Sartorius BCE64i-1CCN Analytical Balance

Overview

The Sartorius BCE64i-1CCN is a high-performance analytical balance engineered for precision mass measurement in regulated laboratory environments. Utilizing a monolithic super-single-cell electromagnetic force compensation sensor mounted on a vibration-dampening die-cast aluminum baseplate, the BCE64i-1CCN delivers exceptional stability and metrological integrity. Its core operating principle relies on real-time electromagnetic feedback to counteract gravitational load—ensuring linear, drift-free measurements across its full 64 g capacity range. Designed and manufactured in Germany under strict ISO 9001-certified production protocols, this balance meets the fundamental performance requirements of ISO/IEC 17025 accredited testing laboratories and complies with key pharmacopeial standards including USP , EP 2.1.3, and JP 2.03. The instrument is classified as Class I (precision) per OIML R 76-1 and fulfills the repeatability and linearity criteria for analytical applications demanding ≤0.1 mg readability.

Key Features

• Monolithic electromagnetic force compensation sensor integrated into a rigid, low-resonance aluminum chassis for minimized mechanical hysteresis and long-term stability.
• isoCAL® internal calibration system—automatically triggered by time intervals or temperature fluctuations (±1.5 °C deviation)—ensures continuous traceability without manual intervention.
• Calibration Audit Trail (CAL Audit Trail) logs every calibration event—including date, time, operator ID (if configured), ambient conditions, and deviation values—supporting full compliance with FDA 21 CFR Part 11 and EU Annex 11 data integrity requirements.
• Chemical-resistant front and side panels withstand routine exposure to acetone, ethanol, and other common lab solvents; surface treatment enables rapid decontamination without degradation.
• Integrated anti-static system: conductive coating on weighing pan and full draft shield assembly dissipates electrostatic charge, reducing measurement drift during low-mass or dry-powder handling.
• Fully detachable five-sided glass draft shield with optimized airflow geometry—designed for minimal turbulence and rapid stabilization—facilitates unobstructed sample access and thorough cleaning between batches.
• Intelligent thermal compensation backplate dynamically adjusts for ambient temperature gradients, mitigating convection-induced errors during extended weighing sessions.

Sample Compatibility & Compliance

The BCE64i-1CCN supports diverse sample types—from hygroscopic powders and volatile solvents to micro-volumes in tare vessels—via its below-balance weighing hook and configurable pan geometry. Its 90 mm diameter stainless steel pan and 240 mm vertical clearance accommodate standard volumetric flasks, crucibles, and filtration assemblies. All firmware and calibration logic adhere to GLP and GMP operational frameworks: audit trails are immutable, user access levels are configurable (admin/operator/guest), and electronic signatures may be enabled via optional Sartorius LabX™ integration. The device is certified to EN 61326-1 (EMC), EN 61010-1 (safety), and carries CE marking for conformity with EU Measurement Instruments Directive (MID) Annex MI-001 for non-automatic weighing instruments.

Software & Data Management

Data export is natively supported via Mini-USB interface using industry-standard protocols: SBI (Sartorius Basic Interface), XBPI (eXtended Balance Protocol Interface), CSV, and plain-text formats—enabling direct import into Microsoft Excel, LIMS, or ELN platforms without proprietary drivers. Output intervals are programmable from 0.1 s to 600 s. Optional LabX™ connectivity provides centralized instrument management, automated report generation (including PDF with digital signature), and full 21 CFR Part 11 compliance—covering electronic records, role-based permissions, and secure audit trail archiving. All calibration metadata—including isoCAL® trigger conditions, sensor diagnostics, and environmental logs—is embedded in exported files for full regulatory traceability.

Applications

• Quantitative preparation of reference standards and working solutions in pharmaceutical QC labs.
• Gravimetric analysis for elemental determination (e.g., ash content, loss-on-drying) per ASTM E1868 and ISO 5725.
• Formulation development requiring sequential addition of multiple components with real-time cumulative mass tracking.
• Density determination of solids and liquids using Archimedean principles with integrated density application module.
• Statistical process control (SPC) of tablet weight variation in manufacturing environments compliant with ICH Q5A and USP .
• Checkweighing of sterile vials, syringes, or lyophilized product units against predefined tolerance bands.
• Dynamic weighing of unstable samples (e.g., drying kinetics, solvent evaporation) with peak-hold and filtering algorithms.

FAQ

What does “isoCAL®” mean, and how often does it activate?
isoCAL® is Sartorius’ patented internal calibration technology that initiates automatically when ambient temperature changes exceed ±1.5 °C or at user-defined time intervals (e.g., every 2, 4, or 8 hours). It performs full span calibration using built-in reference masses.
Is the BCE64i-1CCN compliant with FDA 21 CFR Part 11?
Out-of-the-box, it supports ALCOA+ data integrity principles. Full Part 11 compliance—including electronic signatures and audit trail protection—requires LabX™ software configuration and appropriate IT governance controls.
Can the balance connect directly to a network printer?
Yes—via USB or RS-232 (with optional adapter), the BCE64i-1CCN auto-detects connected printers and formats output per GLP/GMP templates, including date/time stamps, operator ID, and calibration status.
What is the maximum sample height allowed under the draft shield?
The internal vertical clearance is 240 mm from pan surface to top of shield, accommodating tall containers such as 1-L volumetric flasks or desiccators.
Does the balance support density determination of irregular solids?
Yes—the built-in density application guides users through air-weight and submerged-weight steps using the optional density kit (including sinker and holder), calculating density per ISO 1183-1 with uncertainty propagation.