HKM FlidisPump-1 Sterile Medium Dispenser

Overview

The HKM FlidisPump-1 Sterile Medium Dispenser is an engineered solution for precise, contamination-controlled liquid handling in microbiological and cell culture laboratories. Designed around a non-contact, dual-peristaltic pump architecture, it delivers volumetric accuracy without direct fluid-path contact between the pump mechanism and dispensed media—eliminating internal cross-contamination risks. Its low-shear fluid path preserves the integrity of shear-sensitive formulations, including emulsified broths, foaming buffers (e.g., Buffered Peptone Water), and viscous nutrient solutions. The system operates on a stepper motor-driven platform with programmable speed control (0.1–350 RPM), enabling stable, pulse-free flow delivery essential for reproducible dispensing into Petri dishes, contact plates, test tubes, and small-volume Erlenmeyer flasks. As a Class II sterile process aid, it supports aseptic workflows compliant with ISO 13485-aligned laboratory practices and GLP-referenced documentation requirements.

Key Features

• Non-contact dual peristaltic pump heads—no internal wetted surfaces; eliminates carryover and simplifies validation.
• Wet-heat sterilizable silicone or fluoropolymer tubing (autoclavable at 121°C, 15–20 min), compatible with ISO 17664-compliant sterilization protocols.
• Integrated handheld dispenser with ergonomic, torque-optimized actuation—designed to minimize operator fatigue during repetitive dispensing tasks.
• Quick-release bayonet coupling between handheld unit and pump head—enables tool-free tube size changes (ID range: 0.5–6.4 mm) in under 15 seconds.
• Step motor control with zero-start inertia compensation—ensures consistent flow initiation across viscosity gradients, contributing to ±0.5% volumetric accuracy (per ASTM D1298 and ISO 4787).
• Intelligent thermal management: variable-speed fan control maintains ambient enclosure temperature ≤35°C at full load, reducing acoustic noise to <42 dB(A) at 1 m distance.
• Built-in flow calibration routine—user-executable via touchscreen without external standards or service intervention.
• 20 preconfigured dispensing programs stored in non-volatile memory; supports custom parameter sets (volume, rate, pause intervals, repeat cycles).
• Three operational modes: volume-based (µL–mL), time-based (0.1–99.9 s), and copy dispensing (replicate prior sequence with adjustable scaling).
• Dual-layer sealed chassis (IP31-rated)—protects electronics from ambient dust and incidental moisture in ISO Class 7 cleanroom-adjacent environments.

Sample Compatibility & Compliance

The FlidisPump-1 accommodates aqueous and semi-viscous microbial growth media—including Tryptic Soy Broth (TSB), Nutrient Broth, Buffered Peptone Water (BPW), Phosphate-Buffered Saline (PBS), and Ringer’s solution—with validated performance up to 150 cP dynamic viscosity. It is routinely deployed in food safety labs (per ISO 6887-1), pharmaceutical QC environments (aligned with USP verification principles), and environmental water testing (EPA Method 1603). While not FDA 510(k)-cleared as a medical device, its design adheres to ISO 13485:2016 clause 7.5.10 (control of monitoring and measuring equipment) and supports 21 CFR Part 11-compliant data integrity when paired with audit-trail-enabled LIMS interfaces. All tubing materials meet USP Class VI biocompatibility standards.

Software & Data Management

Operation is managed exclusively through a 5.7-inch resistive TFT color touchscreen with localized Chinese firmware. No external PC connection or proprietary software installation is required. All dispensing parameters—including target volume, flow rate, dwell time, and program ID—are logged internally with timestamps and operator ID fields (via manual entry). Event logs (e.g., calibration execution, error codes, power-on cycles) are retained for ≥10,000 entries and exportable via USB 2.0 port in CSV format. The interface supports GMP-style user access levels (Operator, Technician, Administrator) with password protection—enabling role-based parameter modification rights per Annex 11 guidance.

Applications

• Quantitative dispensing of liquid culture media into agar plates, membrane filtration units, and multi-well assay plates.
• Aseptic sampling of potable water, bottled water, and process rinse fluids into sterile containers per ISO 19458.
• Preparation of standardized inoculum suspensions for antimicrobial susceptibility testing (AST) workflows.
• Reproducible filling of diagnostic reagent vials and lyophilization-ready ampoules in R&D settings.
• Time-critical dispensing in rapid microbiological methods (RMM), where consistency across replicate runs directly impacts LOD/LOQ validation.

FAQ

Is the FlidisPump-1 suitable for use in ISO Class 5 laminar flow hoods?
Yes—the unit’s IP31 rating, low particulate generation (<0.1 mg/h airborne particulates measured per ISO 14644-1), and absence of internal fans make it compatible with unidirectional airflow workspaces.
Can tubing be validated for repeated autoclaving cycles?
Certified silicone tubing supplied with the system withstands ≥50 cycles of saturated steam sterilization at 121°C; full validation reports (including extractables profiling per USP ) are available upon request.
Does the device support electronic record retention for audit purposes?
Internal logging meets ALCOA+ principles; exported CSV files include digital signatures, timestamps, and immutable sequence IDs—sufficient for internal QA review and regulatory inspection readiness.
What maintenance is required beyond routine tubing replacement?
No scheduled lubrication or recalibration is needed; annual verification using NIST-traceable gravimetric standards is recommended per ISO/IEC 17025 Clause 6.4.6.
Is third-party integration possible via RS-232 or Ethernet?
The current hardware revision supports only USB-host mode for data export; RS-232 and Modbus RTU options are available under OEM customization agreements.