Thermal Validation

QV Compliance A/S has many years of experience in management and execution of thermal mapping activities within the Pharmaceutical Industry. Critical equipment within a cGMP/regulated environment needs to be qualified/validated. We can help you with:

  • Scope
  • Writing protocols
  • Planning and execution of tests
  • Deviation handling
  • Reporting
  • Management of the thermal validation activities

The V model approach will normally be used for the complete validation package for equipment or process –see V-model. Our specialists have documented experience from design/requirement specification to performance qualification or process validation (URS, IQ, OQ, PQ and PV) with a science and risk-based approach.

We have documented experience with thermal mapping within many different areas. We can adjust to your concerns whether it is sterilization, sanitation or general temperature distribution in your equipment, storage facility or your chain of transport. Our experience cover:

  • SIP (Sterilisation In Place)
    • Bio reactors and Fermentors
    • Process tanks for drugs or API
    • Distribution loops for WFI, PW etc.
  • Autoclaves
  • Depyrogenation tunnels
  • VHP (Vaporized Hydrogen Perioxid) isolators
  • Dry heat ovens
  • Stability facilities
  • Incubators
  • Storage rooms
  • Freezers and refrigerators

We can work with templates within your quality system – or we can develop a customer specific solution.

Specialists in QV-Compliance A/S are familiar with best industry practices and are up to date with current regulation within the field and to the specific equipment.

Examples of used methods are:

  • Lethal rate calculations etc. sterilization of product and utensils in autoclaves
    • D-value
    • F0/Fh
  • Bioburden, overkill and half/partial cycle
  • Monitoring of sterilization efficiency with biological indicators
  • Use of thermocouples and loggers – wired or wireless
  • Statistic evaluation of temperature distribution data
  • Statistic evaluation of humidity distribution data
  • 2D/3D mapping of sensor placement