HIAC 9703+ Sub-Visible Particulate Testing

Light Obscuration Testing to USP<787>, <788> and EP 2.9.19

PharmSpec Software

HIAC liquid particle counter 9703 PlusProgram your SOPs into the counter

Eliminate manual counter configuration and pass/fail calculations by using Procedure Builder to program your own SOPs into the counter so that they are available for the technician via a drop-down selection box.

21 CFR Part 11 ALCOA Data Accuracy and Integrity

  • User Name and Password credentials are controlled by your corporate IT Microsoft Active Directory
  • Multi-level user rights
  • Licensed software modules available to automate pass/fail compendial reporting:
    • USP<787>
    • USP<788>
    • EP 2.9.19
    • JP 11
    • JP 24
    • KP 52
  • Sample result records include the technician’s name, batch number, test result data, pass/fail result and SOP used for the test
  • Review and Approve workflow with electronic signature to create secure electronic records straight from the counter
  • Comprehensive Audit Trail included

Secure database

  • You can choose to locate the database on a separate, secure networked location and the HIAC 9703+ liquid particle counter will automatically save all records to that server across the Ethernet network
  • Alternatively, you can choose to configure the 9703+ to periodically automatically back-up the database to a secure network location

Flexible sampling options

  • The light obscuration sensor can be calibrated at multiple different flow rates to make sampling easier for large volume injectables/infusions testing as well as viscous fluids
  • Alternatively, you can choose to configure the 9703+ to periodically automatically back-up the database to a secure network location

Use in laminar airflow cabinets

  • Design allows HEPA filtered airflow from cabinet to pass over the top of the glassware/vial to help reduce the risk of sample particulate contamination from the air, reducing the possibility of false-positive results

Typical instrument configuration

2089105-01 HIAC 9703+ sampler
2089250-150 Light Obscuration sensor
2086804-01 PharmSpec 3 software CD
700060GP PharmSpec 3 software licence key
700057 USP Compendial Tests
700058 EP Compendial Tests
700055 SOP Procedure Builder software
2089007-025 Calibration @25mL/minute flow rate including certificate
DOC026.53.80099 IQ/OQ Validation document set on CD

USP<787> Therapeutic Protein Injections

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Small tare volume option of just 0.091mL allows you to get results to USP<787> with product sample volumes of just 0.2mL

Small vial clamp for conical vials

Small vial clamp option holds conical vials in line with the sampling probe and upright for automated sampling

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