Facility and Utility

QV Compliance A/S has many years of experience with qualification and validation within the pharmaceutical industry and other regulated industries according to the risk-based approach and the traditional V-model. We can help you with:

• Contamination control strategy of clean rooms (HVAC, cleaning, gowning, behaviour)
• Qualification of classified areas
• Environmental monitoring
• GMP for sterile products
• HVAC qualification & requalification
• Pharmaceutical utility systems (Water & Steam systems (PW, WFI), Process air, Nitrogen etc.)

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:

• 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:

• 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