Rapid and Accurate Bioanalyte Analysis

Measuring pH, Cell Culture Gas, Electrolyte and Metabolite Samples as Small as 65 µl

R&D, QC and Manufacturing Applications

Ideal for micro to large scale cell culture applications, the Vi-CELL MetaFLEX is designed for rapid and accurate Bioanalyte analysis.

Analyzer Performance

Sample volume (all parameters)

65 µl*

Measuring time (all parameters)

35 seconds**

Cycle time

60 seconds*

Throughput

44 samples per hour*

Average uptime

23,5 hours per day**

Quality Management

Automatic quality management system

  • 3 dedicated QC solutions
  • Automatic detection and correction of failures
  • Continuous system and analysis checks
  • Air detection
  • Automatic lockout of parameter that fails QC
  • Customizable QC schedule

Instrument Qualification

  • IQ/OQ

Regulatory Compliance

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the Food and Drug Administration (FDA) to define the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures. Since analytical instrument systems such as the Vi-CELL MetaFLEX generate electronic records, these systems must facilitate compliance with the Electronic Records Rule. The Vi-CELL MetaFLEX features the following key system components to facilitate 21 CFR 11 compliance:

  • Data secured by password protection
  • Electronic signature capability
  • Secure user sign-on
  • 8 user level permissions
  • Administrative configuration tools

* May vary during startup
** May vary during startup; 2.5 min for system calibration is the longest activity

Applications
Topics
  • bioanalyte analyzers

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