Troemner Class E2 Stainless Steel Calibration Weights – Models 8124W and 8458W

Overview

The Troemner Class E2 stainless steel calibration weights—models 8124W and 8458W—are precision-machined reference standards engineered for high-accuracy mass calibration of analytical balances, microbalances, and semi-microbalances in regulated laboratory environments. Designed and manufactured in the United States under strict ISO/IEC 17025-accredited production protocols, these weights comply with OIML R111-1 (2023) and ASTM E617–22 specifications for Class E2 tolerance limits. Each weight is fabricated from non-magnetic, corrosion-resistant 316L stainless steel, featuring a polished surface finish to minimize particulate adhesion and environmental oxidation. The 8124W and 8458W models represent distinct nominal mass values within the 1 mg to 200 g range—commonly deployed as primary or secondary standards in metrology labs, pharmaceutical QC facilities, and ISO 17025-certified calibration service providers.

Key Features

• Class E2 accuracy per OIML R111-1: maximum permissible error (MPE) ±0.03 mg for 1 g weights, scaling proportionally across the full nominal range
• Monolithic construction from vacuum-melted 316L stainless steel—no welds, inserts, or adjustable cavities to compromise long-term stability
• Traceable calibration certificate included: NIST-traceable mass values with expanded uncertainty (k=2), temperature correction coefficients, and air buoyancy correction data
• Hermetically sealed, anti-static transport cases with individually nested compartments and desiccant control—designed to maintain certified mass integrity during handling and storage
• Surface roughness Ra ≤ 0.2 µm, verified by profilometry; passivated per ASTM A967 to eliminate free iron and ensure uniform oxide layer formation
• Compliant with ISO 9001:2015 and ISO/IEC 17025:2017 quality management systems throughout design, machining, cleaning, and certification processes

Sample Compatibility & Compliance

These weights are compatible with all gravity-based mass measurement instruments requiring Class E2 traceability—including electromagnetic force compensation (EMFC) balances, mechanical lever balances, and comparator-based mass comparators. They meet mandatory requirements for use in FDA-regulated environments where USP and govern balance verification, as well as EU Annex 11-compliant GMP facilities performing periodic performance qualification (PPQ). All units undergo rigorous cleaning per ISO 10012-1 prior to packaging and are certified for use at 20 °C ±1 °C and 50% RH ±5%. Documentation includes full metrological history, including previous calibration dates, drift assessments, and environmental exposure logs—essential for GLP audit readiness and 21 CFR Part 11-compliant electronic record retention.

Software & Data Management

While the weights themselves are passive physical standards, their associated calibration reports integrate seamlessly into LIMS and ELN platforms via standardized PDF/A-1b and CSV export formats. Troemner’s digital calibration certificates include machine-readable QR codes linking directly to secure, time-stamped archival records hosted on an ISO 27001-certified cloud repository. Each certificate contains unique identifiers enabling automated reconciliation against internal asset management databases. For laboratories operating under 21 CFR Part 11, the reporting system supports electronic signatures, audit trails, and role-based access controls—ensuring full compliance with data integrity requirements for regulated mass calibration workflows.

Applications

• Primary calibration of analytical balances used in pharmacopeial assay validation (e.g., USP , EP 2.1.6)
• Periodic verification and intermediate checks per ISO/IEC 17025 clause 6.4.10 and EURAMET cg-18 guidelines
• Uncertainty budgeting for mass measurement systems in accredited calibration laboratories
• Reference standards in national metrology institutes (NMIs) and designated calibration centers for inter-laboratory comparisons
• Validation of weighing modules in automated dispensing systems and continuous manufacturing platforms
• Education and training in metrology curricula, emphasizing traceability chains and uncertainty propagation fundamentals

FAQ

Are Troemner Class E2 weights suitable for use in ISO 17025-accredited calibration laboratories?
Yes—each set is supplied with a NIST-traceable calibration certificate issued by an ISO/IEC 17025-accredited calibration provider, fulfilling clause 6.4.10 requirements for certified reference materials.
What is the recommended recalibration interval for these weights?
Troemner recommends annual recalibration under typical laboratory conditions; however, frequency must be risk-assessed per ISO/IEC 17025 and aligned with usage intensity, environmental exposure, and internal quality procedures.
Do the 8124W and 8458W models include magnetic susceptibility testing data?
Yes—certificates report magnetic susceptibility ≤ 0.005 cm³/kg (per OIML R111 Annex C), verified using a superconducting quantum interference device (SQUID) magnetometer.
Can these weights be used for calibrating balances in cleanroom environments (ISO Class 5 or better)?
Yes—their ultra-low particle-shedding surface finish and passivation treatment meet ISO 14644-1 cleanliness requirements for Class 5 operation when handled with Class 100 cleanroom gloves and tweezers.
Is there documentation supporting compliance with FDA 21 CFR Part 11 for electronic records?
While the physical weights do not generate electronic records, Troemner’s digital certificate platform provides Part 11-compliant features including audit trails, electronic signatures, and secure data archiving—fully documented in the system validation package available upon request.