Sartorius SECURA224-1CN Advanced Analytical Balance

Overview

The Sartorius SECURA224-1CN is a high-precision analytical balance engineered for laboratories operating under stringent regulatory frameworks—including pharmaceutical QC, clinical research, and contract testing facilities. Utilizing electromagnetic force compensation (EMFC) technology, it delivers traceable, stable mass measurements with 0.1 mg readability across its 220 g maximum capacity. Designed in Germany and manufactured to ISO 9001-certified processes, the SECURA224-1CN integrates metrological rigor with operational safety and compliance automation. Its core architecture supports Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) workflows through embedded audit-trail capabilities, user access control, and real-time documentation integrity—ensuring full alignment with FDA 21 CFR Part 11, EU Annex 11, and ISO/IEC 17025 requirements.

Key Features

• LevelControl™ Active Leveling: Integrated inclinometer continuously monitors tilt angle; automatic motorized feet adjustment ensures optimal horizontal alignment without manual intervention—critical for long-term measurement stability and repeatability.
• isoCAL™ Fully Automatic Internal Calibration: Temperature-compensated internal calibration routine triggered by time intervals or ambient drift detection (+10 °C to +30 °C validated range), eliminating external weights and minimizing downtime.
• Advanced Pharma Compliance (APC) Suite: Preconfigured workflows for IQ/OQ risk-based qualification, automated generation of validation reports, and built-in templates for USP minimum weight determination and uncertainty estimation per EURACHEM/CITAC guidelines.
• GLP/GMP-Ready Documentation: One-touch printing of fully compliant records—including date/time stamps, operator ID, sample ID, balance ID, environmental conditions (if connected to optional sensors), and digital signature fields—via integrated YDP30 thermal printer support (auto-detected).
• Secure User Management: Role-based password protection (administrator, supervisor, operator levels), customizable access permissions, and encrypted local storage of all weighing events with tamper-evident timestamps.
• Ergonomic Design & Cleanability: Seamless stainless-steel pan and draft shield assembly with minimal crevices; smooth surfaces compatible with common disinfectants (e.g., 70% ethanol, isopropanol); IP54-rated electronics housing for dust/moisture resistance.

Sample Compatibility & Compliance

The SECURA224-1CN accommodates standard analytical samples up to 220 g in mass, with a 90 mm diameter weighing pan and 209 mm chamber height suitable for volumetric flasks, crucibles, and small reaction vessels. Its USP-compliant minimum sample weight of 0.12 g (calculated at k = 2, SD = 0.08 mg) satisfies pharmacopeial requirements for quantitative assay and content uniformity testing. The balance meets OIML R76-1 Class I accuracy specifications and is certified for use in environments governed by ISO/IEC 17025 accreditation standards. Full traceability is maintained through factory-assigned serial numbers, NIST-traceable calibration certificates (available upon request), and optional IQ/OQ documentation packages aligned with GAMP 5 principles.

Software & Data Management

Data export is supported via RS232 and USB interfaces, enabling seamless integration with LIMS, ELN, and ERP systems. Sartorius LabX® software compatibility (optional upgrade) provides centralized instrument management, statistical process control (SPC), trend analysis, and electronic signature enforcement. All local data—including raw weighing values, metadata, and calibration logs—is stored in non-volatile memory with SHA-256 hash verification to prevent unauthorized modification. Audit trail functionality complies with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), supporting regulatory inspections and internal quality audits.

Applications

• Pharmaceutical formulation development and release testing (e.g., active ingredient quantification, excipient blending verification)
• Reference standard preparation and dilution series in analytical method validation
• Residual solvent analysis sample weighing per ICH Q2(R2)
• Stability study sample preparation under controlled temperature/humidity conditions
• Environmental monitoring filter weighing (PM2.5/PM10 gravimetric analysis)
• Academic and industrial research requiring ISO/IEC 17025-compliant mass metrology

FAQ

Does the SECURA224-1CN support external calibration with traceable weights?
Yes—while isoCAL enables fully automatic internal calibration, the balance also accepts external calibration using Class E2 or better certified weights, with full calibration history logging.
Is GLP-compliant print output possible without LabX software?
Yes—the built-in printer interface supports direct GLP/GMP-formatted reports via YDP30, including operator ID, balance ID, timestamp, and sample identifier, without requiring external software.
Can multiple users be assigned distinct permission levels?
Yes—up to 10 user profiles can be configured with granular permissions for calibration, method editing, report generation, and system settings.
What environmental conditions are required for optimal performance?
Operational temperature range: +10 °C to +40 °C; relative humidity: ≤80% RH non-condensing; vibration isolation recommended on non-dedicated lab benches.
Is the SECURA224-1CN compliant with FDA 21 CFR Part 11?
When used with LabX software and appropriate IT infrastructure (e.g., electronic signatures, audit trails, role-based access), it fulfills technical requirements for electronic records and signatures as defined in 21 CFR Part 11.