Process and quality control in the pharmaceutical industry requires highly-discerning contaminant detection, including particulates and residue analysis. These elements are among the primary forms of contamination in the pharmacological industry, and can arise from a broad range of sources including polymer blister packets, undissolved residuals in media or buffer solutions, or metallic manufacturing components such as oven gaskets. Particulates and residue can compromise pharmaceuticals at any stage of manufacturing, from primary and secondary formulation, to packaging and transportation.

In the formation stages, particulates and residue contamination can occur due to cross-reactions with manufacturing media. Excipient materials and active ingredients (AIs) can react with mechanic residue such as oils or lubricants. Machinery degradation or maintenance chemicals can also affect the chemical composition of pharmaceutical compounds. Corroded metals or deteriorating fluoropolymer gaskets can deposit significant volumes of particulates and residues, particularly during thermal processing of pharmaceutical ingredients.

Typical particulates and residues discovered in pharmaceuticals include glass; aluminum; polymers; rubber; and wood. These often enter the product through clean room environments, in which the air volume has been compromised by unsatisfactory sanitization. Particulates and residue can be transported into these atmospheres by containers or clinicians.

The danger of particulates and residues being carried through formulation to the dosage form product or entering the material during the latter stages of production is significant. For example, consumers can experience impaired circulation, with particulates and residues blocking blood vessels and causing damage to their organs.


The Importance of Particulates and Residue Analysis

Particulates and residue analysis is critical for characterizing pharmaceutical contaminants, how they enter the manufacturing process, and the way they perpetuate within the product. Identifying the source of contamination is the primary concern for clinicians and analysts performing particulates and residue characterization.

Microscopy is a common methodology for determining the composition of a particulate or residue in a control sample, and determining the genesis of a contaminating substance within a product. FTIR-Microscopy is used to analyze the heterogeneity of a sample and screen for unknown particles at scales as low as 10 – 15 micrometers (µm), providing accurate chemical composition characterizations to detect the presence of organic particulates.

Scanning electron microscopy (SEM) is also used to distinguish particulates and residue in a sample using a scanning electron beam and a sensitive x-ray detector for acquiring the x-ray emission spectra from particles within the sample. This is used to identify the surface topography and elemental composition of a sample, and to identify undesirable particulates with detection limits of 1,000 – 3,000 parts per million (ppm).


Particulates and Residue Analysis with RQM+ Lab Services Labs

At RQM+ Lab Services, we apply our expertise to the assessment of pharmaceutical products to identify the origin of particulates and residues in failed batches and for quality control processes. We operate with leading equipment and professionalism to ensure that your products and processes fit the stringent compliances of the pharmaceutical sector.

If you would like any more information about performing particulates and residue analysis with RQM+ Lab Services, please do not hesitate to contact us.


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