Abstract

SOLORZANO-ALVAREZ, Ernestina; PEREZ-TORTOLO, Joselyn  and  RODRIGUEZ-DUENAS, José. Biological risk assessment for the production of inactivated vaccines for animal use. Vaccimonitor [online]. 2020, vol.29, n.3, pp. 93-102.  Epub Dec 01, 2020. ISSN 1025-0298.

Vaccination continues being one of the most sustainable and used ways in the control of infectious and contagious diseases in veterinary medicine because of both its greater economic feasibility and thwarting animal products from having antibiotics residues, a big-time issue for human ingestion. The appearance of new generation vaccines has motivated the application of biosafety measures and the need to carry out studies of risk assessments that we undertake to obtaining and producing vaccines, being important critical points in the process of acquiring them. The inactivated vaccines’ area is located in the UP-7 Viral and Bacterial Vaccine Production Company, belonging to LABIOFAM business group in Havana, Cuba; this area is responsible for vaccines, diagnostic means production and quality control. Previous checkups carried out showed that the personnel involved had lack of knowledge and low perception of the existing biological risk in the productive processes carried out there; leading to suggest the investigation. Hazards were identified and characterized and a risk assessment was carried out, using a qualitative estimate risk matrix. Such hazards were assessed as low, moderate or high. Vulnerabilities were identified using a checklist to this purpose, detecting those related to area design, treatment of waste and the biosafety organization, which established the existence of critical points within the production process with high and moderate risk.

Keywords : Biosafety; occupational risks; risk management; vaccines.

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