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MANVALTOL-KT2 Rev. A, 6-15-2010

Operating Instructions

Quality Lab Accessories LLC

Validation Tool Kit, KT2

For use with USP Apparatus #1 & #2

Part Number MANVALTOL-KT2 Rev. A, 6-15-2010

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Summary of Contents for KT2

Page 1: ...Page 1 of 18 MANVALTOL KT2 Rev A 6 15 2010 Operating Instructions Quality Lab Accessories LLC Validation Tool Kit KT2 For use with USP Apparatus 1 2 Part Number MANVALTOL KT2 Rev A 6 15 2010...

Page 2: ...Height 7 4 4 Measuring Paddle Wobble 7 4 4 1 For Hanson and Distek Testers 7 4 4 2 For VanKel Varian Testers 9 4 5 Measuring Basket Shaft Wobble 10 4 5 1 For Hanson and Distek Testers 10 4 5 2 For Van...

Page 3: ...ining the use of an Enhanced Mechanical Calibration procedure as an alternate approach to current Apparatus Suitability procedure for Dissolution Apparatus 1 and 2 as described in the USP General Chap...

Page 4: ...bble Bracket Assembly 970 05 23 4 Universal Level LEVEL UN 5 Indicator Shaft Long 10001006 6 Indicator Shaft Short 10001015 7 Indicator Bracket Assembly 97 05 25 8 Go No Go Gage GNGDEP 9 Depth Set Gag...

Page 5: ...nd does not touch the lines 4 1 3 Adjustments to the tester can be made by raising or lowering the adjustable feet located on the base of the tester Please refer to the dissolution testers operation m...

Page 6: ...10 Figure 1 4 2 2 The paddle or basket assembly is lowered until the bottom of gage touches the inside bottom of the vessel as shown in figure 2 Figure 2 Top of Gage and Bottom of Paddle or Basket Bot...

Page 7: ...lowered to its normal operating position the smaller knob labeled GO must fit in between the bottom of the paddle or rotating basket and the bottom of the vessel While the larger knob labeled NO GO mu...

Page 8: ...the indicator assembly to establish a pre load of at least one revolution of the indicator dial Tighten the thumb screws to lock the gage in place See Figure 4 Figure 4 4 4 1 4 Set the dissolution te...

Page 9: ...Testers 4 4 2 1 Remove the centering ring dissolution vessel and assemble the dial indicator to the bracket assembly as shown in figure 5 Figure 5 4 4 2 2 Place the indicator assembly onto the centeri...

Page 10: ...hown in Figure 3 4 5 1 2 Place the wobble gage onto the top of the dissolution vessel and move the adjustable foot in or out until the assembly is secured to the inside of the vessel as shown in Figur...

Page 11: ...incides with 0 on the indicator As the shaft rotates the pointer will move clockwise to a maximum value This distance is the total indicated reading T I R or wobble Each division on the dial indicator...

Page 12: ...he top of the dissolution vessel and move the adjustable foot in or out until the assembly is secured to the inside of the vessel as shown in Figure 3 4 6 1 3 With the basket secured to the shaft lowe...

Page 13: ...ove clockwise to a maximum value This distance is the total indicated reading T I R or wobble Each division on the dial indicator is equal to 01mm 4 6 2 For VanKel Varian Testers 4 6 2 1 Remove the ce...

Page 14: ...sert the indicator shaft into the spindle such that the hole on the shaft protrudes about 1 inch below the spindle assembly 4 7 1 3 Attach the top of the gage to the bottom of the indicator shaft by t...

Page 15: ...ball is positioned about 2mm above the top of the vessels spherical radius This approximates the normal paddle or basket position Figure 10 4 7 1 5 Set the dissolution tester speed to 25 RPMs and pla...

Page 16: ...tation and raise the drive head so that the indicator ball is near the top of the vessel just below the rim and repeat sections 4 7 1 5 to 4 7 1 7 4 7 2 For Testers with Two Piece Spin Off Shafts 4 7...

Page 17: ...is calibrated and includes Certificates of Calibration and Traceability The complete kit should be returned to QLA for recalibration once a year 6 Maintenance Although the measuring tools and gages co...

Page 18: ...l be invalid if the product is damaged as a result of defacement misuse accident destruction or alteration of the serial numbers repair alteration or maintenance by any person or party other than our...

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