Chemical analysts have long sought a direct and non-destructive method for identifying chemicals or materials within different formulation environments. Classic methodologies, such as high pressure liquid chromatography or gas chromatography, coupled with mass spectroscopy, scanning electron microscopy and nuclear magnetic resonance, require expensive equipment and incur high maintenance costs. Often they require sample preparation, resulting in long and expensive analytical processes. In addition, such equipment is not mobile enough to enable it to be brought to the point of interest.
The recent advances in FTIR and NIR technologies allow a simple sample analysis without extensive sample preparation. Complex mixtures within formations can be deduced by using reference sample subtraction followed by further comparison with known references.
The pharmaceutical and chemical industries share similar operational, product quality and regulatory requirements to produce safe products with controlled operations.
Quality issues can arise when raw materials are exposed to particular situations that may result in contamination from equipment, shipping materials, human source, or due to temperature, oxidation or moisture effects. Poor manufacturing, handling or packaging control can also introduce potential contaminants that may cause product quality failure.
To ensure product quality and safety, regulatory agencies such as the US Food and Drug Administration (FDA) recommend good quality control of raw materials and processes used in pharmaceutical and chemical manufacturing. Lot to lot variation of the raw materials needs to be understood and controlled to validate manufacturing processes. FTIR and NIR can be useful non-destructive techniques used to identify the consistency of the incoming raw material compared with the acceptable reference material. Prevention of product failure at this stage of the manufacturing process is less costly than rejection of the finished product.
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