SOP:Operation and calibration of disintegration test apparatus.

SOP:Operation and calibration of disintegration test apparatus.

 

OBJECTIVE:To ensure that there is a standard procedure followed for operating disintegration apparatus and ensuring efficient working of the instrument.

 

SCOPE:To test disintegration time of capsules and tablets.

 

RESPONSIBILITY:QC – officers, executives –  To follow the procedure as per SOP.QC Head –  To ensure proper execution of SOP.QA – To ensure SOP is being properly implemented.

 

ABBREVIATION :

QA – Quality assurance

QC – Quality control

SOP – Standard operating procedure

N.A. – Not applicable

 

INSTRUMENT DETAILS :

Instrument Name : Tablet disintegration test apparatus Make : VEEGO

Model No. :

Instrument ID

Location : Instrument room

 

PROCEDURE:

For method setting and testing:

insure that instrument is clean and free from dust.

Connect the instrument to mains and put switch ON.

Fill the tank with water.

Press ENTRE key.

Adjust the temperature at 37.00C.

Press ENTER key.

Press START menu key.

Select TEST option.

Select COMBINE TEST option then both motors move Up and DOWN.

Press 4 key and Select PRODUCT SETTING option.

Press ENTER key.

Add test method with expected temperature, DT-Time and alarm time.

Press 4 key to enter the company name and address.

Press ENTER key.

To exit from menu press (        BACK) key.

Press 3 key to set DATE and TIME.

Press ENTER key

Exit the menu by pressing BACK key.

Press START MENU key.

Press ‘1’ key and select the TEST option.

Select LEFT TEST or RIGHT TEST or COMBINE TEST.

Enter the product no. for which test to be performed.

Press ENTER key.

Enter batch no. with numeric keys

Press ENTER key.

Audio signal indicate the beaker temperature reach to 37-00C.

A long beep sound after 30 minutes.

Insert the tablets to be tested in the basket tubes and then place the guided discs on the tablets.

Press ENTRE key.

Connect the printer, an keep it on, load the paper, it will print header and temp. of the beaker after every 7 min.

The basket start moving UP/DOWN.

Press ENTER key.

Monitor the individual DT-TIME of individual tablet.

Mark the tube from LEFT BASKET as 1,2,3,4,5,6.

When one of tube of one of basket observed to be disintegrated then press respective key then time indicated and stored in the memory.

When the elapse time reaches to set test time, the test stop with audio single.

The baskets get parked at its highest level.

Switch off the instrument after finishing the analysis.

 

CALIBRATION:

For validate the RPM (lowering & raising cycle per min of motor) :

Make sure that instrument is clean and free from dust.

Connect plug to the socket.

Switch ON the instrument.

For calibration of motor rpm.

Press START MENU key.

Press key no. 2 to select validation option.

Press enter key.

The counting of rotation displayed.

Press enter key.

Take more two results.

Press enter key.

To exit from menu press (        BACK) key.

For noting the temperature :

Fill the beaker with water and keep thermometer in it.

Adjust the temperature with the help of given knob to specific temperature as given in table below.

Calibration format:

Instrument Name : Tablet disintegration test apparatus   Make :

Model No.             :                  Instrument ID No. :                  Location : Instrument room

Calibration frequency : once in 6 month             Calibration done on :

Calibration due on :

 

  1. Parameters and acceptance criteria :

 

Sr. No.ParameterstatedAcceptance criteria
1Temperature 0C30+ 1 0C
  35+ 1 0C
  40+ 1 0C
  45+ 1 0C
2 RPM (Lowering and raising   per min.)30+ 2
  30+ 2
  30+ 2

 

  1. Observations and results :
  • Temperature:-

 

Sr. No.DateTemperatureResult
Left Right
1    
2    
3    
4    
  • RPM (lowering & raising cycle per min):-

 

Sr. No.DateRPMResult
Left Right
1    
2    
3    

Conclusion:

 

 

Done By :                            Checked By :                            Approved By :

Date                                    Date                                         Date