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Portable Particle Counter – ISO 21501-4 Compliant Cleanroom Monitoring

Fiyat Sorunuz

Advanced handheld particle counter with ISO 21501-4 certified Pulse Height Analyzer for pharmaceutical and cleanroom applications with configurable flow rates (1 CFM, 50 LPM, 100 LPM)

  • ISO 21501-4 compliant internal Pulse Height Analyzer (PHA)
  • Three configurable sampling flow rates: 100 LPM, 50 LPM, and 1.0 CFM (28.3 LPM)
  • Large IR touchscreen display for simplified operation
  • Silent aspiration pump for discrete monitoring
  • Regulatory calculations per ISO 14644-1, EC GMP Annex #1, China GMP, and FS 209E
  • 21 CFR Part 11 compliant data transfer
  • Comprehensive pharmaceutical validation manual included
  • Web browser interface for remote cleanroom access and control
  • Rechargeable interchangeable battery system for continuous mobile deployment
  • Measurement recipe builder to minimize user error
  • Data Analyst software for extended data archiving
  • Integrated thermal printer
  • USB memory card data logging
  • CSV data export capability
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Kargolama ve Teslimat

  • Kurye Teslimatı

Kuryemiz belirtilen adrese teslimat yapacaktır.

2-3 Gün

Ü.A. Kargo

  • Aras Kargo Teslimatı

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1-3 Gün

Ücretsiz Kargo

  • Garanti 2 yıl

Daha fazla detay

  • 14 Günlük ücretsiz iade

Daha fazla detay

Professional-grade portable particle counter featuring internal ISO 21501-4 compliant Pulse Height Analyzer (PHA) for real-time airborne particle monitoring in controlled environments. Supports three sampling flow rates: 100 LPM, 50 LPM, and 1 CFM (measures 1 m³ air in 10 minutes at 100 LPM sampling). Large IR touchscreen display ensures intuitive operation with silent aspiration pump for non-intrusive monitoring. Delivers full regulatory compliance calculations and reporting per ISO 14644-1, EC GMP Annex #1, China GMP, and FS 209E standards. Features 21 CFR Part 11 data transfer capability, comprehensive validation documentation for pharmaceutical sector, web browser interface for remote cleanroom access (configure, acquire measurements, monitor, print, upload data), rechargeable interchangeable batteries for extended mobile operation, measurement recipe creation to reduce operator error, Data Analyst software for long-term data archiving, integrated thermal printer, USB memory storage for extended data retention, and CSV data export functionality.

Technical Specifications

Measurement Channels (310B/310C) 310B: 0.3, 0.5, 1.0, 3.0, 5.0, 10.0 μm | 310C: 0.3, 0.5, 1.0, 5.0, 10.0, 25.0 μm
Measurement Channels (350L) 0.3, 0.5, 1.0, 5.0, 10.0, 25.0 μm
Measurement Channels (5100) 0.5, 1.0, 2.0, 5.0, 10.0, 25.0 μm
Sampling Flow Rate (310B/310C) 1.0 CFM (28.3 LPM) ± 5%
Sampling Flow Rate (350L) 50 LPM ± 5%
Sampling Flow Rate (5100) 100 LPM ± 5%
Calibration Standard NIST-traceable Latex calibration references per ISO 21501-4
Maximum Concentration (310B/310C) > 1,380,270 particles/ft³
Maximum Concentration (350L) > 832,599 particles/ft³
Maximum Concentration (5100) > 688,495 particles/ft³
Counting Efficiency 50% ± 20% at most sensitive channel. Meets ISO 21501-4 requirements
Zero Count (310B/310C) 7.07 particles/m³ (1 CFM)
Zero Count (350L) 4.00 particles/m³ (50 LPM)
Zero Count (5100) 2.00 particles/m³ (100 LPM)
Data Storage 3,000 complete datasets. 21 CFR Part 11 compliant. Long-term archiving and analysis with Data Analyst software
Data Communication Ethernet or RS-232; USB data upload; optional wireless Ethernet
Control Software Facility Net, Pharmaceutical Net, FacilityPro, Microsoft Internet Explorer 5.0+, Firefox
Remote Operation Real-time data transfer via web browser interface to Facility Net or Pharmaceutical Net
Reporting USB reports; printer output; cleanroom certification reports for ISO, EC GMP, and FS 209E; data averaging

Applications

  • Pharmaceutical manufacturing cleanroom certification (ISO 14644-1 compliance)
  • Semiconductor and microelectronics fabrication facility monitoring
  • Hospital and healthcare facility sterile environment validation
  • Food and beverage processing cleanroom monitoring
  • Medical device manufacturing quality assurance
  • Biotechnology laboratory environmental monitoring
  • Contract research organization (CRO) cleanroom qualification
  • Periodic cleanroom recertification and reclassification
  • Real-time particle contamination tracking and trending
  • Equipment installation and validation
  • Contamination source identification and troubleshooting

Frequently Asked Questions

What is the difference between the 310B, 310C, 350L, and 5100 models?
The models differ in sampling flow rate and measurement channel configurations. 310B/310C operate at 1.0 CFM (28.3 LPM), 350L at 50 LPM, and 5100 at 100 LPM. The 310C and 350L share the same channel configuration (0.3-25.0 μm), while 310B includes a 3.0 μm channel and 5100 includes a 2.0 μm channel instead. Higher flow rates enable faster area surveys and larger volume sampling.
Is this particle counter compliant with pharmaceutical regulations?
Yes. The instrument includes ISO 21501-4 certified Pulse Height Analyzer, performs calculations per EC GMP Annex #1, China GMP, and FS 209E standards, provides 21 CFR Part 11 compliant data transfer, and comes with comprehensive validation documentation specifically designed for the pharmaceutical sector.
Can I operate this particle counter remotely?
Yes. The web browser interface allows remote configuration, measurement acquisition, real-time monitoring, printing, and data upload to Facility Net or Pharmaceutical Net networks from any authorized location within your cleanroom facility.
What data formats and export options are available?
Data can be exported as CSV files, stored on USB memory cards, printed via the integrated thermal printer, or transmitted via Ethernet or RS-232 connection. All data storage and transfer methods comply with 21 CFR Part 11 requirements.
How many complete measurement datasets can be stored internally?
The instrument stores up to 3,000 complete datasets internally. For extended archiving beyond this capacity, use the Data Analyst software for long-term data management and analysis.
What calibration standard is used?
NIST (USA National Institute of Standards and Technology)-traceable Latex calibration references per ISO 21501-4 standard.

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