News | May 6, 2024

Convenience Meets Compliance: Introducing The Next-Generation Sterility Testing Pump For The Connected Lab

Source: Sartorius
  • Compact, universal design accommodates different workspaces, including benchtops in laminar airflow cabinets, RABS, and sterility testing isolators MLI
  • Precise and contamination-free transfer of samples and media into Sterisart® canisters
  • 21 CFR Part 11 compliant documentation simplifies electronic record keeping, promoting data integrity and audit readiness
  • Remote operation capabilities reduce the need for direct contact within isolators, improving user safety and operational efficiency

The life science group Sartorius announces the launch of the 4th generation Sterisart® Universal pump, marking a significant innovation in the field of sterility testing. Designed for the reliable transfer of samples and media into Sterisart® canisters, this new pump meets the stringent quality and safety standards demanded by today's pharmaceutical and biotechnology industries.

"Our Gen 4 pump is a game-changer for sterility testing in a connected era," says Eric Clement Arakel, Manager of Product Management for Reagent and Consumable Solutions at Sartorius. "We’ve listened to customers and created a pump that surpasses the industry's standards for safety, reliability, and ease of use. Its sophisticated reporting software and versatile connectivity options empower laboratories to achieve streamlined, compliant operations."

The Sterisart® Universal | Gen 4 transforms sterility testing workflows with remote data sharing and paperless documentation. Advanced reporting software simplifies workflow management and ensures compliance with strict regulatory standards, such as 21 CFR Part 11, through secure electronic signatures and audit trails. This maintains data integrity and supports audit readiness.

Integrated barcode scanning technology streamlines sample tracking by efficiently capturing material data across various formats, including QR codes, 2D matrices, and Codabar. This is particularly effective within the limited space of a sterility testing isolator. A high-performance, intuitive 7-inch touchscreen displays real-time data and menu options, all easily accessible even when wearing isolator gloves.

Customizable operational modes enhance control and navigation, featuring a record mode that logs user interactions to support SOP development and workflow automation. This system also incorporates visual guides to reinforce processes and minimize errors. Remotely enabled pump operation facilitates uninterrupted workflows, improving both productivity and operator safety.

Designed for maximum flexibility, the pump seamlessly integrates into diverse workspaces, including benchtops in laminar airflow cabinets, RABS, and sterility testing isolators, and is compatible with a wide variety of canisters. Its corrosion-resistant surface and user-friendly design ensure easy cleaning and decontamination for reliable sterility testing results.

For more information about Sterisart® Universal | Gen 4, click here.

A profile of Sartorius

Sartorius (XETRA: SRT3 | SRT) is a leading international partner of life sciences research and biopharmaceutical manufacturing. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. The company, based in Göttingen, Germany, has a strong global reach with around 60 production and sales sites worldwide. Sartorius regularly expands its portfolio through the acquisition of complementary technologies. In 2023, the company generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees are working for customers around the globe.


Source: Sartorius