Contaminant Analysis: How to Interpret Particulate Matter

Particulate contamination analysis using microscopy and spectroscopy methods can identify and mitigate contamination in chemical, consumer products, industry or processes. Particulate analysis is the first stage in resolving contamination issues that could be potentially critical. These issues can take place at many points through the supply chain of numerous industries. Particulate contamination identification means that action can be taken to mitigate and prevent further or additional contamination.

How does Particulate Contamination Work?

Particulate contamination investigations involve identifying microscopic particles, the isolation of various particulate phases of in-homogenous production deposits and determining the source of the contaminants.

Mitigating particulate contamination can be done by identifying contaminants through expertise in sampling and sample preparation, chemical identification, physical/visual examination and root cause analysis.

Contaminant particles can be digitally imaged using microscopy to offer forensic traceability. Once the initial microscopical assessment has been carried out, analysis can be undertaken using energy-dispersive X-ray spectroscopy on isolated particles with scanning electron microscopy (SEM) or vibrational spectroscopy. Characterization of the shape or size of particulate contamination can be carried out using photomicrography.

Examples of how Particulate Contamination Analysis can be Used:

• Identifying metal abrasion and corrosions which has caused extraneous metal particles from pipes, pumps, etc. to be present in water.
• Identifying residual particles from cleaning and maintenance
• Identifying mineral particles when the manufacturing or geographic origin is of particular importance.
• Finding glass fragments caused by breakages.
  
  

When particle contaminations are present in valuable samples such as medical devices and pharmaceuticals, the impact is extremely far reaching. These types of particle contaminations can create inefficiencies, delays in delivery and compromised product quality for the consumer and patients.

These particulate contaminations can be caused by a range or sources such as packaging, undissolved residuals in buffer and media solutions, and a range of system components like gaskets and seals.

Particulate contamination can also be a result of side reactions associated with the manufacture of the product, such as charred products and detergent residues or due to degradation or maintenance of the processing equipment such as lubricant oils, metal corrosion and Teflon gasket scoring.

Particulate contamination can spread to the air volume of a clean room in close proximity via airborne contamination or transport of people or containers. This can then cause contamination of both products as well as the manufacturing area. These particles can have negative effects if carried over to the final drug product including microcirculation, blockages of blood vessels, impairment, and organ damage.

Identifying and considering the source of particulate contamination is critical to controlling their spread. Once the source is identified, the removal of the particulate contamination becomes considerably simpler.

At RQM+ Lab Services, we use FTIR-microscopy, SEM-EDX along with other methods of identifying particulate contamination and we are able to provide information about shape, size and surface topography. To find out more, contact us today.