On-line version ISSN 1025-0298
REYES, Otto; LUIS, Lissette M; PEREZ, Rodney and LIMIA, Gerardo. Qualification of a HVAC (Heating, Ventilating and Air Conditioning) system in a production plant of API (Active Pharmaceutical Ingredient). Vaccimonitor [online]. 2006, vol.15, n.3, pp. 5-8. ISSN 1025-0298.
Qualification of aseptic areas is one of the essential requirements to meet national regulations for production of sterile products. Initial qualification (as built) of a plant producing Active Pharmaceutical Ingredients (APIs) for manufacturing vaccines against tetanus, typhoid fever and whooping cough, was carried out. Tests were based on international standards and they were carried out using equipment that fulfills the requirements for the pharmaceutical industry. It was proven that the climate system guarantees all operation critical parameters of clean rooms, although some approaches of optional tests were not met. Results serve as reference for controlling parameters of the HVAC system and taking corrective actions.
Keywords : Qualification of clean rooms; HEPA filter leak test; room particle count.