FAQ: Particulate Identification

Some of the most common inquiries we receive from the pharmaceutical industry is about particulate identification. We are also asked questions regarding turnaround time, analytical methodology and quality documentation. We have addressed the frequently asked questions (FAQ) people have when considering particulate identification analysis with MVA Scientific Consultants.

What is the purpose of analyzing particulate contaminant?

We analyze particles to identify their composition with the ultimate goal of determining the root cause or source of the particulate contaminant.

What analytical techniques does MVA Scientific Consultants use for particulate identification?

MVA Scientific Consultants uses Fourier transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM) combined with energy dispersive x-ray spectrometry (EDS), Raman spectroscopy and polarized light microscopy (PLM) to identify foreign particulate contamination.

What is the turnaround time for particulate analysis?

Our standard turnaround time (TAT) is usually 10 business days. However, we understand that our clients may have emergency situations, so we offer two levels of expedited service. Our rush turnaround time is usually 3 to 5 business days and, for an emergency rush project, we make your project the top priority and devote all necessary resources to it.

Factors that could impact turnaround time include quantity of samples and type of sample preparation needed for analysis.

Can we use MVA’s data for our submissions to regulatory agencies?

Yes, you will receive a detailed report of our analyses for each project.

How much sample do you need for contaminant particulate analysis?

This varies depending on how many analytical techniques we use. In most cases, if you can see the particulate, it will be enough for the analysis.

Visible particulate inside an IV bag.

If you or your clients have a need for foreign particulate analysis, please feel free to give us a call and we will be happy to assist. You can reach us at 770-662-8509 or by emailing info@mvainc.com.