HengaoDe HAD/HAS-100C Slit-Type Air Sampler for Viable Microbial Monitoring
| Brand | HengaoDe |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Authorized Distributor |
| Country of Origin | China |
| Model | HAD/HAS-100C |
| Price | USD 42.50 (FOB) |
Overview
The HengaoDe HAD/HAS-100C Slit-Type Air Sampler is an ISO-compliant, portable microbial air monitoring instrument engineered for quantitative assessment of airborne viable microorganisms in controlled environments. It operates on the Anderson impactor principle—widely referenced in GB/T 18883–2002 and aligned with ISO 14698-1:2003 (Biocontamination control — Part 1: General principles and methods) and EU GMP Annex 1 (2022) requirements for environmental monitoring in aseptic processing. Air is drawn at a calibrated volumetric flow rate across a rotating agar-coated Petri dish; viable particles impact onto the surface via inertial impaction through a precision-machined slit nozzle, enabling colony-forming unit (CFU) enumeration after incubation. Designed for routine surveillance in Grade A–D cleanrooms, the device supports risk-based environmental monitoring programs in pharmaceutical manufacturing, biotechnology labs, hospital isolation units, and food safety testing facilities.
Key Features
- Calibrated sampling airflow of 28.3 L/min ±3%, traceable to NIST-traceable flow meters and validated per ISO 8573-1 for consistent bioaerosol collection efficiency.
- Adjustable Petri dish rotation speed (0–4 rpm) ensures uniform particle deposition and minimizes edge effects during extended sampling periods.
- Integrated 128×64 dot-matrix LCD display with intuitive menu navigation; real-time battery status indicator and auto-backlight dimming (30 s inactivity) conserve power.
- Rechargeable Ni-MH battery pack provides ≥6 hours of continuous operation; internal low-battery warning prompts timely recharging without interrupting scheduled monitoring cycles.
- Detachable stainless-steel sampling head rated for autoclaving at 121°C/20 min, ensuring sterility between sampling sessions in GLP/GMP workflows.
- Automatic shutdown after 5 minutes of non-sampling idle time; programmable timer range: 0–99 minutes in 1-minute increments.
- Ergonomic tilt-adjustable base and 360° swivel head facilitate positioning in laminar flow hoods, isolators, and hard-to-reach HVAC ducts.
Sample Compatibility & Compliance
The HAD/HAS-100C accepts standard 90 mm Petri dishes filled with TSA, SDA, or other pharmacopeial media (USP , EP 2.6.12). Its slit geometry and flow profile maintain >95% collection efficiency for particles ≥0.65 µm aerodynamic diameter, as verified by monodisperse polystyrene latex (PSL) challenge tests. The instrument complies with ISO 14698-2:2003 (Sampling and enumeration of microorganisms) for sampling strategy design and data interpretation. All firmware and calibration records support audit readiness under FDA 21 CFR Part 11 (electronic records/signatures) when paired with validated data management software.
Software & Data Management
While the HAD/HAS-100C operates as a standalone hardware platform, its timed sampling logs—including date, duration, flow confirmation status, and battery level—are retained in non-volatile memory for manual transcription into electronic laboratory notebooks (ELNs) or LIMS. For full digital integration, optional RS232-to-USB adapters enable automated timestamped export of operational metadata to compliant CSV or XML formats. Validation documentation packages—including IQ/OQ protocols, flow calibration certificates, and installation checklists—are available upon request to support GxP validation projects.
Applications
- Environmental monitoring of sterile manufacturing suites (e.g., filling lines, lyophilizers, isolators) per EU GMP Annex 1 §8.32–8.42.
- Baseline qualification and periodic requalification of cleanroom classification (ISO 14644-1 Class 5–8).
- Investigation of microbiological excursions and root cause analysis in contamination events.
- Validation of HVAC system performance and filter integrity testing (complementary to nonviable particle counters).
- Research-grade airborne microbiome profiling in clinical, agricultural, and fermentation process settings.
FAQ
Is the HAD/HAS-100C suitable for ISO 14644-1 particle counting?
No. This device collects viable microorganisms only; it does not detect or size nonviable particulates. Particle counting requires a separate optical particle counter (OPC) per ISO 21501-4.
Can the sampler be used with selective media such as Sabouraud Dextrose Agar?
Yes. The low-velocity slit design preserves microbial viability during impaction, supporting growth of fungi, yeasts, and bacteria on both general and selective media.
What is the recommended calibration frequency?
Annual flow calibration is advised per ISO/IEC 17025:2017; interim verification using a primary-standard rotameter or thermal mass flow meter is recommended before each critical monitoring campaign.
Does the instrument meet FDA requirements for aseptic process simulation (APS)?
It fulfills the sampling methodology requirements outlined in FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing (2004), provided sampling locations, durations, and media are justified in the APS protocol.
Is the device compatible with data integrity frameworks like ALCOA+?
When operated with documented procedures, version-controlled calibration records, and secure ELN/LIMS entry, the HAD/HAS-100C supports ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
