In recent years, the number of protein-
based biologic drug products has grown.
Parallel to this, the use of filling line
isolators in biopharmaceutical manufacturing plants has increased. Some of
these products are extremely sensitive to
oxidation. The majority of aseptic manufacturing isolators are decontaminated
with H2O2, so potential oxidation of these
sensitive products has become a concern (1).
Although this concern has mainly
been associated with isolators, there is also
oxidation risk to drug products filled in
traditional cleanrooms due to the use of
oxidative liquid chemical agents for wipe
downs and mopping. Residual vapors
from sodium hypochlorite (bleach), a
commonly used cleanroom sanitizing agent, have been found to cause oxidation
in proteins more quickly when compared
to hydrogen peroxide/peracetic acid
mixtures
(2).