Rion KL-04, Instruction Manual

Page: 18 / 166

2
Outline
Relationship between Calibration, Performance-Test and
Measurement
When the unit is shipped from the factory, a maximum of 4 optional Calibrations, including
options, is supplied as well as the Performance-Test, used to confi rm that the measurement
system is appropriate (based on the methods decided by RION Co., Ltd. (Basic measure-
ment) and each Pharmacopeia).
The Calibration data is the data used on each calibration method when the unit is shipped
from the factory. By applying one of these calibration settings, the unit can be set to the
same condition as the time when it was initially calibrated. The tests confi rming whether
the system condition is appropriate or not are called Performance-Tests and their results are
called Performance-Test data. The Calibration data applied to each unit and the results of
Performance-Test are recorded in the Performance-Test data. Passing the Performance-Test
indicates that the unit is in the same condition as at the time when it was calibrated.
The relationship between Calibration, Performance-Test and measurement is shown on
the chart below.
In the chart, when the quality control method is a basic measurement, the unit is calibrated
based on the method decided by RION Co., Ltd. upon shipment. The data used there is the
Calibration data KL-04_Basic. The results obtained when confi rming that the condition
of the unit is appropriate, by applying the Calibration data KL-04_Basic, are the Perfor-
mance-Test data KL-04_Basic.
Also, before a measurement can be done the Performance-Test data must be selected in the
measurement parameters. Which calibration data apply to the unit is decided by selecting
the Performance-Test data.
Quality control method
Calibration data
Performance-Test data
Measurement parameter
KL-04_Basic
KL-04_Basic
For basic
measurement
Basic measurement JP
JPxx
(Particle size calibration)
JPxx
(Unit test)
For JP
EP
For EP
USP
USPxx
(Particle size calibration)
USPxx
(Unit test)
For USP
* The basic measurement means that the unit is calibrated based on the method decided by RION Co., Ltd.
Calibration and Performance-Test for JP, USP and EP will be registered only to the customers who has requested this option.
EP has no regulations about Calibration and Performance-Test, so will be applied JP or USP.
JPxx or USPxx
(Particle size calibration)
JPxx or USPxx
(Unit test)