QLA KT2 User manual

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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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MANVALTOL-KT2 Rev. A, 6-15-2010
Table of Contents
1. General Information……………………………………………………………….3
1.1 Introduction……………………………………………………………………3
1.2 Product Specifications…………………………………………………….3
2. Unpacking……………………………………………………………………………….3
3. Product Description………………………………………………………………..4
3.1 Diagram of Validation Tool Kit, KT2…………………………………4
4. Installation / Operating Instructions………………………………………5
4.1 Checking Vessel Plate Levelness………………………………………5
4.2 Setting Paddle / Basket Height………..………………………………5
4.3 Checking Paddle / Basket 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 VanKel / Varian Testers………………………………………..11
4.6 Measuring Basket Wobble………………………………………………11
4.6.1 For Hanson / Distek Testers………………………………………..11
4.6.2 For VanKel / Varian Testers…………………………………………12
4.7 Measuring Vessel Centering…………………………………………….13
4.7.1 For Testers with One-Piece Shafts……………………………….13
4.7.2 For Testers with Two-Piece, Spin-Off Shafts………………..15
4.8 Calculating Vessel Centering…………………………………………….16
5. Qualification and Validation…………………………………………………….16
6. Maintenance…………………………………………………………………………….16
7. Warranty…………………………………………………………………………………..16

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MANVALTOL-KT2 Rev. A, 6-15-2010
1. General Information
1.1 Introduction
Thank you for purchasing the QLA Validation Tool Kit, KT2. This kit
contains a variety of unique measuring tools and gages that
provide an accurate reading of vessel plate levelness, paddle or
basket shaft wobble, basket wobble, paddle or basket height and
vessel centering anywhere within the dissolution vessel. With the
purchase of the optional 80mm Standard (For Vankel / Varian
Testers) and/or 80mm Spacer and Shaft Collar (For Hanson and
Distek Testers), the centering gage can also be used to determine
vessel verticality as described in the new FDA specifications
outlining 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 Chapter <711> Dissolution. The KT2
kit is maintenance free, easy to use and should be returned to
QLA once a year for recalibration.
1.2 Product Specifications
See individual Certificates of Calibration and Traceability.
2. Unpacking
The plastic storage box has been designed to minimize any damage that
may occur during transport and can also be used to ship the KT2 Kit back
to Q.L.A. for recalibration. Check the shipping container for any damage
during transport. Unpack the individual parts carefully. After unpacking,
check the parts for possible damage. Report any damage to the
forwarding shipper immediately and inform Q.L.A. or your local
representative.

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MANVALTOL-KT2 Rev. A, 6-15-2010
3. Product Description
3.1 Diagram of Validation Tool Kit, KT2
Item #
Description
Part #
1Vessel Centering and Verticality Alignment Gage 970-05-21
2Anti-Rotation Handle Included with Gage
3
Wobble 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
9Depth Set Gage DEPSET-25
10
Dial Indicator Assembly
970-05-24
11
Spin Shaft Adapter for Hanson
ADPT-HR
12 Spin Shaft Adapter for VanKel / Varian ADPT-VK
13 Plastic Storage Case 6785TC
14 Foam Insert Current Version
1
10
4
6
11
12
3
7
14 13
2
9
8
5

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MANVALTOL-KT2 Rev. A, 6-15-2010
4. Installation / Operating Instructions
4.1 Checking Vessel Plate Levelness
4.1.1 Place the Universal Level at the approximate center of the
dissolution tester vessel plate and observe the location of
the bubble.
4.1.2 The tester is considered adequately leveled when the bubble
remains completely within the outer ring of the level and
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 manual for
their recommended procedure)
4.2 Setting Paddle / Basket height
4.2.1 The paddle or basket height can be set by placing the 25mm
depth gage, Part # DEPSET-25 onto the paddle or rotating
basket assembly by clamping the support arm onto the
drive shaft and making sure the top of the gage is touching
the bottom of the paddle blade or rotating basket as shown
in figure #1.

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MANVALTOL-KT2 Rev. A, 6-15-2010
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
Bottom of Gage
and Inside
Bottom of Vessel

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.2.3 Once set, secure the paddle or basket shaft in place as
recommended by the appropriate dissolution tester
manufacturer. Then raise the dissolution drive head and
carefully remove the gage.
4.3 Checking Paddle / Basket height
4.3.1 After setting the paddle or basket height. The height can be
checked by using the Go / No-Go Gage as outlined below.
4.3.2 With the dissolution drive head 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” must not.
4.3.3 If the “GO” knob does not fit or the “NO-GO” knob does,
the height needs to be adjusted. (See sections 4.2.1 -4.2.3)
4.4 Measuring Paddle Wobble
4.4.1 For Hanson and Distek tester
4.4.1.1 The paddle wobble can be measured by assembling the
dial indicator assembly, small indicator shaft and
wobble bracket assembly as shown in Figure #3.
Figure #3
Wobble Bracket
Assy.
Adjustable
Foot
Dial Indicator
Assy.
Small Indicator
Shaft

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.4.1.2 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 Figure #3.
4.4.1.3 With the paddle shaft secured, lower and position the
dissolution drive head so that the dial indicator probe
is located about 2cm above the top of the paddle
blade and adjust the location of 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 tester to 25 RPMs. Start the spindle
rotation and observe the dial indicator travel. Rotate
the dial face so that the minimum counter clockwise
pointer position coincides 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 is equal to .01mm.
2cm Above Top of
Paddle Blade
Dial Indicator
Probe

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.4.2 For VanKel / Varian
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 centering ring guide post as shown
in figure #6.
Dial
Indicator
Bracket Assy.

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MANVALTOL-KT2 Rev. A, 6-15-2010
Figure #6
4.4.2.3 Repeat sections 4.4.1.3
& 4.4.1.4
4.5 Measuring
Basket Shaft Wobble
4.5.1 For Hanson and Distek
Testers
4.5.1.1 The basket shaft wobble
can be measured by assembling the dial indicator
assembly, small indicator shaft and wobble bracket
assembly as shown 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 Figure #3.
4.5.1.3 With the basket shaft secured, lower and position the
dissolution drive head so that the dial indicator probe
is located about 2cm above the top of the shaft hub
and adjust the location of the indicator assembly to
establish a pre-load of at least one revolution of the
Centering Ring
Guide Post

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MANVALTOL-KT2 Rev. A, 6-15-2010
indicator dial. Tighten the thumb screws to lock the
gage in place. See Figure #7
Figure #7
4.5.1.4 Set the dissolution
tester to 25 RPMs. Start the spindle rotation and
observe the dial indicator travel. Rotate the dial face
so that the minimum counter clockwise pointer
position coincides 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 is equal to .01mm.
4.5.2 For VanKel / Varian
Testers
4.5.2.1 Remove the centering
ring, dissolution vessel and assemble the dial
indicator to the bracket assembly as shown in figure
#5.
4.5.2.2 Place the indicator
assembly onto the centering ring guide post as shown
in figure #6.
2cm Above
Top of Shaft
Hub
Dial Indicator Probe

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.5.2.3 Repeat sections 4.5.1.3
& 4.5.1.4
4.6 Measuring
Basket Wobble
4.6.1 For Hanson and Distek
Testers
4.6.1.1 The basket wobble can
be measured by assembling the dial indicator
assembly, small indicator shaft and wobble bracket
assembly as shown in Figure #3.
4.6.1.2 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 Figure #3.
4.6.1.3 With the basket secured to the shaft, lower and position
the dissolution drive head so that the dial indicator
probe is touching the bottom rim of the basket and
adjust the location of 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 #8.
Bottom Rim
of Basket
Indicator Probe

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MANVALTOL-KT2 Rev. A, 6-15-2010
Figure #8
4.6.1.4 Set the dissolution
tester to 25 RPMs. Start the spindle rotation and
observe the dial indicator travel. Rotate the dial face
so that the minimum counter clockwise pointer
position coincides 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 is equal to .01mm.
4.6.2 For VanKel / Varian
Testers
4.6.2.1 Remove the centering
ring, dissolution vessel and assemble the dial
indicator to the bracket assembly as shown in figure
#5.
4.6.2.2 Place the indicator
assembly onto the centering ring guide post as shown
in figure #6.
4.6.2.3 Repeat sections 4.6.1.3
& 4.6.1.4
4.7 Measuring
Vessel Centering
4.7.1 For Testers with One-
Piece Shafts

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.7.1.1 Raise the dissolution tester to its highest position.
Remove any existing paddle or basket shafts and
replace it with the Indicator Shaft with Gage as
shown in figure #9.
Figure #9
4.7.1.2 Insert 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 turning the knurled knob clockwise until
snug. Use the anti-rotation handle to insert thru the
indicator shaft. Hold the gage handle in place and
then fully tighten the knurled knob. Raise the
assembled gage into the spindle assembly and then

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MANVALTOL-KT2 Rev. A, 6-15-2010
fully tighten the Chuck Assembly. (Chuck assemblies
are not used on Distek Dissolution Testers).
4.7.1.4 While gently pressing
back on the gage shaft to avoid hitting the vessel rim
or centering ring as shown in figure #10. Lower the
dissolution drive head so that the indicator 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 place one finger in front
of the anti-rotation handle as shown in figure #4.
(Some Distek 5100 series instruments may be
equipped with a drive head position limit switch that
prevents spindle rotation. These instruments require
manual rotation.)
4.7.1.6 Start the spindle
rotation and observe the dial indicator travel. Rotate

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MANVALTOL-KT2 Rev. A, 6-15-2010
the dial face so that the minimum counter clockwise
pointer position coincides with 40 on the indicator.
4.7.1.7 As the shaft rotates, the
pointer will move clockwise to a maximum value. This
distance is the total indicated reading or T.I.R.. Each
division on the dial indicator is equal to .05mm.
4.7.1.8 Stop the spindle
rotation 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
4.7.2.1 Follow the instructions in section 4.7.1 with the
following exceptions. Remove only the lower portion
of the paddle or basket shaft assembly and replace it
with one of the following Spin-Shaft adapters as
shown in figure #11. (Distek Testers do not require
the use of an adapter.)
Figure #11
Spin Shaft Adapter
for VanKel / Varian
Spin Shaft Adapter
for Hanson / Distek

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MANVALTOL-KT2 Rev. A, 6-15-2010
4.8 Calculating Vessel Centering
4.8.1 The actual vessel centering or spindle to vessel misalignment is
calculated by dividing the total indicated reading or T.I.R. by
two.
4.8.2 Example: The dial indicator moved clockwise from 40 to 15. The
total indicated reading is 1.5mm. Thus, 1.5mm divided by
two equals .75mm.
4.8.3 Example: The dial indicator moved clockwise from 40 to 25. The
total indicated reading is 2.5mm. Thus, 2.5mm divided by
two equals 1.25mm.
5. Qualification and Validation
Prior to shipment, the kit 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 contained in this kit are
maintenance free and do not require any daily service, it is
recommended that after each use, the gages and tools are returned to
the plastic protective case for storage.
7. Warranty
This parts contained in this kit are warranted to be free from defects in
materials and workmanship under normal installation, use and service
for a period of (1) year from the date of purchase as shown on the
purchase order receipt. The obligation of QLA under this warranty shall
be limited to repair or replacement (at our option) during the warranty

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MANVALTOL-KT2 Rev. A, 6-15-2010
period, provided the product is returned to QLA with transportation
charges prepaid. This warranty shall 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 own service facility or authorized QLA service
technician.
Rev. Revised On: Revised By: Description of Change
A
6/15/2010
Ray Majeski
Initial Release