DETECTION OF PYROGENS IN ULTRA-PURE WATER BY A SURFACE PLASMON RESONANCE BIOSENSOR

ABSTRACT We report a direct optical evanescent wave sensor operating in a cumulative dose mode for the potential on-line detection of pyrogens in ultra-pure water for use in pharmaceutical and electronics manufacture applications. The demonstration sensor is based upon a surface plasmon resonance sensor coated with an affinity recognition layer consisting of monoclonal antibody with affinity for pyrogenic lipopolysaccharide. The sensor demonstrated a lower detection limit of 0.01 Endotoxin Units per millilitre (EU/ml) that compares favourably with the existing regulatory limits of no greater than 0.25 EU/ml for purified water for injection or infusion according to the US Pharmacopoeia.