Rapid identification of unknown particulate contaminants is critical to ensure patient safety, maintain the high quality of your product and ensure regulatory compliance.
The Food and Drug Administration (FDA) mandates that contaminants in products and process streams be immediately and thoroughly investigated. Particulate identification allows you to distinguish potential sources of unknown foreign materials (including raw materials, materials from manufacturing, filling and packaging lines), thus avoiding any contamination issues.
Exova’s health sciences’ materials laboratory is equipped with advanced tools to assist in contaminant identification. Our team of seasoned experts can quickly and thoroughly assess your particular product or manufacturing issue applying a stepwise and fine-tuned approach,succesfully identifying the source of any foreign particulate matter.
Exova’s contaminant analysis services include:
- Light microscopy with image analysis to show particulate size, shape, morphology and color Micro-Fourier Transform Infrared (Micro-FTIR) Spectroscopy, Raman spectroscopy and a large FTIR spectral database Scanning Electron Microscopy (SEM) coupled with Energy Dispersive X-Ray Spectroscopy (EDS) to understand particle morphology and elemental profiles of unknown particulate, backscattering, 3D imaging available Chemical analysis including quadrupole/time of flight tandem mass spectroscopy (Q-TOF) and Nuclear Magnetic Resonance (NMR) Physical characterization, particle sizing, particulate matter counting, surface area, mechanical testing, X-Ray diffraction
Exova undertakes a comparison of unknown particles against suspect reference materials (mixing blades, rubber gaskets/O-rings, lubricants) to confirm suspect sources of contamination. This provides our customers with opportunities to improve their processes. We have a track record in successfully supporting manufacturer’s modifications of their processes to prevent contamination issues, up to and including full process revalidation studies.
Exova’s contaminant and particulate identification team work closely with you at all stages of analysis, including gathering background information and following up with you to review the data and micrographs when you are in receipt of your report. We also offer remote SEM sessions, which can be particularly useful for collaborative problem solving especially if your in-house experts have knowledge of the suspect materials.
Our instrumentation and processes are Good Manufacturing Practice (cGMP) compliant, so you can be assured that the data supplied in an Exova investigation is robust and suitable for regulatory submission.