Hanuo HN-12N Heated Sterilizable Stomacher-Type Aseptic Homogenizer

Overview

The Hanuo HN-12N Heated Sterilizable Stomacher-Type Aseptic Homogenizer is an engineered solution for standardized, low-shear mechanical homogenization of microbiological and biological samples under controlled thermal and sterile conditions. Based on the stomacher principle—where oscillatory paddle-beat action applies reproducible mechanical energy to sample-containing sterile bags—the HN-12N delivers consistent cell dispersion without significant thermal elevation or structural damage to sensitive microorganisms. Unlike rotor-stator or probe-based homogenizers, this system eliminates direct contact between sample and instrument surfaces, thereby removing cross-contamination risk and eliminating post-run decontamination of internal components. Its integrated heating and UV-C sterilization subsystems enable pre-run chamber conditioning—critical for reducing background bioburden in low-biomass or environmental samples—and support applications requiring temperature-controlled extraction (e.g., thermolabile enzyme recovery or heat-sensitive pathogen stabilization). Designed for compliance-driven laboratories, the HN-12N operates within defined physical parameters aligned with ISO 6887-1, AOAC Official Method 990.12, and USP microbiological enumeration guidelines.

Key Features

• Real-time digital display of beat frequency (3–12 beats/sec), elapsed time (0.1–99 min), and internal chamber temperature (ambient to 60 °C)
• 10 programmable multi-step protocols with independent control over beat frequency, duration, temperature setpoint, and UV exposure timing
• Adjustable beat gap (0–5 mm) to accommodate varying bag thicknesses and optimize energy transfer efficiency
• UV-C sterilization module (253.7 nm, 5-minute cycle) integrated into the stainless-steel chamber ceiling for pre-run surface decontamination
• Full-opening front door with impact-resistant polycarbonate viewport for real-time process monitoring and rapid bag insertion/removal
• Stainless-steel chamber interior with seamless welds and sloped base for complete liquid drainage and residue-free cleaning
• No internal wetted parts: all sample handling occurs exclusively within certified single-use sterile bags (17 × 30 cm, optional filter variants available)
• Auto-compensating beat motor maintains target frequency across load variations, ensuring repeatable mechanical input regardless of sample viscosity or volume

Sample Compatibility & Compliance

The HN-12N accommodates a broad range of solid and semi-solid matrices—including raw meat, poultry, seafood, dairy products, leafy greens, baked goods, cosmetic emulsions, and pharmaceutical suspensions—within its 3–400 mL working volume. Its gentle beat action preserves microbial viability while achieving uniform suspension, making it suitable for subsequent plating, membrane filtration, or automated colony counting per ISO 7218 and FDA BAM Chapter 3. All contact surfaces meet ISO 13485-compliant material specifications (AISI 304 stainless steel), and the device supports GLP/GMP workflows through traceable parameter logging (when paired with optional data export interface). The UV-C lamp output is validated per IEC 62471 photobiological safety standards, and thermal performance adheres to IEC 61000-4-2 EMC requirements for laboratory environments.

Software & Data Management

While the HN-12N operates via embedded firmware without external PC dependency, its parameter memory architecture supports audit-ready operation: each of the 10 stored protocols retains timestamped configuration metadata (temperature setpoint, beat frequency, duration, gap setting). Optional RS-232 or USB-to-serial interface enables integration with LIMS or ELN platforms for electronic record retention. When used in regulated environments (e.g., food safety labs under SQF Code Edition 9 or pharmaceutical QC under 21 CFR Part 11), the system supports manual logbook correlation and can be validated for IQ/OQ using vendor-provided test protocols covering temperature uniformity mapping, beat frequency accuracy, and UV irradiance verification.

Applications

• Microbiological sample preparation for aerobic plate count, coliform detection, and pathogen enrichment (e.g., Salmonella, Listeria, E. coli O157:H7)
• Homogenization of tissue biopsies and clinical specimens prior to nucleic acid extraction or culture isolation
• Preparation of cosmetic challenge-test inocula in accordance with ISO 11930
• Standardized dilution and dispersion of powdered pharmaceuticals and herbal supplements for microbial limit testing (USP , EP 2.6.12)
• Environmental swab and sponge sample processing in food manufacturing facilities per FDA Food Code Annex 3-201.11
• Temperature-modulated extraction of heat-labile enzymes from plant tissues without denaturation

FAQ

What sterilization standards does the UV-C lamp comply with?
The 253.7 nm UV-C lamp meets IEC 62471 Risk Group 2 classification and delivers ≥10 mJ/cm² irradiance at chamber center—sufficient to achieve ≥3-log reduction of Bacillus atrophaeus spores per 5-minute cycle, as verified by third-party bioindicator testing.
Can the HN-12N be used for anaerobic sample processing?
Yes—when operated with oxygen-scavenging sterile bags and pre-flushed with inert gas (e.g., N₂ or CO₂), the sealed chamber environment supports strict anaerobe homogenization; however, UV sterilization must be disabled during such runs.
Is temperature calibration traceable to NIST standards?
Chamber temperature sensors are factory-calibrated against NIST-traceable reference probes (±0.3 °C accuracy at 37 °C); users may perform field verification using a calibrated PT100 thermometer inserted through the bag port.
What maintenance is required beyond routine cleaning?
Annual verification of UV lamp intensity (using calibrated radiometer) and beat motor torque consistency is recommended; no lubrication or internal component replacement is required under normal operating conditions.
Does the system support 21 CFR Part 11 compliance?
The base unit does not include electronic signature or audit trail functionality; however, when connected to validated third-party data acquisition software with role-based access control and electronic signature modules, full Part 11 compliance is achievable.