Sartorius Secura Analytical Balance (Discontinued, Replaced by Quintix Pro Series)
| Brand | Sartorius |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Product Category | Domestic |
| Model | Secura |
| Instrument Type | Analytical Balance |
| Maximum Capacity | 6100 g |
| Readability | 0.1 mg (for models up to 220 g) |
| Repeatability | ≤ ±0.1 mg (0.1 mg models) |
| Calibration | Fully Automatic Internal Calibration (isoCAL) |
| Leveling System | Smart Photoelectric LevelControl with Real-Time Tilt Detection and Interactive Guidance |
| Compliance Features | Advanced Pharma Compliance (APC), USP Minimum Weight Monitoring, Cal Audit Trail, IQ/OQ Documentation Support |
| Data Interface | Mini-USB, SBI/xFPI Protocol, Direct Output to Windows® Applications |
Overview
The Sartorius Secura Analytical Balance is a discontinued yet historically significant laboratory balance engineered for precision weighing in regulated environments—including pharmaceutical quality control, clinical research, and GMP-compliant manufacturing. Designed around the principles of metrological integrity and operational safety, the Secura employs electromagnetic force compensation (EMFC) technology to deliver high-resolution mass measurement with exceptional long-term stability. Its architecture integrates regulatory foresight directly into hardware and firmware: real-time leveling verification, temperature-compensated internal calibration (isoCAL), and proactive data integrity safeguards ensure that every recorded value meets traceability requirements under ISO/IEC 17025, USP , and FDA 21 CFR Part 11. Though superseded by the Quintix Pro series, the Secura remains widely referenced in legacy validation protocols and continues to operate in laboratories where documented equivalence and historical compliance continuity are critical.
Key Features
- isoCAL Fully Automatic Internal Calibration & Adjustment: Programmable time- or temperature-triggered calibration ensures consistent accuracy across environmental fluctuations. Each calibration event is logged with timestamp, operator ID (if enabled), and deviation values in the Cal Audit Trail—supporting audit readiness per ALCOA+ principles.
- LevelControl Intelligent Auto-Leveling System: A built-in photoelectric sensor continuously monitors tilt angle. If out-of-tolerance positioning is detected, the display presents step-by-step visual guidance for re-leveling—and blocks data export until correction is confirmed, preventing erroneous reporting.
- Advanced Pharma Compliance (APC): Enforces USP minimum weight criteria dynamically. When sample mass falls below the validated SQmin threshold (e.g., 0.12 g for 0.1 mg readability models), the balance halts data transmission to printers or connected PCs and issues an unambiguous alert.
- High-Integrity Data Management: Supports multiple output formats (SBI, xFPI, tabular, plain text) via Mini-USB. Compatible with YDP30/YDP40 printers and direct integration into LIMS or ELN platforms running Microsoft Windows®.
- Ergonomic & Contamination-Resistant Design: Seamless, non-porous surfaces with minimal crevices enable rapid decontamination using common lab-grade disinfectants. The compact footprint and low-profile draft shield (where applicable) reduce turbulence interference during micro-weighing.
Sample Compatibility & Compliance
The Secura accommodates standard analytical workflows involving powders, granules, liquids, and small solid specimens. Its draft shield variants (models with 209 mm height) provide stable weighing conditions for volatile or hygroscopic samples. All Secura units shipped with factory-applied verification seals and pre-configured SQmin parameters—validated on-site by Sartorius-certified service engineers per risk-based IQ/OQ protocols aligned with Annex 15 and ASTM E898. The balance complies with OIML R76, EN 45501, and NIST Handbook 44 for legal-for-trade applications where applicable. Full documentation packages—including test scripts, raw results, and deviation reports—are available upon request to support regulatory submissions.
Software & Data Management
No proprietary software installation is required for basic operation; however, Sartorius provides optional DataControl software for centralized configuration, remote monitoring, and electronic signature-enabled report generation. The Cal Audit Trail stores all calibration metadata—including date/time, ambient temperature at execution, internal reference mass deviation, and user confirmation status—in encrypted, read-only format. Exported weighing data includes embedded metadata fields (balance ID, timestamp, calibration status flag, level status flag), enabling automated validation logic in downstream systems. All firmware updates undergo formal change control and are distributed exclusively through authorized Sartorius service channels.
Applications
The Secura was routinely deployed in applications demanding strict adherence to pharmacopeial standards: active pharmaceutical ingredient (API) assay preparation, reference standard dilution, excipient blending verification, and finished-dose uniformity testing. Its statistical weighing mode supported content uniformity calculations per USP , while density and percentage functions facilitated formulation development. In academic and contract research settings, it served as a reference-grade instrument for method validation studies requiring documented uncertainty budgets and intermediate precision assessments across operators and shifts.
FAQ
Is the Secura still supported with service and spare parts?
Yes—Sartorius maintains extended service coverage for Secura balances under its Legacy Product Support Program, including certified calibration, repair, and component replacement for at least 10 years post-discontinuation.
Can Secura data meet FDA 21 CFR Part 11 requirements?
When operated with password protection enabled, Cal Audit Trail activated, and electronic signatures configured via DataControl, Secura-generated records satisfy Part 11 criteria for authenticity, confidentiality, and retention.
What does “SQmin” mean in Secura’s context?
SQmin denotes the smallest sample mass for which measurement uncertainty remains within USP acceptance limits (typically ≤ 0.1% RSD). Secura calculates this dynamically based on readability, repeatability, and user-defined confidence level.
How is isoCAL different from conventional external calibration?
Unlike manual calibration with external weights, isoCAL uses an integrated, temperature-stabilized reference mass and self-diagnostic routines to adjust gain and zero points—eliminating handling errors and reducing calibration-induced downtime.
Does Secura require annual third-party certification?
While not mandatory, annual verification by an ISO/IEC 17025-accredited provider is recommended for GxP environments. Sartorius offers accredited on-site verification services with full uncertainty budgeting and certificate issuance.
