PharmSpec is a Microsoft® Windows® application that is used with the HRLD Light Obscuration sensors and the HIAC 9703+ sampler. PharmSpec collects and analyzes raw data from the liquid particle counting sensors using the USP, EP, JP or KP procedural standards, or user-defined test procedures.

PharmSpec 3.6 Supports

• Windows®11 Professional, 64-bit
• Windows®11 Enterprise, 64-bit
• Windows®Server 2022 Standard, 64-bit
• Windows®10 Professional, 64-bit

Key Features Include:

Supports compliance with 21 CFR Part 11 requirements & ALCOA principles

• Multi-level user rights with user authentication and access control
• Review/approval workflows with electronic signature
• Comprehensive audit trail ensuring full traceability with secure, timestamped records for all system actions and data changes
• Secure, encrypted data storage ensuring integrity of original data
• Enhanced data security and backup options with client/server installation and periodic backup capabilities

Streamlined Lab Workflows

Supports compliance with light obscuration methods as described in:

• USP <787>
• USP <788>
• USP <789>
• Ph. Eur. 2.9.19
• JP
• KP
• ChP

Licensed software modules available to automate pass/fail compendial reporting

Licensed Procedure Builder to create your own SOPs with automated Pass/Fail calculations

Alarm notifications

• Bubble detection
• Sensor contamination
• Invalid configuration
• Sensor calibration due
• Sensor calibration expired

Language Support

• English
• French
• German
• Italian
• Japanese

PharmSpec Software Versions Available for Download

• PharmSpec Latest Compendial Tests USP 42 787 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 42 787 specification. This update is ONLY VALID for PharmSpec V3.3 or newer.
• PharmSpec Latest Compendial Tests USP 43 787 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 43 787 specification. This update is ONLY VALID for PharmSpec V3.3 or newer.
• PharmSpec USP 787 System Suitability Test (zip) – This file contains a compendial test to meet the criteria defined in the USP 42 787 specification. This update is ONLY VALID for PharmSpec V3.3 or newer.
• PharmSpec Latest Compendial Tests USP 42 788 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 42 788 specification.
• PharmSpec Latest Compendial Tests USP 43 788 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 43 788 specification.
• PharmSpec Latest Compendial Tests USP 42 789 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 42 789 specification.
• PharmSpec Latest Compendial Tests USP 43 789 (zip) - This zip file contains compendial tests to meet the criteria defined in the USP 43 789 specification.
• PharmSpec Latest Compendial Tests JP XVI (zip) - This zip file contains compendial tests to meet the criteria defined in the JP XVI specification.
• PharmSpec Latest Compendial Tests JP 17 (zip) - This zip file contains compendial tests to meet the criteria defined in the JP XVII specification.
• PharmSpec Latest Compendial Tests EP 9 (zip) -  This zip file contains compendial tests to meet the criteria defined in the EP 9 specification.
• PharmSpec Latest Compendial Tests EP 10 (zip) -  This zip file contains compendial tests to meet the criteria defined in the EP 10 specification.
PharmSpec Latest Compendial Tests KP11 (zip) - This zip file contains compendial tests to meet the criteria defined in the KP11 specification.
• PharmSpec V3.1.4 Update (zip) - An update for PharmSpec V3.1.1, V3.1.2 and V3.1.3.  This update fixes a bug that causes the Run Counter, Procedural, and IST tests to timeout early under certain, non-typical settings.
• PharmSpec V3.1x (zip) - Language only updates to support German and Japanese. This update is ONLY VALID for PharmSpec V3.1.0 – V3.1.4