Resumo

FERNANDEZ LOPEZ, Cindy Marlene; MORENO MORA, Diana Marcela; ARIAS PALACIOS, Janeth  e  MANUEL GRANADOS, José. Methodology for the validation of the aseptic filling in a lyophilization process. Rev Cubana Farm [online]. 2007, vol.41, n.1. ISSN 0034-7515.

The methodology proposed for the validation of an aseptic filling in a lyophilization process was presented. To this end, 3 tests were made in which 3 batches of 15 000 vials each one were filled with casoy broth. They were incubated at 22.5 ± 2.5 ºC y 32.5 ± 2.5 ºC for 14 days, respectively, in order to detect the possibility of microbial contamination on carrying out the process. During the first three proceses, the microbiological monitoring of environments, surfaces and operators took place. Petrifilm was used in the sampling to detect aerobic mesophiles and yeasts, a procedure accomplished under rest and operation conditions. Likewise, the counting of particulars was made in the area and sterility tests were done for the packing materials (caps and vials). Finally, the validation methodology was designed for the sterilization of the lyophilizer, and Bacillus stearothermophilus was used as an indicator microorganism. The design of the test was made taking into account the recommendations of the Food and Drug Administration (FDA) and the World Health Organization (WHO) for products of parenteral administration.These are the reference organizations for the production and quality control used by the enterprise of veterinary products , where the test was performed. The filled vials were read by turbidity (presence of contamination), and the acceptance criteria were established by the 2 above mentioned entities. To conclude, it was indicated a plan of microbiological monitoring for the evaluated area, in which points of strategical sampling were included, as well as the accomplishment of specific standard operative procedures for this area.

Palavras-chave : Validation; aseptic filling; FDA; WHO; Bacillus stearothermophilus.