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Liquid-Borne PARTICLE COUNTER for Pharmaceutical

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

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  1. Liquid-BornePARTICLE COUNTER for Pharmaceutical Features of Particle Counter KL-04 Shigeru Arashiki RION CO., LTD.

  2. 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

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

  4. 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

  5. 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

  6. 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

  7. KL-04 KL-04 Configuration(software)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

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

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

  18. English Japanese German KL-04 Language

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

  20. KL-04 Usual Operation • Measurement • Performance Test • Calibration

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

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

  23. KL-04 Measurement

  24. KL-04 Performance Test

  25. KL-04 Performance Test

  26. KL-04 Performance Test

  27. KL-04 Calibration

  28. KL-04 Calibration

  29. KL-04 Calibration

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

  31. KL-04 Parameter files • Measurement Parameter • Performance Test Parameter • Calibration Parameter

  32. Syringe Measurement Flush KL-04 Measurement Parameter

  33. Performance Test Particle size Management Information KL-04 Measurement Parameter

  34. Syringe Measurement Flush KL-04 Performance Test Parameter

  35. Calibration Data PSL information KL-04 Performance Test Parameter

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

  37. KL-04 Calibration Parameter • Syringe • Measurement • Flush • PSL • Management information

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

  39. KL-04 Management Tasks • Backup/Restore • System Administration • Set Clock

  40. KL-04 Management Tasks • Administration Tasks • Printer Setup

  41. KL-04 Management Tasks • Administration Tasks • Support Remote Printer Network

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

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

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

  45. KL-04 Miscellaneous System information • Verify System information • Software check using fingerprint

  46. KL-04 Unsupported • Virtual Keyboard • Screen Snapshot

  47. KL-04 Specification

  48. KL-04 Specification

  49. EC Declaration

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

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