Zefon Bio-Pump Plus Air Microbial Sampler

Overview

The Zefon Bio-Pump Plus is a portable, battery-powered active air microbial sampler engineered for reliable, field-deployable collection of airborne viable and non-viable particulates—including bacteria, fungi, yeasts, and spores—onto standardized impactor media such as Air-O-Cell® and Via-Cell® sampling cassettes. Operating on the principle of inertial impaction, the Bio-Pump Plus draws ambient air at a calibrated constant flow rate of 15 LPM (liters per minute) across the surface of the sampling cassette, where particles ≥0.8 µm aerodynamic diameter are efficiently deposited onto the adhesive-coated slide or collection medium. This method ensures high collection efficiency in accordance with ISO 14698-1 (Biocontamination control in cleanrooms and associated controlled environments) and supports compliance with environmental monitoring protocols used in pharmaceutical manufacturing, hospital infection control, HVAC system validation, and indoor air quality (IAQ) assessments.

Key Features

• Consistent 15 LPM volumetric flow rate—calibrated and verified for reproducible sample volume delivery across variable environmental conditions.
• Integrated rechargeable nickel-metal hydride (NiMH) battery providing up to 8 hours of continuous operation or approximately 100 discrete 5-minute sampling cycles—ideal for extended surveillance or multi-location surveys.
• Low-noise motor design enabling discreet use in occupied spaces including laboratories, cleanrooms, patient rooms, and office environments without disruption.
• Real-time elapsed time display with programmable sampling duration (5 minutes to 8 hours), supporting unattended, scheduled operation and minimizing operator dependency.
• Dual “sample complete” indicators: audible tone plus LED status light—ensuring immediate visual and auditory confirmation of sampling termination.
• Compact footprint (11.43 × 6.99 × 20.34 cm) and lightweight construction (0.68 kg) facilitate rapid deployment, handheld use, or mounting on tripods and fixtures via standard ¼”-20 threaded base.
• Fast 3-hour battery recharge cycle using included universal-input (110–230 VAC) charger with North American plug configuration.

Sample Compatibility & Compliance

The Bio-Pump Plus is specifically optimized for use with Zefon’s Air-O-Cell® and Via-Cell® cassettes—widely accepted passive and active impactor devices validated for qualitative and semi-quantitative bioaerosol analysis. Its fixed-flow architecture eliminates the need for inline flow calibration during routine use, though optional traceable calibration (e.g., using TSI 4046 Flow Calibrator) is supported for GLP/GMP-regulated applications. The device meets general electrical safety requirements per UL/CSA 61010-1 and is compatible with ISO 14698-2 test methods for microbiological air sampling performance verification. While not intrinsically rated for hazardous locations, it is routinely deployed in non-explosive environments under ISO 14644-1 Class 5–8 cleanroom classifications and CDC/NIOSH-recommended IAQ investigation workflows.

Software & Data Management

The Bio-Pump Plus operates as a standalone hardware platform with no embedded firmware-based data logging or Bluetooth/Wi-Fi connectivity. Sample metadata—including start time, programmed duration, and completion confirmation—is recorded manually or integrated into laboratory information management systems (LIMS) via standardized chain-of-custody documentation. For regulated environments requiring audit trails, users may pair the pump with electronic logbooks compliant with FDA 21 CFR Part 11 (when implemented with appropriate access controls and electronic signature validation). Calibration records, maintenance logs, and cassette lot traceability are maintained externally per ISO/IEC 17025 requirements for testing laboratories.

Applications

• Pharmaceutical facility environmental monitoring (EM) programs aligned with EU GMP Annex 1 and USP /.
• Hospital epidemiology investigations targeting airborne nosocomial pathogens (e.g., Aspergillus spp., Mycobacterium tuberculosis).
• Post-renovation or post-water-damage mold assessment per AIHA RP-1000 and ASTM D7240 guidelines.
• Validation of HEPA filtration efficacy and airflow patterns in critical process areas.
• Baseline IAQ characterization in schools, offices, and residential buildings under EPA IAQ Tools for Schools protocols.
• Field-based occupational hygiene assessments for bioaerosol exposure in agricultural, composting, and wastewater treatment settings.

FAQ

Is the Bio-Pump Plus suitable for quantitative microbial enumeration?
Yes—when used with culture-based cassettes (e.g., Via-Cell® with nutrient agar) or direct microscopic counting (e.g., Air-O-Cell® with phase contrast microscopy), it supports CFU/m³ or particles/m³ calculations when paired with validated analytical methods.
Does it require periodic flow calibration?
While factory-calibrated for 15 LPM, annual verification using a NIST-traceable flowmeter (e.g., TSI 4046) is recommended for GMP/GLP applications to ensure continued accuracy per ISO 14698-2.
Can it be used with non-Zefon sampling cassettes?
Mechanical compatibility is possible with other 37-mm or 25-mm cassette formats; however, collection efficiency and regulatory acceptance are only guaranteed with Zefon-certified Air-O-Cell® and Via-Cell® media.
What is the expected service life of the NiMH battery?
Under typical usage (1–2 cycles/week), the battery maintains ≥80% capacity for 300+ charge cycles, equivalent to approximately 2–3 years of field service before replacement is advised.
Is the Bio-Pump Plus compliant with FDA 21 CFR Part 11?
The device itself does not store electronic records; therefore, it is not subject to Part 11 requirements. However, its output integrates seamlessly into Part 11-compliant LIMS or electronic lab notebooks when properly governed by organizational SOPs.