SOP
on Cleaning of Volumetric Filling Machine
Objective : To describe cleaning procedure for volumetric filling machine.
Scope : To ensure that
the equipment is clean and free from any starting materials of previous batch
or product residues.
Responsibility : 1.It
is the responsibility of operating staff to clean the equipment.
2. Production
Chemist to ensure that procedure is followed.
Materials &
Equipment :
1.
Cleaning agent: Teepol or liquid soap.
2.
Mops / brush / lint free cloth
Procedure
(1)
Close the outlet valve of the holding tank, detached
the connecting pipes taking care to ensure that any liquid in the line is
emptied into the holding tank.
(2)
Drain out the holding tank for left overs.
(3)
Add 25 liters of boiled tap water to the holding
tank and start the filling machine so that this enables the filling components
to be rinsed with the water and drain the washings.
(4)
Dismantle the syringes, nozzles and connecting pipes
and keep them in a washing tub.
(5)
Prepare a Teepol solution (10ml à 10 liters water)
or liquid-soap (50gm à 5 liters water) and add this solution to the tub.
(6)
Dismantle the parts of syringes and clean the inner
surfaces with the help of a nylon brush.
(7)
Wash the inner surfaces of the syringes by running
tap water for 15 minutes and drain the washings. Repeat the procedure for
another 10 minutes and again drain the washings.
(8)
Wash the inner surfaces of the syringes by using 10
liters of purified water for 15 minutes and drain the washings.
(9)
Finally rinse the syringes with previously boiled purified
water and drain it completely.
(10)
All connecting pipes are immersed in boiling
purified water for 30 minutes. Wash the tubes with boiled purified water for 10
minutes.
(11)
Send the wash water of machine parts for analysis of
residual active ingredients of previous product.
(12)
Let all the machine parts or tubes to dry in air
reassemble the parts in reverse order of dismantling and put a label “Cleaned”
or “Ready for use”.