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Agenda

Agenda. Brief Review of Application Sales tools / literature overview Instrument – What changed/no? Consolidated review of the new stuff Pharmspec – What changed/no? Consolidated review of new stuff Best Practice prior to on-site arrival Review of Inst install (op manual, gotcha’s)

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Agenda

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  1. Agenda • Brief Review of Application • Sales tools / literature overview • Instrument – What changed/no? • Consolidated review of the new stuff • Pharmspec – What changed/no? • Consolidated review of new stuff • Best Practice prior to on-site arrival • Review of Inst install (op manual, gotcha’s) • Review of Pharm install (op manual, gotcha’s) • IQ/OQ – brief review • Support team

  2. Patent Pending

  3. Literature Resources Sales Literature Other Resources HIAC Instrumentation and PharmSpec Software Validation Docs. 9703+ User Manual PharmSpec User Manual 9703+ Quotation Template • 9703+ Flyer • HIAC Global & Domestic Customer lists • 9703+ Postcard • 9703+ Sales Training • 9703+ SOP Migration

  4. What Has Not Changed? • Syringes • 1 ml, 10 ml, 25 ml • Flow rate settings • 10 – 100 ml • Sensors • (MC05 is added) • Sampling Probes • (added short-small bore probe) • Instrument size / shape • Design allows the laminar flow cabinet to act upon the sample • 50%+ of instruments are placed in laminar flow cabinets. Some SOP’s reference flow rates, sensor models, syringes and probes

  5. Instrument View

  6. New Sampling Probe • 3 probes available • 2 probes have not changed (1.2 ml tare, 0.172 ml tare volume) • New small / short probe has 0.09 ml tare volume • Enables the use of 1 ml of product for full suite of compendial tests

  7. Small Vial Clamp • Small Vial Clamp • Can be removed • Can be added in the field or ordered directly • Use • Use 1 hand to compress lever arms • Use other hand to place sample in central location • Decompress hand • Clamp auto-centers and holds sample container. • Removal • Half nut installation • Standard flat head screw driver required (not included)

  8. Docking Module • Docking Module • Enables removal/disabling of the stir bar mechanism • Enables field installation of small vial clamp outside of the laminar flow cabinet • No instrument move forcing a revalidation • Future developments to expand 9703 applications • Auto-sampler docking module in development

  9. Sampling Safety Switch • 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 • This addresses #1 problem revealed during the face-to-face interviews Don’t underestimate the importance of this feature during demo

  10. MC05 Sensor • PharmSpec • Unique calibration curves must be entered for extinction and scatter • PHA available for both extinction and scatter channels 9703+ MC05 • Requires unique sensor mounting • Field retro-fit kits available VOC revealed 12% of respondents are seeking particles down to 0.5 um

  11. Back Panel View – New Items • HRLD cable connector • Ensures stable sensor connection during sampling • USB connection • Light extinction and light scattering connections • Utilized for calibration of either HRLD or MC05 sensor • Utilized for on-site field trouble-shooting of HRLD or MC05 sensor • Power connection • Drain connection • 15-pin sensor connector

  12. Front Panel User Interface Changed interface to separate flushing and syringe change out buttons, from stir speed and instrument probe position • Flushing buttons • Forward flush (top button) • Back-flush (bottom button) • Syringe Open/Close • Enables syringe change-out • Stir Speed – RPM • Precision stir speed in rotations per minute (RPM) • Visual indication that the instrument is still powered • Sampling probe position • Move probe upward • Move probe downward • Set probe sampling position • Button used to set the pre-configured probe test sampling position.

  13. Best Practices Customer computer (major stumbling block) • Brand new computer • Clean Hard-drive • Recycle • Communication port problems Do you have IQ/OQ documents ready (ideally printed and bound) Brief the customer prior to visit

  14. 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

  15. What’s New In PharmSpec 3.0 • Compatibility with the HIAC 9703+ Liquid Particle Counting System • Compatibility with MC particle counting sensors • Users are added to PharmSpec using Windows® User Management • Users log in to PharmSpec using their Windows user account logins and passwords • Password expirations and lockout settings are selected using Windows • USP<789> test procedural standards • CP test procedural standards • Procedural standards and user-defined test procedures can be distributed to other computers by the user

  16. What’s New Con’t • Partial results are recorded for incomplete tests • Automatic checks for procedure and software updates can be scheduled by the user • Batch printing and exporting of reports • Alarms for invalid configuration, calibration due, bubbles detected, concentration limit exceeded, sample probe needs recalibration, sensor blocked and sensor contaminated • Number of reviewer signature lines on printed reports is set by the user • Company logo can be added to reports by the user • FDA 21 CFR Part 11 requirement features can be disabled using a license key (logins, user administration, review and approvals of tests, and audit trails)

  17. PharmSpec Requirements *The PC requirements shown are the minimum requirements supported. *The user may benefit by using a faster processor and/or additional memory. *Windows Vista and Windows 7 users may have higher requirements.

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

  19. Adding A User -Right click on “My Computer” -Click “Manage” -Double click “Users” -Next to the “Users” folder, Right click and select “New User” -The following fields must be filled in: User name, Full name and Password fields. Complete the other fields as needed. -The following fields must be filled in: User name, Full name and Password fields. Complete the other fields as needed.

  20. Add A User To A Group -Click “Groups” -Double click on the Group you wish to add the User to. The four groups from which you can choose to add a User to are: 1)PharmSpecAdmins 2) PharmSpecCalTechs 3) PharmSpecOperators 4) PharmSpecSupervisors - Click Add -Enter the “User Name” in the dialogue box and click “Check Names” **If you are working in a Domain and wish to add a Local User click on “Locations” and select your computer. -Once the User is found select “OK” and the User is added to the selected Group

  21. 9703+ w/ HRLD HRLD components 1 HIAC 9703+ liquid particle counter 2 Sensor, HRLD 3 Cable, sensor

  22. Included Accesories Shipping kit 1 Nut 7 Probe, small bore 2 Hex Key, 1.5 mm 8 Cable, USB 3 Syringe, 10 ml 9 Power supply, 24V 4 Power cord, AC 10 O-rings 5 Stir Bar, Teflon 11 Tubing 6 Probe, large bore 12 Power cord, European

  23. HRLD Sensor Install 1 2 3 4

  24. HRLD Sensor Install Con’t 5 7 6

  25. Instrument Install Guidance Connect the drain line The sample waste from the instrument must be collected in a compatible waste container. Monitor the liquid level in the waste container to prevent overflow. Dispose of waste in accordance with local, state and national environmental regulations. Install the small-vial clamp The optional small-vial clamp connects to the docking module with 2 screws. Connect the power cord A power supply unit is used to supply power to the instrument Install or remove the docking module Docking modules are available for single or multiple-container sampling

  26. Install Guidance con’t Remove the magnetic stirrer The magnetic stirrer in the docking module can be removed if necessary 1. Pull the tab on the docking module away from the instrument to remove the module. 2. Remove the four screws on the bottom plate of the module. Separate the bottom plate from the module enclosure. 3. Pull to remove the stirrer plug from the circuit board. 4. Remove the two holding screws from the stirrer motor flange and remove the magnetic stirrer assembly. 5. Put the bottom plate on the module enclosure and install the four screws. User interface: The buttons on the front panel allow the user to operate the syringe, sample probe and stirrer. 1 Syringe controls 4 Stop button 2 Stirrer speed (RPM) 5 Sample probe controls 3 Power switch 6 LED status indicators

  27. Button Descriptions Button Name Description Stop Stops the movement of the syringe and probe. Sampling is stopped. The stirrer continues to operate. Set Moves the sample probe up or down. Hold to increase speed. Lift/Lower Sends the sample probe to the top or bottom

  28. IQ/OQ -Validation Support Documentation Purpose of the Tests The validation project is a set of tests that are used to make sure that the computer-related system is operating to the specifications that have been identified. Before a full operational qualification (OQ) is done, an installation qualification (IQ) is done. • On-site IQ/OQ service is available. • IQ/OQ documentation offered to customers as an option

  29. Customer Upgrade - Awareness • We are unable to support PharmSpec 1.X historical database report viewing • This can be done in PharmSpec versions 1.X and 2.X but not 3.X • PharmSpec 1.X did not migrate to Windows XP, which is the minimum operating system for PharmSpec 3.0 • All current HRLD sensors in the field must be fitted with the new 9703+ cable when used with new instrument • Due to speed and sensitivity enhancements, the old HRLD cabling is not optimized for the 9703+ • All new HRLD part #’s with new cable have been developed for quotes on 9703+ • Retrofitting the new cable on an old sensor is an acceptable solution • We no longer user PharmSpec application security, we utilize Windows security for login access • Be sure to add your user’s to one of the PharmSpec User groups, clearly outlined in the operator manual

  30. Hach Internal 9703+ Support Team • This is an internal list to be used when normal channels of support have not provided an adequate solution. Software: Tim Rivas x 6535 Software: Guy Wood x 6532 Tech Support: John Moir x 6545 General Questions: Paul Yates x 6528 General Questions: Dave Dunham x 6548

  31. Gary Minnick x 6552 Bill Bars x 6551 ….and when all else fails

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