21 CFR Part 11 Airborne Particle Counter
Airborne Particle Counter (APC) is fully compliant with ISO14644-2015 and ISO21501-4 standard.
Capacitive touch screen8.0″
Zone20,000
Data 5 million sets
Portable 6.1Kg
Product details
Product Feature
8 inch capacitive touchscreen, quick response
Even with two pairs of latex gloves
Sealed 316L stainless steel enclosure and dust plug to prohibit dust and water
Automatically Collect Air Samples
APC data exceed the limit,triggers the BAS to start sampling
Operation Interface
Data
-Standard report: one key to generate ISO/EUGMPI CHINESEGMP reports
-Data review and data export
1. Sum up data by zone.
2.Freely switch counting unit between △/Σ/#,m /ft.
3.Automatically generate UCL values and average values
4.Search for sample records precisely by time,zone and operator.
-Data integrity: featured with audit trail.
Sampling
- Real-time concentration curves, to get a better understanding of environmental particle condition.
- Quick editing function, to make sampling more flexible.
Setup
- Clear layout for orders. Simple and easy to use.
- One-click for system software upgrade.
- Multiple sets of personalized sampling schemes
can be customized for any zone.
Maintenance
Item | Frequency | Operation |
Zero count | After each use or as needed. | Connect the HEPA filter to the inlet using short tubing. Start sampling for 5 minutes. If the result <1count, the zero count is completed. |
Clean the surface | According to operating conditions or as needed | Clean the device surface with a clean wipe wet with 70-80% ethyl alcohol or isopropyl alcohol. |
Battery charging | Recommend once 3-5 month | Plug in the AC adapter for charging. If the battery is not in use for a long time, the battery will start self-protection. Connect the AC adapter to activate the battery. |
Calibration | Minimum once a year | Return the instrument to the factory or a qualified company. |
SPECIFICATIONS
FLOW RATE： A110: 100LPM±3%
A120: 50LPM±3%
A130: 28.3LPM±3%
SIZE RANGE： A110: 0.5µm-25µm
A120, A130: 0.3µm-25µm
SIZE CHANNELS： A110: 0.5µm, 1.0µm, 2.0µm, 3.0µm, 5.0µm, 10.0µm
A120, A130: 0.3µm, 0.5µm, 1.0µm, 3.0µm, 5.0µm, 10.0µm
SIZE RESOLUTION： <15% @ 0.5µm (meets ISO 21501-4)
COUNT EFFICIENCY： A110: 50% ±20% for 0.5µm, 100% ±10% for >0.75µm (meets ISO 21501-4 and JIS B9921)
A120, A130: 50% ±20% for 0.3µm, 100% ±10%for >0.45µm (meets ISO 21501-4 and JIS B9921)
CONCENTRATION LIMIT： A110: 560,000 particles/ft³at 10% coincidence loss
A120: 840,000 particles/ft³at 10% coincidence loss
A130: 1,400,000 particles/ft³at 10% coincidence loss
ZERO COUNT： <1count/5min
EXHAUST： Internal HEPA filter (>99.997%@0.3µm)
ZONE/ LOCATION： 20,000 rooms and 200,000 locations
SAMPLING TIME： 1 second to 168 hours
CYCLES： 1000 samples on one location
LASER SOURCE： Long life laser
DATA STORAGE： 3.5G, ≥5,000,000 sets of sample records
DISPLAY： 8” LCD capacitive touch screen
LANGUAGE： Chinese, English
DATA RELIABILITY： Compliant with 21 CFR Part 11
REPORTS： Compliant with ISO/EUGMP/CHINESEGMP/Fed Std
CALIBRATION FREQUENCY： Recommend at least once a year
DIMENSIONS (HXWXD)： 254x204x263mm
WEIGHT： 6.1Kg (13.45lbs) (without battery)
ENCLOSURE： 316L Stainless Steel
POWER： AC 100-240V, 50 Hz/60 Hz
BATTERY： 10.8V, 9000mAh, rechargeable lithium battery
BATTERY ENDURANCE： A110: running for 4 hours
A120: running for 7 hours
A130: running for 9 hours
MAX POWER： consumption AC 90W
OPERATING CONDITIONS TEMPERATURE:： 5℃-35℃, relative humidity up to 95%
STORAGE CONDITIONS TEMPERATURE： -10℃-40℃, relative humidity up to 98%
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
WARRANTY： 2 years after activation
