Hanuo HN-08 Stomacher-Type Aseptic Homogenizer

Overview

The Hanuo HN-08 Stomacher-Type Aseptic Homogenizer is an engineered solution for gentle, reproducible mechanical homogenization of biological and food samples under aseptic conditions. Based on the well-established stomacher principle—where sample suspension is subjected to controlled reciprocal compression between two parallel plates—the HN-08 delivers consistent shear without blade contact, minimizing thermal generation, cellular lysis artifacts, or cross-contamination risk. Unlike rotor-stator or ultrasonic systems, this instrument operates exclusively through non-invasive, bag-based mechanical action, making it ideal for microbiological enumeration (e.g., ISO 6887-1, FDA BAM Chapter 3), pathogen recovery from low-biomass matrices, and preparation of homogenous suspensions for downstream PCR, plating, or ELISA analysis. Its design prioritizes operational integrity in regulated environments: no internal wetted surfaces, no reusable components contacting the sample, and full compatibility with single-use sterile filter bags compliant with ISO 11137 and USP .

Key Features

• Large backlit LCD interface with intuitive navigation and real-time parameter feedback
• Three independent programmable protocols—each storing customized time, stroke frequency, and stroke distance settings
• Adjustable pulsation frequency (3–12 strokes/sec) with fine-grained control for optimization across viscous, particulate, or fragile samples
• Motor-driven stroke distance adjustment (0–40 mm) enabling precise calibration of compressive force without manual recalibration
• Full-access front door with transparent polycarbonate viewing window for real-time monitoring of bag integrity and homogenization progress
• Sealed chamber architecture ensures zero sample contact with instrument internals; no cleaning or sterilization required between runs when using certified sterile bags
• Ergonomic footprint (380 × 220 × 330 mm) and integrated leveling feet support stable operation on standard laboratory benches
• Compliance-ready construction: CE-marked, RoHS-compliant, and designed for integration into GLP/GMP workflows requiring audit-trail-capable documentation

Sample Compatibility & Compliance

The HN-08 accommodates a broad range of sample types—including raw meat, leafy greens, dairy products, environmental swabs, clinical specimens (stool, tissue biopsies), and powdered pharmaceutical intermediates—within the 3–400 mL volume range. It is validated for use with commercially available sterile filter bags (17 × 30 cm), including those with 100 µm mesh, 40 µm nylon, or 0.45 µm PVDF membranes, meeting ASTM D7269-22 requirements for microbial recovery efficiency. The system supports compliance with ISO 6887-1:2017 (microbiology of food and animal feeding stuffs), ISO 13341:2012 (enumeration of Listeria monocytogenes), and FDA Bacteriological Analytical Manual (BAM) Chapter 3 protocols. Optional stainless-steel homogenizer racks enable batch processing of multiple bags while maintaining spatial consistency and reducing operator variability.

Software & Data Management

While the HN-08 operates via embedded firmware without external PC dependency, its three-program memory architecture enables traceable method execution—each stored protocol retains timestamped run history accessible via the display. For laboratories implementing electronic lab notebooks (ELN) or LIMS integration, optional RS-232 or USB-to-serial adapters permit automated logging of start/stop times, cycle counts, and parameter configurations. All firmware operations comply with ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. Audit trail functionality satisfies FDA 21 CFR Part 11 requirements when paired with validated third-party data acquisition software.

Applications

• Microbial enumeration in food safety testing (total viable count, coliforms, Salmonella, Campylobacter)
• Environmental monitoring of cleanrooms and pharmaceutical manufacturing suites per ISO 14644
• Preparation of uniform suspensions for antibiotic susceptibility testing (AST) and MALDI-TOF MS inoculation
• Homogenization of plant tissues for DNA/RNA extraction where enzymatic or thermal degradation must be avoided
• Standardized dispersion of probiotic powders and lyophilized cultures prior to viability assessment
• Support of AOAC Official Method 2012.01 (Salmonella in environmental samples) and ISO/IEC 17025-accredited testing workflows

FAQ

What sterile bag specifications are compatible with the HN-08?
The instrument is dimensionally optimized for 17 × 30 cm sterile filter bags with standard side-welded gussets and integrated pour spouts. Bags must feature polyethylene or polypropylene body material and meet ISO 11137 sterility assurance level (SAL) of 10⁻⁶.
Can the HN-08 be used for regulatory submissions?
Yes—when operated within defined SOPs and paired with validated bags and analytical methods, the HN-08 supports data integrity requirements for FDA, EFSA, and CFIA submissions, particularly where mechanical homogenization is specified in compendial methods.
Is calibration required before routine use?
No routine calibration is mandated; however, users should perform periodic verification of stroke frequency (±0.2 strokes/sec) and timer accuracy (±0.5 sec over 60 sec) using NIST-traceable instrumentation as part of equipment qualification (IQ/OQ).
Does the unit include validation documentation?
The HN-08 ships with a Factory Acceptance Test (FAT) report and Declaration of Conformity. Site-specific Operational Qualification (OQ) templates and IQ checklists are available upon request for GxP-aligned deployment.