Dissolution apparatus Operational SOP


1.0  OBJECTIVE:
To lay down the operating procedure of Dissolution apparatus.
2.0  SCOPE:
This shall be applicable to the Dissolution apparatus of Quality Control Instrument Laboratory.
3.0  RESPONSIBILITY:
3.1  Technical Assistant/ Helper.
3.2  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
5.0  MATERIAL AND EQUIPMENT:
5.1  Dissolution apparatus.
5.2  Purified water.
5.3  Sample (tablet/capsule).
6.0  PROCEDURE:
6.1  How to operate smooth operation follow the following Steps.
For easy and smooth operation follow the following Steps.
6.1.1     Connect the “Power Plug” to the socket (220V, AC).
6.1.2     Turn ON the “Main Button” which is located at the bottom of right side of the machine, Bulb in the “Main Button” will illuminate.
NOTE: If the bulb does not illuminate, check the main supply.
6.1.3     LCD” (Liquid Crystal Display) which is located on the front panel of the machine will be illuminated and will show following display.
DISSOLUTION 2020+
VERSION 1.00

By pressing any key, following screen will be displayed

MAIN
SV= 00:00:00     RPM 50
Temp 37oC        MOTOR= Off

6.1.4     To start the test press 1 from the front panel, following screen will be displayed.
SV= 00:00:00     RPM 50
Temp 37oC        MOTOR= Off

6.1.5     Press “Start/Stop” button on the front panel to start the test.
6.1.6     Press 8 (Heater) button on the front panel to “Start/Stop” of Heater.
Note:   The temperature will be adjusted to 37oC automatically.
6.1.7     Press 6 (Cir) button on the front panel to “Start/Stop” of PUMP
6.1.8     Press 1 (Light) button on the front panel to “Start/Stop” of Light
6.1.9     For changes in setting, press Esc following screen will be displayed.
The option → and ← is for adjust Temperature, RPM and Time and Ent button for Save Setting and then press Esc button to enter Main Screen
7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  Not Applicable.
9.0  ANNEXURES:
Annexures 1: Description of front panel keys.
Annexures: 1
Description of front panel keys.
Description of front panel keys

1.      0 – 9 digit keys are for numeric entries.
2.      “ 1 “ Key is for flash light, Press and hold “ 1 “ key the flash light will illuminate.
3.      “6 “key is for water circulation.
4.      “8” key is for heater.
5.      “Esc” key is used to go back to previous menu.
6.      “Reset” Key is used to reset the timer.
7.      “Start/Stop” key is used to start or stop the oscillations.
8.      “Enter” key is used to save the entries
9.      and → arrow keys are used to change the options.




10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
QCEO
Quality control equipment operation
F
Format
oC
Degree centigrade


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