Sartorius Secura225D-1CN Advanced Analytical Balance (Dual-Range, 0.01 mg / 0.1 mg)

Overview

The Sartorius Secura225D-1CN is a high-precision dual-range analytical balance engineered for regulated laboratory environments where trace-level mass measurement, data integrity, and procedural compliance are non-negotiable. Operating on electromagnetic force compensation (EMFC) principle, it delivers metrologically traceable measurements with two distinct readability modes: 0.01 mg (up to 120 g) and 0.1 mg (up to 220 g), enabling seamless transition between ultra-micro and standard analytical weighing tasks without instrument changeover. Its design adheres to the fundamental requirements of ISO/IEC 17025, USP <41> and <1251>, and supports full alignment with FDA 21 CFR Part 11 and EU Annex 11 when configured with appropriate software and audit trail settings. The balance integrates hardware- and firmware-based safeguards—including real-time horizontal verification, temperature-compensated internal calibration, and minimum weight enforcement—to eliminate operator-induced variability and ensure measurement validity from first use.

Key Features

• isoCAL Internal Calibration & Adjustment: Fully automatic, time- or temperature-triggered recalibration with built-in reference masses; eliminates manual calibration drift and ensures long-term stability across ambient fluctuations.
• LevelControl System: Patented photoelectric sensor continuously monitors leveling status; halts data output until re-leveling is confirmed, preventing transmission of geometrically compromised results.
• Advanced Pharma Compliance (APC): Embedded workflow guidance for GxP-critical operations including USP minimum weight assessment, user-defined tolerance limits, and auto-suppression of data export when sample mass falls below validated thresholds.
• Cal Audit Trail: Tamper-resistant, time-stamped log of every isoCAL event—including operator ID, environmental conditions, and calibration deviation—exportable in CSV format for QA review and regulatory submission.
• Ergonomic & Containment-Safe Design: Touchscreen interface with intuitive icon-based navigation; no need to lean over or reposition during leveling—critical for safe operation under fume hoods or in BSCs.
• Hygienic Construction: Seamless, chemical-resistant surfaces; minimal crevices and rounded edges compliant with ISO 14644-1 Class 5 cleanroom handling protocols and routine disinfection cycles.

Sample Compatibility & Compliance

The Secura225D-1CN accommodates standard analytical vessels (weighing boats, vials, crucibles) up to Ø130 mm diameter and 200 mm height. Its draft shield features quick-release hinges and static-dissipative glass panels to minimize electrostatic interference during low-mass weighing. All firmware and operational logic comply with USP <41> repeatability criteria and <1251> risk-based method validation frameworks. When deployed in pharmaceutical QC labs, the balance supports full qualification per ASTM E898–22 and ICH Q2(R2) guidelines. Optional IQ/OQ documentation packages—including risk-based test protocols, executed reports, and equipment-specific URS—are available through Sartorius-certified field service engineers at installation.

Software & Data Management

Data output is supported via RS232, USB Device, and optional Ethernet interfaces. The balance natively exports ASCII-formatted weighing records—including timestamp, net/gross/tare values, operator ID, and calibration status—to LIMS, ELN, or MES systems without middleware. When paired with Sartorius LabX® software (sold separately), users gain full 21 CFR Part 11 compliance: electronic signatures, role-based access control, automated report generation, and secure database archiving with immutable audit trails. Raw data files include embedded metadata (e.g., environmental logs, isoCAL history, leveling events) required for GLP/GMP audits.

Applications

• Pharmaceutical formulation development and release testing (API potency, blend uniformity)
• Reference standard preparation and traceability chain maintenance per ISO/IEC 17034
• Environmental analysis (e.g., gravimetric PM2.5 filter weighing per EPA Method 201A)
• Materials science research requiring sub-100 µg mass resolution (e.g., catalyst loading, thin-film deposition quantification)
• Regulated clinical trial sample inventory management with full chain-of-custody logging
• Method validation studies requiring repeatability assessment per USP <41> and EUR Pharm 2.2.17

FAQ

Does the Secura225D-1CN meet USP <41> repeatability requirements?
Yes—its ≤ ±0.01 mg repeatability at 0.01 mg readability fully satisfies USP <41> criteria for loads ≥ 200 mg, and its integrated minimum weight function enforces compliance for lower masses.
Can isoCAL be scheduled automatically based on temperature change?
Yes—users may configure isoCAL to trigger upon predefined ΔT thresholds (e.g., ±1.0 °C from last calibration), ensuring measurement accuracy despite lab HVAC cycling.
Is LevelControl compatible with vibration-prone lab benches?
LevelControl detects tilt only—not vibration—and remains functional on stable anti-vibration tables; however, mechanical isolation is recommended for optimal 0.01 mg performance.
What documentation is provided for GxP validation?
Sartorius offers factory-verified IQ/OQ protocols aligned with Annex 15 and ASTM D5297, including risk assessments, test scripts, executed evidence, and certificate of conformance—all signed by qualified validation engineers.
How is minimum sample weight determined and enforced?
During installation, Sartorius service engineers perform repeatability tests per USP <1251>, program the validated minimum weight into firmware, and affix tamper-evident calibration seals—data export is suspended if actual load falls below this threshold.