Bioresorbable Polymer Analytical Testing Services

Analytical Testing

Testing Analytics

Our wide range of analytical capabilities and polymer testing support the development of medical devices and pharmaceutical products. We perform analysis according to consensus standards and develop custom test methods as needed. Analysis can be performed on an as-requested basis, or as part of release testing.

Customers benefit from our broad capabilities, fast turnaround times, and quality of service. Please contact us for individual tests, or the development of testing protocols.

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Chemical

Inherent Viscosity

A reproducible viscometric technique used in determining the molecular size of a species and is often used as a comparative molecular weight. IV is determined by dilute solution viscometry, analyzing the flow time of a polymer solution through a capillary viscometer as related to the flow time of a pure solvent. Chloroform (CHCl3) and hexafluoro-2-propanol (HFIP) are common solvents used for this technique; IV is reported in deciliters per gram (dL/g).

Fourier Transform Infrared Spectroscopy

A technique in which an infrared light source impinges on a sample. Depending on the molecular construction, light of different wavelengths is absorbed to differing degrees. This is often used to develop individual material reference spectra, and like a molecular fingerprint, each material spectra is unique. Poly-Med utilizes reflectance and transmission sample preparation techniques, either as a solution or in thin film formats.

Ultraviolet - Visible Light Spectroscopy

Gel-Permeation Chromatography

A chromatographic method that separates and detects molecular species based on size. A relative molecular weight (MW) is determined from calibration to known standards. GPC analysis allows for a more detailed description of a species through characterization of polydispersity index (PDI), number average molecular weight (Mn), weight average molecular weight (Mw), size average molecular weight (Mz), and peak molecular weight (Mp). Common solvents used for polymer dissolution are tetrahydrofuran (THF) and dichloromethane (DCM).

Gas Chromatography

For analyzing samples that can be vaporized to the gas phase without decomposing at elevated temperatures. The constituent molecules of the vaporized sample are separated on the column and have different retention times. Separation of molecules by the column allows for the molecular components of the sample to be analyzed qualitatively and quantitatively. Analysis includes sample purity, monomer content, residual solvents, relative amounts of impurities, and/or relative amounts of components in a mixture. Non-volatile samples, such as polymers, can also be analyzed using a headspace unit to collect the volatiles contained within a polymer sample.

High Pressure Liquid Chromatography

A chromatographic method most often used to quantify the presence of a molecule by comparing peak areas to a calibration curve. A solution is injected through a separation column and the analyte is detected by way of a UV detector. Often this is used to study the release kinetics of pharmaceutical compounds from various substrates. Poly-Med’s HPLC also has PDA capabilities, which can be used to study changes in the analyte over time.

Karl Fischer Moisture Content

This analytical technique is used for detecting trace amounts of water in a sample, particularly useful for the analysis of moisture-sensitive materials. The method involves heating a solid sample to vaporize the moisture contained within said sample, and then the vapor is transported to a titration cell via dry, inert gas. Liquid samples can be added directly to the titration cell. An electro-chemical titration named for its inventor, Karl Fischer, determines the amount of water in the sample, which is typically reported in parts per million (ppm).

Nuclear Magnetic Resonance

A method for determining total composition of a sample material by way of measuring the magnetic resonance of hydrogen-1 molecules within the molecules of a substance, which vary based on chemical composition of the molecule. Spectral peaks are associated with different types of bonds, which can be used to calculate the percent presence of known molecules, i.e. determining a polymer contains 94% glycolide and 6% lactide. This is most often performed from a polymer solution using various deuterated solvents.

Thermal

Differential Scanning Calorimetry

An essential analytical technique used for detecting the thermal transitions of both amorphous and crystalline polymers. Transitions include glass transition temperature (Tg), temperature of crystallinity (Tc), heat of fusion (ΔHf), and melting temperature (Tm).

Cone/Plate Rheometry

Melt Flow Index

Mechanical

General Tensile Test

A basic mechanical testing protocol in which a sample (various forms possible) is strained in a single direction, most often to failure. This testing provides insight into material and construct properties such as Ultimate Tensile Strength, Yield Strength, Young’s Modulus, Yield Strain, and Ultimate Strain.

3-Point Bend Test

Compression Test

Suture Tensile Test, Knotted and Unknotted

In addition to tensile testing of sutures, knot-pull test can be conducted under tensile loading to evaluate the knot strength of a suture. USP and EU standards for tensile testing methods are used in knot-pull testing. This analysis provides information about Tensile Strength, Elongation and Young’s Modulus, as well as the critical Ultimate Knot Load, which is used to assess against pharmacopeia suture requirements.

Suture Pull-Out

Burst Test

T-Peel Test

Standard test method to determine the relative peel resistance of adhesive bonds between flexible substrates. For cyanoacrylate adhesives, it is common to use porcine skin as a substrate, although the method most typically used at Poly-Med utilizes a consistent textile fabric soaked in 7.4pH buffered solution. The test output is average and maximum load to adhesive failure is reported per unit width, i.e. N/cm.

In Vitro / In Vivo

Package Stability

The goal of shelf life stability studies is to obtain objective evidence that the absorbable device/component maintains its mechanical and physical properties over a selected period of time (typically ≤ 3 years). The main output of this type of testing is an expiration date. Typically both real-time (25°C) and accelerated aging (40°C) conditions are tested against the release specification.

In Vitro

In Vitro

For absorbable polymers, in-vitro degradation studies are imperative to analyze the change in material properties in a simulated and controlled environment. ASTM standards, such as ASTM F1635, are followed to characterize the degradation rates and changes in material, and physical properties. Any of the tests above can be modeled to characterize material loss profiles. Common test modes include mass loss and strength loss over time.

In Vivo

Solutions

We support client medical device ideas with advanced absorbable materials and processing.

Bioresorbable Polymers

Absorbable polymers can transform the healing process by temporarily restoring functionality in targeted areas. After use, they resorb within the body without a trace, minimizing the need for follow up surgical procedures.

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Bioresorbable Extrusions

Our polymers can be extruded into monofilament fibers, multifilament yarns, or films as inputs into biomedical textile applications. Don’t design for a filament, select the filament for your design.

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Biomedical Textiles

Our polymers can be constructed into a variety of fibrous articles and medical textiles. More polymers equal more responsive designs, with better outcomes. Don’t design for a polymer, select the polymer for your design.

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Electrospinning

Regenerative scaffolds aim to mimic the physical, chemical, mechanical, and biological cues observed in a normal tissue environment. This technology can be tailored to partially, or fully, absorb during the healing process.

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3D Printing

Create lattice-based architectures with 3D-printed absorbable implants via filament-based and resin-based approaches that are inaccessible via injection molding.

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Combination Medical Devices

Our polymeric materials can be used as excipients to allow for facile processing with active pharmaceutical ingredients (APIs) and customizable continued-release profiles for combination medical devices.

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Looking for a trustworthy & competent partner to co-create and manufacture your next-generation absorbable implant? Contact our team to speak to an expert.

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Analytical Testing

Absorbable Medical Device Testing Services

Testing Analytics

Chemical

Inherent Viscosity

Fourier Transform Infrared Spectroscopy

Utraviolet – Visible Light Spectroscopy

Gel-Permeation Chromatography

Gas Chromatography

High Pressure Liquid Chromatography

Karl Fischer Moisture Content

Nuclear Magnetic Resonance

Thermal

Differential Scanning Calorimetry

Cone/Plate Rheometry

Melt Flow Index

Mechanical

General Tensile Test

3-Point Bend Test

Compression Test

Suture Tensile Test, Knotted and Unknotted

Suture Pull-Out

Burst Test

T-Peel Test

In Vitro / In Vivo

Package Stability

In Vitro

In Vivo