Liquid-Borne PARTICLE COUNTER for Pharmaceutical z Features of

Liquid-Borne PARTICLE COUNTER for Pharmaceutical z Features of Particle Counter KL-04 z Shigeru Arashiki RION CO. , LTD.

Standard n JP 14 n n General Rule/ 17. Injections General Test/ 64. Test for Particulate Contamination: Sub-Visible Particles n USP 25 n Physical Test / <788> Particulate Matter in Injections n EP 4 n 2. 9. 19 Particulate Contamination: Sub-Visible Particles

Instrument Standardization n Sample Volume Accuracy n Flow-rate n Calibration n Sensor Resolution n Particle Counting Accuracy n Particle Size Threshold Accuracy

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 - 240 V) • Compliant with USP, JP and EP requirements. • CE certificate

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

KL-04 Configuration (hardware) HDD LCD Display CPU PHA Sensor DISPLAY PRINTER Interface FDD Tape Drive KEYBOARD MOUSE Ethernet Sample Syringe pump Drain PS Printer Keyboard Mouse

KL-04 Configuration (software)

KL-04 Configuration steps Operator Management Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter Performance Test (Basic) Measurement Parameter Measurement

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 steps Operator Management Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter Performance Test (Basic) Measurement Parameter Measurement

KL-04 Configuration steps Operator Management USP/JP (Option) Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter Performance Test (Basic) Measurement Parameter Measurement PSL

KL-04 Configuration steps Operator Management PSL Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter Performance Test (Basic) Measurement Parameter Measurement

KL-04 Configuration steps Operator Management PSL Size Calibration Parameter Size Calibration (Basic) USP/JP (Option) Performance Test Parameter PCRS Performance Test (Basic) Sample Measurement Parameter Measurement

KL-04 Configuration steps Operator Management PSL Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter Performance Test (Basic) Measurement Parameter Measurement PCRS

KL-04 Configuration steps Operator Management PSL Size Calibration Parameter Size Calibration (Basic) Performance Test Parameter PCRS Performance Test (Basic) Sample Measurement Parameter Measurement

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

KL-04 Language n n n English Japanese German

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

KL-04 Usual Operation n Measurement Performance Test Calibration

KL-04 Measurement • Differential • Bar Graph • Pre-Meas. • Information

KL-04 Measurement Pre-measurement Differential Bar-Graph Management Information

KL-04 Measurement

KL-04 Performance Test

KL-04 Calibration

KL-04 Functions n n n Multi-Language Usual Operation View/Set Operation Parameters Management Tasks Miscellaneous

KL-04 Parameter files n n n Measurement Parameter Performance Test Parameter Calibration Parameter

KL-04 Measurement Parameter n n n Syringe Measurement Flush

KL-04 Measurement Parameter n n n Performance Test Particle size Management Information

KL-04 Performance Test Parameter n n n Syringe Measurement Flush

KL-04 Performance Test Parameter n n Calibration Data PSL information

KL-04 Performance Test Parameter n n n Suspension Noise Level ( Management information )

KL-04 Calibration Parameter n n n Syringe Measurement Flush PSL Management information

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

KL-04 Management Tasks n n n Backup/Restore System Administration Set Clock

KL-04 Management Tasks Administration Tasks • Printer Setup

KL-04 Management Tasks Administration Tasks • Support Remote Printer Ne ork tw

KL-04 Management Tasks Operator Management n Administrator who has authority for “Operator Management” can make a new operator n Several authorities for operators.

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

KL-04 Miscellaneous Change Password n High Security Password management n Administrator can clear and avoid the password of the other operator

KL-04 Miscellaneous System information n Verify System information n Software check using fingerprint

KL-04 Unsupported n n Virtual Keyboard Screen Snapshot

KL-04 Specification Optics: Size Range: Sample Flow rate: Max. Concentration: Calibration: Mode: Light Obscuration 1. 3 – 100 µm 25 m. L/min 10000 particles/m. L at 10 coincidence loss by 10 µm PSL in water. Flush, Measurement, Calibration , Noise level, Performance test

KL-04 Specification Sensor Resolution: Sample Flow rate: Sample Volume Acc. : Threshold Acc. : Syringe size: 10 % 25 m. L/min 2% Flow rate range: 5 – 100 m. L/min Power: 100 – 240 VAC 100 VA Dimensions: 360(w), 363(H), 236(D) mm Weight: App. 14 kg 5 % (JP) 25 m. L

EC Declaration

KL-04 Qualification documents Design Qualification Installation Qualification Operation Qualification Performance Qualification