PARTICULATE CONTAMINATION ANALYSIS
Areas of Expertise Include:
- Visible and Sub-visible Particulate Analysis
- Particle Isolation & Identification
- Food & Beverages Contamination
- Workplace Dusts
- Residues & Stains
- Environmental Particulate
- General Unknowns
- Pharmaceutical Tablets, Capsules, Powders & Injectables
Are you concerned about particulate contamination in your products? Do you have the techniques and expertise to identify these unknown materials?
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 piece of cardboard paper coming off the manufacturing equipment 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 identifying particulate contamination involves light microscopy (LM), micro-Fourier transform infrared spectroscopy (micro-FTIR) and scanning electron microscopy coupled with energy dispersive x-ray spectroscopy (SEM-EDS). Light microscopy gives information on the morphology and size of particles in visible and sub-visible ranges, and it provides a quick way to tell whether something is organic or inorganic. FTIR gives you molecular information. It is robust and has a large search database that can readily identify numerous organic materials. SEM-EDS is useful for surface morphology and elemental composition determination. It is a great technique for analyzing glass, metals, inorganic fillers, salts, and many other materials.
Once the contaminants have been identified, the information can be used to determine a source. Samples from potential sources can then be compared to the unknown. Once the particles have been identified, you can take necessary steps to eliminate them.
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.