Fact Sheet
SteriEP - Sterility Testing
Interest Group
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Description
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.
Method
Qualitative Real-Time PCR.
Applied PCR System
Microsart ATMP Bacteria (Sartorius Biotech GmbH).
Applied Extraction
Microsart Sterile Extraction (Sartorius Biotech GmbH).
Process Control
Extraction and Amplification.
Sample Volume / PCR
10 µl.
Average Turnaround Time
24 to 48 hours after sample receipt, express testing scheme* possible.
Sensitivity of Method
< 100 CFU / PCR.
Regulatory Compliance
Based on EP 2.6.1 and 2.6.27 compliant testing, alternative method.
Sample Requirements
Order No.
Sterility Testing ‘SteriEP’ 41-1006
Volume Discount Available
Yes, on request.
Additional Information
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.