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