I am working as a freelance engineer in consultancy for pharmaceutical processes.
My focus is the validation of aseptic manufacturing processes.
This includes guidance in process development, editing of Technical Specifications and the management of Qualification projects.
I gained my skills in the study of biotechnology at the Fachhochschule Gießen, and by many years of professional experience in Qualification / Validation during my work for a pharmaceutical manufacturer and a manufacturer for packaging lines.
The office is located in the district of Kreuzberg in the town of Crailsheim,
which is in Baden-Württemberg in the district of Schwäbisch Hall.
By car via the A6 Heilbronn and Nuremberg or the A7 Würzburg or Ulm. For Details see page Approach
Abbreviation | Description |
BI | Biological Indicator |
CI | Chemical Indicator |
CIP | Cleaning In Place |
DQ | Design Qualification |
FAT |
Factory Acceptance Test |
FDA |
Food and Drug Administration |
IQ |
Installation Qualification |
LHSKM |
Limited Holcomb-Spearman-Karber Method |
OOS |
Out of Specification |
OQ |
Operational Qualification |
PAT |
Process Analytical Technology |
PQ |
Performance Oualification |
QbD |
Quality by Design |
SAT |
Site Acceptance Test |
SOP |
Standard Operating Procedure |
VHP |
Vaporised Hydrogen Peroxide |
Bibliography:
Picture: Adem Demir / www.shutterstock.com