Continuous monitoring and analytics
A holistic cleanroom concept integrates monitoring and analytic measures that not only track the aseptic filling process, but also ensure that both products and employees are fully protected from H2O2. Sensors inside and outside the barrier are tuned to track different variables.
Two Polytron sensors measure H2O2 decay within the cleanroom in grade B, while a Picarro sensor follows the same process in grade A. A flowmeter continuously measures the air flow from inside the barrier area into the ambient cleanroom air.
The analytics concept also includes H2O2 analysis for aqueous solutions. Thus, H2O2 concentrations in WfI (water for injection) or other product solutions can be verified in the lab.
Prepared for tomorrow’s challenges
In addition to high reliability and reproducibility, this cleanroom concept also offers the significant advantage of speed. Depending on the size of the cleanroom, the entire decontamination cycle can be completed in just 2.5 hours.
Suitable catalysts and a highly effective ventilation system enhance H2O2 degradation and lead to short decontamination cycles. Preparations for production and the aseptic set-up of the cleanroom can begin immediately. Shorter downtime streamlines processes and improves overall equipment effectiveness (OEE).
In the near future, pharmaceutical product manufacturing will require significantly increased flexibility and face more stringent requirements for microbial and particulate contamination control. Pharmaceutical and biotech companies around the world are already feeling these pressures on their aseptic filling processes. But many of these organizations are already adapting their strategy accordingly: They’re taking advantage of innovative production methods, designed to enhance and advance current manufacturing processes.
Leveraging these new methods can help pharmaceutical and biotech companies prepare for success in a changing and challenging industry. New approaches like Vetter’s V-CRT create manufacturing processes that deliver all benchmarks—safety, versatility, efficiency, and above all, quality—to meet the ever-evolving demands of the world’s dynamic healthcare market.
About the author
Ute Schleyer, Ph.D. was appointed Project Manager Site & Plant Development of Vetter Pharma-Fertigung GmbH & Co. KG in 2016 and is responsible for supporting projects in the field of pharmaceutical technology. Ute joined Vetter in 2007 as Manager of Aspetic Production. She was promoted to the position of Head of Production in 2008 in the area of manufacturing and filling of sterile drug products, which includes various single and dual-chamber filling lines. Ute holds a Ph.D. in biology from the Johann Wolfgang von Goethe-University Frankfurt, Germany.
First published on 10/14/2020 in Contract Pharma