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HVAC Validation
HVAC (Heating, Ventilation, and Air Conditioning) validation continues to be a source of anxiety for many manufacturers of pharmaceutical and biologic products. HVAC validation is likely to be successful when good strategy and planning are involved in the process. Pharmaceutical Services Corp helps direct you in the right direction. There are many factors to consider in HVAC validation and it is best to take on a realistic approach based on good science, business and compliance sense. We are familiar with HVAC validation requirements and industry standard validation practices for your product forms, what documented evidence is needed for your HVAC Systems (e.g. drawings, specifications, balancing reports), and we know if your control systems are strong enough to be validated. We then develop a general strategy consisting of the following factors:
- Classification of HVAC Systems as GMP or non GMP systems.
- Determination of what documentation you have and what documentation you need to create before validation begins.
- Development of targets for differential pressure, room air changes, temperature, and humidity.
- Concentration of validation efforts on the areas where there is a direct product impact.
- Validation of Building Monitoring Systems that are connected to the HVAC Systems.
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