mechanical qualification guide - agilent€¦ · components should be lubricated, belts checked for...
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Accessories can change in form with use. Thus, a critical element of MQ is inspecting the integrity of the dissolution instrument and its accessories prior to starting a test.
This information is subject to change without notice.© Agilent Technologies, Inc. 2012Printed in U.S.A., October 30, 20125991-1451EN
•Vesselexamination/orientation•Paddleexamination•Basket/basketshaftexamination
•Measurementofinitialvesseltemperatures•Evaluationofvibration•Ensurewaterbathisclean
PreventativeMaintenanceshouldbeperformedevery6months.Theappropriateinternalcomponentsshouldbelubricated,beltscheckedforwear,andallelectricalconnectionsinspected.
Questions?Contactusforcompletemethoddevelopment,regulatoryguidanceandinstrument-related support at [email protected]
FormoreinformationonAgilentDissolutionSystemsproductsandcomprehensiveserviceandsupportoptions,visitwww.agilent.com/lifesciences/dissolution
Mechanical Qualification Guide
Dissolution Mechanical Qualification Specifications and Tolerances
ParameterICH Harmonized (USP, JP, EP) FDA DPA-LOP.002 ASTM E2503-07
USP Toolkit Ver 2.0
Basketandpaddle depth
25 ± 2 mm 25 ± 2 mm 25 ± 2 mm (or <8%)
23-27 mm
Rotational speed
± 4% of specified rate
± 2 rpm of target ± 2 rpm or within 2% of target (larger)
± 1 rpm of target
Shaftwobble No significant wobble
≤ 1.0 mm total runout
≤ 1.0 mm total runout
≤ 1.0 mm total wobble
Shaftverticality Not measured ≤0.5°fromvertical Withinbubble Not measured
Basketwobble ± 1 mm ≤ 1.0 mm total runout
≤ 1.0 mm total runout
≤ 1.0 mm total wobble
Vessel/shaftcentering
NMT 2 mm from centeraxis
≤ 1.0 mm from center line
≤ 1.0 mm from center line
NMT 2.0 mm difference (4-90°positions)
Vesselverticality Not measured ≤1.0°fromvertical(2 - 90° positions)
≤1.0°fromvertical(2 - 90° positions)
NMT 0.5° from vertical
Vesselplatelevel
Not measured Not measured Not measured NMT 0.5° from horizontal
PerformanceVerification
USPPrednisone TabletsRS
Not measured Not measured USPPrednisone TabletsRS
Accessory Inspection
Vessel Measurement
Measurement Capabilities
Pre-run Checklist
Preventive Maintenance Recommendation
Dissolution Hotline
Contact Us
Acceptable Accessory Photos
Unacceptable Accessory Photos
VesselCentering
VesselVerticality(xandyaxis)
ShaftVerticality(xandyaxis)RPM(anylocation)
ShaftWobble
Basket/paddleDepth
Basket Wobble and Vessel Plate Level Not Shown
Temperature ProbePlug-In
VesselPlateLevelandVibrationSensors
VesselVerticalitySensor
BasketWobbleSensor
HeightLever
RPMSensor
VesselDiameter
Arm
Height Arm
USBPlug-In
VesselModulePlug-In
VesselCentering Sensors (Upper)
VesselCentering Sensors (Lower)
New stainless paddle
Rusted stainless steel paddle
Badlydamaged PTFE-coatedpaddle
NewPTFE- coated paddle
Slightlyworn-PTFEpaddle
DamagedPTFE-coatedpaddle
New stainless steelbasket
Bentstainlesssteelbasket
Damaged stainless steelbasketseam
New stainless steel basketshaft
Basketshaftwithbentprongs
O-ring stainless steel basketshaft
280-DS Instrument Module 280-DS Vessel Module