The data presented indicate there is little risk from leachables when using single-use systems. The QbD methodology used to
identify materials ensures incorporation of components with low aqueous solubilities, materials cleared as food contact substances
by FDA, and materials qualified as Class VI by USP.
The low concentrations of leachables that do enter into the product should not affect drug performance or quality-control
As shown in the first case study, if the leachable is introduced upstream, the clarification process will reduce the concentration
below the limit of concern. Realistic working conditions allow the level of leachables to fall below the threshold of concern
for genotoxic compounds.
The second case study demonstrates that the concentration of leachables from the final formulation and fill–finish assemblies
do not pose a risk to patients because concentrations are well below the TTC.
Paul F. Killian, PhD, is a senior research scientist in the analytical technologies group at EMD MIllipore, Bedford, MA, firstname.lastname@example.org
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