HIAC 9703+ Pharmaceutical Particle Counter

HIAC 9703+ liquid sampler and PharmSpec Software for Parenteral Drug Final Product Testing to USP<787>, <788> & EP2.9.19

PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub-visible particle content using light obscuration in accordance with USP<787>, <788> and EP 2.9.19. Flexible calibration at multiple flow rates improves ease of sampling for varying sample viscosities and volumes. Ease of use and data integrity are prioritized in PharmSpec with features such as login credentials controlled by Microsoft Active Directory, multi-level user rights, automated pass/fail compendial reporting, comprehensive audit trail, and auto-flush routines for improved walkaway operation. In addition to the built-in compendial test routines, user-defined SOPs can be programmed into the counter using PharmSpec Software’s Procedure Builder.

  • PharmSpec software is 21 CFR Part 11 ALCOA compliant
  • Secure database is either sited on the local pc operating the HIAC 9703 sampler, or sited remotely on a networked server
  • Periodic database backup can be selected for additional database security
  • Specially designed vial clamp holds sample in place and small-bore sampling probe enables full application of USP<787> for protein based drug products, such as vaccines

Additional Resources

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HIAC 9703+ Liquid Particle Counter Features


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

Sample management

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


  • Program custom SOPs to eliminate manual counter configuration and pass/fail calculations
  • Multi-level security for 21 CFR Part 11 compliance
  • Automatic database backup & recovery loss feature protects valuable results and data


  • 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 1.2 - 600 μm
Concentration Range 0 to 18000 particles/mL
Operating System Windows® 10
Software PharmSpec 3
Temperature Range Operating temp range: 5°C to 40°C
Item Specifications Referenced 2089105-01

Running a Sample


Content and Resources

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Resource Type
【アプリケーションノート】FDA 21CFR Part11のデータインテグリティ要件とALCOA原則と品質管理試験の自動化 ベックマン・コールターの品質管理に関わる測定器は、 どのようにお客様の21CFR Part11 ALCOAコンプライアンスに貢献するのかご紹介いたします。
【アプリケーションノート】USP<1788>Subvisible Particulate Matterの変更 USP<1788>Subvisible Particulate Matterの変更内容について解説いたします。

Technical Documents

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