ZefSci's statement on covid-19

Our approach is unique

  • We use a one standard approach irrespective of instrument manufacturer and model.
  • Instrument acceptance criteria and specifications can be changed and saved for future qualifications.
  • We capture all the data electronically
  • NIST traceable standards.
  • Data traceability
  • All SOPs and Raw data is combined under one large document effortlessly and seamlessly

Liquid Chromatograph

  • Pump flow rates
  • Gradient Tests
  • Temperature accuracy
  • Autosampler precision & carry over
  • Injection linearity
  • Wavelength accuracy (U/V, Fluorescence)
  • Wavelength linearity (U/V, Fluorescence)

Gas Chromatograph

  • Column Oven Temperature Accuracy and Precision
  • Temperatures:
    • Inlet (front & rear)
    • Detector (front & rear)
  • Inlet pressure and tightness
  • Flow rate
  • Detector gas flow rate
  • Precision FID/TCD linearity.

ISPE Baseline Guide, Volume 5 Commissioning and Qualification definition:

“The documented verification that all aspects of a facility, utility, or equipment that can affect product quality operated as intended throughout all anticipated ranges.”

© 2021 ZefSci