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
Applications
- 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
Software
- 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
Support
- Expert SOP & IQ/OQ validation services available
- Routine onsite service available for maximum uptime
- ISO 21501 compliant calibrations
HIAC 9703+ Liquid Particle Counter Specifications
| Software | PharmSpec 3 |
| Industry Standards | CE |
| Light Source | Long Life laser diode with 10 year mean-time-to-failure |
| Particle Size Analysis Range | 0.5 - 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 |