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In the manufacturing process of HyperHEP B, there are several steps with the capacity for viral inactivation or removal.(1) The main steps of the manufacturing process that contribute to the virus clearance capacity are as follows: To provide additional assurance of the pathogen safety of the final product, the capacity of the HyperHEP B manufacturing process to remove and/or inactivate viruses has been demonstrated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties

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In controlled laboratory research settings, bacteriostatic water is utilized to support: All applications are conducted strictly within non-human, non-clinical research models