SPECIFICATIONS
LIGHT OBSCURATION PARTICLE COUNTER
KL-04A
3-20-41 Higashimotomachi, Kokubunji, Tokyo 185-8533, Japan
No. 09009-2E 14-01 Printed in Japan
Outline
The light obscuration particle counter KL-04A detects particles suspended in a fluid and measures
their size and number concentration 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-obscuration principle is op-
timal for performing insoluble particulate matter tests for injections as prescribed by the Japanese
Pharmacopeia (JP), United States Pharmacopeia (USP), European Pharmacopeia (EP), and Korean
Pharmacopoeia (KP).
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.
- Flow rate is 25 mL / min.
- Built-in syringe pump enables measurement without connecting to other flow control sys-
tems.
- Able to set 20 channels of measurable particle size range.
- Built-in hard disk can save several years of measurement data.
- USB flash drive enables backups and restoration of data saved on the hard disk.
- The measurement data can be exported in TSV (Tab Separated Values) format by using the
USB flash drive.
- A printer (PostScript Level 2 and above) can be connected to print out the measurement re-
sults.
- Conformance with the instrument standardization (Calibration, Performance-Test) of the
Japanese Pharmacopeia (JP), United States Pharmacopeia (USP) and Korean Pharmacopoeia
(KP).
RION Co., Ltd. will carry 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 creation, modifica-
tion, and deletion are recorded as audit trail information which can be viewed and printed.
- Access control for functions such as measurement data modification and deletion can be set
for individual operators.
- Data output to a computer is possible via a serial link, using the optional USB-RS-232C con-
version cable.
* All company names and product names mentioned in this specifications are trademarks or
registered trademarks of their respective owners.
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Specifications
Optical system Light-obscuration method
Light source Laser diode (rated output: 3 mW, wavelength: 780 nm)
Laser product class Class 1, IEC 60825-1 (2007)
Class 3B laser is used in the internal particle detection mecha-
nism.
Light detector PIN type photodiodes
Materials of component parts exposed to sample fluid
Sampling tube PFA, (SUS304 as option)
Sensor area Synthetic quartz, PFA, perfluoro (fluorocarbon rubber)
Syringe pump Borosilicate Glass, Kel-F (PCTFE), PTFE, PFA
Tube / Packing / Connector
PTFE, PCTFE
Sample container plate Polyacetal
Allowable sample fluid type
Fluids which do not cause corrosion to the parts in contact with
the fluid
Calibration Using polystyrene latex (PSL) particles (refractive index 1.6) in
pure water
Minimum detectable particle size
1.3 µm
Measurable particle size range
1.3 to 100 µm (when using PSL particles in pure water)
Size range Selectable arbitrarily from 1 to 20 channels
Counting efficiency 100±5% (when measuring PSL particles of 10 µm in pure water
and comparing the count of more than 5 µm with a reference
unit)
Flow rate 25 mL / min (10 mL / min as factory option)
Maximum particle number concentration
10000 particles / mL (when the counting loss is 10% in the vicin-
ity of 10 µm PSL particles in pure water)
Size resolution 10% or less (in the vicinity of 10 µm PSL particles in pure wa-
ter)
Threshold accuracy 5% or less (when particle number concentration is less than 6000
particles / mL in the vicinity of 10 µm and 15 µm PSL particles
in pure water)
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Sampling flow rate accuracy
Within 2% (when measuring 10 mL volume)
Sampling volume accuracy
Within 2% (when measuring 10 mL volume)
Instrument Standardization at each regional pharmacopeia (factory option)
JP
Calibration Particle size calibration using the calibrated particles of 1.3 to 100 µm
which have domestic and international traceability have a margin
of error of less than 3%. However, our own specified method will
be carried out for the calibration of less than 4 µm.
Performance-Test Sample volume accuracy test
Flow rate accuracy test
Particle counting accuracy test, threshold accuracy test and sensor
resolution test using Clintex (Particle Count Reference Standard
Suspension), which is manufactured by JSR.
USP
Calibration Particle size calibration using the calibrated particles of 1.3
to 100 µm, which are traceable and NIST standard reference
materials. However, our own specified method will be carried
out for calibration of less than 4 µm.
Performance-Test Sample volume accuracy test
Flow rate accuracy test
Counting accuracy test and Ratio value test using USP-PC-RS
(USP Particle Count Reference Standard)
Sensor resolution test using calibrated particles of 10 µm.
KP
Calibration Particle size calibration using the calibrated particles of 1.3 to 100 µm
which have domestic and international traceability have a margin
of error of less than 3%. However, our own specified method will
be carried out for the calibration of less than 4 µm.
Performance-Test Sample volume accuracy test
Flow rate accuracy test
Particle counting accuracy test, threshold accuracy test and sensor
resolution test using Clintex (Particle Count Reference Standard
Suspension), which is manufactured by JSR.
EP
Calibration Applied to JP or USP*
Performance-Test Applied to JP or USP*
* EP has no regulations about Calibration and Performance-Test
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Syringe pump
Measurement Sampling flow rate 25 mL / min
Range of drain flow rate 5 mL / min to 100 mL / min
Flushing Range of sampling flow rate 5 mL / min to 100 mL / min
Range of drain flow rate 5 mL / min to 100 mL / min
Sample container size
Maximum size (diameter)
Beaker 300 mL (JIS R 3503)
Maximum height Tall beaker 200 mL (JIS R 3503)
Sample container plate Internal diameter 77 mm, depth 5 mm
Sample fluid dead volume
0.5 mL or less
(Volume of air pocket from tip of sampling tube to detector section)
Maximum sample fluid pressure
50 kPa
Maximum sample fluid viscosity
30 mPa · s (at 25°C)
Sample fluid temperature range
+15°C to +30°C (no condensation on flow cell)
Sample port
INLET Sample fluid inlet
Supplied sampling tube is to be connected to the INLET within
the sensor area.
OUTLET Sample fluid outlet
2 mm × 3 mm dia. flange tube is to be connected to the OUTLET
of the syringe pump.
Display 6.5 inch color LCD
Input / Output connectors
PRINTER Parallel port (IEEE1284 compatible, 25 pin D-sub female type
connector) to connect to a printer (supporting PostScript Level 2
and above).
ETHERNET Interface to connect to a LAN (10 / 100Base-T)
DISPLAY Interface to connect to a display.
(Analogue RGB, 15 pin high density D-sub female type connec-
tor, Resolution: 640×480 pixels,
Scanning frequency: vertical 60 Hz/horizontal 31.5 kHz)
Connected to the built-in display when shipped.
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KEYBOARD Interface to connect to a keyboard
For connection of supplied keyboard
USB (2 front panel ports, 1 rear-panel port)
For connecting devices with USB interface (USB 2.0, type A
female connector)
For connection of supplied mouse, USB flash drive etc.
Power 100 V to 240 V AC, 50 / 60 Hz, Approx. 100 VA
Environmental Requirements
Operational Environments
Indoor Use Only
Altitude Up to 2000 m
Supply Voltage Fluctuations
100 V to 240 V AC ±10%
Installation Category 2
Pollution Degree 2
Environmental conditions for operation
+15°C to +30°C, 20% to 80% RH (no condensation)
Environmental conditions for storage
-10°C to +50°C, 90% RH or less
(no condensation and no freezing of internal piping)
Dimensions Approx. 369 (H) × 400 (W) × 280 (D) mm (maximum)
Approx. 363 (H) × 358.5 (W) × 236 (D) mm (excluding protrud-
ing parts)
Weight Approx. 13 kg
Supplied accessories PFA sampling tube (2 mm × 4 mm dia., length 10 cm) set 1
(includes a nut)
Drain tube (2 mm × 3 mm dia., length 1.5 m) set 1
(includes a connector and a piece of packing)
Mouse 1
Keyboard 1
Power cord 1
USB flash drive (for backup) 1
Cell cleaning brush (included in one case) 2
Screw (M4×10) for mounting electromagnetic stirrer 1
Instruction manual 1
Instruction manual (for Administrator) 1
Liquid-borne particle counter usage precautions 1
Inspection certificate 1
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Optional accessories PFA Sampling tube (2 mm × 4 mm dia., length 10 cm) set
(includes a nut)
SUS Sampling tube (2 mm × 3 mm dia., length 10 cm) set
(includes a nut and 2 pieces of packing)
SUS Sampling tube (1 mm × 2 mm dia., length 10 cm) set
(includes a nut and 2 pieces of packing)
Electromagnetic stirrer Cimarec i Micro
Stirring bar
USB flash drive
USB-RS-232C conversion cable
Printer (support PostScript Level 2 and above)
Printer cable (parallel)
USB cable (2 m)
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Rear view Left side view
400 280
358.5 236
369
363
Front view Right side view
Unit: mm
Dimensional Drawings
Specifications subject to change without notice
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