Sartorius – Sterisart(R) Universal | Gen 4 - Sterility Testing Pump

The Sterisart(R) Universal Gen 4 plays a critical role in sterility testing - an essential procedure to ensure patient safety in pharmaceutical and biopharmaceutical environments. Through precise and sterile transfer of liquids from sample containers and reagent bottles into sterility testing canisters, the pump supports one of the most sensitive steps in quality assurance.

The Sterisart(R) Universal Gen 4 has been developed with a focus on real-world usability, safety, and compliance, incorporating key principles of modern aseptic process design:

1. Hygienic Design
Crafted from high-grade 316L stainless steel, the device is fully compatible with vaporized hydrogen peroxide (VHP) decontamination. All surfaces are designed with cleanability in mind and is free from sharp corners and crevices to meet stringent hygienic requirements in cleanroom environments.

2. Modularity and Flexibility
The pump system is modular by design, enabling adaptation to evolving user needs. This supports scalable operations and cost-effective upgrades over time.

3. Open System Architecture
Rather than locking users into consumables, the open design allows integration with a wide range of canisters already available on the market. This ensures compatibility, reduces procurement complexity, and offers greater flexibility for varied applications.

4. Universal pump
The device has been engineered for universal usability across different cleanroom settings—on benchtops, under laminar airflow hoods, or integrated into isolator systems. A single version serves multiple use cases, eliminating the need for separate models.

5. Ergonomic Considerations
Designed with the operator in mind, the pump supports more comfortable and efficient operation, with all key components being adjustable and flexible. This is especially important for sterility testing, which is often manual and repetitive. 

6. Built-in Safety and Monitoring
To further enhance process security, the system includes an overpressure sensor to monitor the liquid transfer process in real time. This ensures process consistency and helps prevent downtime through errors.

7. Compliance and Digitalisation
A significant design achievement is the system's full compliance with 21 CFR Part 11, without requiring additional peripherals or software. It features a built-in barcode scanner, a high-resolution 7-inch touchscreen and captures all user interactions. This enables digital recordkeeping, reducing manual paperwork and minimizing both errors and administrative workload. Comprehensive digital documentation lays the foundation for standardized operating procedures and facilitates semi-automation.

8. Workflow Support and Visual Guidance
The integrated workflow configurator offers step-by-step visual support during operations. This reduces the chance of user error and standardizes procedures, making training and daily use more intuitive.

9. Remote Operation Capability
To protect users from hazardous substances and improve operational convenience, the pump can be operated remotely. This feature also eliminates the need for manual configuration directly at the device.

10. Focused on Simplicity and Progress
Every aspect of the design reflects our commitment to simplifying processes and supporting digital transformation in sterile manufacturing environments. By replacing paper-based records with secure, electronic logs and offering configurable semi-automated workflows, the system saves time, reduces the risk of human error, and promotes consistent process execution.