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Instruments

HIAC 9703+

HIAC 9703+ liquid particle counters are the leader in Pharmaceutical USP <788> quality control and research applications. Designed for your liquid particle counting application needs, the HIAC 9703+ is highly configurable and easy to use. PharmSpec software makes data management easy and assures security for 21 CFR Part 11 environments. Easy. Accurate. HIAC.

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Benefits

Industry’s smallest samples
Perform a full suite of tests with just 1mL of product.

Manages all your application needs
Handle a full range of sample volumes from1 mL to >1000 mL Pre-configured USP, EP, JP, and KP test routines.

Eliminate uncertainty from data
Alarm notification when bubbles and/or sensor contamination has impacted particle counting results.

Secure sample handling
Small vial holder ensures no expensive sample gets wasted.

Easily configurable for maximum flexibility
Select a preferred flow rate and utilize interchangeable sensors from 0.5 to 600µm particle size detection.

Avoid costly down time
On-site service significantly reduces down time - no shipping of your unit required. Automated notification when your unit is in need of routine service.

Eliminate anxiety of data loss
Data loss recovery feature protects the results in the event of a power interruption or loss. Automatic database backup to a secure network location via PharmSpec.

HIAC Particle Counting Instrument Validation Services
SOP assistance and IQ/OQ validation services Utilize HIAC expertise to get your system out of the box and commissioned.

Applications

USP <788> Particulate Matter in Injections and Parenteral Infusions

  • HIAC 9703+ Liquid Particle Counting System
  • HIAC PharmSpec Liquid Particle Counting Software
  • HIAC HRLD Liquid Particle Counting Sensors
  • HIAC MC05 Liquid Particle Counting Sensor (sub-micron)

USP <789> Particulate Matter in Ophthalmic Solutions

  • HIAC 9703+ Liquid Particle Counting System
  • HIAC PharmSpec Liquid Particle Counting Software
  • HIAC HRLD Liquid Particle Counting Sensors
  • HIAC MC05 Liquid Particle Counting Sensor (sub-micron)

USP <797> Pharmaceutical Compounding - Sterile Preparations

  • HIAC 9703+ Liquid Particle Counting System
  • HIAC PharmSpec Liquid Particle Counting Software
  • HIAC HRLD Liquid Particle Counting Sensors
  • HIAC MC05 Liquid Particle Counting Sensor (sub-micron)

Liquid Particle Counting Release Test Standards

  • USP <788> Particulate Matter in Injections and Parenteral Infusions
  • USP <789> Particulate Matter in Ophthalmic Solutions
  • USP <7897> Pharmaceutical Compounding - Sterile Preparations
  • www.uspnf.com
  • www.usp.org

Parenteral Drug Association

European Directorate for the Quality of Medicines & Healthcare

Accessories

Included

Part Number Description
90450001 Vial sampler probe, 0.063” O.D. X 5.88” long stainless steel
90620008 Vial sampler probe, 0.25” O.D. x 5.88” long Stainless steel
90630002 Nut, for securing vial sampler probes to the sensor
089208-01 Drain tube assembly
230-300-7052 Power Supply, +24 VDC @ 3A
VP623500 Universal EU Power Cord, AC, 6’ long,  230V
VP623501 US Power Cord, AC, 6' long, 115V
460-400-4799 USB Cable 2.0 Pro Series hi-speed
600-100-0003 Magnetic Stirrer Bar, Teflon coated
690-300-4808 Syringe, 10mL XLP style
808-010-200 O-ring Viton, 2-010 for use on sensor fittings, 2 each
680-000-0030 Allen Wrench, 1.5mm
DOC026.97.80097 9703+ User’s manual
 

Optional

Part Number Description
2089006-01 Small vial sampling kit Includes: P/N 2089099-01, Vial clamp assembly P/N 90450004, Vial sampler probe 0.063” x 3” long P/N 690-300-4805, Syringe, 1 mL XLP style
2089099-01 Vial clamp assembly
90450004 Vial sampler probe 0.063” x 3” long
690-300-4805 Syringe, 1 mL XLP style
690-300-4809 Syringe, 25 mL XLP style
FACTORY_CAL_USP_PRE USP Factory calibration per USP <1788>
2089290-01 HRLD Sensor Holder assembly
2089291-01 MC-05 Sensor Holder assembly
2089179-01 Cable Assembly, HRLD to 9703 Plus

Specifications

HIAC 9703+ Liquid Particle Counter

Spec Value
Weight 10.7 kg (23.6 lbs)
Dimensions 343mm W X 337mm D X 482mm H  (13.5 X 13.3 X 19.0 inches)
Operating Temperature 5 to 40°C (40 to 104°F) 0 to 80% relative humidity, non-condensing
Sample Temperature 5 to 40°C (40 to 104°F)
Power 100/230 VAC, 50/60 Hz, 67 W at 115/230 VAC
Viscosity Limit <50 cP
Sample Bottle Clearance 153 mm (6.02 inches)
Volume Accuracy > 95%
Flow Rate Accuracy > 95%
Sample Flow Rate 10 to 100 ml/min; Actual flow rate for the system is determined by the sensor’s flow rate with step-by-step instructions and Pass/Fail results.
Tare Volumes for Probes 0.091 ml for 81 L x 1.2 mm I.D (3.2 x 0.047 inches) 0.172 ml for 154 L x 1.2 mm I.D. (6.1 x 0.047 inches) 1.57 ml for 140 L x 6.35 mm I.D. (5.5 x 0.25 inches) – large bore

   

PharmSpec 3 Software

Spec Value
Processor Pentium® 1.0 GHz
Operating System Windows® XP with Service Pack 3 or later Windows Vista® with Service Pack 2 or later Windows 7 (32 bit)
Memory 512 MB of RAM
Hard Disk 2 GB of available hard-disk space
Drives CD drive, DVD drive, USB port or network connection is required for installation
Display Super VGA video adapter and monitor,1024 x 768 or higher resolution
Power Supply Uninterrupted power supply (UPS)
Removable Drive Removable drive for backing up data, such as a recordable CD or a network server that can back up the computer hard drive
Printer Color printer capable of printing at 300 dpi
COM Port USB port to connect to the particle counting system
Software Internet Explorer 6.0 or higher and Microsoft® Excel®, Word® or Adobe® Acrobat® (to access PharmSpec reports)

Training Courses

File/Info Title Ref. Number
HIAC 9703+ with PharmSpec Operator Training

Webinars & Symposiums

  • Optimizing Quality Control Electronic Records for 21 CFR Part 11 Compliance

    Tony Harrison Senior Marketing Manager, Beckman Coulter

    Click to play  

    The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results...

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