Sievers M9 Laboratory TOC Analyzer
The M9 Lab offers time-tested dependability and accuracy with Sievers TOC technology. Beyond analytical performance and compliance, the M9 Lab has automated features to save you time, an option for simultaneous Stage 1 conductivity testing, and four-second analysis time in Turbo mode. The M9 TOC Analyzers and software comply with 21 CFR Part 11 and meet, or exceed, recent data integrity guidelines. For the pharmaceutical industry, Sievers Validation Support Packages (VSPs) help you navigate the M9 validation process and enable a more efficient instrument implementation. The new Sievers VSP for software is written specifically to address Data Integrity and 21 CFR Part 11 by validating Sievers DataPro2 software.
M9 Lab Features & Benefits
- Two-minute sample analysis time
- Measures discrete grab samples or can be connected to the Sievers Autosampler for high-volume sample analysis
- Automated operations, such as calibration, verification, and data analysis
- Autoreagent feature automatically establishes optimal flow rates for each sample
- Well suited for a variety of sample matrices and concentrations
- Minimal preventive maintenance (typically just a few hours per year)
- 12-month calibration stability
- Optional Stage 1 conductivity capability for simultaneous testing of TOC and conductivity
- Optional Turbo mode for four-second analysis
M9 Lab Specifications
Operating Specifications* |
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Range | 0.03 ppb to 50 ppm |
Precision | < 1% RSD |
Accuracy | ± 2% or ± 0.5 ppb, whichever is greater |
Display Readout | 3 significant digits |
Sample Type | Autosampler or discrete grab sample |
Calibration | Typically stable for 12 months |
Analysis Time | 2 minutes (4 seconds with the optional Turbo mode) |
Sample Temperature | 5–95 °C (41–203 °F) |
Ambient Temperature | 5–40 °C (41–104 °F) |
Instrument Sample Flow Rate |
0.5 mL/min |
Analyzer Specifications |
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Outputs | USB device port (1); USB host ports (3); Modbus TCP/IP |
Display | 7″ WVGA 800X480 pixel, Color LCD with touch-screen |
Power | 100 – 240 V~, 50 -60 Hz, 100 VA |
Fuses | Replace with same type and size fuse: T 1.6 A 250 VAC Fuse (Slow Blow), size 5 X 20 mm appliance inlet |
Dimensions | H: 42.2 cm (16.6 in); W: 24.6 cm (9.7 in); D: 40.0 cm (15.8 in) |
Weight | 9.4 kg (20.6 lb) |
Safety Certifications | ETL, CE (see Declaration of Conformity) |
Sample Conductivity (Optional) |
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Raw Conductivity Range | 0.01 to 2,000 μS/cm |
Conductivity Accuracy | ±0.005 μS/cm or ±1%.whichever is greater |
Precision | <0.25% RSD |
Environment |
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Maximum Relative Humidity | 0 – 95%, non-condensing |
Maximum Altitude | 3,000 m (9.800 ft) |
Pollution Degree | 2 |
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* Stated analytical performance is achievable under controlled laboratory conditions that minimize operator and standards errors. |
M9 Lab Turbo Specifications
Operating Specifications* |
|
---|---|
Range | 0.20 ppb to 10 ppm |
Precision | 2% RSD |
Accuracy | ±10% or ±10ppb whichever is greater |
Display Readout | 3 significant digits |
Sample Type | Grab and Autosampler |
Calibration | Typically stable for 12 months |
Analysis Time | 4 seconds |
Response Time | 3.25 Minutes |
Sample Temperature | 5–95 °C (41–203 °F) |
Ambient Temperature | 10–40 °C (50–104 °F) |
Sample Pressure** | Up to 100 psi |
Instrument Sample Flow Rate |
1.1. ml/min |
Analyzer Specifications |
|
Outputs | USB device port (1); USB host ports (3); Ethernet |
Display | 7″ WVGA 800X480 pixel, Color LCD with touch-screen |
Power | 100 – 240 V~, 50 -60 Hz, 100 VA |
Fuses | Replace with same type and size fuse: T 1.6 A 250 VAC Fuse (Slow Blow), size 5 X 20 mm appliance inlet |
Dimensions | H: 42.2 cm (16.6 in); W: 24.6 cm (9.7 in); D: 40.0 cm (15.8 in) |
Weight | 9.4 kg (20.6 lb) |
Safety Certifications | ETL, CE |
Consumables |
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UV Lamp | 6 months |
Acid Reagent | As needed, typically 6 months |
Oxidizer Reagent | As needed, typically 3-month stability; available in 150- or 300-mL cartridge |
*Stated analytical performance is achievable under controlled laboratory conditions that minimize operator and standards errors.
**If the sample temperature and pressure are above 60 °C and 100 psi, the M9 Analyzer model with the stainless steel iOS is required.
M9 Lab Options and Accessories
- Sievers Autosampler: 63 or 120 sample-position capacity
- DataPro2 Software: Custom sample protocols; automated calibration and validation protocols
- DataGuard Software: Full compliance support for 21 CFR Part 11 and Annex 11
- Inorganic Carbon Remover (ICR): Improves TOC accuracy for samples with high inorganic carbon levels
- Sample Conductivity: Measure and report sample conductivity
- Turbo Mode: Provides four-second analysis time
Sievers M9: M-Power Your Lab for Lean Efficiencies
TOC and conductivity are critical attributes for compendia assurance of water quality that are traditionally tested separately in the lab and can be labor and time intensive. The Sievers M9 offers simultaneous measurement of TOC and conductivity in a single vial to save you time and resources.
Cleaning Validation (Lab, At-Line, and On-Line) with Sievers M9 TOC Analyzers
Not sure which analyzer you need for cleaning validation? This document compares the M9 Lab, Portable, and On-Line to help you select the right analyzer for your application.
21 CFR Part 11 with the Sievers M9 and DataPro2 Software
Sievers M9 Analyzers are compliant with 21 CFR Part 11. Our DataPro2 and Dataguard software are designed for the pharmaceutical industry to offer complete solutions for electronic signatures and audit trails.