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SOP for Operational Qualification of Dissolution Tester


Standard operating procedure to evaluate the performance of Dissolution tester for result accuracy.

1.0  OBJECTIVE 

       To qualify the equipment for reliable and accurate results.

2.0  SCOPE

       This procedure is applicable to all dissolution test apparatus installed in chemical analysis area of quality  control laboratory.

3.0  RESPONSIBILITY

3.1  Doing      : Technical Assistant/Service engineer
3.2  Checking : Executive /Manager

4.0  ACCOUNTABILITY

       Head of the Department
       Qualification frequency : Once in four month

5.0  PROCEDURE             

5.1  QUALIFICATION FOR HEAT DISTRIBUTION :

5.1.1  Operate the instrument as per respective operating procedure.
5.1.2  Set the temperature by the temperature knob at 37.8oC.Start the stirrer at 50 rpm. Ensure that temperature indicator is calibrated and calibration tag is affixed.
5.1.3  Note the observed temperature as shown in Annexure
5.1.4  Observe  the rise in temperature on digital temperature indicator. As soon as it shows 37oC , consider that time as “ZERO” minute. At this time, measure the temperature individually of all dissolution bowls by calibrated thermometer.
5.1.5  Record the temperature at interval as indicated in Annexure.The apparatus is satisfactory if the temperature observed for all bowls are between 36.5 oC and 37.5oC

5.2  QUALIFICATION FOR UNIFORMITY IN ROTATIONAL SPEED  

5.2.1  Operate the instruments as per respective standard operating procedure.
5.2.2  First set the speed at 50 rpm .   
5.2.3  Count the rotation by Takometer.
5.2.4  Change the setting to 75 rpm, 100 rpm.and 150 rpm Count the rotation as above.
5.2.5  Record the measured rpm in Annexure. The apparatus is satisfactory if the rotations at different speed are within limits given in Annexure.

5.3  QUALIFICATION OF HEIGHT

      (Distance between the bottom edge of the apparatus to the inner lower surface of the vessel)
5.3.1  Use calibrated vernier for qualification of height distance validation.
5.3.2  Keep all jars empty and remove lid from it.
5.3.3  Clamp all jars using jar holders provided on jar plate.
5.3.4  Lower the stirrer unit to the bottom position till it stops automatically.  
5.3.5  Use the above vernier, hold it vertical and touching parallel to the paddle shaft.  
5.3.6  Touch the reference bracket of the vernier at bottom face of paddle.
5.3.7  Slide vernier scale down till the point of stylus touches the jar bottom.
5.3.8  Lock the vernier at this position and lift up the stirrer unit.
5.3.9  Take out the vernier and note the readings.  
5.3.10  Limit : 25+/- 2mm

5.4  QUALIFICATION FOR CENTRING WITH RESPECT TO THE JAR

5.4.1  Use the centring device for centring of paddle/basket rod with jar.
5.4.2  Empty all the jars and keep them without the jar lid in respective positions..
5.4.3  Lower the stirrer unit down so as the blades of the paddle just enters the jars.  
5.4.4  Fix the centring gauge meter on the jar.
5.4.5  Rotate the device with both hands ground the shaft of the paddle in the jar, ensure that the bottom plate is not lifted from the jar or is in contact with the jar properly.
5.4.6  Note the four different reading from Jar to Paddle with Vernier and calculate the jar centring with respective formula.
5.4.7  Record the readings as per Annexure
5.4.8  U.S.P. Limit : Jar centring should be within 2mm

5.5  QUALIFICATION FOR PADDLE /BASKET ROD WOBBLING

5.5.1  Use wobble gauge meter.
5.5.2  Empty all the jars and keep them without the jar lid in respective position.
5.5.3  Lower the stirrer unit down so as the blades of the paddle/basket jars enter the jars. 
5.5.4  Ensure that the paddle or basket rod is properly tightened with the spindle. Using the keys provided to tighten it.
5.5.5  Fix the wobble gauge meter so that the pointer is just pressed against the paddle shaft.
5.5.6  Start the rotation of Paddle/Basket rod.
5.5.7  Note the reading of the maximum deviation of the pointer of wobble gauge meter
5.5.8  Repeat the procedure for all remaining paddle or basket rods.
5.5.9  Record the readings as per Annexure
5.5.10  U.S.P. Limit :
            1.  For Basket wobble : Should be less than 1.0 mm
            2.  For Paddle wobble : Should be less than 0.5 mm

6.0  ABBREVIATIONS

6.1  rpm.= Rotation per minute
6.2  oC = Degree centigrade
6.3  hr  = hour



ANNEXURE
QUALITY CONTROL DEPT.
OPERATIONAL QUALIFICATION RECORD OF  DISSOLUTION TESTER                

PERFORMANCE DATE

DATE OF LAST PERFORMANCE
DONE
NEXT DUE FOR
PERFORMANCE





INSTRUMENT DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.





OBSERVATION


QUALIFICATION FOR UNIFORMITY IN ROTATION SPEED

Set Speed
Acceptable   Limit
Speed Observed rpm
50 rpm
48 to 52 rpm

75 rpm
72 to 78 rpm

100 rpm
96 to 104 rpm

150 rpm
145 to 155 rpm


Remarks: From the above results it is confirmed that  the apparatus is satisfactory /not satisfactory for use
Qualification done by          :                                                      Date  :    
Checked by                       :                                                      Date  :

QUALIFICATION FOR HEAT DISTRIBUTION
Ref.no.            :_______________                                                                                                                                    issued date :_______________
thermometer Id No. :__________                        issued by  : _______________

Time in
minute
Observed Temp. in
Digital indicator(Co)
Observed Temperature in vessels (Co)


Bowl No.1
Bowl  No.2
Bowl No.3
Bowl  No.4
Bowl No.5
Bowl No.6
Bowl No.7
Bowl No.8
0









15









30









45









60









90









120









150









180









360









720









1440









1800










(Acceptance Limits: All reading should be between 36.5oC and 37.5oC)
Remarks: From the above results it is confirmed that  the apparatus is satisfactory /not satisfactory for use
Qualification done by          :                                                     Date  :    
Checked by                       :                                                     Date  :

RECORDS OF PADDLE,JAR,BASKET WOBBLE AND CENTRING
TEST
position
basket wobble
paddle
wobble
*jar
 centring
 D1 mm
D2 mm
USP Limit
+/- 1.0mm
<0.5 mm (proposed)
< 2.0 mm
25.0+/- 2
25.0+/- 2






1





2





3





4





5





6





7





8






D1= Distance between the bottom edge of the basket to the lowest inner surface of the vessel
D2= Distance between the bottom edge of the paddle blade to the lowest inner surface of the vessel
Remarks: From the above results it is confirmed that  the apparatus is satisfactory /not satisfactory for use
Qualification done by             :                                                     Date  :    
Checked by                           :                                                     Date  :
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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