PARTICULATE CONTAMINATION ANALYSIS
Areas of Expertise Include:
- Visible particles
- Sub-visible particles
- Particle isolation
- Stains
- Defects
- Injectables
- Powders
- Capsules
- Tablets
- Lotions
Contamination analysis is an important step in determining the root cause of foreign material in a pharmaceutical or cosmetic product. Contamination can cause a halt in manufacturing, so it’s important to address the issue promptly.
This is the reason we offer RUSH services with a quick turnaround.
The contaminants can be either intrinsic or extrinsic. Intrinsic contaminants are from the product itself. For example, a parenteral solution may have multiple components; if the solution has the wrong pH, the ingredients can precipitate out and may be thought of as contaminants. Extrinsic contaminants are from the outside environment. For example, a tablet may have oily black spots scattered through the surface. Analyzing the black spots can determine the composition of the material and whether or not it is from the manufacturing process.
Our approach to contamination analysis may begin with isolation. We use several methods to isolate the unknown material, including filtration. The method is determined by the sample. During the process of identifying particulate contamination we use a combination of isolation, light microscopy (LM), micro-Fourier transform infrared spectroscopy (micro-FTIR), confocal laser Raman microscopy, and scanning electron microscopy coupled with energy dispersive x-ray spectroscopy (SEM-EDS).
Light microscopy provides information on the morphology and size of particles in visible and sub-visible ranges; it is also a quick way to determine whether something is organic or inorganic. FTIR gives you molecular information. It is a robust technique with a large database that can readily identify numerous organic materials. SEM-EDS is useful for surface morphology and elemental composition determination. It is useful for analyzing glass, metals, inorganic fillers, salts, and many other materials.
Once the contaminants have been identified, the information can be used to help determine a source. Samples from potential sources can also be analyzed and compared to the unknown contaminant. Once the contaminants and the source have been identified, our clients can take the necessary steps to address the contamination problem.
Contamination comes in different forms: particles, oily residuals, colored stains, or haze. Whether it is a 50 um particle or an unknown stain, MVA Scientific Consultants has the skill and experience to isolate and identify impurities to help you solve your contamination concerns.
For more information about particulate contamination analysis, please contact us at info@mvainc.com or 770-662-8509.
Contaminant Particulate Analysis and Identification FAQ
Analyzing Particle Contamination – Webinar