OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN

SOP No.:
QUALITY CONTROL DEPARTMENT Page 1 of 5
QCG004
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. :
01 SOP FOR OPERATION AND CALIBRATION OF Review date:
DISINTEGRATION TEST APPARATUS March 2013

1.0 OBJECTIVE:

To describe the procedure for the Operation and Calibration of

Disintegration Test Apparatus.

2.0 SCOPE:

This SOP is applicable to Disintegration Test Apparatus. at M/s. Oasis

Laboratories Private Limited, Dehradun.

3.0 RESPONSIBILITY:

Quality Control Department

4.0 ACCOUNTABILITY:

HOD QC

5.0 PROCEDURE :

5.1 Ensure that instrument is clean and free from dust.

5.2 Ensure that all the switches and knobs are off and in normal
position.

5.3 Switch on the mains of the instrument, so the red light an

indicator is on.

5.4 Set the bath temp. as specified with the knob provided on the
instrument.
5.5 Suspend the basket rack assembly in a beaker having capacity
of 1000 ml containing the specified medium.
5.6 Switch on the heater the green light indicator will be ON and
OFF and the temp. is maintend.
5.7 For time setting, select the time parameter by press Shift Button
as minute/ seconds, set the time by press the button INC or DCR.

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 2 of 5
QCG004
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. :
01 SOP FOR OPERATION AND CALIBRATION OF Review date:
DISINTEGRATION TEST APPARATUS March 2013

5.8 Now add the number of samples (tablets or capsules) as specified

in the monograph, in the cylindrical holes provided in the basket
rack assembly.

5.9 Add discs where applicable and specified. Now on the green light
switch for visualization.

5.10 Start the oscillation by pressing ST/SP Button and note the time
when the samples inside the cylindrical holes is completely
disintegrates.

5.11 Switch off the apparatus when not required.

6.0 CALIBRATION RECORD:-

To achieve accuracy the instrument is calibrated by following.

PARAMETERS:-
6.1 Calibration of Temperature Controller:-
Temperature controller is calibrated by calibrated thermometer
with respect to time, which observed with stop watch.

CALIBRATION OF TEMP. BATH

Set Temp Time Observed Limit

370 C 0 min-30min 10 c
370 C 0min 1 hrs 10 c
370 C 0 min 2 hrs 10 c
TEMPERATURE : CHECKED BY CALIBRATED THERMOMETER
6.2 Calibration of time Controller:-
Time controller is calibrated by calibrated stop watch.

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 3 of 5
QCG004
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. :
01 SOP FOR OPERATION AND CALIBRATION OF Review date:
DISINTEGRATION TEST APPARATUS March 2013

Calibration of time Controller

Set/Display Time Off Time of the Stop Watch Time Tolerance
Instrument
15 .0 Min. 0.5

30.0 Min 0.5

45.0 Min 0.5

Time: By stop watch Calibration

6.3 Calibration for Distance Travelled:-

Distance travelled by the basket between the lowest and the highest
points of oscillation is calibrated with the help of measuring scale.

CALIBRATION OF TRAVELING DISTANCE

S.NO. Time Interval Observed Distance Limit

1 0 -10 min 50 60 mm

2 10-20 min 50 60 mm

3 20-30 min 50 60 mm

6.4 Calibration of Cycle per minute:-

CALIBRATION OF OSCILLATION (RPM)

S. No. Time Count cycle RPM/Minut Limit
1 0 4 min 30 2 RPM

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 4 of 5
QCG004
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. :
01 SOP FOR OPERATION AND CALIBRATION OF Review date:
DISINTEGRATION TEST APPARATUS March 2013

2 0 8 min 30 2 RPM

TIME: BY STOP WATCH CALIBRATION

7.0 Precautions:-
7.1 Proper handling of the instrument.
7.2 Temperature of the liquid medium should be maintained.

8.0 RECORDS:

Calibration Record of disintegration test apparatus (annexure-1).

9.0 ANNEXURES:
Annexure-1 Format for Calibration Record of disintegration test
apparatus.

10.0 ABBREVIATIONS & DEFINITIONS:

SOP : Standard Operating Procedure.
Dept. : Department.
HOD : Head of the Department.
QC : Quality Control

ANNEXURES-1
SOP REF NO QCG004 QC-F-004-01
Name of Instruments : Disintegration Test Apparatus Instruments location: Q.C. LAB.
Name of Manufacturer : Time Star
Instrument ID Number : QC/CS/006
Frequency of calibration : Monthly
Calibration Date :
Next Due calibration Date :

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA
 OASIS LABORATORIES PRIVATE LIMITED, DEHRADUN
SOP No.:
QUALITY CONTROL DEPARTMENT Page 5 of 5
QCG004
Supersedes : Effective:
STANDARD OPERATING PROCEDURE
00 April 2010
Version No. :
01 SOP FOR OPERATION AND CALIBRATION OF Review date:
DISINTEGRATION TEST APPARATUS March 2013

PARAMETER:-
CALIBRATION OF TEMP. BATH CALIBRATION OF OSCILLATION (RPM)

S. Set Time Observed Limit S. No. Time Count cycle RPM/Minut Limit
No Temp
1 370 0 min-30min 10 c 1 04 30 2 RPM
C min
2 370 0min 1 hrs 10 c
C 2 08 30 2 RPM
3 370 0 min 2 hrs 10
c min
C

TEMPERATURE : CHECKED BY CALIBRATED TIME: BY STOP WATCH CALIBRATION

THERMOMETER

Remark:-
CALIBRATION OF TRAVELING DISTANCE CALIBRATION OF TIME CONTROLLER

Set/Display Off Time of Stop Watch Tolerance

S.NO. Time Interval Observed Distance Limit Time the Time
Instrument

1 0 -10 min 50 60 mm 15 .0 Min. 0.5

2 10-20 min 50 60 mm 30.0 Min 0.5

3 20-30 min 50 60 mm 45.0 Min 0.5

Remark:
Done By: Checked By:

Designation Signature Date

Prepared by Chemist - QC
Reviewed by Manager - QC
Approved by Manager - QA