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21 CFR Part 11 Airborne Particle Counter

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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&plusmn;3%

A120: 50LPM&plusmn;3%


A130: 28.3LPM&plusmn;3%

SIZE RANGE: A110: 0.5&micro;m-25&micro;m

A120, A130: 0.3&micro;m-25&micro;m


SIZE CHANNELS: A110: 0.5&micro;m, 1.0&micro;m, 2.0&micro;m, 3.0&micro;m, 5.0&micro;m, 10.0&micro;m

A120, A130: 0.3&micro;m, 0.5&micro;m, 1.0&micro;m, 3.0&micro;m, 5.0&micro;m, 10.0&micro;m

SIZE RESOLUTION: <15% @ 0.5&micro;m (meets ISO 21501-4)

COUNT EFFICIENCY: A110: 50% &plusmn;20% for 0.5&micro;m, 100% &plusmn;10% for >0.75&micro;m (meets ISO 21501-4 and JIS B9921)

A120, A130: 50% &plusmn;20% for 0.3&micro;m, 100% &plusmn;10%for >0.45&micro;m (meets ISO 21501-4 and JIS B9921)

CONCENTRATION LIMIT: A110: 560,000 particles/ft&sup3;at 10% coincidence loss

A120: 840,000 particles/ft&sup3;at 10% coincidence loss

A130: 1,400,000 particles/ft&sup3;at 10% coincidence loss

ZERO COUNT: <1count/5min

EXHAUST: Internal HEPA filter (>99.997%@0.3&micro;m)

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






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mv@micronview.com
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