Over the past two years, two major developments occurred that totally changed the way the pharmaceutical industry will be conducting its future manufacturing operations. One is the decision by the FDA towards implementing more and more real time, on-line process control and monitoring, using a variety of technologies, among them being NIR spectroscopy, a discipline that has some marked advantages over other methodologies. The second change is that Brimrose, anticipating the FDA's decision, teamed up with a major pharmaceutical company to exhibit how such a NIR system would actually work.
To be more specific, the Brimrose Corporation has initiated, with encouragement from the pharmaceutical industry, a plan to develop key products that will enable every pharmaceutical process to be monitored and controlled precisely and reliably, and thereby be in continual compliance with 21CFR, Part 11.
Spectrometry, especially AOTF-NIR spectrometry, is now becoming a very important factor in the pharmaceutical manufacturing process. Beginning with raw material identification, through material dispensing, granulation, blending, and tableting, the entire solid dosage plant will be monitored and controlled by the Brimrose Luminar family of fast, accurate, and rugged analyzers.
Managing this operation is the Brimrose 21 CFR, Part 11 software. Combined with the Brimrose analyzers, a foundation has been established that will enable pharmaceutical manufacturers to attain a degree of confidence in their solid dosage form manufacturing that had previously been unattainable. Batch after batch of product will conform to the requirements of 21 CFR, Part 11.
The benefits will be remarkable, beginning with the reduction of "off-space" material, a large increase in equipment utilization time, reduced laboratory testing, and decreased cycle times from the start of production to the achievement of finished product.
The following introduces the Brimrose family of AOTF-NIR analyzers that are making this possible. Additionally, please visit the
link
that presents a paper by Dr. Ali Afnan of Astra Zeneca. Dr. Afnan describes an Astra Zeneca plant that is operating with this new manufacturing concept.
Pic 1. Luminar 2005, portable, single point Raw Material ID Analyzer.
Pic 2.
Luminar 2060, multiple point analyzer for raw Material ID in receiving (1-3 points), dispensing (1-3 points), and with expansion capability to additional areas.
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Fluidized Bed Operation
Pic 3. Diffuse reflectance probe installed in a Glatt FBD linked to a
Luminar 2060
Multiplexer spectrometer for multiple dryers
Pic 4.
Luminar 3075
full-fledged spectrometer, battery operated for no strings attached ride on the blender. Process any number of algorithms in real time, send a signal to stop the blender when ready.
Question: What is the value of real time knowledge of moisture for you?
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Blender Operation
Pic 5. Typical AOTF-NIR moisture results in a typical FBD process shows the advantage over few computrac results.
Pic 6. Now even smaller, only 18" (450x400x100mm) stainless steel, higher performance battery operated spectrometer with option for external 24V operation and Ethernet cable connection to a stand alone computer.
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Tablet Analysis
Pic 7.
Luminar 3077
tablet analyzer installed in an isolation room for automatic reception and discharge of tablets at programmed intervals.
Pic 8.
Luminar 3077
tablet analyzer during factory acceptance test. Tablets are moving on the belt.
Pic 9. Tablets moving on the belt during factory acceptance test.
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Other Applications
Pic 10. Luminar 3030 "Free Space" spectrometer installed in a moving vila content analysis. Cap color reader is installed for matching cap color with vial content for added security.
Pic 11.
Luminar 3030
"Free Space" analyzer. First derivative spectra of moving transdermal patches.
Pic 12.
Luminar 3030
"Free Space" analyzer. Calibration regression for moving transdermal patches. Investment is returned quickly by having set-up of application machine in minutes rather than 20 hours. Corrections to parameters can be validated in minutes and production started.
Pic 13. Solvent recovery operation with a 10 channel multiplexer analyzer
Pic 14. Typical trend showing the value of real time knowledge of the distillation process.
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For
More Information Please Contact:
process@brimrose.com Brimrose Corporation of America
19 Loveton Circle,
Baltimore, Maryland 21152-9201
Tel:
410-472-7070
FAX: 410-472-7960
