SteriEP - Sterility Testing
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Sterility testing (bacteria and fungi) – state-of-the-art nucleic acid technology (NAT) sterility testing as an alternative method according to EP 2.6.1 and 2.6.27 in accordance with 2.6.21. Rapid testing for bacteria and fungi contamination, from sample submission to result in 24-48 hours.
Recommended Sample Material
Cell cultures, cryo-stocks, sera, antibody formulations and autologous material.
Qualitative Real-Time PCR.
Applied PCR System
Microsart ATMP Bacteria (Sartorius Biotech GmbH).
Microsart Sterile Extraction (Sartorius Biotech GmbH).
Extraction and Amplification.
Sample Volume / PCR
Average Turnaround Time
24 to 48 hours after sample receipt, express testing scheme* possible.
Sensitivity of Method
< 100 CFU / PCR.
Based on EP 2.6.1 and 2.6.27 compliant testing, alternative method.
Sterility Testing ‘SteriEP’ 41-1006
Volume Discount Available
Yes, on request.
Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.