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NAT-based detection of mycoplasmas in biopharmaceuticals

[NAT-based detection of mycoplasmas in biopharmaceuticals]

EPTIS factsheet 1140765 | Last revision 2024-01-17 | URL: https://www.eptis.bam.de/pts1140765 https://www.eptis.bam.de/pts1140765

PT provider
PT provider Minerva Biolabs GmbH Minerva Biolabs GmbH
Based in Germany
Language(s) English
Remarks
Keywords
Product groups Pharmaceutical products, drugs
Testing fields Microbiology
Technical details
Test item Tested property Testing method
Mycoplasma spp. - 5 samples - freeze-dried Detection Limit PCR, QPCR
Robustness -
Aims of the PT scheme
Target group of participants Product release test laboratories
Linked to specific legislation / standards EP 2.6.7, JP G3, USP <1071>
Additional, subsidiary aims validation of testing methods
Number of participants 20
Accredited or otherwise reviewed by a 3rd party
Operation is commissioned / requested by
Fees and frequency
Participation fee 280 €
Regularly operated Yes (annually)
Year of first operation 2013
Contact details of the PT provider
Provider Contact person
Minerva Biolabs GmbH
Schkopauer Ring 13
12681 Berlin
Germany

Phone: +49 30 20004370
Fax:
Web: http://www.minerva-biolabs.com http://www.minerva-biolabs.com
Dr Dirk Vollenbroich
Phone: +49-30-20004370
Fax:
Email: ipt@minerva-biolabs.com ipt@minerva-biolabs.com
If you find any mistakes please contact the responsible EPTIS coordinator in Germany, Mr Johannes van de Kreeke. Mr Johannes van de Kreeke.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5