Transcript Slide 1

Introducing the new HIAC 9703+
and PharmSpec 3.0
HIAC just got easier!
ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
Effects of Particulate Contamination
• Focus has been on injectable liquids
– Possibility to block capillaries and arteries
• Red Blood cells are about 5 µm
• Capillary (5 to 10 µm)
• Large veins (10 to 50 µm)
– Threat of microbial infection
– Allergic reaction to foreign substances
Patent Pending
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
Easier, Faster and Confident Sampling
•
Use less sample, save valuable time protect your investment
– Small vial clamp ensures that sample
does not spill during testing
– Probe needle safety switch prevents
probe damage
– New small needle probe with industry’s
smallest tare volume
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Eliminate uncertainty from data
anomalies
– Bubble alarm notification
– Contamination alarm notification
– Advanced notification when service or
calibration is due
– Invalid configuration notification
ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
HIAC 9703+ Flexibility
• Interchangeable sampling probes, syringes,
and sensors
– Ensure you have one instrument to manage all
applications
– New MC05 sub-micron sensor
– Change configuration with no impact to instrument
validation
• Customized reporting
– Customize the number of reviewer’s and approver’s
for compendial test reports
– Add company logo, user defined descriptors
• Customized test recipes
– Procedure Builder enables the development of
unique test recipes for your application
– Copy a recipe and make the changes!
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
HIAC just got easier!
• Enjoy more walk away time
– Automated flushing and cleaning
routines
– Push a button, walk away and return to a
clean sensor
•
Export your data with ease
– Select one, multiple or all of your
historical data records with our batch
export utility.
– Select pdf, word, excel, or text files
•
Save time with electronic signature
– More strict interpretation of 21CFR Part
11 electronic signature process….
WITHOUT more manual inputs
– Remembers user Login ID
ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
Its the HIAC 9703 you know and trust –
only better!
• 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.
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
PharmSpec 3.0 improved too…
No change to your SOP
required if you reference any
of the following:
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Procedural tests
Run Counter tests
IST tests
Procedure Builder
Historical reporting
Activity Log
Data Storage
Hardware settings
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
Turn-key Validation/After Sale Service
Comprehensive local and on-site HIAC service programs throughout the world
•
Instrument Validation Services
– Utilize our expertise to get your
system ready-to-use
– IQ/OQ Validation Services
– SOP Migration Assistance
– Documented Validation
– ISO-21501-3 Compliant Calibration
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Avoid Costly Downtime
– No need to ship your instrument
– We notify you when it’s time for
routine service
ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
HIAC Just Got Easier – Top Ten
Features
Benefits
Industry’s smallest tare volume
Decrease production costs and save
$$$ using less sample.
Corrective action when data anomalies
occur – Bubbles and contaminated
sensor warnings.
Decrease guesswork and increase
production
Automated cleaning and flushing
routine
Increase walk away time
Interchangeable sensors, syringes and
sample probes
Change applications with no impact to
validation – one instrument will do it all!
Sample safety switch
No sample spills or bent probes
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting
HIAC Just Got Easier – Top Ten
Features
Benefits
Consistent, quality validation through
industry leading on-site service, SOP
consultation & IQ/OQ validation
Minimize your validation costs!
Avoid costly downtime and increase
laboratory through-put.
Pre-configured Compendial testing
from USP, EP, KP and JP
Ease of use, no manual calculations!
Compliance reporting documentation is
automated.
User configurable reports and testing
routines!
Customized reports and test recipes
that suite your application!
Upgraded software and instrument
Minimized and/or eliminated any
impact to your SOP’s
Invalid configuration and calibration due Ease-of-use. Ensure your system is
alarm convention
set up properly and maintenance ontime.
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ANATEL
HIAC
MET ONE
Market Leader in
TOC Analysis
Global Innovator in
Fluid Particle Applications
Leader in Airborne
Particle Counting