The particle size distribution is one of the most critical parameters in drug product quality. Real time understanding and control of particles ensures Quality by Design (QbD) in solid and liquid dosage formulation. FBRM and PVM Process Analytical Technologies (PAT) provide in-process real time measurements of particle dimension, particle shape, and particle count. FBRM and PVM are used to promote faster formulation development, improve process confidence, and control batch-to-batch consistency.
By Mettler - Toledo Int. Inc based in Greifensee, SWITZERLAND.
The pharmaceutical industry is one of the most regulated industries. Contaminants in drug products are examined throughout the manufacturing process, since their presence affects drug stability, behaviour and toxicity. Therefore, regulatory bodies such as the European Medicines Agency (EMEA) and the American Food and Drug Administration (FDA) strictly enforce continuous and ongoing analysis of organic or inorganic impurities from raw materials, excipients and Active Pharmaceutical Ingredients (API) through intermediates of drug products and packaging.
By Xenemetrix Ltd. based in Migdal Haemek, ISRAEL.
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