TIPS TO MANAGE MENTAL HEALTH
SOP FOR DISSOLUTION APPARATUS
1.0 PURPOSE:
1.1 It is intended to provide a
procedure for the operation of a dissolution Apparatus.
2.0 SCOPE:
2.1 Applies to the chemical section
of the quality control department
3.0 LIABILITY:
3.1 Q.C. The analyst is responsible
for performing the exact operation.
3.2 Q.C. Manager to ensure accurate
operation.
4.0
ABBREVIATIONS:
4.1 Quality Control Q.C
4.2 RPM: revolutions per minute
5.0 INSTRUMENT :
5.1 Dissolution Apparatus
6.0 SAFETY
PRECAUTIONS:
6.1 Before turning on the heater
switch, make sure that the tank is filled with purified water without a
container up to the device mark.
6.2 Do not overtighten the paddle/basket and also do not hold the paddle/basket while it is in operation.
6.3 Place the device as far as
possible from strong magnetic or electric fields.
6.4 Avoid strong vibration or
sunlight.
6.5 Protect the device from dust and
corrosive gases
6.6 Never use alkalis, abrasive/etching
materials, or hot concentrated acids.
6.7 The main voltage should be
stable and without temporary fluctuations
7.0 PROCEDURE:
7.1 DESCRIPTION:
7.1.1 Apparatus consists of an acrylic
water bath, twelve containers with twelve paddles, a heating element, and a
front panel;
The front panel contains the
following parts:
7.1.2 The SET button is used to set
the time, temperature, and revolutions per minute.
7.1.3 The Enter key is used to Edit
the set value of the Time and Temperature parameters.
7.1.4 The TIMER button is used to
set the time, stop and select the mode (timer and manual).
7.1.5 TEMP. The button is used to
set the temperature, start the temperature controller and stop the temperature
controller.
7.1.6 Start/Stop button
7.2 WORK OPERATION
7.2.1 Fill the water batch with
distilled water and start heating at a specific temperature, i.e. 37 °C ± 1 °C.
7.2.2 Take the dissolution medium
(900 ml), pour it into a dissolution cup/container as much as needed for testing, and place it in a water bath.
7.2.3 When the specific temperature
is reached, it will be shown on the display, adjust the next parameter
according to the SOP, i.e. set the time using the front panel button and the
number of revolutions also set using the front panel button.
7.2.4 Add the specified tablets to the dissolution container and start operation.
7.2.5 Press the button to start the
pause mixing resolution.
7.2.6 After the dissolution of the
specified period for a specific medicine. Remove the sample from the
dissolution vessel and follow the SOP by taking readings on a UV
spectrophotometer or HPLC.
7.2.7 Now switch off and remove the
plug from the outlet.
7.2.8 If the instrument is not
working properly, do not use it and mark it as "Out of Service" and
notify the Quality Control Manager for repair.
7.2.9 Enter the test description and
time in the device log.
8.0 REFERENCES:
8.1 Operating instructions
9.0 RECORDS:
9.1 Dissolution Equipment Log Sheet
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