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PhAt System
Raman Spectroscopy

Raman Analyzers
RAMANRXN3 PhAT Analyzer

 

The RAMANRXN3PhAT analyzer uses PhAT technology to allow quantitative monitoring and control of solid formulations during unit operations.  The advent of PhAT technology has redefined the standard for simplicity and reliability for Raman spectroscopic analysis of solid samples. The use of PhAT technology is opening up new areas to Raman analysis both in situ and at-line including solid-state chemistries applications and with the pharmaceutical, catalysts, polymers, and specialty chemicals industries.

The RAMANRXN3 PhAT analyzer is a powerful process analytical technology (PAT) analyzer based on Raman spectroscopy. Raman data generated is high in information content.

The sharp Raman peaks can often be interpreted in terms of individual chemical moieties, thus providing a fundamental insight into the critical quality variations and attributes of the process and yielding an increase in process understanding. Kaiser's staff of experts are focused on providing solutions for our users.

PhAT technology has revolutionized solid sampling by eliminating sample irreproducibility and focusing, by measuring a representative volume of sample, and by offering the benefits of non-destructive sampling using laser powers below the ANSI exposure limit for skin.

The RAMANRXN3PhAT analyzer incorporates the most advanced self-calibration and self-diagnostics to ensure the validity of each analysis. The analyzer's precision allows both advanced chemometric analyses and traditional univariate methods to be used.

The RAMANRXN3PhAT analyzer operates in classified environments and is housed in a stainless steel IP 66 enclosure. This analyzer is equally well-suited for formulations development in the lab, or process control in a manufacturing environment. The analyzer’s enclosure package allows the analyzer to be washed down between batches meeting the clean-ability requirements of the pharmaceutical industry. As standard the analyzer is mounted to a trolley so it can be moved between unit operations. Alternatively, the analyzer can be mounted permanently to a wall.

Sampling versatility to various unit operations and a variety of manufacturing equipment is accomplished using a fiber-optically coupled PhAT probe head. Both insertion and non-contact sampling options are available for the PhAT probe head to enhance sampling flexibility.  A special probe interface is available for in situ tablet coating applications. 

 

Applications

  • Analyze powders, slurries, flakes, plaques, gels, or liquids
  • PAT - R&D, primary, secondary or QA/QC
  • API polymorphic form and stability
  • API hydrate, solvate, or salt formation
  • API co-crystal formation
  • Unit operations; blending, granulation, milling, and drying
  • Process induced transformations during unit operations
  • Tablet coating and thickness
  • Tablet API form, content, and stability
  • Low doseage tablets (polymorph and degradants)
  • Lyophilization
  • Hot melt-extrusion
  • PAC - polymers and catalysts

 

 

 

Advantages of Raman Spectroscopy...

Video: Granulation Example

Analyzer Features

  • Easy sampling of solids and slurries
  • Representative mm scale measurement
  • Reproducible sampling
  • “Focus free” alignment
  • Non-contact or insertion sampling
  • Non-destructive measurement
  • 21 CFR Part 11 compatible software option
  • IP 66, stainless steel enclosure
  • Purge for classified environments
  • Modular design for easy maintenance
  • Advanced self calibration protocols

Why Raman?

  • Fast measurements
  • Sharp spectral peaks for qualitative and quantitative analysis
  • Univariate or multivariate prediction mode

Select Customer Publications

"Raman Spectroscopy: A PAT Tool for Quantitative Assessment of Tablet Potency", J. Johansson, J. Eriksson, S. Folestad, and B. Lagerholm, FACSS, 50S. Oct (2004) - AstraZeneca

"Raman Spectroscopy for Quantitative Monitoring of Solid Dosage Manufacturing Process", S-Y. Chang, A. El-Hagrasy, W. Earlv, H. Guo, D. Li, S. Kotliari, S. Paruchuri, and V. Nesarikar, IFPAC, 1-142, Jan 13 (2005) - BMS

"Comparison of Techniques for In-line Monitoring using Raman Spectroscopy.", H Wikstrom, l.R. Lewis and L.S. Taylor, Appl. Spectrosc., 59, 934-941 (2005) - Purdue University

"Raman Spectroscopy for Quantitative Monitoring of Tablet Coating", S-Y. Chang, A. El-Hagrasy, S. Paruchini, S. Kothari. D. Desai, and S. Kiang, FACSS, 92, Oct (2005) - BMS

"Quantitation of Polymorphs in Drug Products by Raman Spectroscopy", F. LaPlant and X. Zhang, Am.Pharn.Rev.,8, 88-95 (2005) - Pfizer

 

 

Product Material
Title
Category
Format
ID#
PhAT Probe for Solids Analysis
Product Flyer
PDF
PF0024

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