopy (FT-IR) is a versatile analytical instrument used for determining the chemical composition of organic compounds. In the medical device industry, it serves as a critical tool for identifying materials and ensuring the consistency of products throughout the manufacturing process. Because each type of covalent bond has a specific absorption frequency in the infrared spectrum, FT-IR allows for precise molecular fingerprinting.
At EBI, we utilize FT-IR to confirm the identity of medical devices and detect any significant variances from reference standards, ensuring the highest level of safety and quality control.
Why use FT-IR for your Medical Device?
FT-IR spectroscopy is a mandatory component of chemical characterization within the risk management process. It is used to:
- Verify Material Identity: Confirming that the device is manufactured from the correct polymers or elastomers.
- Assess Quality and Consistency: Ensuring that different production batches remain within the specified chemical parameters.
- Identify Unknown Compounds: Using vast spectral libraries to identify contaminants or unexpected additives.
Methodology: Attenuated Total Reflectance (ATR)
Our laboratory employs advanced spectral analysis techniques to provide reliable results for both solid and liquid samples:
- ATR Recording: The spectra of solid medical devices are recorded using Attenuated Total Reflectance (ATR). This non-destructive method allows for the direct measurement of the device surface.
- Spectral Comparison: Recorded spectra are compared against extensive online reference-library databases of known compounds.
- Bond Analysis: We evaluate specific covalent bond absorptions to verify the presence of functional groups and molecular structures.
Sample Requirements and Turnaround Time
To perform an accurate FT-IR analysis, the following sample requirements must be met:
- Material Dimensions: 30 cm² (thickness < 0.5 mm) or 15 cm² (thickness ≥ 0.5 mm).
- Weight/Volume: 5 grams for solid items or 5 ml for liquids.
- Minimum Quantity: At least 1 test item.
- Standard Turnaround Time: 8 weeks.
Compliance and Standards
EBI conducts FT-IR analysis in accordance with international pharmacopeial and biological standards:
- USP <197>: Spectrophotometric Identification Tests.
- ISO 10993-18: Chemical characterization of medical device materials.
- MDR 2017/745: Supporting documentation for material safety and equivalence.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: FT-IR Spectroscopy
What kind of compounds can FT-IR identify?
FT-IR is most effective for organic compounds and polymers. It identifies materials by recognizing specific chemical bonds, such as C-H, O-H, or C=O, which are characteristic of medical plastics, rubbers, and adhesives.
How does spectral library matching work?
Our software compares the unique „fingerprint” of your device against thousands of known spectra. This analysis confirms the identity of the device and quantifies any variance from the reference compound.
Can FT-IR analyze liquid medical device components?
Yes, we can record spectra for both solid items and liquid extracts or raw materials using specialized sampling accessories.
What kind of compounds can FT-IR identify?
FT-IR is most effective for organic compounds and polymers. It identifies materials by recognizing specific chemical bonds, such as C-H, O-H, or C=O, which are characteristic of medical plastics, rubbers, and adhesives.
How does spectral library matching work?
Our software compares the unique „fingerprint” of your device against thousands of known spectra. This analysis confirms the identity of the device and quantifies any variance from the reference compound.
Can FT-IR analyze liquid medical device components?
Yes, we can record spectra for both solid items and liquid extracts or raw materials using specialized sampling accessories.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
Get in touch
