HIAC 9703+ Pharmaceutical Particle Counter

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

Paired with PharmSpec Software, this instrument delivers precise liquid particle analysis for parenteral drug final product testing in compliance with:

  • USP <787>
  • USP <788>
  • USP <789>
  • EP 2.9.19

Engineered with features that support ease of use, data integrity and compliance, this system ensures fast, repeatable testing of protein-based drugs and traditional injectables. Whether you're testing low-volume vaccines or high-viscosity biologics, the HIAC 9703+ instrument and PharmSpec Software offer the precision, compliance and efficiency your lab demands.

Benefits

  • Supports light obscuration methods in compliance with applicable standards
  • Improves test accuracy across sample types
  • Streamlines workflows & minimizes operator workload via: Automated testing routines, built-in SOPs, walkaway functionality
  • PharmSpec Software supports 21 CFR Part 11 compliance & ALCOA principles with: User authentication, access control, secure, encrypted data storage
  • Provides enhanced data security & backup options via secure database architecture

Key Features

  • Flexible calibration and specialized probe design deliver consistent results for a wide range of parenteral formulations
  • Small-bore sampling probe & secure vial clamp ensure proper handling of delicate samples, including protein-based drug products (e.g., vaccines).
  • Built-in pass/fail test routines generate compliant reports instantly & automatically.
  • Full audit trail traceability with secure, timestamped records for all system actions & data changes.
  • Auto-flush routines reduce cross-contamination and enable walkaway operation with less manual intervention.

Explore HIAC 9703 Plus Models

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Content and Resources

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Resource Type
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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