Fact Sheet

SteriEP - Sterility Testing

Interest Group

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).

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

Minimum: 4 to 6 ml depending on validation status and project setup.
Optimum: 2 units of 4 ml (6 ml) each, label as sample A and sample B (backup, please mark in accession form).

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.