HIAC 9703+ Pharmaceutical Particle Counter

The HIAC 9703+ liquid particle counter with capability to handle a full range of sample volumes (1 mL to >1000 mL pre-configured USP/EP/JP/KP test routines) can take on all your application requirements. With auto-flush routines and test recipe setup wizards, operators enjoy more walkaway operation with the HIAC 9703+.

  • PharmSpec software ensures efficient compliance for 21 CFR Part 11 environments
  • Automatic database backup & recovery loss feature protects valuable results data
  • Expert SOP & IQ/OQ validation services available

Documentation and Application Notes

HIAC 9703+ Liquid Particle Counter

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HIAC 9703+ Liquid Particle Counter Features

Applications

  • Small volume injectable (SVI)
  • Large volume injectable (LVI)
  • Research & development
  • Troubleshooting
  • Stability testing

Sample management

  • Instant particle contamination notification
  • Small vial holder preserves costly samples
  • Configurable flow rates & interchangeable sensors for 0.5 µm - 600 µm particle size detection
  • Interchangeable sample probes & syringes

Software

  • No manual calculation with pre-configured compendial test recipes (injectible drugs, ophthalmics, inhalants)
  • Multi-level security for 21 CFR Part 11 compliance
  • Automatic database backup & recovery loss feature protects valuable results data

Support

  • Expert SOP & IQ/OQ validation services available
  • Routine onsite service available for maximum uptime
  • ISO 21501 compliant calibrations
 

HIAC 9703+ Liquid Particle Counter Specifications

Industry Standards CE
Light Source Long Life laser diode with 10 year mean-time-to-failure
Particle Size Analysis Range 0.50|600.00|μm / 0.5|600|μm
Concentration Range 0.00|18,000.00|particles/mL
Item Specifications Referenced 2089105-01

Running a Sample

HIAC 9703+ Liquid Particle Counter Documentation

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Title Description
Quality Control Electronic Records for 21 CFR part 11 Compliance
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This paper describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.
Automating Biopharma Quality Control to Reduce Costs and Improve Data Integrity
{442DF88C-CA7F-4B78-AF75-9D2B985534C0}|{E588CF40-730C-4137-A5DC-8DDEAB7CF7D9}
This whitepaper takes a look at four common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst also saving time and reducing operating costs. The four quality control procedures discussed in this paper form a common thread in the biopharmaceutical manufacturing industry and are water quality testing, cleanroom routine environmental monitoring, biological cell counting and viability testing and final injectable drug particulate testing.
21 CFR Part 11 QC Instrument Suite
{279C6CA2-9797-4CFE-9CAA-5EAFAC29B60D}
This datasheet outlines QC steps, instruments, applications, regulations, and ALCOA compatibility.
Certified HIAC Calibration Services
{9E29D7A5-B5EC-470A-A5C1-4EF9BFAE9959}
ISO 11171 & 21501-3 calibration services for your HIAC liquid particle counter
Quality Control Testing Instrumentation Solutions for GMP Manufacturing
{A7DF4F56-8AF9-4BF1-88BE-766AB73FBC6B}
Raw Materials QC, Production QC, and Final Product QC product solutions
Automating Quality Control Testing for Improved 21 CFR Part 11 and ALCOA Data Integrity
{A0D0EF0B-43F2-431C-BEB0-69F98765BDC4}
Infographic showing manual to automated - how our QC Suite instruments help you comply with 21CFR part 11 ALCOA


Technical Documents