Jena multi N/C® pharma HS Total Organic Carbon Analyzer

Overview

The Jena multi N/C® pharma HS Total Organic Carbon Analyzer is a purpose-built, regulatory-compliant instrument engineered exclusively for pharmaceutical water quality control and validation. It employs high-temperature catalytic combustion oxidation (up to 1,000 °C) coupled with non-dispersive infrared (NDIR) detection to quantify total organic carbon (TOC), total carbon (TC), and total inorganic carbon (TIC) in aqueous samples ranging from ultrapure water (UPW) and purified water (PW) to wastewater and saline matrices (up to 80 g/L chloride). Unlike general-purpose TOC analyzers, the pharma HS variant integrates hardware and software architecture aligned with pharmacopoeial requirements—including USP , European Pharmacopoeia 2.2.44, and Chinese Pharmacopoeia 0912—ensuring traceable, auditable, and repeatable measurements essential for GMP environments. Its core measurement principle relies on quantitative oxidation of all organic carbon to CO₂, followed by precise NDIR quantification under rigorously controlled gas flow, temperature, and moisture conditions.

Key Features

• Pharma-specific design: The only TOC analyzer globally certified for direct compliance with pharmaceutical water monographs and validation workflows.
• VITA® technology: A proprietary hardware-software synchronization system that continuously monitors and compensates for transient fluctuations in carrier gas flow, eliminating drift-induced variability and delivering ≤3% RSD repeatability over extended operation.
• Swab-test solid sampling module: Enables direct analysis of pharmaceutical surface swabs without solvent extraction or pre-digestion—validated for particulate-laden wipes (up to 300 µm) and compliant with cleaning validation protocols.
• Single-solution calibration: Generates full-range calibration curves using one standard solution via programmable variable-volume injection—eliminating multi-point dilution errors and reducing analyst workload.
• Platinum-catalyzed combustion: Achieves complete oxidation at lower thermal setpoints than conventional Ni-based systems, enhancing catalyst longevity and improving low-level sensitivity (detection limit: 0.05 ppm).
• Peltier-based membrane dryer: Solid-state, chemical-free moisture removal with integrated temperature compensation—no desiccant replacement, no maintenance downtime.
• Modular TN upgrade path: Optional total nitrogen (TN) module enables simultaneous TC/TN/TOC determination in a single injection, supporting elemental mass balance studies in bioprocess monitoring.

Sample Compatibility & Compliance

The multi N/C® pharma HS accommodates diverse sample types critical to pharmaceutical manufacturing: purified water, water for injection (WFI), clean-in-place (CIP) rinse solutions, fermentation broths, and environmental monitoring swabs. It tolerates high salinity (≤80 g/L NaCl), suspended solids (≤300 µm), and acidic matrices (automated on-board acidification). All operational parameters—including method execution, user access logs, electronic signatures, audit trails, and data integrity controls—are fully aligned with FDA 21 CFR Part 11, EU Annex 11, and ISO/IEC 17025 requirements. The system supports IQ/OQ/PQ documentation packages generated either onsite by Jena-certified engineers or autonomously via the embedded qualification wizard—ensuring seamless integration into regulated quality systems.

Software & Data Management

multiWin® pharma software is a validated, closed-system application built for GxP environments. It features role-based user management (admin/operator/auditor), immutable audit trails with timestamped event logging, encrypted electronic signatures, and hidden raw-data archiving. Calibration curves support linear and quadratic regression; all results are automatically linked to associated metadata (sample ID, operator, instrument state, ambient conditions). The software complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) and includes automated report generation per USP/EP templates. Data export is supported via secure CSV, PDF, and LIMS-compatible ASCII formats—with optional 21 CFR Part 11-compliant digital signature certificates.

Applications

This analyzer is deployed across pharmaceutical quality control laboratories for routine release testing of PW/WFI per pharmacopoeial limits (e.g., ≤500 ppb TOC for WFI); cleaning validation of manufacturing equipment via swab analysis; process water monitoring in bioreactor feed lines; and environmental monitoring of HVAC condensate and purified steam condensate. Its robustness extends to QC labs in contract manufacturing organizations (CMOs), API synthesis facilities, and sterile fill-finish operations—where reproducibility, regulatory readiness, and minimal operator intervention are non-negotiable.

FAQ

Does the multi N/C® pharma HS meet USP and EP 2.2.44 requirements?
Yes—the system’s combustion efficiency, detection specificity, and calibration traceability have been independently verified against both monographs.

Can it analyze swab samples without extraction?
Yes—the optional Swab-Test module allows direct insertion and thermal desorption of pharmaceutical-grade swabs, with full validation documentation provided.

Is 21 CFR Part 11 compliance built-in or add-on?
Compliance is native: multiWin® pharma includes electronic signatures, audit trail encryption, and system access controls out-of-the-box.

What is the maximum salt tolerance for liquid samples?
The instrument handles up to 80 g/L total dissolved solids (TDS), including NaCl, without performance degradation or catalyst poisoning.

Can I perform IQ/OQ/PQ without external vendor support?
Yes—the integrated Qualification Assistant guides users through protocol execution and auto-generates compliant reports in PDF and editable formats.