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Pharmaceutical PAT applications

While LIF monitoring is established in other manufacturing industries, it is relatively new within the pharmaceutical industry. The application of real-time intrinsic LIF for the manufacture of pharmaceuticals in general can be broken in to three areas (i) classic (small molecule) final drug product manufacturing (ii) biopharmaceutical prodnct manufacturing and (iii) factory operational applications. [Pg.349]

The first demonstration of solid state fluorescence of API dates back to 1961, while its in-line use for final drug product manufacturing was not demonstrated until recently. While in its infancy as a process analytical technology for real-time monitoring and product parametric real-time release, the applications identified and in some instances demonstrated include (i) blend endpoint API content nniformity detection (ii) segregation monitoring or API content at various process critical control points and (iii) at-line tablet content uniformity determination. The fundamentals of solid-state luminescence spectroscopy for pharmaceutical solids has been covered by Brittain.  [Pg.349]

As already discnssed, intrinsic LIF bioreactor monitoring is the most common application within biopharmaceutical manufacturing. Other extrinsic PAT LIF methods are also possible for biopharmacenticals snch as varions flnorescence immunoassays facilitated by flow injection analysis or other real-time approaches. As PAT begins to emerge within biopharmaceuticals the wider used of sensitive and precise in-line intrinsic and extrinsic approaches such as optodes and at-line extrinsic methods is likely to occnr.  [Pg.349]

Biofouling/biomediation (e.g., oil in water, soils, etc.) Environmental/Marine science Petrochemical 50, 53, 54 [Pg.350]

Algal pigments Lake/reservoir management Water treatment 55  [Pg.350]


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On-line PAT Applications of Spectroscopy in the Pharmaceutical Industry

Pharmaceutical applications

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