Analytical Services
In-house analytical testing is a cornerstone of our business and how we help our clients assess absorbable materials.
Absorbable Medical Device Testing Services
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.
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.
Chemical
Inherent Viscosity
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
Ultraviolet - Visible Light Spectroscopy
Gel-Permeation Chromatography
Gas Chromatography
High Pressure Liquid Chromatography
Karl Fischer Moisture Content
Nuclear Magnetic Resonance
Thermal
Differential Scanning Calorimetry
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
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
Suture Pull-Out
Burst Test
T-Peel Test
In Vitro / In Vivo
Package Stability
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 Vivo
LET’S CONNECT
Looking for a trustworthy & competent partner to co-create and manufacture your next-generation absorbable implant? Contact our team to speak to an expert.
