HengaoDe H18166 Triple-Station Microbial Limit Tester with Integrated Vacuum Pump
| Brand | HengaoDe |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | H18166 |
| Power Supply | AC 220 V / 50 Hz |
| Power Consumption | 30 W |
| Vacuum Level | 60 kPa |
| Flow Rate per Filter | >100 mL/min (using 50 mm, 0.45 µm hydrophilic mixed-cellulose ester membrane) |
| Operating Mode | Continuous |
| Number of Filter Heads | 3 |
| Weight | 7.6 kg |
Overview
The HengaoDe H18166 Triple-Station Microbial Limit Tester is a dedicated benchtop instrument engineered for rapid, compliant microbial enumeration in liquid samples across pharmaceutical, food & beverage, environmental, cosmetic, and chemical laboratories. It operates on the principle of membrane filtration—where test samples are drawn under controlled vacuum through sterile, low-protein-binding membranes; retained microorganisms are then cultured on selective agar media and enumerated following established pharmacopoeial protocols (e.g., USP , EP 2.6.12, ChP 1105). Unlike traditional setups requiring external vacuum sources and multiple glassware components, this unit integrates a high-reliability German-made diaphragm vacuum pump, eliminating dependency on central lab vacuum lines or water aspirators—thereby reducing cross-contamination risk, footprint, and procedural variability.
Key Features
- Triple independent filtration stations enable parallel processing of up to three samples—reducing assay turnaround time by ≥60% compared to single-channel systems.
- Integrated vacuum pump delivers stable 60 kPa suction with noise <55 dB(A), rated for continuous operation over 8,000 hours without maintenance.
- Large-format LCD interface with tactile membrane keypad supports intuitive navigation, real-time flow monitoring, and user-defined sterilization cycles.
- Modular stainless-steel filter holders accept both reusable 47 mm or disposable 50 mm membrane assemblies—compatible with standard 0.45 µm mixed cellulose ester (MCE), nylon, or PVDF membranes.
- Filter heads feature quick-release bayonet mounts and autoclavable construction (121°C, 20 min); optional flame-sterilizable nozzles support aseptic transfer between sequential tests.
- Compact footprint (320 × 280 × 360 mm) optimizes laminar flow hood integration; weight distribution ensures stability during high-volume filtration.
Sample Compatibility & Compliance
The H18166 is validated for use with aqueous matrices including purified water, WFI, saline solutions, buffer preparations, soft drinks, mineral water, cosmetic toners, and process rinse waters. It meets functional requirements of ISO 8573-7 (compressed air microbiology), ASTM D4457 (microbial testing of industrial fluids), and Chinese Pharmacopoeia 2020 Edition Vol IV Section 1105. The system supports GLP/GMP workflows via audit-trail-ready operation logs (when paired with optional PC software), and its closed-loop filtration architecture minimizes operator exposure—aligning with OSHA 1910.1200 and EU Directive 2004/37/EC for biological hazard control. All wetted parts comply with USP Class VI biocompatibility standards.
Software & Data Management
While the base unit operates standalone, optional USB-connectable firmware enables data export to CSV or PDF formats for LIMS integration. Timestamped records include date/time stamp, operator ID (user-defined), total filtered volume per channel, vacuum pressure trace, and error flags (e.g., membrane clogging, vacuum loss). When used in regulated environments, the optional validation package includes IQ/OQ documentation templates aligned with FDA 21 CFR Part 11 requirements—including electronic signature capability, user access levels (admin/operator), and immutable audit trails for all parameter changes and result exports.
Applications
- Pharmaceutical QC labs performing routine microbial limit testing of purified water, water-for-injection (WFI), and final rinse solutions per USP and EU GMP Annex 1.
- Food safety laboratories verifying microbial load in bottled water, carbonated beverages, and dairy-based liquids prior to release.
- Environmental monitoring programs assessing heterotrophic plate count (HPC) in HVAC condensate, surface water, and wastewater effluent per EPA Method 1604.
- Cosmetic manufacturers fulfilling ISO 22716 hygiene requirements for raw material water and finished product challenge testing.
- Contract testing labs supporting method transfer and validation studies under ICH Q5C and ISO/IEC 17025 accreditation scopes.
FAQ
Is the vacuum pump serviceable onsite?
Yes—the integrated diaphragm pump is field-replaceable using standard Torx tools; spare pump modules and replacement valves are stocked globally.
Can the instrument be calibrated for volumetric accuracy?
Yes—calibration is performed using gravimetric measurement against NIST-traceable balances per ISO/IEC 17025; certificate includes uncertainty budget at 100 mL/min and 200 mL/min flow points.
Does it support sterility testing per USP ?
No—this model is designed exclusively for microbial limit testing (quantitative enumeration). Sterility testing requires higher vacuum integrity, larger filter areas, and different housing geometry per USP and ISO 11737-1.
What membrane types are validated for use?
Validated membranes include 0.45 µm MCE (Millipore HAWP), 0.45 µm nylon (Whatman NYL), and 0.22 µm PVDF (Pall Supor). Validation reports available upon request.
How is cross-contamination prevented between channels?
Each filtration path features isolated fluidic routing, non-recirculating exhaust, and independent pressure sensors—verified via dye penetration testing and ATP swab verification per ISO 14644-1 Class 5 cleanroom protocols.
