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21 CFR Part 11 compliant software available for use with New M420Cs Flame Photometer

publication date: Oct 30, 2019
 | 
author/source: Sherwood Scientific Ltd

M420Cs Flame Photometer with Caesium Internal Reference


The Model 420Cs is the latest addition to Sherwood Scientific Ltd.’s Flame Photometer range. Based on the established M420, the Model 420Cs offers improved performance and flexibility.

Where the Model 420Cs comes into its own is with the addition of a Caesium filter, enabling use of a Caesium internal reference as an alternative to the Lithium reference channel offered on Sherwood Dual Channel models up to now. This additional feature, gives operators the ability to choose the internal reference element based on the sample matrices or to adapt existing procedures originally developed for discontinued instrumentation such as the IL 943 Flame Photometer.

A primary example where this is beneficial is Lithium measurement in clinical samples with the increased precision afforded by the use of the Caesium internal reference feature. The M420Cs also benefits from a number of enhancements made recently to all Sherwood’s 420 range of instruments; that now offer a performance specification for precision of < 0.5% CV.

Used as a standalone instrument the M420 Cs allows the operator to simultaneous measure up to two of three available elements (Sodium, Potassium and/or Lithium) and a choice of Caesium or Lithium as the internal reference.

Since introduction of the M420Cs we now stock a 160.0 Na & 8.00 K mmol/l calibration solution, Stock Code 001 56 160; in addition to the 10,000ppm Caesium internal reference solution, Stock Code001 56 601.

 

Learn more about- M420Cs Flame Photometer

Download Product Brochure


 

Regulated BlueNotes 420 Software

M420Cs-Flame-Photometer-Caesium-Internal-Reference


 

Also new from Sherwood is a “Regulated” version of our M420 BlueNotes software. This latest software package allows the analyst to use the M420Cs Flame Photometer in a way that enables them to work in a manner compliant with 21 CFR Part 11 and enable analysis of up to three elements simultaneously; both with single point or multipoint calibrations.

 

Regulated features include:

  • 3 tier login system with different levels of access (Operator, Supervisor and Administrator).
  • Unique user names and passwords for every user.
  • Audit trails record all operations with detailed information concerning the user and the software version, Windows version and PC name to ensure traceability and accountability.
  • Robust data file system which is tamper evident and inaccessible to users without elevated Windows privileges.
  • Tamper evident data format used for analysis result, system configuration and method files to ensure data integrity.
  • Auto generated PDF analysis reports provide a comprehensive summary of all information relevant to an analysis run in one clear and concise document.

 

Since introduction of the M420Cs we now stock a 160.0 Na & 8.00 K mmol/l calibration solution, Stock Code 001 56 160; in addition to the 10,000ppm Caesium internal reference solution, Stock Code001 56 601.

 

Learn about BLUENOTES 420 SOFTWARE

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