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SOURCE: http://www.ltindustries.com/appspharmpat.htm
The Process Analytical Technology (PAT) initiaves by the FDA and EMA seek to improve the efficiency and quality of pharmaceutical production through in-process analysis and control. This involves the design, analysis and control of manufacturing processes through measurement of key process parameters that affect key quality attributes. The goal is to have quality built-in to the manufacturing process, not just tested after (Quality by Design [QbD]). NIR process systems have been widely regarded as a leading technology for the PAT initiative due to their capabilities for rapid, non-destructive analysis of a wide range of chemicals and materials in liquid, solid and slurry forms. LT-NIR has the tools necessary to meet your PAT project goals.
Process Measurement Solutions
Get real-time analysis of:
| Mixing and Blending | End Product Identification | Fermentation Bioreactors |
| API drying and coating | Raw Material Analysis | Cell culture |
| Granulation | Polymorphic Forms | and more… |
LT-NIR Process systems are designed to be user-friendly, easy to integrate, and extremely cost effective. With up to 20 measurement points per analyzer, sterilizable CIP/SIP probes, and communication software for Modbus, 4-20mA and other protocols, designing a PAT solution with a high rate of return is within reach. LT Industries also provides commissioning, model development, and training onsite. Continuing product support is always available following installation–the systems can be accessed and troubleshooted remotely by LT’s team of experts.
Additional Pharmaceutical Measurements
LT-NIR can also handle final product quality tests and incoming material validation. Measure dosage in tablets, uniformity, actives and excipients. Identify grades, sources, and counterfeits in seconds for raw materials and final products. IsoPharm Benchtop instruments can be used by operators of any skill level. Analysis is done with the push of a button and qualitative or quantitative results are displayed on screen in accordance with your measurement requirements.
