Hanuo HN-10N Sterilizable Pulsed-Action Aseptic Homogenizer

Overview

The Hanuo HN-10N Sterilizable Pulsed-Action Aseptic Homogenizer is an engineered solution for standardized, low-shear mechanical homogenization of microbiological and biological samples under controlled aseptic conditions. Operating on the principle of controlled reciprocal pulsation—commonly referred to as stomacher-style action—the instrument applies calibrated mechanical energy through rhythmic, bidirectional impact between two parallel plates, uniformly disrupting sample matrices without generating significant thermal load or cellular lysis beyond intended dispersion. Designed specifically for regulatory-compliant microbial recovery workflows, it enables reproducible release of microorganisms from food, environmental, clinical, and pharmaceutical matrices—including solid tissues, composite foods (meat, fish, produce, baked goods), cosmetic suspensions, and sterile-filtered drug products—while maintaining viability and minimizing stress-induced artifacts. Its sealed, UV-C–equipped chamber and single-use aseptic bag system eliminate cross-contamination risk and obviate post-run decontamination of internal surfaces, supporting high-throughput laboratory environments where traceability, repeatability, and audit readiness are critical.

Key Features

• Integrated UV-C sterilization module (253.7 nm wavelength) with programmable 5-minute pre-run disinfection cycle for the internal chamber—validated per ISO 15883-1 for surface microbial reduction.
• Large backlit LCD interface with intuitive navigation and real-time pulse counter display; supports user-defined parameter recall across 10 independent multi-step protocols.
• Adjustable pulsing gap (0–50 mm) and frequency (3–12 pulses/sec) enable optimization for diverse sample rheologies—from viscous dairy emulsions to fibrous muscle tissue—without manual intervention.
• Full-opening front door with transparent polycarbonate viewport allows unobstructed visual monitoring during operation and facilitates rapid bag insertion/removal and chamber inspection.
• Aseptic sample containment via certified sterile, low-extractable polyethylene bags (17 × 30 cm); eliminates direct contact between sample and hardware, removing need for cleaning validation or autoclaving between runs.
• Passive thermal management design ensures temperature rise ≤1.5 °C during standard 2-minute homogenization cycles—critical for preserving thermolabile microbes and enzymatic activity in QC testing.
• Robust stainless-steel chamber construction (AISI 304) resists corrosion from disinfectants and organic solvents, complying with ISO 13485 cleanroom-compatible equipment requirements.

Sample Compatibility & Compliance

The HN-10N accommodates heterogeneous solid and semi-solid matrices within the 10–400 mL volume range, including raw and processed foods (e.g., ground meat, leafy greens, cheese), animal tissues (liver, spleen, skin), environmental swabs, and pharmaceutical suspensions. It conforms to internationally recognized microbiological preparation standards, including ISO 6887-1 (microbiology of food and animal feeding stuffs), ASTM D5600 (standard guide for homogenization of environmental samples), and USP and for microbial enumeration and absence-of-pathogens testing. The closed-bag workflow satisfies GLP and GMP documentation requirements by enabling full batch traceability, preventing carryover, and eliminating operator-dependent variability associated with manual stomaching or blender-based methods.

Software & Data Management

While the HN-10N operates as a standalone benchtop instrument without network connectivity, its embedded firmware supports full audit-trail functionality: each run logs timestamp, selected protocol ID, actual pulsing duration, real-time frequency output, and UV-C activation status. All parameters are retained in non-volatile memory for ≥10,000 cycles and exportable via USB port (optional adapter) for integration into LIMS or electronic lab notebook (ELN) systems. Protocol storage adheres to ALCOA+ principles—Attributable, Legible, Contemporaneous, Original, Accurate—and supports FDA 21 CFR Part 11 compliance when paired with validated electronic signature modules.

Applications

• Microbial recovery from food and feed samples per ISO/IEC 17025-accredited methods.
• Preparation of homogenates for pathogen enrichment (e.g., Salmonella, Listeria monocytogenes) in ready-to-eat products.
• Standardized tissue dissociation for veterinary diagnostics and biobanking workflows.
• QC release testing of sterile ointments, creams, and suspensions under pharmacopoeial guidelines (EP 2.6.12, JP 4.07).
• Environmental monitoring of swab and sponge samples in pharmaceutical cleanrooms per ISO 14644-1 Class 5–8 requirements.

FAQ

Is the UV-C sterilization cycle validated for microbial kill efficacy?

Yes—UV-C irradiation at 253.7 nm delivers ≥3-log reduction of Bacillus atrophaeus spores on stainless-steel surfaces under defined chamber conditions, per internal validation reports aligned with ISO 15883-1 Annex B.
Can the HN-10N be used with non-Hanuo branded aseptic bags?

Only bags certified for dimensional compatibility, burst pressure (>1.2 bar), and extractables profile per USP are recommended; third-party bags may compromise seal integrity or generate particulate interference.
Does the instrument meet electrical safety and EMC requirements for EU laboratories?

It complies with IEC 61010-1 (Safety) and IEC 61326-1 (EMC) and carries CE marking under the Low Voltage Directive and EMC Directive.
What maintenance is required beyond routine cleaning of the chamber?

Annual calibration of pulsing frequency and timer accuracy is advised; no lubrication or consumable replacement is needed—motor and drive mechanism are sealed and maintenance-free for ≥5 years under normal use.
Is technical support available in English for international customers?

Yes—Hanuo provides remote troubleshooting, protocol optimization guidance, and installation qualification (IQ) documentation in English upon request.