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Liquid-Borne PARTICLE COUNTER for Pharmaceutical Features of Particle Counter KL-04 Shigeru Arashiki RION CO., LTD. JP14 General Rule/ 17. Injections General Test/ 64. Test for Particulate Contamination: Sub-Visible Particles USP25 Physical Test / <788> Particulate Matter in Injections

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liquid borne particle counter for pharmaceutical

Liquid-BornePARTICLE COUNTER for Pharmaceutical

Features of Particle Counter KL-04

Shigeru Arashiki RION CO., LTD.

standard
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

Standard
instrument standardization
Sample Volume Accuracy

Flow-rate

Calibration

Sensor Resolution

Particle Counting Accuracy

Particle Size Threshold Accuracy

Instrument Standardization
kl 04 features

KL-04

KL-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 04 options

KL-04

KL-04 Options
  • Post Script Printer
  • Electromagnetic stirrer
  • Sample tubing (i.d. 1 mm)
  • Standardization (USP ,JP)
  • Qualification documents (IQ/OQ)
  • Traceability documents
slide6

KL-04

KL-04 Configuration(hardware)

DISPLAY

FDD

Tape

Drive

LCD

Display

HDD

CPU

PRINTER

PS Printer

PHA

KEYBOARD

Keyboard

Interface

Sensor

MOUSE

Mouse

Ethernet

Sample

Syringe pump

Drain

kl 04 configuration steps

KL-04

KL-04 Configuration steps

Operator Management

Operator Management

Size Calibration Parameter

Size Calibration (Basic)

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement

kl 04 login

KL-04

KL-04 Login
  • Operators are authorized by the administrator
  • Login name & password required
  • Double click the operator icon to enter the login name
kl 04 configuration steps10

KL-04

KL-04 Configuration steps

Operator Management

Size Calibration Parameter

Size Calibration Parameter

Size Calibration (Basic)

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement

kl 04 configuration steps11

KL-04

KL-04 Configuration steps

Operator Management

PSL

USP/JP

(Option)

Size Calibration Parameter

Size Calibration (Basic)

Size Calibration (Basic)

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement

kl 04 configuration steps12

KL-04

KL-04 Configuration steps

Operator Management

PSL

Size Calibration Parameter

Size Calibration (Basic)

Performance Test Parameter

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement

kl 04 configuration steps13

KL-04

KL-04 Configuration steps

Operator Management

PSL

Size Calibration Parameter

Size Calibration (Basic)

USP/JP

(Option)

PCRS

Performance Test Parameter

Performance Test (Basic)

Performance Test (Basic)

Sample

Measurement Parameter

Measurement

kl 04 configuration steps14

KL-04

KL-04 Configuration steps

Operator Management

PSL

Size Calibration Parameter

Size Calibration (Basic)

PCRS

Performance Test Parameter

Performance Test (Basic)

Measurement Parameter

Measurement Parameter

Measurement

kl 04 configuration steps15

KL-04

KL-04 Configuration steps

Operator Management

PSL

Size Calibration Parameter

Size Calibration (Basic)

PCRS

Performance Test Parameter

Performance Test (Basic)

Sample

Measurement Parameter

Measurement

Measurement

kl 04 functions

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameter
  • Management Tasks
  • Miscellaneous
kl 04 functions17

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameter
  • Management Tasks
  • Miscellaneous
language
English

Japanese

German

KL-04

Language
kl 04 functions19

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameter
  • Management Tasks
  • Miscellaneous
usual operation

KL-04

Usual Operation
  • Measurement
  • Performance Test
  • Calibration
measurement

KL-04

Measurement
  • Differential
  • Bar Graph
  • Pre-Meas.
  • Information
measurement22

KL-04

Measurement

Pre-measurement

Differential

Bar-Graph

Management Information

kl 04 functions30

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameters
  • Management Tasks
  • Miscellaneous
parameter files

KL-04

Parameter files
  • Measurement Parameter
  • Performance Test Parameter
  • Calibration Parameter
measurement parameter
Syringe

Measurement

Flush

KL-04

Measurement Parameter
measurement parameter33
Performance Test

Particle size

Management Information

KL-04

Measurement Parameter
performance test parameter36
Suspension

Noise Level

( Management information )

KL-04

Performance Test Parameter
calibration parameter

KL-04

Calibration Parameter
  • Syringe
  • Measurement
  • Flush
  • PSL
  • Management information
kl 04 functions38

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameter
  • Management Tasks
  • Miscellaneous
management tasks

KL-04

Management Tasks
  • Backup/Restore
  • System Administration
  • Set Clock
management tasks40

KL-04

Management Tasks
  • Administration Tasks
  • Printer Setup
management tasks41

KL-04

Management Tasks
  • Administration Tasks
  • Support Remote Printer

Network

management tasks42

KL-04

Management Tasks

Operator Management

  • Administrator who has authority for “Operator Management” can make a new operator
  • Several authorities for operators.
kl 04 functions43

KL-04

KL-04 Functions
  • Multi-Language
  • Usual Operation
  • View/Set Operation Parameter
  • Management Tasks
  • Miscellaneous
miscellaneous

KL-04

Miscellaneous

Change Password

  • High Security Password management
  • Administrator can clear and avoid the password of the other operator
miscellaneous45

KL-04

Miscellaneous

System information

  • Verify System information
  • Software check using fingerprint
unsupported

KL-04

Unsupported
  • Virtual Keyboard
  • Screen Snapshot
qualification documents

KL-04

Design Qualification

Installation Qualification

Operation Qualification

Performance Qualification

Qualification documents