Agilent Technologies 280-DS Operator's Manual page 10

2 Introduction
The 280-DS Mechanical Qualification System (MQS) is a device which measures
the critical physical parameters of a dissolution apparatus. A Windows®-based
software interface captures data from and communicates through USB with two
independent modules that comprise the physical part of the device. A hand-held
temperature probe is included as an additional accessory.
The 280-DS MQS is capable of measuring the following parameters on a 1-liter
dissolution apparatus: vessel plate level and vibration, bath or vessel
temperatures, paddle or basket height, spindle shaft centering, spindle shaft
verticality, spindle shaft wobble, spindle shaft speed (RPM), vessel verticality, and
basket rim wobble.
The software interface, which is designed to run on Microsoft Windows 7 or 10
(32-bit and 64-bit), implements controls for the Electronic Records and Electronic
Signatures Rule (21 CFR Part 11) established by the FDA. The interface also
supports the mechanical qualification tests required by the ASTM, USP, Chinese
Pharmacoepeoia and US FDA standards bodies for USP Apparatus 1 (Basket)
and 2 (Paddle) dissolution apparatus.
10 280-DS Operator's Manual