This page does not exist in your selected language. Your preference was saved and you will be notified once a page can be viewed in your language.
This page is also available in your prefered language. Switch to that version.
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.
Request a Quote or Demo
The quality of the needle plays a decisive role in determining the ease and safety of piercing closures on product containers and rinsing liquid bags, as well as of transferring culture media into the canisters:
Our patented metal dual-needle spike is easier to use due to its built-in sterile vent filter
A wide choice of versions with user-friendly adapters is available for the most common sample containers
The protective shield protects the user from injury
An air filter is essential for sterile venting. But if it comes in contact with the culture medium, it can easily become clogged. At the same time, it can pose a risk to your sample as a result of microbial growth.
That’s why we designed it with a safety clearance of 1 cm to effectively protect the filter from coming in contact with the culture medium, even if foaming or the slightest vibration occurs.
Working in an isolator calls for the highest dexterity and concentration – every single extra manual step can add up to stress.
Instead of being sealed in a separate, difficult-to-open package, the easy-to-handle yellow plugs for closing the canisters are right where you need them: in extra pockets directly inside the primary packaging. This facilitiates your workflow and lets you stay focused on your core tasks.
With standard gas-permeable primary packaging, you first have to perform a complicated rinsing procedure inside an isolator to flush out residual gas from sterility test units before you can even begin testing.
Our gamma-sterilized and gas-impermeable primary packaging entirely eliminates the need for this rinsing step. You can begin right away with sterility testing, saving steps and rinsing liquid.
The extra-large, grip-optimized filter caps are directly attached to the vent filters. You'll find this practical – and not only that. The caps connected by a band to the vent filters cannot fall off or touch any surfaces of the isolator so they are safe from contamination.
The article ID codes consisting of the lot number, individual number and product number, permit 100% traceability and identification of the materials.
No liquid can splash onto the membrane thanks to the anti-foaming inlet flow design. Instead, liquid flows along the interior of the canister, preventing foaming. This along with a safety clearance of 1 cm, or over 2 1/2", from the air filter provides double protection in preventing this sterile filter from coming in contact with culture medium. As a result, this minimizes the risk of microbial growth.
Making responsible decisions in final quality control for release of safe products can be highly stressful because every step has consequences – especially when you cannot tell one canister apart from the other. You can readily confuse these in busy-day routines.
The two different color-coded clamps on Sterisart® tubing eliminate the risk of confusion, making it easy for you to identify and fill the canisters with the correct media. Now you can work confidently without worrying about such risks.
A critical step in sterility testing is sampling from or injecting into a canister. You usually do this by piercing a tube. This conventional method is not only complicated and involves the hazard of injury. It also increases the risk of false-positive results as this compromises the integrity of the closed system. There is a better and safer way: septum closures.
The septum technology of our Sterisart® units has been proving its effectiveness for more than ten years as the method of choice for aseptic transfer of liquids. Your sample will remain safely protected against contamination, as the septum ensures a sterile barrier. At the same time, the simple piercing mechanism minimizes your risk of puncture injuries.
A comprehensive solution for the entire testing procedure, including Sterisart® Universal peristaltic pump.
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
Visual Guide for a 21 CFR Part 11 Sterility Testing Workflow
Maintaining positive pressure within sterility testing canisters is indispensable.
How to configurate the workflow
This video provides an overview of the manufacturing process for our Sterisart® Sterility Testing Canisters.
Discover how the Sterisart® Universal | Gen 4 ensures your pharmaceutical processes meet the stringent requirements of 21 CFR Part 11.
Membrane filtration-based sterility testing is particularly suited for products with microbial growth-inhibiting properties, such as antibiotics.
This interactive PDF/playbook helps you to easily identify the right sterility testing canister for your application. The playbook also provides an ov...
Where Convenience Meets Compliance
April 29, 2020 | Flyer
August 30, 2022 | Product Datasheet
Choose the right Sterisart® Canister or Pump using our search and filter tools
Please select your country so we can show you products that are available for you.
The content of our website is always available in English and partly in other languages. Choose your preferred language and we will show you the content in that language, if available.
Shop Sartorius Products Now