Mechanical Qualification System for Dissolution Testing

15 May 2012
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Agilent Technologies Inc. has introduced the 280-DS Mechanical Qualification System, a new instrument for routine calibration of dissolution apparatus. The 280-DS accurately measures, verifies and documents physical parameters established with recently enhanced mechanical qualification standards, eliminating the need for visual interpretation of measurements from manual gauges.

Dissolution is a technique used in the pharmaceutical industry to determine the rate at which active pharmaceutical ingredients release from solid dosage forms such as tablets and capsules. The 280-DS Mechanical Qualification System, with its 280-DS Workstation Software, redefines dissolution qualification with optical-sensing technology that delivers virtually hands-free measurements in seconds.

“Pharmaceutical customers now have one instrument that supports whichever type of qualification their dissolution laboratory requires,” said Allan Little, Agilent director of marketing for dissolution systems. “The 280-DS precisely measures the critical parameters required for qualification in a fraction of the time it used to take. Efficiency, time savings, accuracy, and documentation are all realized with this instrument.”

The 280-DS Mechanical Qualification System supports traditional and enhanced qualification methods to meet current Good Manufacturing Practices (cGMP). Whether the laboratory uses the U.S. Pharmacopeia’s Performance Verification Test (PVT) or the U.S. Food and Drug Administration and American Society for Testing and Materials (ASTM) Enhanced Mechanical Qualification standards, the 280-DS offers unprecedented measurement capabilities.

The 280-DS enables users to:

• Qualify any dissolution apparatus that has an open-head design, including Agilent’s 708-DS and 709-DS.
• Obtain accurate, precise and repeatable measurements with limited hands-on interaction using optical sensors and the 280-DS Workstation Software.
• Determine quantitative values for each parameter with data recorded and stored in 21 CFR Part 11-compliant software.
• Track physical performance data of the dissolution apparatus over time in order to maintain the apparatus in top mechanical condition.

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