1.0 OBJECTIVE:
To
lay down the operation procedure for Pressure vessel, peristaltic pump and spraying gun.
2.0 SCOPE:
This
SOP shall be applicable for the operation of Pressure vessel, peristaltic pump and spraying gun in
Coating Room of Production department.
3.0 RESPONSIBILITY:
3.1
Supervisor/
Machine Operator.
3.2
Production
Pharmacist & above.
4.0 ACCOUNTABILITY:
4.1
Manager-Production
department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Pressure vessel, peristaltic pump and spraying gun.
6.0 PROCEDURE:
6.1 Assure
the cleanliness of the coating pan.
6.2 Charge
the core tablets into the pan.
6.3 Set
atomization air limit switch. This will set ‘OFF’ spray system if atomization
air pressure falls below set air pressure manually.
6.4 Remove
the lid of the liquid vessel and load the coating solution of required
quantity. Close the lid of the liquid vessel. Activate the stirrer by opening
the compressed air supply knob.
6.5 Set
the dosing percentage of the feed pump as per requirement by rotating the knob
provided on the top of the pump.
6.6 Set the spray gun for liquid volume flow and
spray pattern as follows:
6.6.1
Put ‘OFF’ the
compressed air supply valve of atomization air.
6.6.2
Press the selector
switch on PDM bypass.
6.6.3
Press the selector
switch on ‘Manual’ position.
6.7 Start
the pan, inlet damper & then start exhaust blower maintain the bed
temperature as per BMR by pressing the heater ‘ON’ position.
6.8 Press
the hot air blower switch to start hot air blower.
6.9 Start
coating pan & adjust the distance between tablet bed & gun.
6.10
Introduce the
spray gun assembly into the coating pan. Keep the gun to the tablet bed
distance between 8-12cm for non-aqueous coating & for aqueous coating
7-10cm. Then close the lock the front window.
6.11
Check the weight
of 20 core tablet before loading & after drying & finally check the
weight gain.
6.12
After completion
of operation. Put ‘OFF’ the mains.
6.13
Affix ‘To be Cleaned’ status label.
6.14
And fill the ‘Equipment Log Book.’
7.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1
Not Applicable.
9.0 ANNEXURES:
9.1
Not Applicable.
10.0
ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard operating
procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
PM
|
Production machinery
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
|
cm
|
Centimeter
|
|
BMR
|
Batch manufacturing
record
|