Introducing the new HIAC and PharmSpec 3.0

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Presentation transcript:

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

Patent Pending

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

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!

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

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.

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

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

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

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 alarm convention Ease-of-use. Ensure your system is set up properly and maintenance on-time.