Sartorius Cubis® II MCA Manual Mass Comparator

Overview

The Sartorius Cubis® II MCA Manual Mass Comparator is a metrology-grade instrument engineered for high-accuracy mass comparison in national metrology institutes, accredited calibration laboratories, and primary standards facilities. It operates on the principle of electromagnetic force compensation (EMFC), utilizing a next-generation super-monolithic sensor architecture that eliminates mechanical hysteresis and thermal drift commonly associated with traditional strain-gauge or flexure-based load cells. Designed in strict accordance with OIML Recommendation R 111-1 (2022 edition) and ASTM E617–23, the Cubis® II MCA delivers traceable mass comparisons at F-class environmental conditions—defined as ambient temperature stability ±0.5 °C, relative humidity 30–70 % RH, and air pressure variation ≤1 kPa/h. Its core function is not simple weighing, but rather the deterministic evaluation of mass ratios between reference standards and test weights under rigorously controlled conditions, enabling full uncertainty budgeting per GUM (JCGM 100:2018) and ISO/IEC 17025:2017 clause 7.6.

Key Features

• Super-monolithic EMFC sensor system with integrated thermal mass stabilization, delivering sub-microgram repeatability and <3-second stabilization across all models (MCA36 to MCA1004)
• Optimized weighing chamber geometry with motorized auto-door and laminar-flow air guidance—reducing convective disturbances by >60% compared to previous generation comparators
• Real-time environmental monitoring (temperature, pressure, humidity) coupled with automatic compensation algorithms compliant with OIML R 111-1 Annex C
• Integrated MassCal software suite enabling fully guided, step-by-step mass calibration workflows—including automated sequence execution, uncertainty propagation, and certificate generation per ISO/IEC 17025
• Clean QApp—a validated, audit-ready cleaning protocol module supporting ISO 17025 clause 7.9 and USP analytical instrument qualification (AIQ)
• Full 21 CFR Part 11 compliance: role-based user authentication, electronic signatures, immutable audit trail with time-stamped event logging, and data export in PDF/A-2b or CSV with cryptographic hash verification

Sample Compatibility & Compliance

The Cubis® II MCA supports manual mass comparison of weights conforming to OIML R 111 classes E₁, E₂, F₁, and F₂, as well as ASTM Class 0, 1, and 2 reference masses. It accommodates cylindrical, hexagonal, and parallelepiped weight geometries up to 1110 g (MCA1004 model), with maximum height clearance of 120 mm and base diameter compatibility up to 85 mm. All models are CE-marked and type-approved per MID Directive 2014/32/EU Annex MI-002 for legal metrology applications. The instrument’s mechanical design satisfies ISO 14644-1 Class 5 cleanroom compatibility when operated with optional HEPA-filtered air purge kit.

Software & Data Management

MassCal is the native metrological software platform embedded within the Cubis® II MCA’s Linux-based operating system. It implements OIML R 111-1 Annex D procedures for substitution weighing, ABBA and BACB sequences, and multi-step uncertainty analysis incorporating Type A (statistical) and Type B (systematic) components. Raw measurement data—including timestamped sensor output, environmental parameters, and operator actions—is stored in an encrypted SQLite database with SHA-256 integrity checksums. Export formats include XML (in compliance with EURAMET cg-18), PDF/A-2b (archival-grade), and CSV with metadata headers required for LIMS integration. Remote diagnostics and firmware updates are performed via secure TLS 1.3 channel with certificate pinning.

Applications

• Primary and secondary calibration of weight standards in NMIs and DAkkS-accredited labs
• Verification of mass standards prior to use in pharmaceutical balance validation (per USP and EU GMP Annex 15)
• Uncertainty budgeting for ISO/IEC 17025 accreditation assessments
• Inter-laboratory comparison studies coordinated by BIPM or regional metrology organizations
• Support of ISO 10012-based measurement management systems in manufacturing QA environments
• Traceable mass assignment for certified reference materials (CRMs) under ISO Guide 35

FAQ

Does the Cubis® II MCA support automated mass comparison sequences?
No—it is a manual comparator designed for operator-controlled substitution weighing. Fully automated operation requires the Cubis® II ACA (Automatic Comparator Assembly) configuration.
Can MassCal generate certificates compliant with ISO/IEC 17025?
Yes—MassCal produces editable, digitally signed calibration certificates containing full uncertainty budgets, environmental correction factors, and traceability statements aligned with ILAC P10:2022.
What environmental conditions are required for OIML R 111-1 compliance?
F-class conditions: temperature stability ±0.5 °C over 24 h, humidity 30–70 % RH, air pressure variation ≤1 kPa/h, and vibration isolation per ISO 25378.
Is the Cubis® II MCA suitable for use in cleanrooms?
Yes—when equipped with the optional cleanroom package (HEPA filtration, stainless-steel housing, static-dissipative surface finish), it meets ISO 14644-1 Class 5 requirements.
How is measurement traceability maintained?
Through direct linkage to national standards via Sartorius’ DAkkS-accredited calibration services, documented in the instrument’s digital metrological passport and verified annually per ISO/IEC 17025 clause 6.6.