Sartorius MD8 Airscan Desktop Viable Air Sampler

Overview

The Sartorius MD8 Airscan Desktop Viable Air Sampler is an engineered solution for quantitative airborne microorganism monitoring in critical pharmaceutical environments—specifically designed to meet the stringent requirements of ISO 14698-1, EU GMP Annex 1 (2022), and USP . Unlike conventional impaction or centrifugal samplers, the MD8 Airscan employs a validated gel membrane filtration principle: air is drawn through a sterile, pre-packaged 0.2 µm hydrophilic membrane that captures viable particles onto a nutrient-impregnated gel matrix. This method preserves microbial viability during sampling and eliminates desiccation stress, thereby minimizing false-negative results commonly associated with dry-plate impaction techniques. The system’s modular architecture separates the command unit (located outside Grade A zones) from the sampling head (installed directly within the Grade A environment), connected via a VHP-resistant conduit. This design ensures uninterrupted environmental integrity while enabling full compatibility with vaporized hydrogen peroxide (VHP) decontamination cycles—critical for aseptic processing suites operating under continuous qualification.

Key Features

• Modular two-unit configuration: Command unit remains outside classified areas; only the sterilized, triple-packed sampling head enters Grade A zones—no additional mounting hardware required.
• VHP-compatible construction: Entire system—including tubing, connectors, and internal flow path—validated for ≥20 cycles of standard VHP decontamination (≤1000 ppm, 60–90 min exposure).
• Precise volumetric control: Adjustable flow rate (30–115 L/min, equivalent to 2.0–8.0 m³/h) with real-time digital feedback and ±2% accuracy across 1–16 m³/h range per ISO 21501-4 calibration traceability.
• Flexible sampling protocols: Programmable duration from 1 to 99 minutes; extended continuous mode supports up to 8 hours of unattended dynamic monitoring for trend analysis and intervention threshold detection.
• Ready-to-use sampling heads: Pre-sterilized in triple-layer packaging; no on-site disinfection or autoclaving needed; certified retention efficiency ≥99.9% for Bacillus atrophaeus spores (ATCC 9372) and enveloped viruses (e.g., Φ6 bacteriophage surrogate).
• Delayed start function: Enables synchronization with process events (e.g., isolator door opening, glove port usage) to capture transient bioburden spikes while reducing operator exposure risk.

Sample Compatibility & Compliance

The MD8 Airscan is validated for use with Sartorius-certified gel membranes (e.g., RODAC-type nutrient gels containing Tryptic Soy Agar or Sabouraud Dextrose Agar formulations). Its sampling head geometry and laminar flow profile comply with ISO 14698-2 guidance on sampler placement and isokinetic sampling criteria. All firmware and operational logic adhere to ALCOA+ data integrity principles. Full 3Q documentation (IQ/OQ/PQ) is provided, including factory calibration certificates traceable to NIST standards. The system supports audit-ready electronic records compliant with FDA 21 CFR Part 11 when integrated with Sartorius LabX software—enabling electronic signatures, role-based access control, and immutable audit trails.

Software & Data Management

The MD8 Airscan interfaces seamlessly with Sartorius LabX Microbiology software (v4.0+), offering centralized configuration, remote parameter setting, automated report generation (PDF/CSV), and integration into enterprise LIMS or MES platforms via OPC UA or HL7. All sampling events—including flow rate, duration, timestamp, operator ID, and alarm logs—are stored with cryptographic hash verification. Data export includes raw sensor readings, calibration history, and VHP cycle logs—ensuring full traceability for regulatory inspections under EMA, PMDA, or Health Canada review scopes.

Applications

• Continuous environmental monitoring (CEM) in Grade A filling lines, RABS, and isolators.
• Media fill simulation support and aseptic process validation (APV) studies.
• Investigation of microbial excursions and root cause analysis in cleanroom investigations.
• Qualification and requalification of VHP decontamination efficacy across multiple cycles.
• Supporting Annex 1 §6.43 requirements for “representative sampling locations” and “dynamic monitoring strategies.”

FAQ

Is the MD8 Airscan suitable for ISO Class 5 (Grade A) environments?
Yes—the sampling head is certified for direct installation in Grade A zones without compromising laminar airflow or requiring supplemental engineering controls.
Can the system be integrated into existing facility monitoring networks?
Yes—via Ethernet/IP or RS-485, with native drivers for Siemens Desigo, Honeywell Experion, and Emerson DeltaV DCS systems.
What is the maximum allowable distance between the command unit and sampling head?
Up to 30 meters using supplied VHP-rated polyurethane conduit with integrated pressure and flow sensors.
Does the device meet FDA 21 CFR Part 11 requirements out-of-the-box?
When operated with LabX Microbiology software and configured with appropriate user access policies, it satisfies electronic record and signature requirements—including audit trail, retention, and change control provisions.
Are replacement gel membranes supplied with sterility assurance documentation?
Yes—all membranes are gamma-irradiated (25 kGy), individually packaged, and accompanied by CoA, CoC, and bioburden test reports per ISO 11137-3.