.
1.0 OBJECTIVE:
To lay down the procedure for Operation of Rapid Mixer
Granulator.
2.0 SCOPE:
This SOP shall be applicable for Rapid
Mixer Granulator capacity-600 litre in Granulation
area in Production department.
3.0 RESPONSIBILITY:
3.1 Execution : Operator
3.2 Checking : Production Pharmacist &
Above
4.0 ACCOUNTABILITY:
HOD-Production / Assigned Designee
5.0 PROCEDURE:
5.1 Production
person shall ensure the cleanliness
of the machine & area and ‘CLEANED’ label on it.
5.2 Before starting
the operation production person get the line clearance from Q.A person by
writing the status label with Product Name, batch Details to equipment &
area.
5.3 Switch “ON”
the mains electrical supply panel. Check the air pressure in panel.
5.4 Check the
air pressure in panel. It is between 0.200 - 0.250 kg/cm2 & green color glowing in pressure
indicator.
5.5 Press
“Login” and enter password 1, 2, 3 & 4, then main screen will show in HMI
(Human Machine Interface) with manual mode & auto mode.
5.6 For Manual
Mode - Press “MANUAL MODE” two times then press “MANUAL ACTION” in HMI (Human
Machine Interface), green light will glow in upper side of screen & HMI
will show mixer slow, mixer fast, chopper slow, chopper fast, Ampere load, RPM (revolution / minute)
,lid open/ close & discharge valve open/ close.
5.7 Open the
bowl lid by disengaging the clamps.
5.8 Engage the
emergency button.
5.9 Fix the
impeller, chopper blade & disengage the emergency button.
5.10 Close the
discharge assembly.
5.11 Open the
compressed air valve to supply the air to impeller & chopper, maintain
adequate air pressure. Ensure that air is coming out through the vent port
provided on lid.
5.12 Unlock the
toggle clamp & Open the lid by press open top lid & Charge the material
which is to be granulated and close the lid by
using HMI (Human Machine Interface) in screen.
5.13 Set the
timer for dry mixing in HMI (Human Machine Interface) by entering time as per
BMR (batch manufacturing record).
5.14 Start the
dry mixing by press agitator at slow or fast speed (as required) through HMI
(Human Machine Interface).
5.15 After
completion of dry mixing reset the timer as per BMR and add the paste /Binder
for binding through charging port.
5.16 Similarly
set the timer for chopper by entering in HMI (Human
Machine Interface) as per BMR and
operate the chopper at fast or slow speed.
5.17 Rack the
product by opening of lid. Then After
achieving the desired specific end point (Ampere Load) given in BMR, stop the operation
and keep the bowl below discharging point open the discharge valve with the
help of HMI.
5.18 Start
the mixing motor at slow speed (chopper
motor should be “OFF”) and discharged the material and collect in bowl.
5.19 Engage the
emergency push button and scrap the left over material from inner surfaces of
mixer and chopper and add into the bowl and transferred for further process.
5.20 Put “OFF”
the mains after completion of operation.
5.21 For Auto
Mode – press auto mode through pressing “PREVIOUS”.
5.22 Enter the
password of auto mode i.e 3, 4, 5 & 6. Main screen show like as manual.
Feed the status as per Batch Manufacturing Record. Other things are same as
manual.
5.23 Affix ‘To
be Cleaned’ label after completion of process from the concerned area and fill
the “Equipment Log Book”.
NOTE: Check
operation of limit switches of lid and discharge port before starting the operation.
6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure
6.2 HMI : Human Machine Interface
6.3 BMR : Batch Manufacturing Record
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