Real-time BioAerosol Monitoring System for Sterility Test
PRODUCT FEATURES
Continuous Monitoring 24/7 continuous monitoring
lmmediate Data
Real-time data for both particlesand biological particles
People Oriented
Efficient user oriented design
Stable and reliable
First truly portable microbial monitoring device
Compliance with FDA21 CFR Part 11
Principle
Particle detecting: Mie scattering
Biological particle detecting: Laser induced flouresence
Waiting Time vs Realtime
Current airborne microbial monitoring uses interval, ad-hoc and event-driven sample collections, which require incubation.BAMS uses AFU to count microbes,and the monitoring results can be viewed in real time without the need for culture or courting.
Compendial Method
1-7 days
More scheduled/ unscheduled breaks
Unlikely contamination identification
Compendial Method
Unlikely contamination identification
Compendial Method
Sampled monitoring
Reduced accuracy
Limited trending
Greater contamination risk
Greater risk of production loss
BAMS Benefits
Continuous monitoring
Trend data and improved analysis
Reduced contamination and production loss risks
SPECIFICATIONS
SIZE RANGE: 0.5µm - 25µm
LASER SOURCE: Long life laser
COUNT EFFICIENCY: 50% ±20% for 0.5µm, 100% ±10% for >0.75µm (meets ISO 21501-4 and JIS B9921)
FLOW RATE: 5LPM±3%
ZONE / LOCATION: 20,000 rooms and 200,000 locations
SAMPLING MODE: Manual, auto, beep, cumulative count Σ/ differential count Δ or concentration
CONCENTRATION LIMIT: 4,000,000 particles/ft³at 10% coincidence loss
EXHAUST: Internal HEPA filter (>99.997%@0.3µm)
COMMUNICATION: RJ45, USB, SENSER-HUB, WIFI
EXPORT FILE: PDF file or EXCEL file
DATA STORAGE: 119G
DATA SECURITY: Authority management, authority level divide into admin, operator and supervisor
ALARM: Audible built-in alarm
DIMENSIONS (HxWxD): 10x7.87x10.39 in/255x200x264mm (with handle and foot mat)
WEIGHT: 12.8lbs/5.8Kg (without battery)
ENCLOSURE: 316L Stainless Steel and anodized aluminum
OPERATING CONDITIONS: Temperature: 5°C -35° C / 41°F - 95°F, Relative humidity: 5-90% non-condensing
SAFETY: 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, EN 300 328 V2.1.1: 2016, ETSI EN 301 489-1 V2.2.0: 2017, ETSI EN 301 489-17 V3.2.0: 2017, EN 62311:2008, EN 62479: 2010
