Abstract

BELDARRAIN, Alejandro et al. Evaluating sterilizing filtration for API-HBsAg. Biotecnol Apl [online]. 2009, vol.26, n.3, pp. 244-250. ISSN 1027-2852.

The sterilizing filtration procedure for the active pharmaceutical ingredient of the Cuban anti-hepatitis B vaccine (HBsAg API) was evaluated by using cellulose nitrate type 113 membranes and Sartobran P capsules (Sartorius, Germany). The study of sterilization processes using saturated steam for two loads, one for the flat membranes within their respective carcasses and the other for auxiliary materials, demonstrated that the measuring points reached an F₀ > 15 minutes, guaranteeing an appropriate sterilization. The physical integrity of both filtration media was maintained after the filtration process, indicating a successful operation. The extractables were studied by Fourier transformed infrared spectroscopy (FTIRS) and reverse phase high performance liquid chromatography (RP-HPLC), showing the lack of membrane-derived contaminants. The bacterial retention test was carried out at industrial scale simulating the operations used for the buffer and HBsAg API. Both filtration media were able to remove a microbiological load of ≥ 10⁷ c.f.u./cm² of Brevundimonas diminuta (ATCC 19146), ensuring filtrate sterility. These results indicate that the API HBsAg sterilization procedure is safe and reliable.

Keywords : Sterilizing filtration; steam sterilization; filtration simulation; integrity testing; extractable analysis; microbiological challenge test.

        · abstract in Spanish     · text in English     · English ( pdf )