Aseptic Sample Transfer out of a Closed, Sterile System with the Sterisart®️ Septum Technology
Sterisart® - Reliability and Simplicity Exemplified
Sterility Testing Playbook
Designed for sampling. Acting as a sterile barrier the Sterisart® Septum allows for a safe, aseptic sample transfer out of a closed, sterile system. This enables you to take samples whenever needed or to transfer samples into a rapid detection system after only a few days of incubation. A secure and flexible method no one else can offer you.
A Best Practice Video Guide for Sterility Testing with Sterisart
Watch our best practice guide on sterility testing in advanced aseptic processing systems such as RABS (Restricted Access Barrier System) and isolators.
Sterility Testing Meets Rapid Detection
Sartorius has partnered with Charles River Laboratories to offer customers a complete solution for rapid sterility testing: The Sartorius Sterisart® NF closed filtration system is qualified specifically for use with Charles River's Celsis® instruments.
Sampling via tubing can compromise the integrity of the sterility test, precluding re-incubation of the sterility testing canisters. The Sterisart® Septum sampling port eliminates the risk of false positives, ensures operator safety, and prevents accidental spillage during sampling. The Septum simplifies and de-risks the critical step of sample extraction for detection on Celsis® instruments.
Discover more about the synergies between Sartorius consumables and Charles River instrumentation and how they create a combined solution for rapid sterility testing.
The Sterisart® gamma-sterilized and gas-impermeable packaging eliminates the need for rinsing and the cost of rinsing liquids.
Sterisart® includes a safety clearance of 1 cm (less than 2.5 in) for the air filter, which effectively protects the filter from coming into contact with the culture media. This safety clearance prevents clogging of the filter and subsequent risk of contamination – even in the case of foaming or vibration.
Sterisart® CA* units, with cellulose acetate membranes, delivered the fastest flow rates in customer tests. As pioneers of membrane filtration, we have successfully developed a specific membrane structure that is less hydrophilic than conventional cellulose acetate membranes.
*Currently not available with Sterisart® Septum technology
Clearly visible graduated volume marks.
Optimized canister design with anti-foaming inlet.
The Sterisart® Universal Pump chassis is made of stainless steel for chemical compatibility with sterilants used in isolators, and the unique, closed pump motor reduces the need for maintenance.
Space is often at a premium in isolators and on clean benches; the Sterisart® Universal Pump was specifically designed with a compact footprint and a low profile to take up little space, especially in front of and above the pump. It can be integrated into clean benches or installed counter-sunk into isolators. The Universal Pump’s user-friendly construction also ensures ease when threading tubing into the pump rotor, and the pump head is easily accessible for cleaning and disinfecting. The modular design means the external control unit of the basic version can be upgraded later, without needing to purchase an entirely new pump.
The Sterisart® Universal Pump has a closed-pump chassis, eliminating the need for motor ventilation. The pump will not release particles or microbes into your cleanroom or isolator environment, nor will it cause turbulence in laminar-flow areas. In a head-to-head comparison test at the highest speed, our Sterisart® Universal Pump was far below international regulations of no more than 3,520 particles per m3 in ISO class 5 cleanrooms for sterility testing. In fact, our results were 60 times lower than those of competitor A.
With model 16420, recall and run your own SOPs downloaded from an attached PC. The built-in display runs software that can collect data while the pump is in use. Input data, such as pump speed and time elapsed during pumping, either manually or automatically. Document the complete process sequence of your sterility tests to ensure compliance with agency directives.
New Application Note
In this study, the closed system sterility testing device, Sterisart®️ septum version, was evaluated for the recurrent sterile extraction of samples. The results demonstrate that even after more than 100 repeated septum sampling events, which far exceeds any foreseeable sampling requirements, the septum remains intact and the growth media contained in these canisters remains sterile.
Sterisart® Second Supplier Validation Guide
There are several detailed guidelines for sterility testing, besides the pharmacopeial chapters. We have compiled the most important points to be considered during the validation | revalidation of your sterility testing canisters.
Sterility Testing Playbook
December 02, 2020 | Product Sheet
Sterisart® Easy ConfigurationPDF | 848.3 KB
August 30, 2022 | Product Datasheet
Sterisart® Family - Consumables for Sterility TestingPDF | 1.3 MB
August 30, 2022 | Brochure
Sterisart® NF: Sterility Testing Made Easy and ReliablePDF | 366.8 KB
April 29, 2020 | Flyer
Sterisart® Sterility TestingPDF | 349.7 KB
January 28, 2021 | Flyer
Sterisart® Sterility Testing: Redefining StandardsPDF | 685.8 KB
August 30, 2022 | Brochure
The Sterisart® Universal PumpPDF | 1003.2 KB
August 05, 2020 | Application Note
Sterisart® Septum Enables Reliable Sampling from a Closed System Sterility Testing UnitPDF | 1.5 MB
August 14, 2020 | Guide
Points to Consider When Validating Your Sterility Testing CanistersPDF | 922.5 KB
August 30, 2021 | Podcast Transcript