Risk Management for Technological Change in the Production of Polyribosyl Ribitol Phosphate at the Finlay Institute of Vaccines

Abstract

Polyribosyl Ribitol Phosphate (PRP), the capsular polysaccharide of Haemophilus influenzae type b, constitutes the principal protective antigen in the Quimi-Hib® and Heberpenta® L vaccines. Its production at the Finlay Institute of Vaccines requires highly controlled synthesis and semi-purification processes to ensure traceability and safety. Traditionally, solid–liquid extraction has been performed using the Soxhlet method, a continuous reflux technique with limitations that compromise reproducibility and regulatory compliance.

This study evaluates the transition to a mechanical agitation extraction system employing a jacketed reactor with integrated filtration. To support this technological shift, risk management tools recognized under ISO/IEC 31010 were applied, including the Ishikawa diagram and Failure Mode and Effects Analysis. The results demonstrate that, although critical failure modes were identified, effective controls allow the residual risk to be classified as acceptable, thereby confirming the value of risk management in the production of processed PRP

Keywords: processed PRP, solid–liquid extraction, risk management