Improving Your Sterility Testing with the Sterisart Universal | Gen 4

Sterility testing is crucial for ensuring sterile pharmaceuticals, ophthalmic preparations, and medical devices are safe. This process generally filters products through a membrane, rinses inhibitors away, adds microbial growth media, incubates them, and checks for microbial growth to see if there are any contaminating microorganisms. Sartorius has made sterility testing for labs easier with the Sterisart^® Universal | Gen 4 pump. This pump is designed to make testing more efficient and compliant.

Key Features and Benefits

Eric Arakel, who leads the product management team for microbiological testing at Sartorius, talks about the Sterisart Universal | Gen 4. "It's a next-generation peristaltic pump designed for closed membrane filtration-based sterility testing," Eric says. The pump is small, so it fits well in laminar flow cabinets, clean rooms, and isolators. Its mirror-finish 316L stainless steel construction makes it easy to clean and meets strict decontamination standards.

Replacing the previous Sartorius pump models, the new pump comes in three versions: Basic, Essential, and Advanced. These replace the older models. Eric highlights the pump's ability to achieve regulatory-compliant, paperless documentation in advanced aseptic processing systems. It meets 21 CFR Part 11/Annex 11 requirements, ensuring it follows regulatory standards and keeps data secure.

Innovative Design

The Sterisart Universal | Gen 4 has a universal, open, hygienic, modular, and ergonomic design. Eric explains, "Universal: Developed both for benchtop use and with the capability to integrate into isolators. Open: Our system is compatible with most sterility testing canisters available on the market. Modular: Allows upward upgradability to new requirements with a reduced ecological footprint."

The hygienic design uses 316L grade stainless steel, which can be cleaned with common sterilants and is compatible with Vaporized Hydrogen Peroxide (VHP). The ergonomic design focuses on comfort and usability, reducing user fatigue during tests in tight spaces.

Enhanced Workflow and Global Compatibility

The Sterisart Universal | Gen 4 improves sterility testing workflow by recording all user interactions. This helps with transparency and traceability. Eric notes, "By documenting user interactions, the pump enables the creation of SOPs and allows for semi-automation through a workflow configurator." The pump guides users visually through each stage of the sterility test, step by step.

It supports 10 languages: English, French, German, Portuguese, Spanish, Italian, Russian, Chinese, Japanese, and Korean. This makes it suitable for labs around the world.

Real-Life Impact

Eric shares insights from early adopters who have upgraded to the new system. "Paper-based documentation is often tedious and prone to errors. For example, manually recording material data of reagents and consumables used during sterility tests is cumbersome," he explains. The integrated barcode scanner and record feature on the pump streamline these processes, automatically documenting every user interaction in a comprehensive electronic report.

This shift from paper-based documentation saves time, costs, and effort, especially during audits, where records can be accessed with just a few keystrokes.

Ensuring Compliance

Compliance with 21 CFR Part 11 is crucial for sterility testing in the pharmaceutical industry because it guarantees the integrity and security of electronic data, ensures accurate record-keeping, and facilitates regulatory audits. Adhering to these standards helps maintain the quality and safety of sterile products, protecting public health and meeting stringent regulatory requirements.

To see the Sterisart Universal | Gen 4 in action, watch the Video Guide for a 21 CFR Part 11 Sterility Testing Workflow: https://sar.to/sterisartpump-labonlineau.