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FDA-gerechte Qualifizierung lufttechnischer Anlagen

Ulrich Bieber

Boehringer Ingelheim Pharma KG, Ingelheim/Rhein

FDA-compliant Qualification of Air Conditioning Systems

The air in pharmaceutical areas is used for different purposes. If it is used as process air, it acts like a raw material and has a direct impact on the quality of the products. When exposed products are handled, the so-called “room air” comes into contact with these products. Airborne particles can cause cross-contamination. In fact, adverse conditions may result in a product becoming adulterated. Therefore stringent acceptance criteria must be defined. HVAC-Systems are similar to production machines and must comply with similar qualification procedures. The qualification process which should be compliant with the FDA requirements can be a challenging task for the qualification team because the cooperation of various departments is necessary. In this article we discuss the regulatory principles and the specific aspects of the qualification work. However the emphasis will be on the essential concepts of qualification. The experience of the author shows that thorough planning is a precondition to achieving successful results.

Key words GEP (Gute Engieneering Praxis) · Monitoring, protected conditions, controlled conditions · Produktschutzkonzept · Raumbuch · Zonenkonzept