International pharmacopeia stipulate a 14 day sterility test period. As ATMPs may have a shelf-life of less than 48 hours, traditional methods cannot be used for release testing of ATMPs prior to treatment. The risk of administering potentially contaminated ATMPs to patients necessitates new solutions for rapid detection of total bacteria prior to treatment.
Sartorius cares for patient safety and has created a validated Microsart® ATMP Bacteria Kit to give you the performance you deserve, with the compliance you expect. User benefits include:
- Detection of >95% of all known bacteria in a single test
- 3h result: prior to treatment
- Specific TaqMan® probes reduce false-positives
- Non-infectious validation standards
- Less pipetting: controls already included
For additional product information and documentation, or to request a free trial kit, please visit us online.
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