Office Information

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


Glossary

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