EMTEK P100SS Portable Air Microbial Sampler

Overview

The EMTEK P100SS Portable Air Microbial Sampler is a precision-engineered, impaction-based viable air sampler designed for quantitative monitoring of airborne microorganisms in controlled environments. It operates on the principle of inertial impaction: aerosolized particles—carrying viable bacteria, fungi, or yeasts—are drawn at calibrated high velocity through a precisely engineered stainless-steel slit orifice array onto standard 90 mm or 100 mm nutrient agar plates. Particle inertia causes microorganisms to impact and adhere to the agar surface, where they remain viable for subsequent incubation and colony enumeration. This method ensures high collection efficiency across clinically and industrially relevant aerodynamic particle sizes (D₅₀ = 0.67 µm at 28.3 L/min; 0.92 µm at 100 L/min), making the P100SS suitable for routine environmental monitoring in ISO Class 5 (Class 100) and ISO Class 7 (Class 10,000) cleanrooms, isolators, laminar flow hoods, biosafety cabinets, aseptic processing lines, and pharmaceutical manufacturing suites.

Key Features

• Robust 316 stainless-steel construction—resistant to aggressive disinfectants (e.g., hydrogen peroxide vapor, sporicidal quaternary ammonium compounds, and alcohol-based sanitizers) commonly used in GMP-regulated facilities.
• Dual selectable flow rates (28.3 L/min and 100 L/min) enabled by interchangeable inlet caps—each optimized for distinct D₅₀ cutoffs and jet velocities (25 m/s), ensuring compliance with both traditional and high-volume sampling protocols.
• Electronic closed-loop mass flow control system with integrated thermal mass flow sensor—maintains flow stability within ±1.5% of setpoint under variable backpressure and ambient conditions.
• 32-bit PIC microprocessor core with real-time clock, enabling precise time-stamped run logging, programmable start/stop intervals, and multi-user access control (up to 100 configurable accounts).
• On-device visual and audible alerts—including flow deviation (>±5%), low battery, calibration expiration, and critical error states—with user-adjustable volume and screen-based notification overlays.
• Comprehensive data output options: USB export of CSV-formatted raw logs, encrypted PDF audit reports compliant with FDA 21 CFR Part 11 requirements (electronic signatures, audit trail, data integrity), and optional thermal label or plain-paper printing via integrated printer interface.

Sample Compatibility & Compliance

The P100SS accepts standard 90 mm and 100 mm Petri dishes filled with TSA, SDA, or other pharmacopeial-compliant media. Its impaction geometry and validated airflow profile meet the performance criteria outlined in ISO 14698-1 (Biological contamination control — General principles and methods), EN 17141 (Air quality — Measurement of airborne micro-organisms), and EU GMP Annex 1 (Manufacture of Sterile Medicinal Products). The device carries CE marking and is designed for use in environments subject to GLP and GMP audits. All calibration parameters—including flow offset, temperature compensation, and pressure correction—are stored in non-volatile EEPROM with write-protection, supporting full traceability and revalidation cycles.

Software & Data Management

EMTEK’s proprietary PC software enables remote configuration, firmware updates, historical data review, and report generation. Each sampling run stores timestamped metadata including operator ID, location tag, flow rate, duration, total volume, ambient temperature/humidity (if connected to external sensors), and pass/fail status against preset tolerances. Audit trails record all user actions—including parameter changes, calibration events, and report exports—with immutable timestamps and user attribution. Data encryption (AES-256) and role-based access control ensure alignment with data integrity expectations under ALCOA+ principles and regulatory inspection readiness.

Applications

• Routine environmental monitoring (EM) programs in sterile drug manufacturing and cell/gene therapy facilities.
• Qualification and periodic requalification of isolators, RABS, and laminar airflow workstations.
• Investigation of microbial excursions and root cause analysis during deviations or OOS events.
• Validation of cleaning and disinfection efficacy in critical zones.
• Research-grade bioaerosol studies requiring reproducible, volumetrically accurate sampling in laboratory and field settings.
• Integration into centralized monitoring systems via Ethernet connectivity for real-time dashboard visualization and alarm escalation.

FAQ

What are the required maintenance intervals for the P100SS?
The unit requires annual calibration verification using NIST-traceable flow standards. Routine cleaning of the stainless-steel inlet cap and impaction surface is recommended after each use with approved non-corrosive agents.
Can the P100SS be used in humid or high-altitude environments?
Yes—operational specifications cover 10–80% RH (non-condensing) and altitudes up to 2000 m (6560 ft); however, uncorrected flow may drift above 1500 m without barometric compensation—consult EMTEK for altitude-specific firmware tuning.
Is the device compatible with automated environmental monitoring platforms?
Yes—the Ethernet port supports Modbus TCP and HTTP API interfaces for integration with SCADA, MES, or EMMS platforms.
Does the P100SS support 21 CFR Part 11 compliance out-of-the-box?
Yes—when configured with password-protected user roles, electronic signatures, and encrypted PDF reporting, it satisfies core technical controls for electronic records and signatures.
How is sample volume accuracy ensured during extended runs?
Real-time mass flow feedback continuously adjusts pump speed to maintain setpoint; cumulative volume is calculated from time-integrated flow data with internal clock synchronization and checksum-verified storage.