HIAC 9703+ Sub-Visible Particulate Testing
Light Obscuration Testing to USP<787>, <788> and EP 2.9.19
PharmSpec Software
Program 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
| PART NUMBER | DESCRIPTION |
|---|---|
| 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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