HIAC 9703+ Pharmaceutical Particle Counter

Accurate, Compliant Sub-Visible Particle Testing for Parenteral Drug Products

The HIAC 9703+ Particle Counter paired with PharmSpec Software, delivers precise liquid particle analysis for parenteral drug final product testing in compliance with USP <787>, USP <788>, USP <789>, and EP 2.9.19. Engineered with features that support ease of use, data integrity and compliance. This system ensures fast, repeatable testing of both protein-based drugs and traditional injectables.

Purpose-Built for Parenteral Product Testing

Whether you're testing low-volume vaccines or high-viscosity biologics, the HIAC 9703+ with PharmSpec Software offers the precision, compliance, and efficiency your lab demands.

Key Features

  • Regulatory Compliant Testing Supports light obscuration methods in compliance with USP 787, USP 788, USP789, and EP 2.9.19 standards.
  • Custom Vial Clamp and Probe Design Small-bore sampling probe and secure vial clamp ensure proper handling of delicate samples, including protein-based drug products like vaccines.
  • PharmSpec Software Supporting 21 CFR Part 11 Compliance Features ALCOA-compliant data handling, and customizable SOPs via Procedure Builder.
  • Automated Compendial Reporting Built-in pass/fail test routines generate compliant reports instantly.
  • Comprehensive Audit Trail Full traceability with secure, timestamped records for all system actions and data changes.
  • Flexible Calibration & Sampling Multi-flow rate calibration accommodates varying viscosities and sample volumes.
  • Auto-Flush Routines Reduces cross-contamination and enables walkaway operation with less manual intervention.

Benefits

  • Ensure Regulatory Readiness Confidence in compliance with global pharmacopeial requirements for sub-visible particle testing.
  • Simplify Data Integrity Compliance Supports 21 CFR Part 11 compliance and ALCOA principles with user authentication, access control, and secure, encrypted data storage.
  • Streamline Lab Workflows Automated testing routines, built-in SOPs, and walkaway functionality minimize operator workload.
  • Improve Test Accuracy Across Sample Types Flexible calibration and specialized probe design deliver consistent results for a wide range of parenteral formulations.
  • Enhanced Data Security & Backup Options Secure database architecture with periodic backup capabilities.

Explore the full potential of the HIAC 9703+ Pharmaceutical Particle Counter:

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HIAC 9703+ 实验室液体颗粒计数器

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Content and Resources

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Resource Type
Changes to USP <1788> Subvisible Particulate Matter
HIAC 9703+ Sub-Visible Particulate Testing Light Obscuration Testing to USP&lt;787&gt;, &lt;788&gt; and EP 2.9.19
Achieving Compliant Batch Release – Sterile Parenteral Quality Control This paper describes common QC instrumentation compliance elements and gives examples of best practice for instruments used for compliant QC batch release.
Quality Control Electronic Records for 21 CFR part 11 Compliance 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 This paper 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.

Technical Documents

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