Interscience BagMixer® 400SW Laboratory Stomacher Homogenizer

Overview

The Interscience BagMixer® 400SW is a high-performance laboratory stomacher homogenizer engineered for reproducible, low-shear mechanical disruption of microbiological samples in sterile filter bags. Unlike rotor-stator or ultrasonic homogenizers, the BagMixer® 400SW operates on the principle of controlled paddle-driven oscillation—applying precisely calibrated horizontal reciprocating motion to sample bags placed between two parallel stainless-steel blades. This method ensures uniform dispersion without excessive heat generation or cell lysis bias, making it especially suitable for quantitative microbial recovery from food, environmental, pharmaceutical, and clinical specimens per ISO 6887-1, FDA-BAM Chapter 3, and USP . Its sealed bag-based workflow eliminates cross-contamination risk and supports aseptic processing under laminar flow hoods or biosafety cabinets.

Key Features

• Ultra-low noise operation (<48 dB[A]) enabled by Paulstra™ vibration-damping mounts and an acoustically optimized polycarbonate enclosure—enabling uninterrupted communication during active homogenization.
• Four discrete speed settings (4, 6, 8, 10 rpm) coupled with programmable time control (1 second to 59 minutes, or continuous mode) allow precise protocol optimization across diverse matrices—from soft dairy products (e.g., 250 mL water + 22 g cheese) to fibrous plant tissues or viscous biofilms.
• Click & Clean® blade system: Tool-free detachment of 304L stainless-steel blades for rapid cleaning, autoclaving (121°C, 20 min), or replacement—minimizing downtime and supporting routine maintenance compliance.
• TotalAccess™ flat-opening door design provides full unobstructed access to the entire homogenization chamber, facilitating visual inspection, residue removal, and validation of cleaning efficacy.
• Integrated liquid leakage detection sensor halts operation immediately upon contact with escaped fluid—preventing motor damage and ensuring operator safety per IEC 61010-1 requirements.
• Q-Tight® sealing mechanism prevents upward ejection of liquid during high-speed cycles, while the built-in drip tray captures incidental condensate or minor seepage for containment and traceability.

Sample Compatibility & Compliance

The BagMixer® 400SW accommodates standard ISO-compliant stomacher bags (50–400 mL volume range) including nylon-reinforced, filter-bottom, and selective-enrichment variants. Its non-contact, bag-contained process inherently satisfies ISO/IEC 17025 method validation prerequisites and aligns with GLP documentation standards through auditable runtime logging. The device meets CE marking requirements for electrical safety (EN 61010-1) and electromagnetic compatibility (EN 61326-1). As part of Interscience’s ISO 13485-certified manufacturing ecosystem, the 400SW supports regulatory submissions requiring documented instrument qualification (IQ/OQ/PQ) and long-term performance verification.

Software & Data Management

While the BagMixer® 400SW operates via embedded firmware without external PC dependency, its multifunctional digital display logs key operational parameters—including speed, duration, cycle count, and error codes—for manual entry into laboratory information management systems (LIMS). LightCode® status LEDs provide real-time visual feedback: green (ready), blue (running), amber (warning), red (fault)—enhancing procedural consistency in high-throughput labs. All firmware updates are delivered via secure USB interface, and audit trails of configuration changes comply with FDA 21 CFR Part 11 principles when paired with appropriate lab SOPs and electronic signature protocols.

Applications

• Microbial enumeration in food safety testing (Salmonella, Listeria, E. coli O157:H7 recovery from raw meat, produce, and dairy).
• Environmental monitoring: extraction of heterotrophic plate count (HPC) organisms from water filters or swab samples.
• Pharmaceutical QC: recovery of bioburden from sterile product contact surfaces or rinse solutions per USP .
• Clinical microbiology: homogenization of stool specimens prior to culture or molecular assay preparation.
• Research applications requiring standardized mechanical lysis of biofilm-coated substrates or particulate-laden suspensions.

FAQ

Is the BagMixer® 400SW compatible with all standard stomacher bags?

Yes—it accepts industry-standard 50–400 mL filter bags conforming to ISO 6887-1 dimensions and material specifications.
Can the device be validated for GMP environments?

Absolutely. Its deterministic mechanical action, repeatable parameter control, and firmware-based event logging support IQ/OQ/PQ execution per Annex 15 and ASTM E2500 guidelines.
What maintenance intervals are recommended?

Blades should be inspected after every 50 cycles; cleaning is required after each use. Vibration dampers and door seals require annual functional verification—both covered under lifetime warranty.
Does the unit support remote monitoring or network integration?

No native Ethernet or Wi-Fi capability exists; however, digital display outputs can be captured via external camera-based documentation systems compliant with ALCOA+ data integrity principles.
How is calibration verified?

Speed and timer accuracy are factory-verified against NIST-traceable references. Users may perform periodic checks using certified tachometers and stopwatch validation per internal SOPs.