Mettler Toledo PAT (Process Analytical Technology) solutions are a suite of software tools, primarily anchored by the LabX™ Laboratory Software platform and specialized reaction analysis software like iC IR and iC Kinetics™. This integrated software ecosystem is designed to enable Quality by Design (QbD) strategies by providing real-time process understanding, data management, and regulatory compliance.
Key Capabilities & Features:
- Centralized Control: LabX acts as a single interface to manage and control a wide range of METTLER TOLEDO laboratory instruments, including balances, titrators, pH meters, UV/Vis spectrophotometers, and more, across a network.
- SOP Guidance: The software provides full, step-by-step Standard Operating Procedure (SOP) guidance directly on the instrument terminal touchscreens, minimizing user errors and ensuring consistent workflows.
- Real-Time Analysis: Specialized PAT software (e.g., iC IR, iC Kinetics) interfaces with in-situ analytical tools (FTIR, Raman, FBRM) to monitor chemical reactions, crystallization, and other unit operations in real time, providing kinetic and mechanistic data.
- Data Integrity & Compliance: The system ensures secure, traceable, and complete data management in compliance with the FDA 21 CFR Part 11 and ALCOA+ principles. Technical controls include a comprehensive audit trail, electronic signatures, user level management, and access control.
- Seamless Integration: LabX is designed to integrate fully with major laboratory and enterprise systems (LIMS, ELN, MES, CDS, ERP, SAP) via a single interface, facilitating a paperless, bi-directional data flow from the instrument to the final data repository.
Target Users and Use Cases:
- Target Users: Process Engineers, Analytical Chemists, R&D Scientists, Quality Control (QC) Technicians, and IT/Compliance Managers in regulated industries.
- Use Cases: Pharmaceutical R&D and manufacturing, API (Active Pharmaceutical Ingredient) production, bioprocess monitoring, chemical synthesis, process scale-up, and quality assurance/control.