Huan Kai HKM-III A-100 Airborne Microbial Sampler

Overview

The Huan Kai HKM-III A-100 Airborne Microbial Sampler is a precision-engineered, portable active air sampler designed for quantitative monitoring of viable airborne microorganisms in controlled environments. It operates on the Andersen impactor principle—a well-established, physics-based sampling method where aspirated air is accelerated through an array of precisely calibrated micro-orifices and impinged at controlled velocity onto the surface of standard 90 mm nutrient agar plates. This isothermal, isokinetic sampling strategy ensures that the inlet velocity closely matches the ambient air velocity in cleanrooms (typically 0.3–0.5 m/s), minimizing particle bounce, re-entrainment, and inertial separation artifacts. As a result, the HKM-III A-100 achieves ≥95% physical collection efficiency for particles ranging from 0.8 µm to 19.0 µm aerodynamic diameter—validated per ISO 14698-1 Annex B and C protocols. Its design supports regulatory alignment with pharmaceutical, biotechnology, medical device, and food-grade manufacturing environments governed by EU GMP Annex 1, USP , and ISO 14644-1/2 standards.

Key Features

• Isokinetic Sampling Architecture: Dual-stage flow control and optimized orifice geometry maintain inlet velocity equivalence with cleanroom airflow, significantly reducing sampling bias and improving representativeness of microbial load.
• Intuitive Human-Machine Interface: 3.5-inch high-resolution capacitive touchscreen with bilingual (English/Chinese) menu navigation, real-time display of cumulative sampled volume (0.01–6.0 m³), location code, delay timer, backlight duration, and date/time stamp.
• Universal Culture Media Compatibility: Accepts standard 90 mm Petri dishes without proprietary consumables—eliminating vendor lock-in and enabling full flexibility in media selection (e.g., TSA, SDA, Sabouraud, or selective formulations).
• Adjustable Sampling Orientation: Rotatable sampling head (0°–90°) accommodates horizontal, vertical, or angled placement; optional tripod mount enables stable deployment in dynamic or constrained locations.
• Multi-Orifice Impactor Plate: 400-micron orifice array minimizes colony overlap and improves colony isolation fidelity—verified by Feller correction modeling to ensure linear correlation between recovered CFUs and true airborne concentration.
• Robust Embedded Data Management: Onboard non-volatile memory stores up to 8,000 complete sampling logs, each containing unique session ID, timestamp, volume, location tag, battery status, and operator identifier—supporting full traceability and GLP/GMP audit readiness.
• Extended Field Operation: High-capacity rechargeable lithium-polymer battery delivers up to 15 hours of continuous sampling at 100 L/min, with no memory effect and integrated thermal protection circuitry.
• Dual-Mode Remote Control: Bluetooth-enabled mobile application allows remote configuration of sampling volume, static/dynamic mode switching, start/stop commands, and real-time status monitoring—without requiring physical access to the instrument.

Sample Compatibility & Compliance

The HKM-III A-100 is validated for use with conventional microbiological growth media solidified in standard 90 mm disposable or reusable Petri dishes. It meets critical performance criteria outlined in ISO 14698-1 (Biological contamination control — General principles and methods) and ISO 14698-2 (Evaluation of bioaerosol sampling equipment), including particle size-dependent collection efficiency, flow stability under variable backpressure, and reproducibility across repeated trials. It is routinely deployed in facilities complying with EU GMP Annex 1 (Manufacture of Sterile Medicinal Products), FDA Guidance for Industry on Environmental Monitoring, and Chinese GMP requirements for pharmaceutical and medical device production. All firmware and software modules support ALCOA+ data integrity principles, with configurable electronic signatures, user access levels, and time-stamped audit trails aligned with 21 CFR Part 11 expectations.

Software & Data Management

The dedicated HKM Sampler Software (Windows-compatible) enables secure bidirectional communication via USB interface. Users can download, filter, export (CSV/PDF), and archive raw sampling logs—including metadata such as environmental conditions (if externally logged), operator credentials, and calibration history. The software enforces role-based permissions and generates compliant reports suitable for internal review or regulatory submission. When paired with the official mobile application, field technicians can initiate sampling protocols, verify battery charge status, and receive push notifications upon completion—all while maintaining synchronized timestamps and encrypted local storage. Data export formats include ISO-compliant summary tables and graphical trend plots for spatial-temporal analysis across multiple sampling points.

Applications

This sampler serves as a primary tool for environmental monitoring programs in Grade A–D cleanrooms, isolators, RABS, and aseptic processing suites. It is routinely applied during routine surveillance, media fill investigations, qualification of HVAC systems, and root cause analysis following microbial excursions. Beyond pharmaceutical manufacturing, it supports validation activities in hospital operating theatres, biosafety laboratories (BSL-2/3), vaccine production facilities, dairy and beverage processing plants, and academic research labs conducting aerobiology, infection control, or indoor air quality studies. Its portability and rapid setup make it especially suited for mapping microbial gradients, assessing intervention efficacy (e.g., after disinfection cycles), and supporting ISO 14644-2 classification re-certification.

FAQ

What sampling standard does the HKM-III A-100 comply with?

It conforms to ISO 14698-1/-2, GB/T 16293-2010, and supports compliance with EU GMP Annex 1, USP , and FDA environmental monitoring guidance.

Can the instrument be used in high-humidity environments?

Yes—it operates reliably across ambient relative humidity levels, provided condensation does not form on internal components or agar surfaces.

Is calibration traceable to national standards?

Flow sensors are factory-calibrated using NIST-traceable mass flow meters; users may perform periodic verification using secondary calibrators per ISO 17025 guidelines.

Does the device support automated multi-point sampling sequences?

Yes—programmable cycle mode allows up to 99 sequential runs with independent volume, delay, and location settings per run.

How is data integrity ensured during transfer from device to PC?

All communications employ CRC-32 checksum validation; software enforces write-once-read-many (WORM) logging and maintains immutable audit trails for all parameter changes and data exports.