Particle Counter

Product Details:

• It measures particle sizes from 0.3 µm to 25 µm, covering six size channels: 0.3 µm, 0.5 µm, 1.0 µm, 3.0 µm, 5.0 µm, and 10.0 µm.

• The size resolution is less than 15% at 0.5 µm, in full compliance with ISO 21501-4.

• Count efficiency is 50% ±20% for 0.3 µm particles, and 100% ±10% for particles >0.45 µm, as specified by ISO 21501-4 and JIS B9921 standards.

• It offers a high concentration limit of 1,400,000 particles/ft³ at 10% coincidence loss, ensuring performance in demanding environments.

• The zero count level is less than 1 count per 5 minutes, guaranteeing cleanroom-level sensitivity.

• An internal HEPA filter with >99.997% efficiency at 0.3 µm ensures safe exhaust filtration.

• It supports mapping of up to 20,000 rooms and 200,000 sampling locations, ideal for large-scale monitoring.

• Sampling durations are configurable from 1 second to 168 hours, and it can store 1,000 samples per location.

• The device includes 3.5 GB of storage, capable of holding over 5 million sets of sample records.

• A bright, user-friendly 8-inch LCD capacitive touchscreen allows intuitive operation.

• The interface supports both English and Chinese languages.

• The system ensures data integrity in compliance with 21 CFR Part 11, supporting secure electronic records.

• Calibration is recommended at least once per year to maintain measurement accuracy.

• The unit has compact dimensions of 254 × 204 × 263 mm and weighs 6.1 kg (13.45 lbs) without the battery.

• The durable 316L stainless steel enclosure ensures corrosion resistance and hygienic operation.

• It operates on AC 100–240V, 50/60 Hz power and includes a 10.8V, 9000 mAh rechargeable lithium battery.

• Battery life supports up to 9 hours of continuous use.

• Operating conditions range from 5°C to 35°C with up to 95% relative humidity, and storage conditions range from -10°C to 40°C with up to 98% relative humidity.

Product Details:

• Features a responsive 8-inch capacitive touchscreen, operable even with two pairs of latex gloves.

• Enclosed in a sealed 316L stainless steel housing with dust plugs to prevent dust and water intrusion.

• Compliant with FDA 21 CFR Part 11, ensuring secure electronic data and audit trail capabilities.

• Supports automatic air sample collection.

• When particle levels exceed limits, the device can trigger BAS (Building Automation System) to initiate additional sampling.

• Provides real-time concentration curves for a comprehensive understanding of particle conditions.

• Includes a quick editing function for flexible and efficient sampling adjustments.

• One-touch generation of standard reports compliant with ISO, EU-GMP, Chinese GMP, and FED STD.

• Built-in functions for data review, export, and summarization by zone.

• Allows users to switch between counting units (Σ, #, m³, ft³) freely.

• Automatically calculates Upper Control Limit (UCL) and average values.

• Advanced search functions let users retrieve sample records by time, zone, or operator.

• Equipped with full audit trail support to ensure data integrity and traceability.

• Size Range: 0.3 µm to 25 µm

• Size Channels: 0.3 µm, 0.5 µm, 1.0 µm, 3.0 µm, 5.0 µm, 10.0 µm

• Size Resolution: <15% @ 0.5 µm (ISO 21501-4 compliant)

• Count Efficiency:

  • 50% ±20% at 0.3 µm

  • 100% ±10% for particles >0.45 µm
    (Meets ISO 21501-4 and JIS B9921)

• Concentration Limit: 840,000 particles/ft³ at 10% coincidence loss

• Zero Count Level: <1 count per 5 minutes

• Sampling Time: 1 second to 168 hours

• Sampling Cycles: Up to 1,000 samples per location

• Zone/Location Management: Supports 20,000 rooms and 200,000 locations

• Laser Source: Long-life laser

• Data Storage: 3.5 GB, capable of storing ≥5,000,000 sample records

• Languages Supported: English and Chinese

• Reports: Fully compliant with ISO, EU-GMP, Chinese GMP, and FED STD standards

• Calibration Frequency: Recommended at least once per year

• User Interface:

  • Clean layout for orders and sample setup

  • One-click system software upgrade

  • Multiple customized sampling schemes can be configured for any zone

Product Details:

• Generates standard ISO, EU-GMP, and Chinese GMP reports with one-touch functionality for easy documentation.

• Fully compliant with FDA 21 CFR Part 11, ensuring data integrity, audit trail, and electronic record security.

• Displays real-time particle concentration curves, providing a clearer understanding of the environmental particle status.

• Offers a quick editing function to adapt sampling plans flexibly and efficiently.

• Audit trail functionality ensures full data traceability and compliance with regulatory standards.

• Advanced search capabilities allow users to retrieve sample records precisely by time, zone, or operator.

• Particle Size Range: 0.5 µm to 25 µm

• Size Channels: 0.5 µm, 1.0 µm, 2.0 µm, 3.0 µm, 5.0 µm, 10.0 µm

• Size Resolution: <15% at 0.5 µm (ISO 21501-4 compliant)

• Count Efficiency:

  • 50% ±20% at 0.5 µm

  • 100% ±10% for particles >0.75 µm
    (Meets ISO 21501-4 and JIS B9921 standards)

• Concentration Limit: 560,000 particles/ft³ at 10% coincidence loss

• Zero Count Level: <1 count per 5 minutes

• Sampling Time Range: 1 second to 168 hours

• Sampling Cycles: Stores up to 1,000 samples per location

• Zone/Location Tracking: Supports monitoring of up to 20,000 rooms and 200,000 locations

• Laser Source: Long-life laser for consistent performance

System & Data:

• Storage Capacity: 3.5 GB, capable of saving ≥5,000,000 sets of sample records

• Display: 8-inch LCD capacitive touchscreen for intuitive operation

• Languages Supported: English and Chinese

• Reports: Compliant with ISO, EU-GMP, Chinese GMP, and FED STD formats

• Data Reliability: Fully supports 21 CFR Part 11 standards

• Calibration Frequency: Recommended at least once per year

Power & Environment:

• Power Supply: AC 100–240 V, 50/60 Hz

• Battery Endurance: Up to 4 hours of continuous operation

• Maximum Power Consumption: 90 W

• Operating Conditions: Temperature 5–35°C; Relative humidity up to 95%

• Storage Conditions: Temperature -10–40°C; Relative humidity up to 98%

Build & Safety:

• Built-in safety and electromagnetic compliance with standards including:
  EN 61010-1:2010, EN 61326-1:2013, EN 61326-2-2:2013, EN 60825-1:2014, EN 61000-6-1:2007, EN 61000-6-3:2007+A1, FCC Part 15 Subpart B

• Warranty: 2 years from the date of activation