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Introducing the new HIAC 9703+ and PharmSpec 3.0. HIAC just got easier!. 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) - PowerPoint PPT Presentation
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Market Leader in TOC AnalysisANATEL
HIACMET ONE
Global Innovator in Fluid Particle Applications
Leader in Airborne Particle Counting
Introducing the new HIAC 9703+ and PharmSpec 3.0
HIAC just got easier!
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
3
Market Leader in TOC AnalysisANATEL
HIACMET ONE
Global Innovator in Fluid Particle Applications
Leader in Airborne Particle Counting
Patent Pending
Market Leader in TOC AnalysisANATEL
HIACMET ONE
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
• Eliminate uncertainty from data anomalies– Bubble alarm notification
– Contamination alarm notification
– Advanced notification when service or calibration is due
– Invalid configuration notification
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Market Leader in TOC AnalysisANATEL
HIACMET ONE
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!
Market Leader in TOC AnalysisANATEL
HIACMET ONE
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
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Market Leader in TOC AnalysisANATEL
HIACMET ONE
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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Market Leader in TOC AnalysisANATEL
HIACMET ONE
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:– Procedural tests– Run Counter tests– IST tests– Procedure Builder – Historical reporting– Activity Log– Data Storage– Hardware settings
Market Leader in TOC AnalysisANATEL
HIACMET ONE
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
• Avoid Costly Downtime– No need to ship your instrument– We notify you when it’s time for
routine service
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Market Leader in TOC AnalysisANATEL
HIACMET ONE
Global Innovator in Fluid Particle Applications
Leader in Airborne Particle Counting
HIAC Just Got Easier – Top Ten
Features BenefitsIndustry’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
11
Market Leader in TOC AnalysisANATEL
HIACMET ONE
Global Innovator in Fluid Particle Applications
Leader in Airborne Particle Counting
Features BenefitsConsistent, 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 alarm convention
Ease-of-use. Ensure your system is set up properly and maintenance on-time.
HIAC Just Got Easier – Top Ten
