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| Brimrose offers a Total Solution, providing robust and reliable Acousto - Optic Tunable Filter AOTF - NIR Analyzers and 21 CFR Part 11 Compliant software through the entire production processes |
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Raw material ID in the warehouse |
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Multi-stream analysis in the dispensing |
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Moisture in Fluid Bed |
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Spray and Vacuum dryers |
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Blend uniformity |
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Tablet properties in the tablet stage |
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| In each stage, Brimrose analyzers stand out as excellent, "Industrial Hardened" systems for real on-line, in-line, at-line and off-line quantitative and qualitative analysis. |
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| PAT (Process Analytical Technology) initiative requires pharmaceutical manufacturers to improve the critical quality performance monitoring for ensuring final product quality. PAT in pharmaceutical production and quality control is helping to move the industry away from empirical, and towards science based standards for manufacturing control. It is an effort to facilitate the introduction of new technology for the manufacturing sector of the pharmaceutical industry. |
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| Many applications in PAT can be addressed using NIR Spectroscopy. For drug product sites, NIR spectroscopy can be used at almost each step of tablet manufacture, from Raw Material Control to Content Uniformity Analysis of the dosage unit. Traditionally Content Uniformity Analysis has been performed by HPLC, Destructive Analysis. These are high volume, time consuming, labour intensive processes. This system requires that test samples be taken from production area to QC/QA laboratory where the samples are prepared and analyzed for content uniformity. |
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| With the implementation of PAT, Pharmaceutical companies are striving to improve product quality and most importantly reduce manufacturing costs to be competitive in the market. Near Infra Red spectroscopy has proven to be Rapid and Quick, Cost Effective, Low Time Consuming, Convenient, Non-Destructive and Alternative for Routine Content Uniformity Test. |
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