
Analytical Services
In-house analytical testing is a cornerstone of our business and how we help our clients assess absorbable materials.
In-house analytical testing is a cornerstone of our business and how we help our clients assess absorbable materials.
Providing in-house analytical testing limits 3rd-party vendor touch points, resulting in faster speed to market during the product development cycle . In-house analytical testing for absorbable components and finished medical devices also simplifies a product’s manufacturing supply chain. Leverage the power of Poly-Med’s vertical integration for your next bioresorbable medical device.
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.
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).
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.
An analytical technique that measures the absorption or reflectance in the UV and visible spectral regions. Molecular compounds with π-electrons, or non-bonding electrons, can be measured due to absorption in the UV and visible range and related to concentration using the Beer-Lambert law. One common use for UV/Vis is to determine dye concentrations.
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).
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.
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.
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).
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.
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).
A fluid or molten sample is placed between a horizontal plate and a shallow (1°) cone. The cone is rotated to determine shear stress within the material at varying rotational velocities and temperatures. This is often used for low molecular weight polymers and to study the gelation kinetics of polymer systems.
Analysis that measures the flow of a material through a capillary under set conditions of temperature and pressure. MFI is typically reported in grams of material to flow through the capillary in 10 minutes (g/10 min.)
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 testing is completed when a specimen is placed on two parallel support beams, and a load is applied downward between the two parallel beams. 3-point bending is useful for providing insight into the flexural stress, flexural strain, and modulus of elasticity in bending.
A test to evaluate a specimen’s mechanical and displacement response under compressive loads. Compressive testing is used to determine the compressive strength and modulus of a material.
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.
A commonly used method of testing the resistance of surgical mesh to failure at suture tie-in points. Suture Pull-out tests involve passing a suture through the construct and pulling in tensile to determine the failure load of the base material. Procedure-specific suture sizes and types are typically used, and the output is a failure load.
Ball burst testing involves constraining a section of mesh and impressing a polished hemispherical plunger to measure the resistance of the mesh to deformation and failure.
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.
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.
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 studies may be performed in conjunction with Godley-Snell Animal Research Center. This often includes feasibility trials to determine tissue response of an implanted device, or degradation kinetics of a prototype in various small animal models.
We can help you develop a device or drug delivery system from polymer to finished good. Let's get started.
Free ConsultationBioresorbable Medical Device Overview: Bioresorbable medical devices are implantable materials designed for a particular treatment and degrade over time once the scaffold is no longer necessary. Bioresorbable polymer materials may be synthetic or naturally-derived, exhibit high biocompatibility, and may degrade through mechanisms including but not limited to bulk hydrolysis, surface erosion, or enzymatic degradation depending […]
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Interested in understanding Poly-Med Inc.'s design and development process? Complete this form for a Welcome Packet.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our ISO Certificate.
Please provide your name and email to view our Max-Prene® Polymer Data Sheet.
We provide an adaptable approach to customer needs for any medical application. How can we help you?
We provide an adaptable approach to customer needs for any medical application. How can we help you?
Please provide your name and email to view our Photoset® 311 Resin Data Sheet.
Please provide your name and email to view our Dioxaprene® Polymer Data Sheet.
Please provide your name and email to view our Glycoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Lactoprene® Polymer Series Data Sheets.
Please provide your name and email to view our Aquaprene® Polymer Data Sheet.
Please provide your name and email to view our Max-Prene® 955 3DP Filament Data Sheet.
Please provide your name and email to view our Dioxaprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Lactoprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® 5525 3DP Filament Data Sheet.
Please provide your name and email to view our Caproprene® 100M 3DP Filament Data Sheet.
Please provide your name and email to view our Strataprene® Polymer Series Data Sheets.
Please provide your name and email to view our ISO Certificate.