SOP FOR DISINTEGRATION APPARATUS | STANDARD OPERATING PROCEDURE CLEANING,OPERATION & CALIBRATION OF DISINTEGRATION APPARATUS

1.0              OBJECTIVE

To lay down the procedure for cleaning, operation & Calibration of Disintegration Apparatus

2.0              SCOPE

This SOP shall be applicable for cleaning, operation & Calibration of Disintegration Apparatus  in Chemistry Lab.

3.0              RESPONSIBILITY

3.1              Chemist  and above shall be responsible for the preparation and execution of this SOP

3.2              QC & QA Head shall be responsible for the checking and approval of this SOP.

4.0              ACCOUNTABILITY

Head QC

5.0              PROCEDURE

5.1              Cleaning

5.1.1        Ensure that power supply to the Disintegration apparatus is switched ‘OFF’ before cleaning and plug shall be remove from the socket.

5.1.2        All surface, walls, top, bottom of the Disintegration apparatus shall be wipe with dry lint free cloth on daily basis so that there will be no dust particles in the Disintegration apparatus

5.1.3        All the parts and outer surface of the Disintegration apparatus shall be wipe with wet lint free cloth soaked in purified water, on weekly basis.

5.2              Operation

5.2.1        Ensure the cleanliness of the instrument.

5.2.2        Ensure that” the power supply to apparatus is switch  “ON.

5.2.3        Ensure for the electronic temperature controller displays the chamber temperature.

5.2.4        Required temperature shall be set  by pushing the “PUSH” switch and the coarse potentiometer knob shall be rotate clockwise or anticlockwise until the required temperature attain.

5.2.5        Temperature shall be set with  the help of fine potentiometer knob.

5.2.6        Ensure for the Indicator Bulb glows indicates that the power to the heater is “ON”.

5.2.7        Ensure that before attempting the testing, the apparatus shall be switched on for at least 20 minutes before.

5.2.8        Ensure that the number of strokes per minute of the basket shall be  recorded.

5.2.9        Ensure that the temperature of water shall be checked for the disintegration by a calibrated  thermometer. It shall be 37± 2.0⁰C.

5.2.10    Ensure If the number of the strokes and temperature of water are within the tolerance limit; the instrument shall be calibrated and performing correctly.

5.2.11    Enter the cycle period in daily usage log book.

5.2.12    Calibration Procedure

Calibration of Disintegration Apparatus shall be done by external party on annual frequency.

6.0              REFERENCES

Not Applicable

7.0              ANNEXURE

Not Applicable

8.0              ABBREVIATIONS

SOP         :           Standards Operating Procedure

QC           :           Quality Control

HOD        :           Head of the Department

QA           :           Quality Assurance

QCD        :           Quality Control Department

QAD        :           Quality Assurance Department

EQP         :            Equipment

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