On-line Cleaning Validation
Cleaning validation is a very important issue in the batch production of pharmaceuticals
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•Brochure: CleanScan™
Cleaning validation is a very important issue in the batch production of pharmaceuticals. Production run campaigns are followed by periods of 'Change-Over' and this can have considerable impact on the production capacity. A reactor has to be thoroughly cleaned by a validated process before the next production cycle can start and large volumes of solvent such as methanol and acetone are used.
•Brochure: CleanScan™
•Brochure: CleanScan™
Cleaning validation is a very important issue in the batch production of pharmaceuticals. Production run campaigns are followed by periods of 'Change-Over' and this can have considerable impact on the production capacity. A reactor has to be thoroughly cleaned by a validated process before the next production cycle can start and large volumes of solvent such as methanol and acetone are used.
Samples from the wash cycle are measured off-line that is time consuming and costly. Final analysis is typically by a swab samples and HPLC.
The solution is to install an on-line analyser that has a fast response time and sensitivity to monitor the status of the cleaning process in real time.
Benefits
- Reduces Change-Over time and increases production
- Reduces the consumption of expensive methanol and other reactor wash solvents
- Eliminates operator error
- Highly reproducible and stable diode array system
- Easy to use software
- UV is very sensitive, possible LOD of 1 ppm (depends on chromophore)
•Brochure: CleanScan™
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