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PharmSpec 3.0

PharmSpec 3.0. HIAC just got easier!. PharmSpec 3.0. Many of the functions have not changed Procedural tests Run Counter tests IST tests Procedure Builder Historical reporting Activity Log Data Storage Hardware settings. Bubble Detection Alarm. 1) Clear description of alarm.

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PharmSpec 3.0

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  1. PharmSpec 3.0 HIAC just got easier!

  2. PharmSpec 3.0 Many of the functions have not changed • Procedural tests • Run Counter tests • IST tests • Procedure Builder • Historical reporting • Activity Log • Data Storage • Hardware settings

  3. Bubble Detection Alarm 1) Clear description of alarm 2) Recommended actions 3) Potential cause and where to go for help Ships disabled as standard.

  4. Current 9703 does not validate that the instrument configuration is not suitable for use New 9703 will: Ensure the sampling probe, syringe, and flow rate setup are viable configurations The strength of the 9703 is its ability to manage a wide range of LPC application We tested all possible mechanical configurations to ensure the instrument is not a contributor to bubble generation 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Invalid Configuration Alarm

  5. Warns the user if the sensor detects excessive concentration in the sample A standard input during hardware setting 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Concentration Limit Alarm

  6. Warns the user that the sensor is contaminated Probable causes: Sensor window/cell is dirty Void (air pocket) passed through the sensor Significant over concentration of the sensor Recommendation: Forward-flush the system multiple times with cleaning solution For protein-users, we recommend Conrad 70 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Sensor Contamination Alarm

  7. PHA PHA enables Troubleshooting Secondary sizing validation Diagnostic Dual channel PHA Light Scattering Light Extinction Changes: Utilizing histogram Added scatter

  8. Batch Export Current version of PharmSpec 2.X only allows 1 test to be exported PharmSpec 3.0 will enable mass or selectable export functions to: Word Excel Adobe Text

  9. Electronic Signature Improvements • More strict interpretation of 21CFR Part 11 electronic signature process…. WITHOUT more manual inputs

  10. 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Calibration Due Alarm • Advanced awareness that your instrument is due for Calibration • Configure your calibration due warning timeline or turn it off

  11. 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Probe Change Warning • Sampling safety switch • Ensures the sampling probe does not crash (and bend or break) into the docking module. • Ensures the probe does crash and/or tip the sample container

  12. Configure Alarms and Alerts to Suit • Turn them On! • Turn them Off! • Or do both! Factory default is off Ships disabled as standard.

  13. 1) Clear description of alarm 2) Recommended actions 3) Where to go for help Manage Multiple Alarms

  14. Customized Reporting

  15. Customized Reporting

  16. Give your customers more walk away time Automate flushing/cleaning routines Step #1 Place 1 ml - 1000 ml of Conrad 70, IPA, or other cleaning solution Step #2 Push a button Step #3 Walk away Step #4 Return to a thoroughly cleaned instrument Automation of Flush Routine Estimated time savings: 20 - 30 minutes minimum

  17. R&D: Partial Results Are Captured

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