HIAC 9703+ Pharmaceutical Particle Counters

Description

The HIAC 9703+ is a liquid particle counter system from Beckman Coulter Life Sciences, configured for pharmaceutical final product testing. It is designed to measure sub-visible particles in parenteral drugs in compliance with standards such as USP <787>, <788>, and EP 2.9.19. The system detects particles within a size range of 0.5 to 600 micrometers. It operates with the accompanying PharmSpec 3 software, which manages test routines, data integrity, and user security. The software supports features including login credential management via Microsoft Active Directory, multi-level user rights, automated pass/fail reporting, and a comprehensive audit trail to meet 21 CFR Part 11 requirements. The physical sampler unit has dimensions of 34.3 cm wide by 33.7 cm deep by 48.2 cm high. Operational flexibility is provided through configurable flow rates to accommodate samples of different viscosities and a specially designed vial clamp and small-bore sampling probe for testing protein-based products like vaccines. The system also allows for the programming of user-defined standard operating procedures and includes features for database security and automated flushing routines.