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Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC just got easier!

Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

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Page 1: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

PharmSpec 3.0

HIAC just got easier!

Page 2: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

2

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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

Page 3: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

Bubble Detection Alarm

1) Clear description of alarm

2) Recommended actions

3) Potential cause and where to go for help

Ships disabled as standard.

Page 4: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

4

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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

1) Clear description of alarm

2) Recommended actions

3) Where to go for help

Page 5: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

5

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Concentration Limit Alarm

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

Page 6: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

6

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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 1) Clear description of alarm

2) Recommended actions

3) Where to go for help

Page 7: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

7

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

PHA

• PHA enables– Troubleshooting

– Secondary sizing validation

– Diagnostic

• Dual channel PHA– Light Scattering

– Light Extinction

• Changes:– Utilizing histogram

– Added scatter

Page 8: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

8

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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

Page 9: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

9

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Electronic Signature Improvements

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

Page 10: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

10

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Calibration Due Alarm

• Advanced awareness that your instrument is due for Calibration

• Configure your calibration due warning timeline or turn it off

1) Clear description of alarm

2) Recommended actions

3) Where to go for help

Page 11: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

11

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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

1) Clear description of alarm

2) Recommended actions

3) Where to go for help

Page 12: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

12

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Configure Alarms and Alerts to Suit

• Turn them On!• Turn them Off!• Or do both!

Factory default is off

Ships disabled as standard.

Page 13: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

13

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Manage Multiple Alarms

1) Clear description of alarm

2) Recommended actions

3) Where to go for help

Page 14: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

14

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Customized Reporting

Page 15: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

15

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

Customized Reporting

Page 16: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

16

Market Leader in TOC AnalysisANATEL

HIACMET ONE

Global Innovator in Fluid Particle Applications

Leader in Airborne Particle Counting

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

Page 17: Market Leader in TOC Analysis ANATEL HIAC MET ONE Global Innovator in Fluid Particle Applications Leader in Airborne Particle Counting PharmSpec 3.0 HIAC

R&D: Partial Results Are Captured