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.


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Sterisart® Pump

A comprehensive solution for the entire testing procedure, including Sterisart® Universal peristaltic pump.

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Sterisart® Canisters Features

Uncompromising
  • 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

User-Friendly
  • 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


     

Reliable
  • Bar-coded, gas impermeable packaging to eliminate the risk of false-negatives, following VHP-decontamination in isolators

Compliant
  • Adheres to the sterility testing requirements of major pharmacopeias, including USP <71>, Ph. Eur. 2.6.1, and JP 4.06

Related Resources

Product Resources

eBook

Sterility Testing Playbook

This interactive PDF/playbook helps you to easily identify the right sterility testing canister for your application. The playbook also provides an ov...

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Sterisart®️ Universal | Gen 4 - A Universal Pump for Any Space

Where Convenience Meets Compliance

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Data

Product Datasheet - Sterisart®️ Universal | Gen 4 

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Brochure

Sterility Testing for a Connected Era - Sterisart®️ Universal | Gen 4

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Featured Resources

Flyer

Sterisart® Sterility Testing

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Product Datasheet

Sterisart® Family - Consumables for Sterility Testing

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