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280-DS Mechanical Qualification System Brochure

280-DS Mechanical Qualification System Brochure
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280-DS Mechanical Qualification System Brochure - 1

Agilent 280-DS Mechanical Qualification System REDEFINE DISSOLUTION

280-DS Mechanical Qualification System Brochure - 2

SIMPLIFY MECHANICAL QUALIFICATION Maximize Laboratory Efficiency and Data Integrity The Agilent 280-DS Mechanical Qualification System (MQS) will change your perspective on dissolution qualification. Using the 280-DS’s two devices – an Instrument Module (IM) and a Vessel Module (VM) – all critical physical parameters of the dissolution apparatus are verified with unprecedented simplicity. The modules are powered by the intuitive Agilent 280-DS Workstation Software that steps the user through each measurement with easy-to-follow directions. Consolidation of measurement devices backed by a...

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280-DS Mechanical Qualification System Brochure - 3

The 280-DS Instrument Module positioned on the vessel plate to measure level (X and Y axes) and vibration (X, Y and Z axes). The 280-DS Vessel Module can be utilized on any open-head dissolution apparatus, but has distinct advantages when used with an Agilent model such as the 708-DS. The 280-DS Instrument Module measures: The Instrument and Vessel Modules are all that is necessary to perform any required measurement during mechanical qualification of your dissolution apparatus. • Vessel plate level The 280-DS Vessel Module measures: • Spindle speed (RPM) • Shaft and basket wobble • Shaft...

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280-DS Mechanical Qualification System Brochure - 4

The New Standard for Dissolution Qualification The innovative design of the 280-DS modules provide accurate and repeatable measurements with limited hands-on interaction required. These images illustrate the position of the various sensors included in each module. 280-DS Instrument Module Temperature Probe Plug-In Vessel Plate Level and Vibration Sensors 280-DS Vessel Module Basket Wobble Sensor Vessel Verticality Sensor Height Lever RPM Sensor Vessel Centering Sensors (Upper) Vessel Diameter Arm Vessel Module Plug-In Vessel Centering Sensors (Lower) USB Plug-In Height Arm

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280-DS Mechanical Qualification System Brochure - 5

Leading the Mechanical Qualification Revolution The Agilent 280-DS is the latest tool of its kind. Whether it be efficiency, data integrity or everyday verifications, this tool provides instant value to every dissolution laboratory. 280-DS Hardware Highlights No more calibration of individual measurement gauges. The 280-DS replaces all of the individual tools you’re currently using to verify physical parameters. Now you can conveniently return the all-in-one system to an Agilent calibration center for a complete and traceable certification. Reduce your qualification time by as much as 50%!...

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280-DS Mechanical Qualification System Brochure - 6

ENHANCED COMPLIANCE AND CAPABILITIES Designed to Meet Current Regulations and Improve Failure Investigations The 280-DS Workstation Software is an integral part of this measurement system and serves to separate the 280-DS even further from its predecessors. The software naturally progresses the user through a customized series of measurements in a 21 CFR Part 11 compatible environment. All relevant information about the dissolution apparatus and measurement gauges is conveniently stored and visible on the final report. • Configuration files maintain all relevant apparatus data including...

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280-DS Mechanical Qualification System Brochure - 7

Advanced Software Capabilities • Inspect individual position measurements using the data trending feature. • Select specific positions to be tested for quick investigations. Step-by-Step Mechanical Qualification with the 280-DS Workstation Software. • Record exact orientation of vessel within the data file. • Filter past reports using various criteria including dates, operator, apparatus, and so on. • Conveniently monitor system and/or method changes with built-in audit trail reports. 2 Select apparatus and test method from previously created and securely stored files. 3 Execute test...

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280-DS Mechanical Qualification System Brochure - 8

280-DS Workstation Software Highlights Current regulatory methods are preloaded for quick setup traditional parameters and tolerances as well as the flexibility to create a custom protocol to meet your laboratory's requirements. Revisions to the software are easily managed meaning the 280-DS will always be up to date. Easily search and retrieve data files from a secure database. Records for every 280-DS test can be viewed using various filtering criteria to simplify report recovery. Complete reports can be searched by serial number, operator and date just to name a few. Intuitive,...

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280-DS Mechanical Qualification System Brochure - 9

Apparatus Qualification? The ongoing debate concerning the best method for periodic qualification of dissolution apparatus continues to attract attention. While the USP endorses enhanced mechanical qualification, in addition to the Prednisone acceptance test, the enhanced mechanical calibration procedure, prescribed guidance's from ICH and FIP-continues to gain acceptance throughout the dissolution industry. Regardless of which procedure is performed in your laboratory, the Agilent 280-DS can be utilized productively to verify the critical physical parameters of your dissolution apparatus....

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280-DS Mechanical Qualification System Brochure - 10

UNIVERSAL QUALIFICATION SOLUTION Recognize Cost Savings and Maximize Efficiency Curious to see just how much you could save by incorporating the 280-DS Mechanical Qualification System into your laboratory’s dissolution qualification repertoire? See the following table for some examples and then visit Agilent’s 280-DS webpage to perform your own savings estimate: www.agilent.com/lifesciences/ 280-DS_calculator Combine this savings with qualification frequency flexibility and added dissolution data integrity, and you’re sure to be rewarded. USP PVT (PQ) - Single Stage USP PVT (PQ) - Two Stage...

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280-DS Mechanical Qualification System Brochure - 11

Agilent's Dissolution Compliance Services Agilent Support Services offer a flexible menu of comprehensive services to help you maximize your uptime and enhance your productivity. Our dedicated, worldwide network of specialists can assist with installation, training and ongoing support, while simultaneously providing the balance between your current needs and future requirements. Agilent streamlines compliance procedures across your entire enterprise to save you time and money with a solution that's compatible with instruments from all leading vendors. Support Services Use Agilent Analytical...

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