Qualification & Validation

We have a wide range of expertise within the pharmaceutical industry, and clients will therefore be met by experienced validation consultants.

We offer qualification of:

  • All types of SIP-installations (Steam In Place)
  • Bioreactors and fermentors
  • SIP-Equipment
  • Shells
  • Bottle Pack
  • Bulk process equipment
  • Isolators
  • Depyrogenation tunnels
  • Dry heat sterilization tunnels
  • Autoclaves
  • Qualification of loggers – e.g. Yokogawa etc.
  • VHP (Vaporized Hydrogen Peroxide)
  • Cycle Progression
  • Temperature distribution
  • BI-Tests Incl. D-value calculations

Our experience with Autoclaves is unique

Qualification and validation

Cycle and load-progress

  • F0-Calculations
  • Bioburden, overkill & half and partial cycle approach
  • D-value calculations

Revalidation

Controlling of effective air removal and vapor permeation (Bowie-Dick Test)

  • Program changes
  • Cycle progress and changes
  • Copying and transferring of existing programs

Our work is based on standards like EN 285, HTM, PDA and ISPE