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. 2012 Printed in U.S.A., October 30, 2012 5991-1451EN • Vessel examination/orientation • Paddle examination • Basket/basket shaft examination • Measurement of initial vessel temperatures • Evaluation of vibration • Ensure water bath is clean Preventative Maintenance should be performed every 6 months. The appropriate internal components should be lubricated, belts checked for wear, and all electrical connections inspected. Questions? Contact us for complete method development, regulatory guidance and instrument-related support at [email protected] For more information on Agilent Dissolution Systems products and comprehensive service and support options, visit www.agilent.com/lifesciences/dissolution Mechanical Qualification Guide Dissolution Mechanical Qualification Specifications and Tolerances Parameter ICH Harmonized (USP, JP, EP) FDA DPA-LOP.002 ASTM E2503-07 USP Toolkit Ver 2.0 Basket and paddle 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 Shaft wobble No significant wobble ≤ 1.0 mm total runout ≤ 1.0 mm total runout ≤ 1.0 mm total wobble Shaft verticality Not measured ≤ 0.5° from vertical Within bubble Not measured Basket wobble ± 1 mm ≤ 1.0 mm total runout ≤ 1.0 mm total runout ≤ 1.0 mm total wobble Vessel/ shaft centering NMT 2 mm from center axis ≤ 1.0 mm from center line ≤ 1.0 mm from center line NMT 2.0 mm difference (4-90°positions) Vessel verticality Not measured ≤ 1.0° from vertical (2 - 90° positions) ≤ 1.0° from vertical (2 - 90° positions) NMT 0.5° from vertical Vessel plate level Not measured Not measured Not measured NMT 0.5° from horizontal Performance Verification USP Prednisone Tablets RS Not measured Not measured USP Prednisone Tablets RS Accessory Inspection Vessel Measurement Measurement Capabilities Pre-run Checklist Preventive Maintenance Recommendation Dissolution Hotline Contact Us Acceptable Accessory Photos Unacceptable Accessory Photos Vessel Centering Vessel Verticality (x and y axis) Shaft Verticality (x and y axis) RPM (any location) Shaft Wobble Basket/paddle Depth Basket Wobble and Vessel Plate Level Not Shown Temperature Probe Plug-In Vessel Plate Level and Vibration Sensors Vessel Verticality Sensor Basket Wobble Sensor Height Lever RPM Sensor Vessel Diameter Arm Height Arm USB Plug-In Vessel Module Plug-In Vessel Centering Sensors (Upper) Vessel Centering Sensors (Lower) New stainless paddle Rusted stainless steel paddle Badly damaged PTFE-coated paddle New PTFE- coated paddle Slightly worn-PTFE paddle Damaged PTFE- coated paddle New stainless steel basket Bent stainless steel basket Damaged stainless steel basket seam New stainless steel basket shaft Basket shaft with bent prongs O-ring stainless steel basket shaft 280-DS Instrument Module 280-DS Vessel Module
Transcript of Mechanical Qualification Guide - Agilent€¦ · components should be lubricated, belts checked for...
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
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