The Sterisart® System Simplifies the Sterility Testing of Therapeutics with Antimicrobial Properties
Membrane filtration-based sterility testing is particularly suited for products with microbial growth-inhibiting properties, such as antibiotics. These compounds need to be purged from the system to mitigate the incidence of false negatives. This is achieved by constructing the sterility testing canisters with materials that exhibit minimal to no non-specific binding.
Overview
In this study, the recovery of microorganisms following the filtration of ciprofloxacin for intravenous administration and gentamicin for intramuscular injection using the Sterisart® closed system sterility testing device was evaluated. The results demonstrate that the Sterisart® canisters containing regenerated cellulose membranes are optimal for the sterility testing of antibiotics.
Document type: Application Note
Page count: 8
Read time: 5 min
Last updated: December 2023
Authors: Nils Jäger, Anna-Lena Weißenborn, Eric Clement Arakel
Key Takeaways
- Sterisart® canisters are optimal for testing sterile pharmaceuticals with antimicrobial properties, including those products that cannot be effectively neutralized.
- The Sterisart® Sartochem® Regenerated Cellulose Membrane stands as a universal membrane, characterized by minimal to no non-specific binding properties.
- The unique Sterisart® septum port eliminates the risk of false positives and eases aseptic supplementation for antibiotic inactivation or aseptic sampling.
- The Sterisart® sterility testing portfolio is fully compliant with every pharmacopeial need.
This Resource is Designed for:
- Microbiological Testing Lab Managers
- Microbiology Managers for Pharma QC
- Sterility Testing Operators
- QC Analysts
- Method Validation Experts
Applications Supported:
- Sterility Testing
- Pharmaceutical Applications
- Microbiological Quality Control
Preview of Application Note
