Plastics in the
pharmaceutical isolator
Technik
Key Wordsisolator technology | packaging material | risk evaluation | polymers | hydrogen peroxide
Abstract
Pharmaceutical isolators are a common tool for the safe manufacturing and testing of pharmaceutical products by providing an aseptic environment for critical processes. Hydrogen peroxide (H2O2) is used as the decontamination agent to achieve aseptic processing conditions. Any material present or introduced in the isolator chamber should be easy to be decontaminated, show good persistence to H2O2 as well as various chemicals and not facilitate the growth of microorganisms.
Various materials handled in the isolator are packaged in or made of plastic and certain parts of the isolator chamber itself or the installed equipment are made of plastic construction materials. The presence of plastic materials in the isolator chamber requires careful consideration of their potential influences on the product and the decontamination cycle. Hydrogen peroxide can be absorbed by or even diffuse through certain plastic materials and thereby affect the quality and integrity of the products, as well as the efficiency and duration of the decontamination cycle. Therefore, suitable packaging materials must be chosen to protect the product and equipment must use materials of construction that do not absorb H2O2.
 | Max Mittelviefhaus, PhD joined SKAN AG in 2021 as a researcher in the Research and Strategic Business Development department. As an interdisciplinary natural scientist with a keen interest in innovative and next generation technology, he is working on different research topics, such as H2O2 sensing, material testing and various other aspects related to the decontamination process. In this role he is conducting and supporting internal as well as external scientific studies. In 2007, Theresa Ladwig joined SKAN AG as a project engineer in the cycle development department and carried out cycle developments and |
