Hold times caused by micro QC test have a significant impact on the manufacturing cycle. Many companies try to overcome this bottle neck by choosing a “continue at risk” approach because for a long time this was the only option that was available.
Due to the advent of more advance micro QC test methods, manufacturers do not need to accept the risk anymore as shorter time to result makes results available which allow for data driven decisions. Based on selected applications which not only focus on product testing, but more holistically on micro QC testing along the manufacturing process, opportunities for enhanced contamination control and sterility assurance will be discussed.
Key Learning Outcomes- How to assess the impact of micro QC hold times on the manufacturing cycle
- How to quantify the value of more rapid micro QC results
- How to identify potential applications for advanced microbiological detection methods
After receiving his Doctorate Degree in organometallic chemistry from the University of Wuerzburg, Dr Ulrich Herber started his career in the pharmaceutical industry at Sartorius as Product Manager for sterile filtration process validations. He then moved to Concept Heidelberg where he was the Operations Director for their business segment “Microbiological Quality Control and Biotechnology”. Later on Dr Herber headed the European activities of Accugenix.
In his current role at Charles River he is the Director of Technology and Market Development for the Microbial Solutions division. Dr Herber is co-author of scientific papers on new methods applied in microbiological quality control. He has held several talks covering recent developments in the area of rapid microbiological methods and is an Advisory Board Member of the Pharmaceutical Microbiology Working Group at the European Compliance Academy.