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SOP for Operational Qualification of Dissolution Test Apparatus

OBJECTIVE
To qualify the equipment for reliable and accurate results.

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

RESPONSIBILITY
Doing: Technical Assistant/Service engineer
Checking: Executive /Manager

ACCOUNTABILITY
Head of the Department
Qualification frequency: Once in four-month


PROCEDURE

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

Qualification for Uniformity in Rotational Speed
  • Operate the instruments as per the respective standard operating procedures.
  • First set the speed at 50 rpm.
  • Count the rotation by Tachometer.
  • Change the setting to 75 rpm, 100 rpm, and 150 rpm. Count the rotation as above.
  • Record the measured rpm in Annexure. The apparatus is satisfactory if the rotations at different speeds are within the limits given in Annexure.

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

Qualification of  Centering with Respect to the Jar 
  • Use the centering device for centering of paddle/basket rod with the jar.
  • Empty all the jars and keep them without the jar lid in their respective positions.
  • Lower the stirrer unit down so that the blades of the paddle just enter the jars.
  • Fix the centering gauge meter on the jar.
  • Rotate the device with both hands ground the shaft of the paddle in the jar, and ensure that the bottom plate is not lifted from the jar or is in contact with the jar properly.
  • Note the four different readings from Jar to Paddle with Vernier and calculate the jar centering with the respective formula.
  • Record the readings as per Annexure
  • USP Limit: Jar centering should be within 2mm

Qualification of  Paddle / Basket Rod Wobbling
  • Use a wobble gauge meter.
  • Empty all the jars and keep them without the jar lid in their respective positions.
  • Lower the stirrer unit down so that the blades of the paddle/basket jars enter the jars.
  • Ensure that the paddle or basket rod is properly tightened with the spindle. Use the keys provided to tighten it.
  • Fix the wobble gauge meter so that the pointer is just pressed against the paddle shaft.
  • Start the rotation of the Paddle/Basket rod.
  • Note the reading of the maximum deviation of the pointer of the wobble gauge meter
  • Repeat the procedure for all remaining paddle or basket rods.
  • Record the readings as per Annexure
  • 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

ABBREVIATIONS
rpm.= Rotation per minute
°C = Degree centigrade
hr = hour


ANNEXURE


REVISION HISTORY
Nil

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