Medical Device Testing
The development of resorbable bioplastics has revolutionized the plastic industry.
Polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO) and copolymers such as PLGA are commonly used for a host of applications in a variety of industries. Mechanical strength, biocompatibility, and the ability to be broken down and absorbed by the body over time have made these polymers ideal choices for many implantable medical devices.
Since 1987 SGS PSI has provided testing solutions for resorbable bioplastics. We have a variety of characterization and release testing methods in place for resorbable polymers and copolymers. Additionally, we are able to develop and validate customized methods. Test methods we use to analyze resorbable or bioabsorbable polymers include:
- Inherent and Intrinsic Viscosity using chloroform and HFIP, for example
- Gel Permeation Chromatography / Size Exclusion Chromatography (GPC) using THF, chloroform, or HFIP, for example. Including both absolute and relative molecular weights
- Residual Monomer via Gas Chromatography (GC) Mass Spectrometry (GC/MS)
- Residual Solvents via Headspace Gas Chromatography (GC)
- Hydroxyl End Group Titration
- Carboxylic Acid End Group Titration
- Comonomer Ratios by NMR
- Heavy Metals
- Sulfated Ash
- Moisture by Karl Fischer Titration (KFT)
- Differential Scanning Calorimetry for glass transition (Tg), melting point (Tm), and Crystallinity (DSC)
- Tin Content by Inductively Coupled Plasma – Optical Emission Spectroscopy (ICP-OES)
- Fourier Transform Infrared Spectroscopy (FTIR)
- Scanning Electron Microscopy with Energy Dispersive Spectroscopy (SEM/EDS)
- Mechanical Testing
- In-vitro Aging and Stability Studies
- Degradation and Aging Studies
We have extensive experience testing PLA, PGA, PCL, PDO, and related copolymers.
Examples of products we’ve tested that use resorbable polymers, include:
- Tissue scaffolds
- Drug delivery systems
- Regenerative medicine devices
- Hydroxyapatite filled polymer
- Tricalcium phosphate filled polymer
There are numerous ways to approach the testing of bioabsorbable polymers and each approach has different sample requirements. The first step is getting in touch with us to discuss your testing needs. Our team will work with you to develop a unique testing plan that will achieve your goals and will provide guidance about the best way to provide us with samples.
Please contact an expert to get that conversation started.