Sterisart® Canisters: Reliability & Simplicity in Sterility Testing
Sterility tests are routinely performed in pre-sterilized closed membrane filtration device to reduce the risk of false positives. These devices employ membranes with a maximum pore size of 0.45 µm, proven to effectively trap microbial contaminants present in the test sample throughout the filtration process. After the membranes are rinsed with an appropriate solution, the canisters are filled with either Soybean-Casein Digest Medium (TSB) or Fluid Thioglycollate Medium (FTM). These media support the growth of a wide range of microorganisms, including both aerobic and anaerobic types. The canisters are then incubated for a recommended period of 14 days, a duration that allows even slow-growing, dormant, or stressed microbes to proliferate.
Sterility is assessed through visual inspection: a clear and transparent culture medium indicates a sterile sample, whereas any turbidity suggests contamination. In the event of turbidity, a thorough investigation is initiated to identify the cause, followed by either a retest of the sterility, disposal of the affected manufacturing lot, or implementation of corrective and preventive actions (CAPA).
Our gamma-sterilized sterility test canisters represent the pinnacle of our commitment to quality. They undergo rigorous quality control to ensure reliable results, thereby preventing the costly and time-consuming consequences of erroneous testing and protecting patients from the dangers of microbial contamination in therapeutics.
Discover our comprehensive portfolio and the specially designed features that ensure ease of use, detailed below.
Sterisart® Canisters Features
Safe aseptic sampling with the Sterisart® septum port for rapid microbial release or for genotypic/phenotypic identification during a sterility test failure
Convenient sampling for sub-culturing or for the preservation of uncontaminated environmental isolates
Secure supplementation of growth media with antibiotic inactivators
Patented dual needle with built-in sterile venting and large protective plate for safe and easy piercing
Pre-installed, tethered, extra-large, grip-optimized filter caps
Anti-foaming inlet with flow-director
Recess in packaging housing directly-accessible, large outlet plugs
Bar-coded, gas impermeable packaging to eliminate the risk of false-negatives, following VHP-decontamination in isolators
- Adheres to the sterility testing requirements of major pharmacopeias, including USP <71>, Ph. Eur. 2.6.1, and JP 4.06