PharmSpec 3.0

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
Invalid Configuration Alarm

• 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

5
Concentration Limit Alarm

• Warns the user if the sensor detects excessive
  concentration in the sample
• A standard input during hardware setting

6
Sensor Contamination Alarm

• 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

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
Calibration Due Alarm

• Advanced awareness that your instrument is due
  for Calibration
• Configure your calibration due warning timeline
  or turn it off

11
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
Manage Multiple Alarms
14
Customized Reporting
15
Customized Reporting
16
Automation of Flush Routine

• 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

Estimated time savings 20 - 30 minutes minimum
17
RD Partial Results Are Captured