Total organic carbon (TOC) and conductivity testing are two key analytical methods that support Cleaning Validation, Verification and Monitoring (CVVM). These two analytical methods supporting CVVM can be performed in the laboratory, in the production workshop (sideline measurement), or in the end flow of the final rinse water of the automatic cleaning cycle (online measurement).
| M9 laboratory typeTOC analyzer | M9 portableTOC analyzer | M9 online typeTOC analyzer | |
| Where is sample analysis performed? | Quality Control QC Laboratory | Side line or production area | Connect to clean-in-place (CIP: clean-in-place) systems |
| What sample type? | Rinse and wipe | Rinse and wipe | Rinse only |
| Who takes the samples? | Production, verification or technical service personnel | Production, verification or technical service personnel | automatic sampling |
| Who does the analysis? | Quality Control QC Analyst | Production, verification or technical service personnel | automatic analysis |
Sievers® M9 TOC Analyzer Benefits
M9 Laboratory Analyzer
➤ Detection mode that fits your current laboratory and data analysis, efficient integration of analyzers
Lean analysis of TOC and conductivity
- Two-in-one Pharmacopoeia Testing
- Save analysis time and improve analysis efficiency
Increase productivity and speed up analysis
- Automatic reagent mode creates methods faster
- Reduce non-compliant OOS (Out of Specification) investigations caused by errors in environment, sample processing, transcription, etc.
- Optional Turbo Mode reduces analysis time from 2 minutes to 4 seconds, saving hours of autosampler time per run
M9 online analyzer
➤ No sample transfer
➤ Enable Process Analytical Technology (PAT)
➤ Continuous monitoring of cleaning cycles
➤ Combined with automation, equipment can be released immediately
Increase productivity and speed up analysis
- Results in 2 minutes (standard mode)
- Optional Turbo mode updates TOC, IC, and TC detection results every 4 seconds to ensure short-term excursions are captured
M9 Portable Analyzer
➤ Portable analyzers get analysis results and equipment release faster
➤ Reduce sample transportation
➤ A single instrument monitors multiple equipment cleaning cycles
➤ Enable process analytical technology (PAT)
➤ Quickly troubleshoot cleaning problems
➤ In-process testing
High-performance and accurate analysis of TOC and conductivity
- Two-in-one Pharmacopoeia Testing
- Save analysis time and improve analysis efficiency
Increase productivity and speed up analysis
- Automatic reagent mode creates methods faster
- Reduce non-compliant OOS (Out of Specification) investigations caused by errors in environment, sample processing, transcription, etc.
- Optional Turbo mode updates TOC, IC, TC test results every 4 seconds, no need to wait
Sievers also offers cleaning validation support packages
The Validation Support Package for Cleaning Validation (CVD 50000-01) can help you simplify your work process. Authentication support package includes:
- guide
- Case
- worksheet
- template
- Sample protocol
