Validation of the aseptic filling at the Parenteral Products Plant 3 in BioCen

Abstract

As part of the continuous improvement process, a new parenterals production plant (PPP3) was constructed at the National Center for Bioproducts. The validation of the aseptic filling process is a key element to carry out before manufacturing products. Therefore, the aim of this work was to obtain documented evidence that all the operations were carried out according the regulations of Good Manufacturing Practices for liquid and lyophilized sterile products during the aseptic filling at the Parenterals Product Plant 3. The study was designed for lyophilized products connected to the manifold of the peristaltic pump and to the four rotary piston pumps. Besides, during the filling operation four interventions were planned. The validation was carried out with three consecutive batches of media fill. In the first processed lot no vial was contaminated, but in the second and third lots there was one contaminated vial. For that reason, an investigation was performed in order to know the cause of the contamination. Finally, with this wok the validated condition was obtained, following the regulations of Good Manufacturing Practices for sterile liquids and lyophilizes products during the aseptic filling process at the Parenterals Products Plant 3.