Rion KL-04 User manual

3-20-41 Higashimotomachi, Kokubunji, Tokyo 185-8533, Japan
http://www.rion.co.jp/english/
INSTRUCTION MANUAL
LIGHT OBSCURATION
PARTICLE COUNTER
KL-04

i
Organization of this manual
This manual describes the features and operation principles of the Light Obscuration Particle
Counter KL-04. For information regarding the operation of other equipment in the case of incor-
porating the KL-04 into a measurement system with other equipment, always make sure to refer
to the documentation of the other equipment. The following pages contain important information
on safety. Be sure to read this part.
This manual contains the following sections.
Outline
Describes the features of the unit.
Controls and Features
Briey identies and explains the buttons, lamps, connectors and all other parts of the
unit on the front, left side and rear panel.
Preparation
Describes how to connect the sampling tube, drain tube, power cord and other parts of
the unit.
Window Operation
Describes the basic operation of the windows.
Start Up
Describes how to start / stop the unit.
Operator Management
Describes how to register operators and how to set / change their access authoriza-
tions.
Measurements
Provides a basic explanation of measurement.
Performance-Test
Provides a basic explanation of Performance-Tests.
Calibration
Provides a basic explanation of calibration.
Print
Provides a basic explanation of printing.

ii
Export the measured data
Describes how to export the measured data by using the built-in oppy disk drive.
Back Up
Describes how to back up / restore measurement data by using the built-in tape drive.
System Setting
Provides a basic explanation of how to set the clock and how to connect with a net-
work.
Useful Tools
Describes how to use the virtual keyboard and how to take a snapshot of the screen.
Audit Trail
Describes the audit trail function.
Maintenance
Describes the inspection and maintenance of the unit and how to change the syringe.
Troubleshooting
Describes checking procedures and countermeasures in case there is a problem during
start up and operation.
Specications
Lists the technical specications of the unit.
* All company names and product names mentioned in this manual are trademarks
or registered trademarks of their respective owners.

iii
FOR SAFETY
In this manual, important safety instructions are specially marked as shown below. To
prevent the risk of death or injury to persons and severe damage to the unit or peripheral
equipment, make sure that all instructions are fully understood and observed.
Caution
WARNING
Important
Disregarding instructions printed
here incurs the risk of death or se-
vere injury to persons.
Disregarding instructions printed
here incurs the risk of injury to per-
sons and/or damage to peripheral
equipment.
Disregarding instructions printed
here incurs the risk of damage to the
product.
Mentioned about the tips to use this
unit properly. (This messages do not
have to do with safety.)
Note

iv

v
Caution
Types of sample uids
The unit is designed for measuring liquid-borne particles.
Never use the unit with the liquid types listed below, to prevent false measurement and
the possibility of accidents and damage to the unit.
- Explosive liquid or mixtures containing explosive uid
- Hydrouoric acid or other uid which can cause corrosion of parts in contact with
the uid or mixtures containing such uid
- Liquid with a temperature of less than +15°C or more than +30°C
When using different types of sample uid where mixing can lead to reactions such as
thermal build-up, hardening, or particle generation, always perform thorough cleaning to
ensure complete replacement.
Weight
The weight of the unit is about 14 kg.
When transporting or otherwise moving the unit, use a suitable trolley or other implement
and ensure safety to prevent the risk of injury.
When setting the unit, hold the handle tight with one hand and with the other hand hold
the cut-out on the opposite side panel.

vi
WARNING
Sample uid danger prevention
When toxic sample uid comes into contact with any part of the human body or when
toxic gases generated by the sample uid are breathed, there is a danger of severe injury
or death.
Sample uid also involves the risk of re, explosion, corrosion, deformation and other ef-
fects when other objects are in the surrounding area. Observe the following points closely
to prevent leakage and adherence of sample uid.
Do not pass hydrouoric acid or other sample uids which can cause corrosion of
uid-contacting parts (their materials are described in the specications) through the
system.
Observe the following points when setting up or dismantling a measurement system.
- Check the sample uid for any risks due to toxicity or other harmful properties.
- Make sure that sample uid cannot leak from the system and come into contact
with body parts, clothing etc.
- When attaching or detaching tubes, connectors etc., always use appropriate protec-
tive tools and wear dual-layer gloves.
- Double-check all connections before starting the sample uid ow.
When using sample uid which may produce harmful gases, provide adequate ventila-
tion as prescribed by applicable laws and regulations.
Before and after measurement, clean the entire sample uid system thoroughly to re-
move any remnants. Otherwise unwanted effects such as thermal build-up, hardening,
particle accumulation etc., can occur. This is especially important to prevent the pos-
sibility of serious accidents when using the unit to measure different types of sample
uids.
Before starting to prepare the system for storage, complete the cleaning process with
pure water and verify neutrality (pH7).
Dispose of waste sample uid only as prescribed by applicable laws and regulations.
Never mix waste sample uid with other substances unless absolute safety has been
established.

vii
WARNING
The unit uses a laser source
This unit is designated as a class 1 laser product according to
IEC 60825-1(2001). The internal particle detector mechanism
uses a laser, but it is fully shielded so that the beam cannot
exit from the enclosure.
The identication label shown at right is afxed to the rear of the unit.
"Caution - use of controls or adjustments or
performance of procedures other than those
specied herein may result in hazardous radiation
exposure."

viii

ix
Precautions
Operate the unit only as described in this manual.
Use the unit in locations within the prescribed temperatures and humidity ranges (+15°C
to +30°C, 20% to 80% RH).
Store the unit in locations within the prescribed temperatures and humidity ranges (-10ºC
to +50°C, 90% RH and less).
Do not use or store the unit in locations which
- may be subject to condensation by sudden changes in temperature, or
- may be subject to freezing inside the piping, or
- may be subject to splashes of water or other uids, or to direct sunlight, or
- may be subject to air with high salt or sulfur content, to corrosive chemicals, or to
gases, or
- may be unstable or inclined, or
- may be subject to vibrations or shock.
Before using the unit, make sure that all cord, cable and tube connections are correctly
and safely established. Do not subject the cords, cables and tubes to excessive bend-
ing or other force. When disconnecting the cords, cables and tubes, disconnect while
holding onto the end of the plug, connector or tube.
Use stable power with minimum excessive electrical noise or voltage uctuation, which
meets the conditions in the specications. Excessive electrical noise, voltage uctuation
or external noise can cause the unit to operate abnormally or malfunction.
Ground the unit securely by using a grounded AC outlet. Ungrounded operation incurs
the risk of electric shock and damage to the unit.
Do not disassemble the unit or attempt internal alterations. If a malfunction should
happen to occur, do not try to solve the problem on your own, but rather note the con-
dition of the unit clearly and contact the supplier.
The end plugs are required to seal the unit when returning it for maintenance or servic-
ing. Store the plugs in a safe location for later use.
The sample uid system of the unit must always be lled with sample uid (during
measurement, storage, and transport). If the sample uid system dries up, particle de-
tector problems can occur.
Before returning the unit for maintenance or servicing, thoroughly purge the piping
with pure water. Then ll the piping with ethyl alcohol and install the end plugs. In
addition, use the special packaging box so as to prevent the unit from being subjected
to vibrations and shock.

x

xi
Contents
FOR SAFETY.............................................................................................iii
Outline ......................................................................................................... 1
Relationship between Calibration, Performance-Test and Measurement .... 2
Light Source ........................................................................................... 5
Particle Size Detection............................................................................ 5
Controls and Features................................................................................... 6
Front Panel ............................................................................................. 6
Left Side Panel ....................................................................................... 7
Rear Panel .............................................................................................. 8
Preparation................................................................................................... 9
Installing the Sample Container Plate..................................................... 9
Connecting Sampling Tube................................................................... 10
Connecting the Drain Tube................................................................... 12
Connecting the Keyboard and Mouse ................................................... 14
Connecting Power Cord ........................................................................ 15
Connecting the Printer (Local Printer) ................................................. 16
Connecting to a Network (LAN Cable)................................................. 17
Connecting the External Display .......................................................... 18
Electromagnetic Stirrer (Option)........................................................... 19
Controls and features....................................................................... 19
How to install.................................................................................. 20
How to use ...................................................................................... 22
Window Operation ..................................................................................... 24
Virtual Desktop .................................................................................... 24
Window Menu ...................................................................................... 26
Pop-up Window .................................................................................... 27
Changing the Overlap Order of the Windows ....................................... 28
Moving a Window ................................................................................ 28
Changing the Window Size................................................................... 29
Selecting Window................................................................................. 29
Closing Windows.................................................................................. 30
Start Up ..................................................................................................... 32
Power ON ............................................................................................. 32
Login .................................................................................................... 34
Workspace Menu .................................................................................. 35
KL-04 - Start New Window ................................................................. 36
Change Displayed Language................................................................. 38

xii
Password Registration and Change ....................................................... 38
Completion (Logout) Method................................................................ 39
Operator Management................................................................................ 40
Operator ............................................................................................... 40
Operator Registration............................................................................ 40
Add Operator........................................................................................ 42
Change of Operator Registration Details .............................................. 43
KL-04 - Operator Management Window .............................................. 44
Measurements ............................................................................................ 47
Basic Operations .................................................................................. 47
Measuring Sequence............................................................................. 48
The Measurement Result ...................................................................... 50
To Display Previously Measured Data .................................................. 51
Measurement - Data Selector window ............................................. 52
Measurement Parameter Setting ........................................................... 53
Change Measurement Parameters ......................................................... 55
Measurement Parameters...................................................................... 56
Performance-Test ....................................................................................... 63
Performance-Test Sequence .................................................................. 63
The Performance-Test Result ................................................................ 66
Performance-Test Parameter Setting ..................................................... 67
Changing the Performance-Test Parameters.......................................... 68
Performance-Test Parameters................................................................ 69
Calibration ................................................................................................. 77
Calibration Sequence ............................................................................ 78
The Calibration Result.......................................................................... 82
Display Calibration Data....................................................................... 84
Calibration Parameter Setting............................................................... 85
Change Calibration Parameter .............................................................. 86
Calibration Parameter ........................................................................... 87
Print ........................................................................................................... 92
PS Files ............................................................................................... 95
Print Samples........................................................................................ 96
Export the measured data......................................................................... 104
Export the measured data ................................................................... 104
Back Up ................................................................................................... 107
Backup................................................................................................ 107
Restore................................................................................................ 109

xiii
System Setting ..........................................................................................110
Set Clock .............................................................................................110
KL-04 - Set Clock Window .................................................................112
Network Settings .................................................................................113
Settings for a Printer Connected to the Network..................................116
Useful Tools ..............................................................................................119
Virtual Keyboard.................................................................................119
TkSnapshot......................................................................................... 120
TkSnapshot (Version 0.31) Window .................................................... 122
The TkSnapshot - Save Window ......................................................... 123
Audit Trail ............................................................................................... 125
Operations recording in the audit trail ............................................... 126
Format for recorded items .................................................................. 127
Searching and Viewing the Audit Trail File ....................................... 128
Audit Trail Backup and Restore ......................................................... 130
When Clock Setting Was Changed .................................................... 130
Maintenance..............................................................................................131
Syringe Replacement ...........................................................................131
Handling the Syringe.......................................................................... 135
Cleaning main unit ............................................................................. 135
Noise Level Check and Flow Cell Cleaning........................................ 136
Cleaning Using a Cell Cleaning Brush ............................................... 138
Periodic Maintenance ......................................................................... 140
The Standardization of Units by the Regional Pharmacopeia ............. 140
Transport ............................................................................................ 140
Troubleshooting ........................................................................................141
When the Letters / Figures on the KL-04 Controller Window
appear in Red ..................................................................................141
When the Letters / Figures are Displayed in Orange
on the KL-04 Controller..................................................................141
When the Performance-Test Fails ........................................................141
When Message Window Appears .......................................................142
When KL-04 Does Not Start Up Normally ....................................... 144
Cannot Perform Backup/Restore ....................................................... 144
Syringe Response Problem ................................................................ 144
Specications ............................................................................................145

xiv

1
Outline
The Light Obscuration Particle Counter KL-04 detects particles suspended in a uid and
measures their size and numbers using the light-obscuration method.
The unit is an automatic particle measurement system specially designed for process step
control and quality management for example at medical production. The light-obscura-
tion principle is optimal for performing insoluble particulate matter tests for injections as
prescribed by the Japanese Pharmacopeia (JP), United States Pharmacopeia (USP), and
European Pharmacopeia (EP).
The unit also provides compliance with regulations for electronic records and signatures,
such as “21 CFR Part 11: Electronic Records; Electronic Signatures” by the American
FDA. However, signature support is provided for handwritten signatures only.
The features of the unit are as follows.
- Measurable particle size range of 1.3 to 100 µm.
- Rated sample uid ow of 25 mL / min.
- Built-in syringe pump enables measurement without connecting to other ow control
systems.
- Able to set 20 channels of measurable particle size range.
- Built-in hard disk can save several years of measurement data.
- Built-in tape drive enables backups and restoration of data saved on the hard
disk.
- Measurement data can be transferred by connecting to networks. Also the mea-
surement data can be exported in TSV (Tab Separated Values) format by using the
built-in oppy disk drive.
- A printer (Post Script Level 2 and above) can be connected to print out the mea-
surement results.
- Conformance with the Instrument Standardization (Calibration, Performance-Test)
of the Japanese Pharmacopeia (JP) and the United States Pharmacopeia (USP).
RION Co., Ltd. carries out a standardized system test (Calibration, Performance-
Test) as a factory option.
- Whether the measurement result is acceptable or not can be decided.
- An external display can be connected.
- All major operations affecting electronic records such as measurement data cre-
ation, modication, and deletion are recorded as audit trail information which can
be viewed and printed.
- Access control for functions such as measurement data modication and deletion
can be set for individual operators.

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 con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 con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 con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)

3
Outline
In other words, if the Performance-Test data KL-04_Basic is selected, the Calibration data
KL-04_Basic is applied to the unit and the unit is in the calibrated condition based on the
method decided by RION Co., Ltd.
Important
The Performance-Test data complying with the purpose of the
quality control test must be selected. An accurate measure-
ment cannot be performed when wrong Performance-Test
data are selected.
Multiple Performance-Test parameters (condition of test, condition of acceptance or rejec-
tion) can be registered to the same Calibration data. This is useful when carrying out the
Performance-Test as an inspection before starting any measurement.
A formal Performance-Test must be implemented to judge if the condition of the unit is
appropriate. However, it is possible to conrm the condition of the unit by setting up a
Performance-Test parameter with a name dif-
ferent from the formal Performance-Test, such
as the chart on the right, and implement the
Performance-Test when needed, such as at an
inspection before commencement. In other
words, multiple Performance-Test parameters,
such as formal Performance-Test and simple
Performance-Test, can be set to the same Cali-
bration data and used appropriately.
Important
Performance-Test data obtained with appropriate or equivalent
(to a chosen pharmacopeia) Performance-Test parameters
must be selected for a measurement. The measurement
cannot be carried out properly if the Performance-Test
data is obtained with inappropriate Performance-Test pa-
rameters.
Performance-Test
Measurement parameter
Performance-Test 1
Calibration
Simple Performance-Test

4
Outline
Procedure from preparation to measurement
The ow chart below shows the general procedure from preparation to measurement.
Detailed information on each procedure is described in the page number referenced in
the chart.
Preparation
(Refer to page 9)
Operator Registration (Refer to page 40),
System Setting (Refer to page 110)
Start Up
(Refer to page 32)
Login
(Refer to page 34)
Calibration
(Refer to page 77)
Logout
(Refer to page 39)
Do you
want to check the performance
of the unit before starting
a measurement?
Measurements
(Refer to page 47)
Performance-Test
(Refer to page 63)
Ye s
No
Password Registration and Change
(Refer to page 38)
*Password registration and change are carried out by operators after they log-in, if necessary.
When the unit is started
for the first time after being
shipped from the factory
When calibration is
to be carried out