liquid-borne particle counter for pharmaceutical

Liquid-BorneLiquid-BornePARTICLE COUNTER PARTICLE COUNTER

for Pharmaceuticalfor Pharmaceutical

Features of Particle Counter KL-04Features of Particle Counter KL-04Shigeru Arashiki RION CO., LTD.Shigeru Arashiki RION CO., LTD.

StandardStandard

JP14 General Rule/ 17. Injections General Test/ 64. Test for Particulate

Contamination: Sub-Visible Particles USP25

Physical Test / <788> Particulate Matter in Injections

EP4 2.9.19 Particulate Contamination: Sub-Visible

Particles

Instrument StandardizationInstrument Standardization

Sample Volume AccuracyFlow-rateCalibrationSensor ResolutionParticle Counting AccuracyParticle Size Threshold Accuracy

KL-04 FeaturesKL-04 Features

• Particle Counter for Injections

• Developed under ISO 9001 certified

• Stand alone system

• Login using ID & Password

• Built in FDD for exporting data

• Built in Tape Streamer for data backup

• World Voltage (100- 240V)

• Compliant with USP, JP and EP requirements.

• CE certificate

KL-04KL-04KL-04KL-04

KL-04 OptionsKL-04 Options

• Post Script Printer

• Electromagnetic stirrer

• Sample tubing (i.d. 1 mm)

• Standardization (USP ,JP)

• Qualification documents (IQ/OQ)

• Traceability documents


LCDDisplay

HDD

Tape Drive

PS Printer

PHA

Sensor

KL-04 Configuration (hardware)

FDD

SampleSyringe pump

Drain

CPU

MouseInte

rface

DISPLAY

PRINTER

KEYBOARD

MOUSE

Keyboard

Ethernet


KL-04 Configuration (software)KL-04 Configuration (software)

M easurem ent

Perform anceTest

C alibration

N oise Level

O peration

M easurem ent

Perform anceTest

C alibration

Param eters

Backup/R estore

O peraterM anagem ent

Set C lock

SystemAdm inistrator

M anagem ent

C hangePassw ord

Systeminform ation

V irtua lKeyboard

S c reanS naps hot

O thers...

KL-04


Operator Management

KL-04 Configuration steps KL-04 Configuration steps

Size Calibration Parameter

Operator Management

Size Calibration (Basic)

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement


KL-04 LoginKL-04 Login

• Operators are authorized by the administrator

• Login name & password required

• Double click the operator icon to enter the login name




Operator Management





Measurement





Operator Management





Measurement

PSLUSP/JP(Option)

USP/JP(Option)






Operator Management





Measurement

PSL





Operator Management





Measurement

PSL

PCRS

Sample

USP/JP(Option)

USP/JP(Option)





Operator Management





Measurement

PSL

PCRS


Measurement



Operator Management





Measurement

PSL

PCRS

Sample


KL-04 FunctionsKL-04 Functions

Multi-Language Usual Operation View/Set Operation

Parameter Management Tasks Miscellaneous


LanguageLanguage

English Japanese German


Usual Operation Usual Operation

Measurement Performance Test Calibration


Measurement

•Differential

•Bar Graph

•Pre-Meas.

•Information


Pre-measurementPre-measurement

DifferentialDifferential

Bar-GraphBar-Graph

Management Information

Management Information

Measurement


Measurement


Performance Test


Calibration




Parameters Management Tasks Miscellaneous


Parameter files Parameter files



Calibration Parameter


Measurement Parameter Syringe Measurement Flush


Measurement Parameter Performance Test Particle size Management

Information



Syringe Measurement Flush



Calibration Data PSL information



Suspension Noise Level ( Management

information )


Calibration Parameter

Syringe Measurement Flush PSL Management

information


Management TasksManagement Tasks

Backup/Restore System Administration Set Clock


Management Tasks


Administration Tasks•Printer Setup

Management Tasks


NetworkNetwork

Administration Tasks•Support Remote Printer

Management TasksManagement Tasks

Operator Management Administrator who

has authority for “Operator Management” can make a new operator

Several authorities for operators.


MiscellaneousMiscellaneous

Change Password High Security

Password management

Administrator can clear and avoid the password of the other operator


MiscellaneousMiscellaneous

System information

Verify System information

Software check using fingerprint


UnsupportedUnsupported

Virtual Keyboard Screen Snapshot


SpecificationSpecification


Optics: Light Obscuration

Size Range: 1.3 – 100 µm

Sample Flow rate: 25 mL/min

Max. Concentration:

10000 particles/mL at 10 coincidence loss by 10 µm PSL

Calibration: PSL in water.

Mode: Flush, Measurement, Calibration , Noise level, Performance test

SpecificationSpecification


Sensor Resolution: 10 %

Sample Flow rate: 25 mL/min

Sample Volume Acc. :

2 %

Threshold Acc. : 5 % (JP)

Syringe size: 25 mL

Flow rate range: 5 – 100 mL/min

Power: 100 – 240 VAC 100 VA

Dimensions: 360(w), 363(H), 236(D) mm

Weight: App. 14 kg

EC Declaration

Qualification documentsDesign Qualification

Installation Qualification

Operation Qualification

Performance Qualification


liquid-borne particle counter for pharmaceutical

Documents