 |
Global pharmaceutical water regulations continue to evolve and a move to continuous TOC monitoring is the next challenge for many pharma companies. Drug manufacturers want confidence in analytical instrumentation to ensure compliance with pharmacopeia requirements and regulatory pharmaceutical audits. Failure to meet even one requirement, such as total organic carbon (TOC), could potentially produce non-conforming product, risking fines and possibly even human lives.
The 6000TOCi system exceeds all requirements to meet pharmacopeia regulations while providing the end-user advanced features, including predictive diagnostics.
This document summarizes how METTLER TOLEDO's 6000TOCi provides an audit-ready solution for the pharmaceutical industry. Sections covered in the document include:
- Meeting global pharmacopeia requirements
- Full transparency from real-time TOC monitoring demonstrates control for your auditors
- UV oxidation technology is recognized as a proven method by auditors
- Sensor diagnostics show auditors that your analyzer has been measuring correctly
- Comprehensive documentation for answering auditor inquiries
The 6000TOCi is METTLER TOLEDO Thornton’s Total Organic Carbon sensor for the pharmaceutical industry. It is an audit-ready solution for pharma water systems. This on-line continuous, real-time TOC sensor reports data every second for full transparency of TOC levels. Its unique hydro-mechanical design ensures measurement repeatability and stability over the lifetime of the instrument. Additionally, its design provides a solution with minimum complexity and eliminates many high-risk points of failure. Most importantly, it is compliant with all major global pharmacopeia for TOC with the necessary records to support audits.
The 6000TOCi features Intelligent Sensor Management (ISM), METTLER TOLEDO's process analytics platform that combines the advantages of in-line analytical measurements in pharmaceutical companies with modern digital technology. ISM sensors offer improved performance over analog probes for a number of reasons. ISM predictive diagnostics help to ensure that the sensors do not fail during operation.
