HIAC 9703+ Pharmaceutical Particle Counters
- 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
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