1.0 Purpose
1.1 To define a standard cleaning and operating procedure of Rapid Mixer Granulator (RMG).
2.0 Scope
2.1 This procedure is applicable for Rapid Mixer Granulator of tablet manufacturing area at “NAME” Pharmaceuticals Ltd.
3.0 Responsibility
3.1. Only concern operator is responsible for normal operation. He/ She inform the supervisor about any
deviation from normal operation. He also maintains logbook.
3.2. Sr. Officer- Production/Officer- Production is responsible for monitoring day to day activity.
3.3 Production and Quality Assurance Officer shall ensure that the procedure is implemented properly.
4.0 Abbreviations and Definitions
4.1 RMG : Rapid Mixer Granulator
5.0 Materials and Equipment
5.1 Poly bag
5.2 Hose pipe
5.3 Tap water
5.4 Purified water
5.5 Hand brush
5.6 Scrapper
5.7 Clean lint free cloth
5.8 Detergent Solution / Cleaning agent: 0.4% (w/v) Sodium Lauryl Sulphate solution ; 4 gm Sodium lauryl
Sulphate
is dissolved in 1.0 liter of portable /
tap water to prepare detergent solution.
5.9 70 % Isopropyl Alcohol.
6.0 Precaution / Health and Safety Considerations
6.1 Don’t press electric switch with wet hand.
6.2 Protect the operating panel board from contact with water by covering with a poly bag.
6.3 Do not put your hand inside the discharge chute or bowl while the machine is running or blade is moving due to inertia.
7.0 Procedure
7.1 Cleaning Procedure
7.1.1 Connect electric plug and compressed air line and turn on power switch.
7.1.2
Open the lid cover of Rapid Mixer Granulator by
turn “On” the switch of Lid Cover.
7.1.3
Remove all adhered materials from the bowl,
mixing blade/arm, chopper blade and discharge outlet
by using scrapper and cloth.
7.1.4
Pour potable water into the bowl (1/3 of its volume)
and closed the lid cover by turn “Off” the switch
of Lid Cover.
7.1.5
Run the mixer and chopper blade for 5 minutes
at slow speed.
7.1.6
Place a tub just below the discharge chute to
collect washing water.
7.1.7
Open the pneumatic outlet valve of discharge
chute to collect water into the tub.
7.1.8
Remove adhered material using detergent
solution, by rubbing with cotton cloth.
7.1.9
Add detergent solution with tap water into the
bowl (1/3 of its volume). Run the mixer and chopper
blade for 5 minutes at slow speed. Remove the waste water.
7.1.10
Rub the inner surface, outer surface, mixing
arm, chopper blade and lid with cotton cloth and sufficient potable water.
7.1.11
Wash 2 times with potable water until detergent
solution / cleaning agent is removed.
7.1.12
Finally rinse with purified water.
7.1.13
Dry the Rapid Mixer Granulator with compressed
air to remove the deposited water in the different
junction
7.1.14
Wipe the machine with wet cotton cloth
7.1.15
Wipe the whole machine with clean dry cotton
cloth to remove adhered water.
7.1.16
Wipe the product contact part with isopropyl
alcohol and allow drying in air condition room.
7.1.17
Machine operator / worker will request
Production Officer and QA Officer for checking visual inspection.
7.1.18
At first Production Officer will check the
machine and its surroundings, then QA Officer will check the machine and its surroundings. If it found
satisfactory result, then he / she will issue “Cleaned”
label.
7.1.19
Record in Machine logbook (Annexure-I) and
attach the label of “Cleaned” in the machine.
7.1.20 After cleaning the machine if it remains without operation for next 72 hour, will undergo Re-cleaning operation.
7.2 Operation Procedure
7.2.1 Before starting the operation production person get the line clearance from QA person by writing the status label with Product Name, batch details to equipment and area.
7.2.2 Connect electric plug and compressed air line.
7.2.3
Switch on the main electrical supply and check
that all indicator working properly.
7.2.4
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.
7.2.5
Open the lid cover by turn “On” the switch of
Lid Cover.
7.2.6
Feed the materials into the bowl of Rapid Mixer
Granulator.
7.2.8
Start the mixing blade at slow or fast speed
(as required) as per Batch Manufacturing Record.
7.2.9
After completion of dry mixing reset the timer
as per Batch Manufacturing Record and add the paste
/ Binder for binding through charging port.
7.2.10
Similarly set the timer for chopper as required
and operate the chopper at fast or slow speed given
in panel.
7.2.11
Open the lid and rack the material then closed
the lid. Start the agitator / mixing blade by setting
timer in panel. After achieving the desired specific end point (Ampere Load)
given in BMR, stop the
operation.
7.2.12
Keep the bowl below discharging point and open
the discharge valve with the help of knob provided
on panel.
7.2.13
Start the mixing motor at slow speed and
collect the material in bowl.
7.2.14
Stop the mixing motor and scrap the left-over
material from inner surface of mixer and chopper
and add into the bowl and transferred for further process.
7.2.15
Put off the main switch after completion of
operation.
7.2.16
Affix “To Be Cleaned” label and fill the Machine
Logbook. (Annexure-I)
8.0 Reference Document
8.1 Quality Manual 3.11.
9.0 Annexure
9.1 Annexure- I : Format of Machine Logbook
10.0 Revision History
|
Revision
No. |
Brief reason for the revision |
Effective Date |
Remarks |
|
01 |
New |
|
|
|
02 |
|
|
|
11.0 Training
11.1 Head
of Production or his nominee give the training of operator and worker.
