Sartorius FC64EDE-SXCE FC Series Intrinsically Safe Explosion-Proof Scale

Overview

The Sartorius FC64EDE-SXCE is a certified intrinsically safe, explosion-proof scale engineered for precise, legally compliant weighing in hazardous environments classified under ATEX Zone 1, FM Class I Division 1, and CSA Class I Division 1. Designed and manufactured in Germany, this 34 kg capacity scale operates on the principle of electromagnetic force compensation (EMFC), delivering high reproducibility and long-term stability under dynamic industrial conditions. Its intrinsic safety architecture ensures that no spark or thermal effect generated during normal operation or fault conditions can ignite flammable atmospheres containing gases, vapors, or dusts—making it suitable for pharmaceutical manufacturing suites, chemical synthesis labs, solvent-handling cleanrooms, and bulk powder processing lines where ignition risk is strictly controlled per IEC 60079-11 and EN 60079-15 standards.

Key Features

• Intrinsically safe design certified to ATEX II 2 G EEx ib IIC T4, FM Class I, Div 1, Groups A–D, T4, and CSA Class I, Div 1, Groups A–D, T4 — validated for use in gas groups IIA, IIB, and IIC.
• 34 kg maximum capacity with 0.1 g readability, meeting OIML R76 accuracy class III and legal-for-trade requirements per MID Annex MI-001.
• Integrated motorized auto-calibration system with isoTEST functionality: one-button initiation triggers full internal recalibration using built-in reference masses, eliminating manual intervention and ensuring metrological integrity between external audits.
• Flexible power architecture supporting dual-voltage AC input (100–120 V / 220–240 V), 24 V DC industrial power supply (suitable for installation in both safe and hazardous zones), and rechargeable battery operation (certified for Zones 1, 21, and 20).
• Backlit graphical LCD display with intuitive English-language prompts, dot-matrix character rendering, and real-time status icons — fully functional in low-light or glove-operated environments typical of process control areas.
• Robust stainless-steel display unit (FCA variant) and IP65-rated load cell housing ensure resistance to cleaning agents, condensation, and mechanical stress in regulated production settings.

Sample Compatibility & Compliance

The FC64EDE-SXCE accommodates a broad range of sample types—including powders, granules, liquids in containment vessels, and packaged intermediates—without compromising safety or measurement fidelity. Its 400 × 300 × 122 mm pan geometry supports standard IBCs, drums, and tote bins while maintaining center-of-gravity stability. All models are type-approved per European Measuring Instruments Directive (MID 2014/32/EU), compliant with EN 45501 for non-automatic weighing instruments, and support traceable calibration documentation aligned with ISO/IEC 17025 requirements. The device satisfies critical regulatory expectations for GLP and GMP environments, including audit-ready calibration logs, operator identification fields (when integrated with SartoPac Basic), and configurable data retention policies compatible with FDA 21 CFR Part 11 electronic record controls when deployed with validated software configurations.

Software & Data Management

Standard RS232C interface enables seamless integration into existing laboratory information management systems (LIMS) or manufacturing execution systems (MES). Up to eight FC-series scales may be daisy-chained via serial networking for centralized batch weighing oversight. Two primary software packages are supported: SartoPac Basic provides configurable data export (CSV, TXT), user access levels, and basic statistical evaluation; the Average Weight Control Terminal Software delivers real-time statistical process control (SPC) for packaging line compliance with USP , Ph. Eur. 2.1.5, and FDA guidance on average weight testing. Data output includes timestamped weight values, net/gross/tare identifiers, pass/fail flags for tolerance checks, and calibration event records — all structured for import into validated electronic quality management systems.

Applications

This scale is routinely deployed in applications demanding simultaneous safety certification and metrological rigor: formulation weighing of active pharmaceutical ingredients (APIs) in containment isolators; in-process verification of blend uniformity in high-potency facilities; final container fill checks for sterile vials and syringes; density determination of solvents in explosion-hazardous solvent recovery units; and dynamic checkweighing of hazardous material shipments prior to transport. Its compatibility with animal weighing, percentage mode, piece counting, and over/under-tolerance alerts further extends utility across R&D pilot plants, QC release laboratories, and contract manufacturing organizations operating under EU GMP Annex 1 or FDA cGMP Part 211.

FAQ

Is the FC64EDE-SXCE certified for use in Zone 1 classified areas?
Yes — it carries ATEX II 2 G EEx ib IIC T4 certification, permitting installation in Zone 1 gas atmospheres where explosive mixtures are likely to occur periodically.
Does the scale support automatic calibration without external weights?
Yes — the integrated isoTEST function activates the motor-driven internal calibration mass for fully automated, operator-independent recalibration at scheduled intervals or on demand.
Can the display be operated with gloved hands in cleanroom environments?
Yes — the graphical LCD features large, high-contrast icons and tactile feedback-compatible soft keys optimized for use with nitrile or latex gloves.
What documentation is provided for regulatory audits?
Each unit ships with a factory calibration certificate traceable to national standards, MID type approval documentation, ATEX/IECEx conformity statements, and optional IQ/OQ protocol templates for GxP validation.
Is battery operation approved for Zone 20 dust environments?
Yes — the rechargeable battery option is certified for Zone 20 (combustible dust) and Zone 21 (cloud formation) per IEC 60079-31 and EN 60079-31.