DATA SHEET

MET ONE ISO 21501

Certied Air Particle
Counter Calibration
Ensure count accuracy and reproducibility
Features and Benefts
ISO 21501 is a new family of standards describing the instruments
and calibration requirements for determining particle size distribution
using light interaction methods. It represents the culmination of work
by instrumentation manufacturers and industry leaders and comes at
a critical time for the industry with the increasing trend for real-time
air particle monitoring in cleanrooms.
Air Particle Counters and ISO 21501
The calibration of an air particle counter presents challenges due
to the need to generate air samples containing sub-microscopic
particles of homogenous size and distribution. Although the
technology of air particle counting is well understood, the ability to
calibrate any two air particle counters so that they produce the same
results when sampling the same air sample has proven to be difcult,
bringing into question the accuracy of these instruments. ISO 21501
now delivers a calibration method that can signicantly improve the
repeatability and reproducibility of these air particle counters.
CoreCal 3 Calibration
Hachs MET ONE brand is the global leader in particle counting
and has the largest installed base of air particle counters in the
world. To support this base, Hachs calibration system, CoreCal 3,
was designed and developed to perform full ISO 21501 compliant
calibrations. The CoreCal 3 system, backed by globally deployed
calibration tools, procedures and technician training, has enabled all
of Hachs worldwide service teams to provide ISO 21501 compliant
calibrations at your site or at the companys local service depots.
In May, 2007, the International Standards Organization
(ISO) introduced a new standard for the calibration
of air and liquid particle counters. This new standard,
ISO 21501, incorporates a number of new tests that
are designed to reduce count variability between
different instruments. Specically, the standard
species new counting resolution and counting
efciency tests be performed at routine calibration
cycles, typically every six or twelve months. In 2011,
ISO 21501 compliant calibrations for air particle
counters will become mandatory for aseptic lling
under EU-GMP Annex 1 and FDA cGMP Guidance.
From the ISO 21501 Standard:
The purpose of ISO 21501 is to provide a calibration procedure and verication method
for particle counters, so as to minimize the inaccuracy in the measurement result by a
counter, as well as the differences in the results measured by different instruments.
The full list of elements that ISO 21501 requires to be tested are as follows:
Size calibration: The error in the detectable minimum particle size and other sizes
specied by the manufacturer of an air particle counter shall be equal to or less than 10%.
Counting efciency: The counting efciency shall be (50 20)% for calibration
particles with a size close to the minimum detectable size, and it shall be (100 10)%
for calibration particles with a size of 1.5 times to 2 times larger than the minimum
detectable particle size.
Size resolution: The size resolution shall be equal to or less than 15% for calibration
particles of a size specied by the manufacturer.
False count rate: The false count rate is determined by measuring the particle number
concentration in the unit of counts per cubic meter at the minimum reported
size range when sampling clean air.
Concentration limit: The coincidence loss is determined by the ow rate, the
time required for particles to pass through the sensing zone and the electrical signal
processing time. These values are determined by the design of the air particle counter.
Sampling ow rate: The standard uncertainty of volumetric ow rate shall be equal
to or less than 5%. An external ow meter is used to measure the volumetric ow rate
of the sample being taken. Volumetric ow measurements allow for greater accuracy by
removing the variance due to altitude.
Sampling time: The standard uncertainty in the duration of sampling time shall be
equal to or less than 1% of the preset value. Sampling time is measured by comparing
the sample time as directed by the instrument under test to a calibrated stopwatch or
timing device.
Calibration interval: It is recommended that the calibration interval of an air particle
counter be one year or less. Calibration at the calibration interval should include at least
size calibration, size resolution, counting efciency and sampling volume uncertainty.
Current instruments designed to comply with ISO 21501 Calibration:
MET ONE 3400 Series, MET ONE 6000 Series and MET ONE 7000 Series
Other legacy instruments may comply. Please contact Hach technical support
for further information.
Only Hach certied and trained Field Service Engineers and
agents with the Hach CoreCal 3 calibration tool and reference
instrument are able to perform fully ISO 21501 compliant
calibrations on MET ONE air particle counters.
For more information and to receive a copy of the ISO 21501 Sourcebook:
www.hach.com/iso21501
Lit. No. 5247
F10 Printed in U.S.A.
Hach Company, 2010. All rights reserved.
In the interest of improving and updating its equipment, Hach Company reserves the right to alter specifications to equipment at any time.
At Hach, its about learning
from our customers and
providing the right answers.
When it comes to the things
that touch our lives...
Keep it pure.
Make it simple.
Be right.
For current price information,
technical support, and ordering
assistance, contact the Hach
offce or distributor serving
your area.
In the United States, contact:
HACH COMPANY World Headquarters
P.O. Box 389
Loveland, Colorado 80539-0389
U.S.A.
Telephone: 800-227-4224
Fax: 970-669-2932
E-mail: [email protected]
www.hach.com/metone
U.S. exporters and customers in Canada,
Latin America, sub-Saharan Africa, Asia,
and Australia/New Zealand, contact:
HACH COMPANY World Headquarters
P.O. Box 389
Loveland, Colorado 80539-0389
U.S.A.
Telephone: 970-669-3050
Fax: 970-461-3939
E-mail: [email protected]
www.hach.com/metone
www.hach-latinoamerica.com
In Europe, the Middle East, and
Mediterranean Africa, contact:
HACH LANGE GmbH
Willsttterstrae 11
D-40549 Dsseldorf
GERMANY
Tel: +49 (0) 211 5288-0
Fax: +49 (0) 211 5288-143
E-mail: [email protected]
www.hach-lange.com
Specifcations