Decontamination processes in pharmaceutical isolators
Technik
Abstract
The use of isolators in the manufacture of sterile medicinal products has been a trend for years and has received a further significant boost with the publication of the new Annex 1 to the EC GMP Guideline. This is understandable, as isolators provide the safest background environment for aseptic processing. The core process in the application of isolator technology is fully automated decontamination, which can be performed using different methods. As different as the methods are, they are all based on the same active principle, the evaporation of liquid to gaseous hydrogen peroxide, which has proven to be the most suitable decontamination agent. A deep and fundamental understanding of the process is a prerequisite for safe, robust, efficient and effective decontamination and thus for ensuring the best possible aseptic conditions.
Correspondence:
Dr. Timo Krebsbach
SKAN AG, Kreuzstr. 5, 4123 Allschwil
timo.krebsbach@skan.ch
 | Dr. Timo Krebsbach looks back on 22 years of professional experience in various positions in the pharmaceutical industry: Head of Microbiological Quality Control, Head of Marketing & Sales, Managing Director of a GMP contract laboratory. Since Jan 2024, he has been working as a Strategic Product Manager at SKAN, where he is responsible for decontamination systems. In addition to his own publications, he is the editor of the 3 books “Reinraum in der pharmazeutischen Industrie”, |
