Carl Zeiss
Source: Carl Zeiss
The pharmaceutical industry is one of the industries with the highest sales, but also with the most stringent regulations regarding production standards. The development of new drugs may take up to 10 years and cost more than €500m. The development cycle from discovery to production start is very complex and necessitates close cooperation between many different departments in research and development, process development and production. The possibility of shortening the times required for analysis and performing on-line production monitoring is a major requirement of the pharmaceutical industry, because this speeds up the time-to-market. In addition, more efficient analyzing methods such as NIR spectroscopy allow 100% quality control. The use of process analysis technology in production will shorten product cycles, reduce costs and considerably increase reliability.
Carl Zeiss has provided solutions for a great number of applications, based on two spectrometer systems:
- CORONA
- MCS 500
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Research
& Development
Development of methods for quantitative analysis and color measurement. |
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Quality control
In-line and at-line measurement solutions for non-destructive determination of homogeneity, potency, humidity, purity and color of initial, intermediate and end products by means of reflection and transmission measurements.
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Process control and determination of release
rates
One of the factors influencing the effect of drugs is the release rate of their active agents. Fiber optic probes are used to determine the release kinetics of new drugs. |
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Monitoring of cleaning processes
The measurement of active residues during and after cleaning of pharmaceutical process equipment is an important aspect in the validation of cleaning processes. |
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Drying processes
The drying of active agents in pharmaceutical production is an essential phase in the manufacturing process. On-line monitoring of the drying process may eliminate the need for subsequent drying, minimize rejects, reduce the costs for laboratory analyses and hence enhance process productivity. |
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Mixing processes
When mixing drugs, the homogenous blending with the carrier material must be guaranteed. To eliminate under- or overblending, the process can be monitored on-line. The batch will not have to be reprocessed or, even worse, be lost. |