Date: August 29, 2018
As biologics have supplanted small molecules as the dominant focus for many leading pharmaceutical companies, robust manufacturing processes for isolators and RABS continues to be an evolving process. In this environment, as the need for significantly better VHP monitoring has grown quickly, Picarro H2O2 analyzers have increased in popularity.
Vaporized hydrogen peroxide (VHP) treatment is the dominant approach for decontamination in cleanrooms, restricted access barrier systems, and isolators, commonly a part of manufacturing operations for high-potency active pharmaceutical ingredients (HPAPI), large molecule drugs, and aseptic processing for dosage form fill and finish. Irrespective of the environment, decontamination is followed by an aeration cycle designed to ensure drug efficacy, safety, and stability, typically at levels well below 0.1 parts per million (ppm). Further, published research is showing product oxidation at residual VHP concentrations of 30 parts per billion (ppb) or 0.03 ppm.1
Traditional electrochemical sensors do not have, nor will have, the accuracy, precision or stability to adequately measure and report VHP concentrations in these regimes and now leading pharmaceutical companies around the world are adopting Picarro's Hydrogen Peroxide Analyzers to meet the typical new standards of today’s lower residual VHP levels.
Picarro PI2114 method detection limit test, <1.0 ppb
The PI2114 is built on Picarro’s industrial instrument platform and is able to accurately and reproducibly measure VHP concentrations as low as 3 ppb in a continuous, real-time monitoring mode. The data is acquired and controlled in a manner designed to be compliant with your 21 CFR Part 11 protocols and the system can be incorporated into GxP environments. Better yet, we offer devices that can be used in research or pilot plant areas first, with the capability to switch into a full manufacturing mode as isolators are brought on-line.
We’ve written a new whitepaper which discusses the Traceable Calibration of Hydrogen Peroxide in Picarro’s Cavity Ring-Down Spectrometers. Or, contact us for a discussion on our systems and how they can work for the new challenges in VHP monitoring.
1- Hubbard, Aaron, et al. "Vapor Phase Hydrogen Peroxide Sanitization of an Isolator for Aseptic Filling of Monoclonal Antibody Drug Product-Hydrogen Peroxide Uptake and Impact on Protein Quality." PDA journal of pharmaceutical science and technology (2018): pdajpst-2017.