Pharmaceutical Products
GE Analytical Instruments offers the following products for pharmaceutical applications:
TOC Analyzers and Sensors
- Sievers 500 RL On-Line TOC Analyzer
- Sievers 900 Laboratory TOC Analyzer
- Sievers 900 On-Line TOC Analyzer
- Sievers 900 On-Line Turbo TOC Analyzer
- Sievers 900 Portable TOC Analyzer
- Sievers 900 Portable Turbo TOC Analyzer
- CheckPoint Portable/On-Line TOC Sensor
Quality System Optimization (QSO) Documents and Services
Quality System Optimization (QSO) provides a risk-based, scientific framework for moving TOC testing from the laboratory to the production floor. It incorporates Lean manufacturing and Six Sigma® best practices, aligned with current Good Manufacturing Practices (cGMPs) and regulatory guidance. QSO provides a practical roadmap on how to evaluate variability and identify opportunities for improvement in TOC sample analysis processes. Services and documentation includes:
- Sievers 500 RL Installation Package - This aligns the Sievers 500 RL TOC Analyzer with regulatory Expectations and ASTM best-practice standards for on-line TOC testing.
- Validation Support Package (VSP) II
- Method Validation - Specificity and Robustness Protocols (for the Sievers 900 and 500 RL Series TOC Analyzers)
- Method Comparability and Transfer
- Measurement System Equivalency
- Historical Data Collection and Review
- Point of Use Quality Verification
- Cleaning Validation Support Package (CVSP)
- Consulting services
- Strategic workshops
Accessories and Software
- TOC Standards and Certified (<10 ppm) TOC Vials
- GE Autosampler
- Data Pro/Data Guard software
- DataShare software
Contact us to learn more.