A&D SV-1A Handheld Laser Particle Counter
| Brand | A&D |
|---|---|
| Origin | Japan |
| Model | SV-1A |
| Instrument Type | Handheld |
| Flow Rate | 0.1 ft³/min (2.83 L/min) |
| Particle Size Channels | 0.3 µm, 0.5 µm, 5.0 µm |
| Data Storage Capacity | 10,000 sample records |
| Power Supply | 4× AA Ni-MH rechargeable batteries (included) |
| Weight | 0.68 kg (1.5 lb) |
| Communication Interface | RS-232 / RS-485 |
| Compliance | ISO 21501-4, ISO 14644-1, JIS B 9921 |
| Warranty | 1 year |
Overview
The A&D SV-1A Handheld Laser Particle Counter is an ISO 21501-4–compliant optical particle counter engineered for rapid, portable, and traceable airborne particulate monitoring in controlled environments. Utilizing a high-stability 780 nm laser diode and a precision forward-scatter photodetector assembly, the SV-1A detects and classifies particles based on Mie scattering theory, delivering real-time counts across three fixed size channels: ≥0.3 µm, ≥0.5 µm, and ≥5.0 µm. Its compact, palm-sized form factor (1.5 lb / 0.68 kg), combined with a regulated 2.83 L/min (0.1 ft³/min) sampling flow—maintained via integrated diaphragm pump with low-noise operation—enables reliable point-of-use verification in cleanrooms, isolators, laminar flow hoods, and HVAC ducts. Designed for GLP- and GMP-aligned workflows, the instrument supports audit-ready data integrity through time-stamped records, firmware-based calibration traceability, and optional IQ/OQ validation documentation.
Key Features
- Three simultaneous particle size channels (≥0.3 µm, ≥0.5 µm, ≥5.0 µm) with single-pulse discrimination logic to minimize coincidence error
- Stable 2.83 L/min volumetric flow rate, actively monitored and compensated for inlet pressure variations
- Integrated rechargeable Ni-MH battery pack (4× AA) providing >6 hours of continuous operation; hot-swappable for uninterrupted monitoring
- On-device LCD interface with intuitive menu navigation, real-time histogram display, and configurable sampling duration
- Five programmable sampling modes: Manual, Timed, Continuous, Triggered, and Sequence—each supporting user-defined start/stop conditions
- RS-232 and RS-485 serial interfaces for integration into facility monitoring systems or connection to PCs running included data download software
- Internal memory stores up to 10,000 complete sample records—including date/time stamp, location ID, operator code, and all channel counts
- Direct CSV export capability compatible with Microsoft Excel and LIMS platforms without proprietary conversion tools
Sample Compatibility & Compliance
The SV-1A is validated for use with ambient air and compressed gases (oil-free, dry, non-corrosive) within temperature ranges of 10–30 °C and relative humidity ≤70% RH (non-condensing). It meets the optical detection and sizing accuracy requirements specified in ISO 21501-4:2018 for light-scattering airborne particle counters. Its counting performance is referenced against NIST-traceable PSL standards and conforms to cleanroom classification protocols defined in ISO 14644-1:2015 and JIS B 9921:2019. The device includes factory calibration documentation and optional IQ/OQ qualification kits compliant with FDA 21 CFR Part 11 expectations for electronic records and signatures. All firmware versions are version-controlled and retain full audit trails for parameter changes and calibration events.
Software & Data Management
The bundled Windows-compatible software provides secure local data retrieval, visualization, and report generation. Each downloaded record contains full metadata: sample ID, timestamp (with millisecond resolution), environmental conditions (if logged externally), channel-specific cumulative and differential counts, and instrument status flags. Data files are saved in plain-text CSV format with UTF-8 encoding, ensuring compatibility with statistical process control (SPC) packages, ELN systems, and enterprise data warehouses. The software supports batch export, filtering by date range or location tag, and automatic generation of ISO 14644-1 compliance summary reports—including calculated UCL (Upper Confidence Limit) for particle concentration uncertainty. Audit logs capture all user actions, including login attempts, data deletions, and configuration modifications.
Applications
- Cleanroom certification and routine monitoring per ISO 14644-1 Class 5–8 environments
- Point-of-use verification at critical processing locations (e.g., filling lines, glove ports, transfer hatches)
- Filter integrity testing and leak detection in HEPA/ULPA installations using challenge aerosols
- Mobile surveillance during facility maintenance, construction, or equipment relocation
- Environmental baseline assessment prior to commissioning of pharmaceutical manufacturing suites
- Educational and research applications requiring portable, calibrated particle counting without fixed infrastructure
FAQ
What calibration standards are used for the SV-1A?
The instrument is calibrated using NIST-traceable polystyrene latex (PSL) spheres and certified reference aerosols per ISO 21501-4 Annex C.
Can the SV-1A be used in compressed air systems?
Yes—provided the air is oil-free, dried to a dew point ≤ −40 °C, and filtered to remove condensate; a pressure regulator and inline coalescing filter are recommended upstream.
Is remote data logging supported?
The SV-1A does not support Ethernet or Wi-Fi natively, but RS-485 output enables integration with industrial PLCs or SCADA gateways for centralized logging.
How is measurement uncertainty addressed in compliance reporting?
The device’s stated sizing accuracy (±10% for ≥0.3 µm) and counting efficiency (≥50% at 0.3 µm, ≥100% at ≥0.5 µm) align with ISO 21501-4 tolerances; UCL calculations follow ISO 14644-1:2015 Annex D.
Does the unit meet FDA 21 CFR Part 11 requirements?
While the hardware itself is not Part 11–certified, its firmware and associated software support electronic signatures, audit trails, and role-based access control when deployed within a validated IT environment.
