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ONETEST Launches 100LPM Microbial Air Sampler for Cleanroom Air Monitoring with FDA 21 CFR Part 11 Compliance

ONETEST Launches 100LPM Microbial Air Sampler for Cleanroom Air Monitoring with FDA 21 CFR Part 11 Compliance

2026-09-09

ONETEST-100FBS Airborne Microbial Sampler: A New Benchmark in Cleanroom Microbial Air Monitoring

Guangdong, China — ONETEST, a professional manufacturer of environmental monitoring instruments, has officially launched the ONETEST-100FBS airborne microbial sampler, a high-performance microbial air sampler for cleanroom environments. Featuring a 100L/min sampling flow rate, Anderson impactor stage 5 performance and full FDA 21 CFR Part 11 compliance in a compact desktop all-in-one design, the new instrument is purpose-built for pharmaceutical research and development, biological laboratories, hospital operating rooms, and other controlled environments where microbial air quality must be continuously and reliably monitored.

As a dedicated microbial air sampler for cleanroom use, the ONETEST-100FBS operates on the multi-hole suction principle with a 315-hole φ0.6mm precision micro-hole sampling head, delivering an impaction velocity of 18m/s that meets Anderson stage 5 requirements. This ensures airborne microbial particles larger than 1µm are efficiently captured, providing accurate and repeatable data for cleanroom microbial monitoring programs.

에 대한 최신 회사 뉴스 ONETEST Launches 100LPM Microbial Air Sampler for Cleanroom Air Monitoring with FDA 21 CFR Part 11 Compliance  0

Key Features

  • 315-hole φ0.6mm precision micro-hole sampling head for uniform particle collection
  • 100L/min large flow rate with stable flow control (±5%) and adjustable sampling volume from 0.01 to 9,999L
  • 5-inch HD touchscreen with a responsive, glove-operable human-machine interface
  • 200,000-record data storage with USB flash drive export in PDF, CSV and TXT formats
  • Optional Bluetooth wireless printing for instant on-site documentation
  • Up to 100 rooms and 100 sampling points per room with customizable names
  • Three-level management authority with complete audit trail, compliant with FDA 21 CFR Part 11
  • Portable desktop housing in aluminum alloy with built-in lithium battery (≥6 hours) and a low-noise, high-pressure centrifugal fan

Data Integrity for Regulated Industries

Cleanroom microbial monitoring in pharmaceutical and healthcare settings demands more than accurate sampling; it requires complete data integrity. The ONETEST-100FBS addresses this with three-level user management and role-based permission assignment, ensuring that only authorized personnel can operate the device or modify records. Every action is captured in a full audit trail, helping facilities meet the electronic record requirements of FDA 21 CFR Part 11 and supporting smooth qualification and inspection processes.

Technical Specifications

Sampling Flow Rate 100L/min ±5%
Sampling Volume 0.01-9,999L
Impaction Velocity 18m/s (Anderson stage 5)
Petri Dish φ90 x 15mm standard universal dish
Display 5-inch resistive touchscreen
Room / Point Management 100 rooms, 100 points per room
Data Storage 200,000 records
Battery Life ≥6 hours
Operating Environment 0-50°C, 0-65%RH
Housing Material Aluminum alloy
Dimensions / Weight 120 x 110 x 230mm / 2.6kg

Wide-Ranging Applications

The ONETEST-100FBS is widely used in pharmaceutical R&D and production facilities, biological laboratories, hospital operating rooms, food and beverage plants, and electronics cleanrooms. Its customizable sampling parameters, room and point management, and fast data review make it an ideal microbial air sampler for cleanroom routine monitoring, validation studies and environmental trend analysis.

에 대한 최신 회사 뉴스 ONETEST Launches 100LPM Microbial Air Sampler for Cleanroom Air Monitoring with FDA 21 CFR Part 11 Compliance  1

Availability and After-Sales Service

The ONETEST-100FBS is available for global order with a minimum order quantity of one unit and a delivery time of 7-15 working days. Each instrument is backed by professional calibration and maintenance services, rapid fault repair, telephone and online remote training, and an extended 2-year warranty with 7x12-hour after-sales support. For pricing and further information, contact the ONETEST sales team today.