1.0 OBJECTIVE:
To
lay down the calibration procedure of Dissolution apparatus.
2.0 SCOPE:
This
shall be applicable to the Dissolution
apparatus of Quality Control Instrument Laboratory.
3.0 RESPONSIBILITY:
3.1
Technical
Assistant/ Helper.
3.2
Q.C Analyst.
4.0 ACCOUNTABILITY:
4.1
Manager-Quality
Control.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Dissolution apparatus.
5.2
Calibrated
thermometer.
5.3
Purified water.
6.0 PROCEDURE:
6.1
Switch ON the
mains.
6.2
Operate the
apparatus according to SOP.
6.3
Calibration
of RPM:
6.3.1
Enter the required
RPM value in the range of 30 to 200.
6.3.2
Press ENTER key to
terminate. The SET RPM key LED will now be put off. If the RPM value is not in
the range error message Er is displayed on the RPM display.
6.3.3
If the error
message is displayed then go back to resetting. If the error message “Er” is
displayed on the RPM display and the ENTER key is pressed then the last
correctly set value of RPM for that step will be accepted and the SET RPM LED
will be put off.
6.3.4
Suppose the RPM
VALUE 100 is to be entered. First press the SET-RPM key. The SET-RPM key LED
will be illuminated. Next press no. 1 key once following by 0 key twice. Then
press ENTER key. The SET-RPM key LED will go OFF. Then the RPM DISPLAY will
show 100.
6.3.5
Record the RPM
manually & enter in the calibration log.
6.4
Calibration
of Temperature:
6.4.1
Press the SET key.
The SET TEMP key LED will be illuminated TEMP.
6.4.2
Enter the required
temperature value in the range of 30oC to 100oC.
6.4.3
Press ENTER key to
terminate. The SET TEMP key LED will now be put off. If the TEMP value is not
in the range error message Er is displayed on the TEMP display. If the error
message is displayed then go back to resetting.
6.4.4
If the error
message “Er” is displayed on the TEMP display and the ENTER key is pressed then
the last correctly set value of TEMP for that step will be accepted and the SET
TEMP LED will be put off.
6.4.5
Set the temp. 35oC,
37oC & 40oC and check the temperature of bowl with
the thermometer & record the data in calibration log.
6.4.6
To view the set
temperature presses the SET TEMP key again. Then the TEMP DISPLAY will show set
TEMP in oC.
6.4.7
If the calibration is not found within the
specified limits immediately inform to QC head.
6.4.8
Affix the
calibration label on the instrument.
6.5
Calibration
of Apparatus suitability:
6.5.1
Calibration
for Disintegrating Type:
6.5.1.1
Prepare
standard solution of Prednisone:
6.5.1.1.1
Prepare the
standard solution by dissolving the 25mg of prednisone to 50.0ml of purified
water.
6.5.1.1.2
Further dilute
5.0ml from this solution to 50.0ml with purified water.
6.5.1.1.3
Again make
dilution of this 5.0ml to 25.0ml with purified water.
6.5.1.1.4
And take
absorbance at 242nm against the purified water.
6.5.1.1.5
NOTE:
If
the standard is not dissolve first add not more than 2.5ml of alcohol.
6.5.1.2
Dissolution
calibration by using Prednisone tablet:
6.5.1.2.1
Ensure that mains
of instrument and supply are “ON”.
6.5.1.2.2
Set the time
program for 30 min, temperature 37oC±0.5oC and for 50
RPM.
6.5.1.2.3
Fit the required apparatus
paddle.
6.5.1.2.4
Place 900.0ml of
deaerated water. De-aerate the purified water according to SOP for de-aeration
of dissolution media.
6.5.1.2.5
After achieving
the temperature place one tablet in each bowl and start the time program.
6.5.1.2.6
After completion
of time program withdraw the sample solution from each bowl and filter through
the filter paper in individual tubes. Discard first 50.0ml filtrate, take 5.0ml
of filtrate and dilute with purified water to 25.0ml and take the absorbance at
242nm against the purified water.
6.5.2
Calculate the
content of prednisone.
6.5.3
Also carry out
above procedure for 100 RPM.
6.5.4
Enter the data in
the calibration record.
6.5.5
Also carry out
above procedure by changing the basket apparatus for 100 RPM and enter the data
in calibration log.
6.5.6
Precautions:
6.5.6.1
If the calibration
is not found within the specified limits immediately inform to QC head.
6.5.6.2
Record the result
on the “Calibration Record”,
“Calibration Log Book” & paste the “Calibration
Status Sticker” on Dissolution
apparatus.
6.5.6.3
In case of
noticing any malfunctioning of instrument, inform the maintenance dept. and
Head of dept.
6.6
Checking
of physical parameters for the apparatus:
6.6.1
Basket:
6.6.1.1
Make identity of
each basket which is in use and make the inventory.
6.6.1.2
Check the physical
parameters for the each basket like appearance, opening, height, total height of
basket, ID of basket, external diameter of basket, external diameter of ring,
vent hole diameter, height of coupling disk.
6.6.1.3
All parameters
should be fall within the limit as given in the calibration log.
6.6.2
Paddle:
6.6.2.1
Make identity of
each paddle which is in use and make the inventory.
6.6.2.2
Check the physical
parameters for the each paddle like appearance, height, shaft diameter, blade
upper chord, lower chord, height, radius (disk), thickness, and distance from
bottom, distance shaft axis and vertical axis of vessel.
6.6.2.3
All parameters
should be fall within the limit as given in the calibration log.
6.7
Checking
of wobbling, rotations & distance parameters for the apparatus:
6.7.1
Wobbling:
6.7.1.1
Fix the paddle/
basket apparatus to the instrument, lower the apparatus.
6.7.1.2
Fix the wobbling
meter on the top of the bowl.
6.7.1.3
The needle of
wobbling meter should touch to the surface of the apparatus.
6.7.1.4
Measure the
wobbling on the meter.
6.7.2
Rotations:
6.7.2.1
Fix the paddle/
basket apparatus to the instrument.
6.7.2.2
Set the RPM
50/100.
6.7.2.3
The needle of
tachometer should touch to the surface of the apparatus.
6.7.2.4
Press the “Start”
key of tachometer to start.
6.7.2.5
Fix the tachometer
with apparatus.
6.7.2.6
Start the
rotation.
6.7.2.7
The tachometer
will show result on display.
6.7.3
Distance
from the apparatus:
6.7.3.1
Fix the paddle/
basket apparatus to the instrument, lower the apparatus.
6.7.3.2
Insert the vernier
calipers between the bottom of the apparatus and the bottom of the bowl.
6.7.3.3
Measure the
reading on the display.
7.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1 Not Applicable.
9.0 ANNEXURES:
Annexure 1: Calibration
of RPM of Dissolution apparatus.
Annexure 2: Calibration
of Temperature of Dissolution apparatus.
Annexure 3: Calibration
Log of Suitability of Dissolution apparatus (by disintegrating type).
Annexure 4: Checking
of Physical parameters of Basket/ Paddle.
Annexure 5: Checking
of wobbling, rotation & distance parameters of apparatus.
Annexure:
1
Calibration
of RPM of Dissolution Apparatus
|
Calibration of RPM of
Dissolution apparatus
OBSERVATIONS
Conclusion:
Satisfactory/ Not satisfactory.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Annexure:
2
Calibration of
Temperature of Dissolution apparatus
|
Calibration of
Temperature of Dissolution apparatus
OBSERVATIONS
Conclusion:
Satisfactory/ Not satisfactory.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Annexure:
3
Calibration
Log of Suitability of Dissolution apparatus (by disintegrating type)
|
Calibration
Log of Suitability of Dissolution apparatus (by disintegrating type)
OBSERVATIONS
Standard
preparation:
Transferred ______mg to
50.0ml in volumetric flask, dissolved and diluted to 50.0ml with purified
water.
Diluted _______ml to
50.0ml with purified water and mix.
Diluted _______ml to
25.0ml with purified water and mix.
Conclusion:
Satisfactory/ Not satisfactory.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Annexure:
4
Checking
of Physical parameters of Basket/ Paddle
|
Checking
of Physical parameters of Basket
OBSERVATIONS
Conclusion:
Satisfactory/ Not satisfactory.
Checking
of Physical parameters of Paddle
OBSERVATIONS
Conclusion:
Satisfactory/ Not satisfactory.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Annexure:
5
Checking
of wobbling, rotation & distance parameters of apparatus
|
Checking
of wobbling, rotation & distance parameters of apparatus
OBSERVATIONS
Conclusion:
Satisfactory/ Not satisfactory.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
10.0
ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard operating
procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
Q.C
|
Quality control
|
|
Q.A
|
Quality assurance
|
|
QCEB
|
Quality control
equipment calibration
|
|
F
|
Format
|
|
g
|
Grams
|
|
mm
|
Millimeters
|
|
%
|
Percentage
|
|
Sr.#
|
Serial number
|
|
RPM
|
Rotation per minute
|
|
oC
|
Degree centigrade
|
|
ml
|
Milliliter
|
|
mg
|
Milligram
|
|
nm
|
Nanometer
|
|
ID
|
Identification
|
|
UV
|
Ultra violet
|
|
Max.
|
Maximum
|
|
Min.
|
Minimum
|
|
min
|
Minutes
|