Sartorius Sterisart® Universal 4th Generation Sterility Testing Pump
| Brand | Sartorius |
|---|---|
| Origin | Germany |
| Manufacturer Type | Authorized Distributor |
| Origin Category | Imported |
| Model | 16421-A |
| Instrument Type | Automated Sterility Testing System |
| Detection Throughput | Qualitative |
| Filter Cup Capacity | 120 mL (graduated at 50, 75, and 100 mL) |
| Filter Membrane Diameter | 0.45 µm |
| Filtration Method | Peristaltic Pump |
| Flow Rate Control | 0–100 rpm |
| Dimensions (min) | 26 × 22.5 × 54.6 cm (W × D × H) |
| Dimensions (max) | 33.7 × 26.2 × 54.6 cm (W × D × H) |
Overview
The Sartorius Sterisart® Universal 4th Generation Sterility Testing Pump is an engineered solution for quantitative membrane filtration-based sterility testing in regulated pharmaceutical, biotechnology, and contract manufacturing environments. It operates on the principle of controlled peristaltic vacuum-assisted filtration, enabling precise, aseptic transfer of liquid samples and culture media into Sterisart® filter cartridges under Grade A or ISO 5 conditions. Designed explicitly for integration into isolators, RABS, and laminar flow hoods, the system eliminates manual handling risks while maintaining full compliance with pharmacopoeial requirements—including USP , Ph. Eur. 2.6.1, and JP 4.07. Its architecture supports both direct membrane filtration and enrichment-based workflows, ensuring compatibility with aerobic, anaerobic, and fungal growth detection protocols.
Key Features
- 316L stainless steel fluid path with electropolished finish and fail-safe tube locking mechanism—validated for repeated VHP (vaporized hydrogen peroxide) cycles and compatibility with common disinfectants including 70% ethanol and sodium hypochlorite solutions
- Real-time pressure monitoring with automatic flow rate adjustment to prevent membrane rupture or sample channeling—critical for viscous or particulate-laden formulations
- Modular pump head design allowing rapid reconfiguration between single- and multi-sample configurations without tooling
- Compact footprint optimized for glovebox and isolator integration; minimum width of 26 cm enables placement within narrow access ports
- Integrated 7-inch capacitive touchscreen with glove-compatible operation, built-in barcode scanner, and context-sensitive visual workflow guidance
- Multi-language UI supporting English, French, German, Spanish, Italian, Portuguese, Russian, Japanese, Korean, and Simplified Chinese—configured at system initialization per user preference
Sample Compatibility & Compliance
The Sterisart® Universal 4th Gen accommodates all standard 0.45 µm pore-size sterile filtration membranes used in pharmacopeial sterility testing—including mixed cellulose ester (MCE), polyethersulfone (PES), and nylon variants—and accepts filter cartridges from third-party suppliers meeting ISO 8536-4 dimensional specifications. Each filtration cycle records timestamped metadata (operator ID, sample ID, filter lot, volume filtered, pressure profile, and environmental chamber status if linked via optional I/O interface). Audit trails are cryptographically signed and stored locally in tamper-evident format, satisfying FDA 21 CFR Part 11 Subpart C requirements for electronic records and signatures. System validation documentation—including IQ/OQ/PQ templates, risk assessments (FMEA), and traceable calibration certificates—is provided as part of the delivery package.
Software & Data Management
The embedded Sterisart® Connect software provides fully electronic batch record generation with configurable report templates aligned to internal SOPs and regulatory submission formats. All user actions—including method selection, parameter entry, start/stop commands, and result annotation—are logged with immutable timestamps and operator authentication. Role-based access control (RBAC) enforces segregation of duties across analyst, supervisor, and administrator levels. Data export supports CSV, PDF/A-2, and XML formats for LIMS integration; optional OPC UA server module enables real-time data streaming to MES or SCADA platforms. Electronic signature capability includes biometric fallback (PIN + badge) and dual-approval workflows for critical release decisions.
Applications
- Final product sterility testing of injectables, ophthalmic solutions, and lyophilized biologics
- In-process monitoring of buffer and media sterilization efficacy during upstream and downstream processing
- Environmental monitoring filter analysis in cleanroom classification studies (ISO 14644-1)
- Validation of sterilizing-grade filters per ASTM F838-22 and PDA Technical Report No. 26
- Support for compendial alternative methods under USP and Ph. Eur. 5.1.6
FAQ
Is the Sterisart® Universal 4th Gen compatible with non-Sartorius filter housings?
Yes—mechanical and dimensional compatibility has been verified with filter cartridges conforming to ISO 8536-4 (e.g., Millipore Sterivex™, Pall Acrodisc™, and Merck Millex™ series), provided membrane pore size remains 0.45 µm and housing material withstands peristaltic compression.
Does the system support GLP or GMP audit readiness out of the box?
Yes—the firmware includes pre-configured audit trail logging, electronic signature enforcement, and 21 CFR Part 11-compliant electronic records storage. Full validation support packages (including URS, FDS, and test scripts) are available upon request.
Can pressure profiles be exported for root cause analysis of filtration failures?
Yes—raw pressure vs. time datasets are retained for each run and exportable in CSV format for statistical process control (SPC) analysis or trending in JMP or Minitab.
What maintenance intervals are recommended for the peristaltic tubing?
Tubing life is validated for ≥500 cycles under nominal load (50 rpm, aqueous buffer); replacement is triggered automatically based on cumulative runtime and pressure deviation thresholds—no manual calendar-based scheduling required.
