Methods are the "recipes" for your particle counting. PharmSpec 3 comes pre-loaded with standard compendial methods, including:
Once a test is complete, the software automatically compares results against the pass/fail criteria defined in the Method.
is a critical software package designed for the pharmaceutical industry, specifically developed to work with HIAC particle counters. It provides a robust environment for particle counting, data analysis, and reporting while ensuring strict compliance with regulatory standards like 21 CFR Part 11 . pharmspec 3 software user manual
PharmSpec 3 uses a secure database to store all test results. During installation, you will define the database location—ensure this is on a backed-up server if you are in a high-volume environment.
Run a "Blank" (filtered DI water) to ensure the system background count is near zero. Methods are the "recipes" for your particle counting
Usually caused by a loose USB or Serial connection. Restart the "Sampler Service" in the Windows Task Manager if the software fails to "see" the hardware. Summary Table: Quick Reference Navigation Path Audit Trail Security > View Audit Trail Reviewing historical changes for compliance. Method Editor Setup > Method Configuration Creating custom test parameters. Calibration Tools > Sensor Calibration Ensuring particle sizing accuracy. User Access Security > User Accounts Managing permissions and logins.
Choose your desired Method from the dropdown menu. It provides a robust environment for particle counting,
Always enable the "Audit Trail" feature. This logs every action—from login attempts to parameter changes—creating a permanent record for inspectors. 3. Creating and Managing Test Methods
Whether you are a lab technician or a quality assurance manager, understanding the core functionalities of PharmSpec 3 is essential for maintaining data integrity and operational efficiency. 1. Getting Started: Installation and Setup