EMTEK P100 Airborne Microbial Sampler

Overview

The EMTEK P100 Airborne Microbial Sampler is a portable, high-efficiency isokinetic impactor engineered for quantitative collection of viable airborne microorganisms in controlled and uncontrolled environments. It operates on the principle of inertial impaction—where aerosolized particles are accelerated through precisely sized orifices and deposited onto nutrient agar surfaces at velocities matched to ambient airflow (isokinetic sampling), minimizing particle bounce and re-entrainment. This ensures representative recovery of cultivable microorganisms—including bacteria, yeasts, and molds—across a broad aerodynamic size range down to 0.1 µm. The P100 is purpose-built for compliance-driven applications in pharmaceutical manufacturing, sterile compounding, hospital cleanrooms, biotechnology labs, and environmental health surveillance, where accurate, reproducible, and auditable microbial air data are essential for risk assessment and process validation.

Key Features

• Two selectable volumetric flow rates—28.3 L/min (standard for ISO 14698-1 calibration traceability) and 100 L/min—for flexibility across regulatory protocols and time-constrained monitoring scenarios.
• Dual sampling head architecture: interchangeable standard multi-orifice impactor heads and patented rotating-slit™ heads, enabling uniform deposition without microbial overlap or edge effects—even during extended sampling durations.
• Microban®-treated Kydex® housing and anodized aluminum inlet assemblies inhibit surface colonization, eliminating instrument-mediated contamination and preserving sample integrity.
• Adjustable agar depth positioning mechanism compensates for variations in poured agar thickness, ensuring consistent impaction energy and minimizing colony coalescence artifacts.
• Full programmability: user-defined start delay, sampling duration, interval timing, cycle count, and pause intervals—supporting both single-point and time-series monitoring strategies.
• Integrated touch-enabled LCD interface with real-time flow verification, elapsed volume tracking, and battery status; IR remote control minimizes operator proximity during critical sampling phases.
• Onboard storage for 500 complete sampling logs—including date/time stamp, flow rate, total volume, head type, and operator ID—with thermal label printing (adhesive tags) and plain-paper receipt output options.

Sample Compatibility & Compliance

The P100 supports standard 90 mm Petri dishes filled with TSA, SDA, or other validated growth media. Its impaction geometry and velocity profile have been verified against reference methods per ISO 14698-1 Annex B and ASTM E2995–15 for biological collection efficiency. The device meets design and performance criteria outlined in EU GMP Annex 1 (2022 revision) for environmental monitoring in Grade A–D cleanrooms and aligns with USP recommendations for viable particle enumeration. All firmware and data handling routines support audit-trail generation required under FDA 21 CFR Part 11 when paired with compliant software platforms. Exhaust air is HEPA-filtered (≥99.99% @ 0.3 µm), with optional ducted exhaust configurations available for containment-sensitive areas.

Software & Data Management

Raw sampling metadata—including timestamps, cumulative volumes, flow deviations (<±2.5%), and head identification codes—are stored in non-volatile memory with tamper-evident logging. Data export is supported via USB-C to CSV format for integration into LIMS, ELN, or statistical process control (SPC) systems. Optional EMTEK Connect Suite provides secure cloud synchronization, role-based access control, automated report generation (PDF/Excel), and trend visualization across multiple instruments and locations. All electronic records comply with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) and support GLP/GMP audit readiness.

Applications

The EMTEK P100 is deployed across regulated and research-intensive settings requiring precise, repeatable airborne bioburden assessment. Key use cases include routine environmental monitoring in aseptic processing suites, isolator qualification, HVAC system validation, outbreak investigation in healthcare facilities, bioaerosol characterization in biosafety level (BSL)-2 laboratories, and microbial load benchmarking in food-grade production environments. Its portability and battery autonomy make it suitable for field-based epidemiological studies, indoor air quality assessments in public buildings, and emergency response deployments following water-damage events or suspected pathogen releases.

FAQ

What regulatory standards does the P100 support?
It is designed to facilitate compliance with ISO 14698-1, EU GMP Annex 1 (2022), USP , and FDA guidance on environmental monitoring in sterile manufacturing.
Can the P100 be used in laminar airflow hoods or isolators?
Yes—its compact footprint, low vibration profile, and optional remote exhaust configuration allow safe integration into Grade A environments without disrupting unidirectional airflow.
How is calibration verified?
Flow accuracy is validated using NIST-traceable primary standards (e.g., dry calibrators or bubble meters); annual recalibration is recommended per ISO/IEC 17025-accredited service providers.
Is the rotating-slit™ head compatible with all P100 units?
Yes—rotating-slit™ and standard impactor heads share identical mounting interfaces and are fully backward-compatible with all P100 firmware versions.
Does the device require external power during operation?
No—the internal rechargeable Li-ion battery supports >12 hours of continuous operation at 28.3 L/min, with hot-swappable battery options available for 24/7 monitoring campaigns.