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Organic solvents determination in CNBr Sepharose CL-4B and immunoaffinitymatrix

Leonardo Gomez, Rodolfo Valdes, Yanet Tambara, Yanelis Gonzales, Janet Garcia

In general, the effects of organic solvents exposure are narcosis, anesthesia, central nervous system depression, respiratory arrest, unconsciousness, and death. Many countries have issued several regulations to control and reduce the exposition of the personnel to this kind of solvents. Matrix and researchers are exposed to organic solvents during the immunoaffinity chromatography gel manufacture. In this case the manufacture of the immunosorbent CB.Hep-1 used for the immunopurification of the HBsAg, active raw material of Cuban vaccines against Hepatitis B. In this process any organic solvents are used. Gas chromatography and total organic carbon assay were used to determine the presence of Ethanol, Acetic acid,Acetonitrile andAcetone. CNBr Sepharose CL-4B showed an average 274.2 ppm of Ethanol; 28 ppmAcetic acid; 288 ppmAcetone/ Acetonitrile. In addition to this very low level of organic solvents in activated matrix, the presence of themwere not detected in the immunosorbent therefore the risk to organic solvent exposure in the final purified antigen does not exist.