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:
Planning and execution of tests
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.
VHP (Vaporized Hydrogen Perioxid) isolators
Dry heat ovens
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
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