Zefon Bio-Culture™ APB-708200 Portable Single-Channel Viable Air Microbial Sampler

Overview

The Zefon Bio-Culture™ APB-708200 is a portable, single-channel, constant-flow viable air microbial sampler engineered for quantitative collection of culturable airborne microorganisms—including bacteria, fungi, yeasts, and spores—onto standard 90 mm × 15 mm agar-filled Petri dishes. It operates on the principle of inertial impaction: aerosolized particles are drawn at a precisely controlled volumetric flow rate through a precision-drilled stainless-steel sampling head containing 380 uniformly spaced 1 mm orifices. Particles with sufficient aerodynamic diameter (typically ≥0.65 µm) impact onto the nutrient agar surface with high collection efficiency (>99% for ≥2.0 µm particles per ISO 14698-1 Annex B), while smaller particles remain entrained in the airflow and bypass the collection medium. This design ensures reproducible, colony-forming unit (CFU)-based enumeration compliant with ISO 14698-1 (Biocontamination control), EU GMP Annex 1 (2022), and USP guidelines for environmental monitoring in cleanrooms, pharmaceutical manufacturing facilities, hospitals, and research laboratories.

Key Features

• Constant-flow operation across a user-selectable range of 30–120 LPM, maintained via integrated mass-flow-controlled blower and closed-loop feedback regulation
• Compact, lightweight chassis (≤2.8 kg) with ergonomic handle and integrated 1/4″-20 tripod socket enabling flexible vertical, horizontal, or wall-mounted deployment
• Sampling head fabricated from medical-grade stainless steel; fully autoclavable (121 °C, 15 psi, 20 min) or compatible with ethylene oxide or hydrogen peroxide vapor sterilization
• Rechargeable lithium-ion battery pack supporting continuous operation for 6–8 hours at 60 LPM; full recharge in ≤4 h using included 240 V AC charger
• Dedicated mechanical timer with four preset durations (1, 2, 5, and 10 minutes); no software dependency ensures reliability in regulated environments
• Optional NIST-traceable flow calibration head (sold separately or as part of APB-7082ZZ-KIT) enables on-site verification and adjustment without external instrumentation

Sample Compatibility & Compliance

The APB-708200 is validated for use with conventional microbiological growth media—including Tryptic Soy Agar (TSA), Sabouraud Dextrose Agar (SDA), and Malt Extract Agar (MEA)—and supports both active (viable) and passive (settling plate) comparative studies. Its sampling geometry and flow dynamics conform to ISO 14698-1 requirements for “viable particle sampling devices” and meet the performance criteria outlined in ISO 8573-7 for compressed air microbiological testing. The device is CE-marked and designed to support compliance with FDA 21 CFR Part 11 when paired with validated electronic logbook systems (e.g., LIMS-integrated audit trails). All materials in contact with sampled air or culture media comply with USP Class VI biocompatibility standards.

Software & Data Management

The APB-708200 operates as a standalone hardware platform with no embedded firmware, cloud connectivity, or proprietary software—eliminating validation overhead associated with electronic records. All operational parameters (flow rate setting, timer selection, run duration, battery status) are indicated via tactile switches and LED status indicators. For regulated environments requiring electronic data capture, users may integrate manual entry into validated LIMS or ELN platforms using standardized templates aligned with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Optional calibration certificates include NIST-traceable uncertainty statements and are issued with unique serial-numbered documentation for audit readiness.

Applications

• Environmental monitoring (EM) programs in ISO Class 5–8 cleanrooms and aseptic processing suites
• Pharmaceutical facility qualification (IQ/OQ/PQ) and routine surveillance per EU GMP Annex 1
• Hospital infection control assessments—including operating theatres, isolation rooms, and HVAC duct sampling
• Biotechnology R&D labs conducting aerosolized pathogen challenge studies or bioaerosol dispersion modeling
• FDA-regulated sterile product manufacturing environments requiring compendial (USP ) and risk-based EM strategies
• Validation of HEPA filter integrity and room air change effectiveness through sequential time-point sampling

FAQ

Is the APB-708200 suitable for ISO 14644-1 particle counting?
No—it is a viable (culture-based) sampler only; non-viable particulate monitoring requires optical particle counters compliant with ISO 21501-4.
Can the sampling head be cleaned between runs without compromising accuracy?
Yes—autoclaving at 121 °C for 20 minutes or exposure to validated low-temperature sterilants (e.g., vaporized H₂O₂) preserves orifice geometry and flow characteristics.
Does the device require annual recalibration?
While not mandated by regulation, Zefon recommends annual verification using the NIST-traceable calibration head—especially after mechanical shock, filter replacement, or extended storage.
What is the minimum detectable concentration supported by this sampler?
Detection limit depends on agar medium, incubation conditions, and analyst technique; typical lower limits of quantitation (LLOQ) range from 0.1 to 1 CFU/m³ at 100 LPM for 10-minute sampling.
Is the 240 V version compatible with standard European Schuko outlets?
Yes—the APB-708200 includes an IEC 60320 C14 inlet and ships with a region-specific 240 V AC power cord meeting EN 60335-1 safety requirements.