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
- As recommended in USP<788> and <787> the HIAC 9703+
sampler is specifically designed for use in a HEPA-filtered laminar
airflow cabinet to reduce risk of contamination