SOP For operation and Calibration of Disintegration Tester Apparatus

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  1. OBJECTIVE:

The purpose of this Standard Operating Procedure (SOP) is to describe the procedure for handling, Operation, maintenance and Calibration of Disintegration Tester Apparatus.

  1. SCOPE:

This SOP is applicable to Disintegration Tester Apparatus in Quality Control Department at manufacturing facility of XXX.

  1. RESPONSIBILITY: 
  1.   Analyst / Section Head or his designee shall be responsible for follow the SOP.
  1. The Head of Quality Department or his designee shall be responsible and implementation of the SOP.
  1. PROCEDURE:
  1. PRELIMINARY CHECK:
  1.   Fill water tank up to marked level, and placed the Glass / borosil beaker.
  1. Connect the heater wire and external probe in the socket provided at the rear right   hand side.
  1. 4.1.2.1.   Connect the main cord to a 230 V A.C. socket.
  1.   Do not put the mains `ON’ if there is no water in the tank up to the marked level or if   the tank is empty.
  2. Ensure that the heater connected is not loosely connected.
  3. While engaging or disengaging the basket assembly, do not apply excessive force.
  1. Basic Operation :
  • Switch on the mains to the instrument and the power switch on the instrument                (provided    at the rear right hand side) after ensuring that the instrument set up is okay.
  1.   Place two 1000 ml beakers containing the suitable liquid medium in space provided    

  on the beaker stand.  Adjust the volume of the liquid in the beaker such that the wire   

  mesh of the basket is at highest point is at least 15 mm below the surface of the liquid.

  1.   Place the external probe in the slot provided in both of the basket assemblies.
  1. Initialization & System Diagnostics system initializes to home position and    check LCD displays status.
  1. Check the RESET key and check the system Resets and initializes to home position.
  1. Press Enter key to display Main Menu.
  1.   Follow this procedure to set the temperature of water bath.
  1. Fill the bath with fresh water upto the water level mark.
  1. Fill the beakers (1000ml) approx.700 ml with required buffer & put in to the water bath
  1. Hang the basket racks on the basket arm.
  1.   Put the RTD in the basket racks.
  1.   Check bath temperature on display & check the same with external RTDs.
  1. In “Function” mode select “Validation” & Enter media temperature 37°C and bath temperature 38°C, Enter No. of log point up to 4.2.8 to 4.2.12.
  1. Instrument will start heating & on Display it will give temperature of beaker A, Beaker    B & Bath. At ready condition (set + 2°C as per USP) it will give beep, put external RTD in both beaker and check the temperature.
  2.   Prepare method with required temperature and time.
  1.   Run the same method.   
  2. Select 3 rd option for both beaker in “Beaker selection.”  Enter ID No. of tablet in Beaker A & Beaker B respectively & Press Enter Key. 
  1. At ready condition Instrument will give beep sound. 
  1. Press Enter –Instrument will stop at home position.  
  1. Put Tablet in each cylinder & Press Enter.
  1.   Observe the tablet manually after complete disintegration of tablet

NOTE: Disintegration does not imply complete dissolution of the unit or even of its active constituent. Complete disintegration is defined as that state in which any residue of the unit, except fragments insoluble coating or capsule shell, remaining on the screen of the test apparatus of surface of the discs, if used, is a soft mass having no palpably firm core.

  1. Record the usage entry of disintegration test apparatus in instrument usage log book.                                    
  2. CALIBRATION PROTOCOL:

            Calibration Frequency: Quarterly

  1. Record the frequency of mechanical rod for six times on both the sides. 

            The acceptance criteria:  29 to 32 cycles / min.

  1. Record the distance of the mechanical rod for six times from the highest point to the lowest point on both the sides.  

              The acceptance criteria   :  53 to 57 mm.

  1. Calibration of timer: Adjust the set time to 5 minutes. Press the start button and   

Simultaneously start the stopwatch. When alarm starts, check the time on the stopwatch.   

Follow the procedure for 10, 15 and 20 minutes as above.

  1. Calibration of Heater:
  1. 22.3.4.1.Set the temperature of the water in the beaker at 37°C.
  1. 22.3.4.2.Set the temperature of the water bath at 37°C.
  1. 22.3.4.3.Set the timer at 60 minutes.
  1. 22.3.4.4.Start the apparatus using `Start / Stop’ key.
  1. 22.3.4.5.Record the temperature of the water inside the beakers at the 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60 minutes intervals.  

The acceptance criteria:   36°C to 38°C.

  1. Sieve Integrity Check :
  1. 22.3.5.1.Check the integrity of the sieve visually against the bright light for following     

            parameters.

  1. Intactness of the each sieve opening.
  2. Any cracks, Abrasion
  3. Dents

Acceptance criteria: Visually the integrity must be acceptable with respect to the above   parameters.

  NOTE: If the sieve does not comply for the above parameters, change the Sieve. 

  1. Enter the entry of usage of instrument in Usage log book.
  1. TRAINING: 

Trainer : Head – Quality Control 

Trainees : Sectional Heads / Analyst / Officers

  1. DISTRIBUTION: 

Controlled Copy No.1 :  Head of Department – Quality Assurance

Controlled Copy No.2 :  Head of Department – Quality Control

Display Copy No.1     :  Dissolution room

Original Copy :  Head – Quality Assurance 

  1. ANNEXURE: 

Annexure I : Calibration Test Data Sheet

  1. REFERENCES: 

Equipment User Manual

  1. REVISION HISTORY: 

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