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Products and Services

Instrument qualification

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v-kit is a unique product for performing installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), of HPLC, LCMS, GC, GCMS, and Tablet Dissolution systems.
 
Launched by NLG in 2003, and now sold to service providers globally, v-kit was developed to provide a complete, out-of-the-box solution for analytical instrument qualification, regardless of make.
 
The advantages of vendor independence include cost savings and a standard platform to harmonise qualification across different makes of chromatography equipment, even when instruments are in laboratories in various locations.
 
System qualification from NLG (using v-kit Pro) will comprise of:
  • Expert consultation to select OEM templatesj or map initial protocos to your specific needs
  • The use, by engineers, of modern Windows-based, web browser software to manage and run qualification protocols
  • Traceable chemical reference standards
  • Copies of Standard Operating Procedures
  • Finalised Logbook
Other data incorporated (for full traceability):
  • Certificate of Analysis for standards
  • Material Safety Data Sheets
  • Tool Calibration certificates
  • Engineer Training certficates
  • Raw data
Inspection Material:
 
v-kit results are finalised with the auditor in mind  and include a comprehensive 'logbook', secure .pdf reports, and archived data -- which aid compliance to informational regulatory compliance authorities such as FDA (USA), MHRA (UK), IMB (Ireland), etc.
 
Additional Technical Info:
  • Protocols securely encrypted
  • Restricted access levels
  • Intelligent data fields
  • Fully validated calculations
  • Strict revision and change control
HPLC v-kit protocols include:
  • Pump flow rate accuracy and precision
  • Gradient composition accuracy and linearity
  • UV/Vis, PDA/DAD and fluorescence detector wavelength accuracy
  • UV/Vis, PDA/DAD, fluorescence, refractive index and ELS and conductivity response linearity
  • Injection volume precision and carry-over
  • Injection volume linearity
  • Column oven and tray temperature accuracy
GC v-kit protocols include:
  • Column oven, inlet detector and detector temperature accuracy
  • Column oven, inlet and detector temperature stability
  • Inlet pressure accuracy and tightness
  • Inlet and detector flow accuracy (including split, purge, make-up, fuel gases)
  • Autosampler injection precision, carryover and retention-time reproduceability
  • Detector response linearity (FID/TCD)

 

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v-kit is operated by NLG Analytical Ltd, 16 John Bradshaw Court, Alexandria Way, Congleton Business Park, Congleton, Cheshire, CW12 1LB, UK

Tel: +44(0)1260 274-266 Fax: +44(0)1260 273-319

© 2012 NLG Analytical Ltd. All rights reserved.

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Page as at 22 May 2012 01:31:51.