Sterilization and Validation of sterilization methods

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

Define scope based on risk-analysis
Writing protocols
Planning and execution of tests
Deviation handling
Reporting
Management of the sterilization validation activities

The risk-based approach or the V model will normally be used for the complete validation package for equipment or process (see the risk-based approach and 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

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/F_h
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