How is Raman Microscopy Used in the Pharmaceutical Industry?

When developing, producing, and ensuring the quality control of pharmaceuticals, particularly stringent requirements must be met. In order to follow the requirements of Good Practice (GxP), the highest accuracy and precision is demanded when performing analysis.

Efficiency is essential to a productive workflow in both QA and QC. Fortunately, customers are provided with this by the SENTERRA II, courtesy of the following features:

  • Fast Raman Imaging and permanent automatic calibration
  • Simple and compact instrument design
  • Intuitive software packed with analytical toolsets
  • Easy analysis of solid dosage forms, tablets, granules, and formulations
  • Rapidly visualize the uniformity and distribution of APIs and excipients
  • Instrument test procedures which are entirely automated according to Ph.Eur. 2.2.48, USP 1120, E2529-06, and ASTM E1840
  • Completely compliant with cGMP/GLP, international Pharmacopeias and 21 CFR part 11, and GLP

Maximum User Convenience

The SENTERRA II offers unmatched accessibility for users without any experience in Raman microscopy, easing users into a workflow which is self-explanatory. Well-refined software combined with flawless automation in order to provide users with control of all hardware parameters with just a click of a mouse.

Full Support of your Validation Needs

Bruker also provides extensive help to customers when it comes to validation. Several support options are offered based on the customer’s individual needs.

Certified appropriate software protocols are incorporated into the SENTERRA II, in order to guarantee entirely automated instrument test routines. The system provides a timely warning when it is beyond specified parameters.

Furthermore, Bruker provides installation and qualification of instruments, in addition to annual certification by their certified, factory-trained service engineers.

Powerful Instrument

Research-grade spectroscopic performance is exhibited by the SENTERRA II, with high spectral resolution, as many as 100 spectra per second, the entire spectral range, and Raman microscopy capabilities which are confocal as well as having a high throughput. Its qualities are completed by rapidly switching multi-laser excitations and minimized fluorescence via an optional 1064 nm excitation.

Ensure Product Quality

Raman microscopy analyzes foreign contaminants and production flaws reliably and quickly, even when inside packaging or behind glass.

Guard Yourself

Raman microscopy provides the ideal toolset to protect your businesses, whether you need to assess already established products, or you are faced with infringement by ruthless competitors.

Enhance your Production

Raman microscopy enables the on-the-spot evaluation of changes in morphology, elucidating error-prone steps during processing by the thorough characterization of intermediates.

Speed up Development

Both effort and time are saved courtesy of the flawless workflow and efficient automation. Energy and resources are focused where they are most required, thanks to the SENTERRA II.

Absolute Data Security, Integrity and Traceability

  • A Protected Data Pool safeguards electronic records against loss or deletion
  • Our User and Signature Management guarantees consistent separation of user responsibilities. Signatures can be double checked and password complexity individually configured
  • The Global Audit Trail is comprehensive and provides filtering for smart audit trail review
  • Compliance to FDA’s Data Integrity guidelines and cGxP requirements e.g. 21 CFR Part 11

About Bruker Optics

Bruker Optics, part of the Bruker Corporation is one of the world’s leading manufacturer and worldwide supplier of Fourier Transform Infrared, Near Infrared and Raman spectrometers.

Bruker entered the field of FTIR spectroscopy in 1974. The early instruments set new standards in research FTIR with evacuable optics, high resolution, and automatic range change. Since then, the product line has been continuously expanding with instruments suitable for both analytical and research applications with exceptional performance characteristics.

Today, Bruker Optics offers complete technical solutions for various markets which cover a broad range of applications in all fields of research and development as well as industrial production processes for the purpose of ensuring quality and process reliability.

Bruker Optics’ R&D and manufacturing center is located in Ettlingen, Germany, technical support centers and sales offices are located throughout Europe, North and South America, Asia, India, Middle East, and Africa.

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Last updated: Mar 8, 2021 at 9:47 AM


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