PDA Letter Article

Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

by Stefan Kleinmann, PhD, METALL+PLASTIC, Matthias Scheu, METALL+PLASTIC, Roland Schuhwerk, Cilag AG, and Volker Baur, Cilag AG

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).